Pregnancy Special Case No1. Pregnancy Antibiotics

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Pregnancy Special Case No1. Pregnancy Antibiotics

যত গুলি Antibiotics এর নাম *C* অক্ষর দিয়ে শুরু হয়, তার মধ্যে মাত্র 3 টা ব্যতীত বাকি সব গুলি প্রেগন্যান্সি তে নিরাপদ ভাবে ব্যবহার করতে পারেন-

C অক্ষর দিয়ে Antibiotics যা প্রেগন্যান্সিতে দিতে পারেন নির্ভয়ে-

****** mark করা গুলি দেখেন ভালো ভাবে—-

1. Cloxacillin

Capsule 1:-A-Clox 500 mg (AS A Cloxacillin Sodium As A Penicillinase-resistant penicillins).

Indications of Capsule :-A-Clox 500 mg (AS A Cloxacillin Sodium As A Penicillinase-resistant penicillins).

গ্রাম-পজিটিভ জীবাণু দ্বারা সৃষ্ট সংক্রমণের চিকিৎসায় ক্লক্সাসিলিন নির্দেশিত। পেনিসিলিনেজ উৎপাদনক্ষম স্টেফাইলোকক্কাই জনিত সংক্রমণের চিকিৎসায়ও এটি নির্দেশিত। এ জাতীয় সংক্রমণের মধ্যে রয়েছেঃ

স্কিন ও সফ্‌ট টিস্যু সংক্রমণ: ফোঁড়া (boils), পূজাশয় (abscess), কার্বাংকল, ফারানকুলোসিস, সেলুলাইটিস, সংক্রমিত ক্ষত (infected wounds), সংক্রমিত পোড়া (infected burns), ত্বক প্রতিস্থাপন প্রতিরক্ষা (protection for skin grafts), ত্বকের বিভিন্ন সংক্রমণ যেমন আলসার, একজিমা ও একনি।

রেসপিরেটরী ট্র্যাক্ট, নাক, কান ও গলার সংক্রমণ: নিউমোনিয়া, ফুসফুসের পূজাশয় (lung abscess), এমপায়েমা, সাইনোসাইটিস, ফ্যারিনজাইটিস, টনসিলাইটিস, কুইনসি, অটাইটিস মিডিয়া ও এক্সটারণা।

ক্লক্সাসিলিন–সংবেদনশীল (sensitive), জীবাণু জনিত অন্যান্য সংক্রমণ: অসটিওমায়েলাইটিস, এনটেরাইটিস, এনডোকারডাইটিস, ইউরিনারী ট্র্যাক্ট সংক্রমণ ও সেপটিসেমিয়া।

Dosage & Administration of Capsule :-A-Clox 500 mg (AS A Cloxacillin Sodium As A Penicillinase-resistant penicillins).

প্রাপ্তবয়স্কদের প্রচলিত মাত্রা–
খাওয়ার জন্য: ৫০০ মিগ্রা দিনে চার বার আহারের আধা থেকে এক ঘন্টা আগে।
ইনজেকশন হিসেবে:

মাংসপেশীতে ইনজেকশন হিসেবে: ২৫০ মিগ্রা চার থেকে ছয় ঘন্টা পর পর।
শিরাপথে ইনজেকশন হিসেবে: ৫০০ মিগ্রা চার থেকে ছয় ঘন্টা পর পর। প্রয়োজনবোধে উপরোল্লিখিত মাত্রাকে দ্বিগুণ করা যেতে পারে।
প্লুরাল কেভিটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা দিনে এক বার।
জয়েন্ট কেভিটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা দিনে এক বার।

শিশুদের প্রচলিত মাত্রা–
খাওয়ার জন্য: ২ থেকে ১০ বৎসর পর্যন্ত- প্রাপ্তবয়স্ক মাত্রার অর্ধেক। ২ বৎসরের নীচে- প্রাপ্তবয়স্ক মাত্রার এক-চতুর্থাংশ।
ইনজেকশন হিসেবে:

মাংসপেশীতে ইনজেকশন হিসেবে: ২৫০ মিগ্রা এর সাথে ১.৫ মিলি কিংবা ৫০০ মিগ্রা এর সাথে ২ মিলি ওয়াটার ফর ইনজেকশন বিপি মিশিয়ে দ্রবীভূত করতে হবে।
শিরাপথে ইনজকেশন হিসাবে: ৫০০ মিগ্রা এর সাথে ৫-১০ মিলি ওয়াটার ফর ইনজকেশন বিপি মিশিয়ে দ্রবীভূত করতে হবে। এরপর এই দ্রবণকে তিন থেকে চার মিনিট ধরে ধীরে ধীরে শরীরে প্রয়োগ করতে হবে। ক্লক্সাসিলিন ইনজকেশনকে ইনফিউশন উপযোগী যে কোন তরলে মিশিয়ে দেয়া যায় অথবা যথাযথ ভাবে হালকা করে ড্রপি টউিবে তিন থেকে চার মিনিট ধরে ধীরে ধীরে প্রয়োগ করা যায়।
প্লুরাল কেভেটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা এর সাথে ৫ থেকে ১০ মিলি ওয়াটার ফর ইনজকেশন বিপি মিশিয়ে দ্রবীভূত করে প্রয়োগ করতে হবে।
জয়েন্টে কেভেটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা এর সাথে অনধকি ৫ মিলি ওয়াটার ফর ইনজকেশন বিপি অথবা ০.৫% লিগনোকেইন হাইড্রোক্লোরাইড দ্রবণ মিশিয়ে দ্রবীভূত করে প্রয়োগ করতে হবে।

Contraindications of Capsule :-A-Clox 500 mg (AS A Cloxacillin Sodium As A Penicillinase-resistant penicillins).

পেনিসিলিনে অতি-সংবেদনশীল (hypersensitive) রোগীদের ক্ষেত্রে ক্লক্সাসিলিন প্রয়োগ নিষিদ্ধ।

Side Effects of Capsule :-A-Clox 500 mg (AS A Cloxacillin Sodium As A Penicillinase-resistant penicillins).

ক্লক্সাসিলিন এর পার্শ্ব-প্রতিক্রিয়া অন্যান্য পেনিসিলিনের মতই। এগুলো সাধারণতঃ মৃদু ও ক্ষণস্থায়ী হয়ে থাকে। এই সমস্ত পার্শ্ব-প্রতিক্রিয়ার মধ্যে রয়েছে জ্বর, ডায়রিয়া, অজীর্ণ (indigestion), র‍্যাশ-আরটিকারিয়েল অথবা ইরিথিমেটাস জাতীয়। যে কোন ধরণের র‍্যাশে রোগীকে এ ওষুধ দেয়া বন্ধ করতে হবে।

2. CEFAZOLIN

IM/IV Injection 1:-Zolibac 1gm/vial AS A (Cefazolin Sodium First generation Cephalosporins).

Indications of IM/IV Injection :-Zolibac 1gm/vial AS A (Cefazolin Sodium First generation Cephalosporins).

Zolibac is indicated in the treatment of the following serious infections due to susceptible organisms: Respiratory Tract Infections, Urinary Tract Infections, Skin and Skin Structure Infections, Biliary Tract Infections, Bone and Joint Infections, Genital Infections, Septicemia, Endocarditis and Perioperative Prophylaxis.

Pharmacology of IM/IV Injection :-Zolibac 1gm/vial AS A (Cefazolin Sodium First generation Cephalosporins).

Cefazolin is a 1st generation broad spectrum parenteral Cephalosporin antibiotic.It interferes with the synthesis of bacterial cell wall by inhibiting transpeptidase enzyme. As a result the bacterial cell wall is weakened,the cell swells and then ruptures.

Dosage & Administration of IM/IV Injection :-Zolibac 1gm/vial AS A (Cefazolin Sodium First generation Cephalosporins).

Adult Dose

Moderate to severe infection: 500 mg to 1 gm for every 6 to 8 hours
Mild infections caused by susceptible Gram-positive cocci: 250 mg to 500 mg for every 8 hours
Acute uncomplicated urinary tract infections: 1 gm for every 12 hours
Pneumococcal pneumonia: 500 mg for every 12 hours
Severe life-threatening infections (e.g. Endocarditis, Septicemia): 1 gm to 1.5 gm for every 6 hours. In rare instances, doses up to 12 gm per day can be used

Perioperative Prophylactic Use: To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

1 gm IM or IV administered half hour to 1 hour prior to the start of surgery.
For lengthy operative procedures (e.g. 2 hours or more), 500 mg to 1 gm IM or IV during surgery.
500 mg to 1 gm IM or IV every 6 to 8 hours for 24 hours postoperatively.

In surgery where the occurrence of infection may be particularly devastating (e.g. open-heart surgery and prosthetic arthroplasty), the prophylactic administration may be continued for 3 to 5 days following the completion of surgery.

Interaction of IM/IV Injection :-Zolibac 1gm/vial AS A (Cefazolin Sodium First generation Cephalosporins).

Probenecid may decrease renal tubular secretion of Cephalosporins when used concurrently, resulting in increased and more prolonged Cephalosporin blood levels.

Contraindications of IM/IV Injection :-Zolibac 1gm/vial AS A (Cefazolin Sodium First generation Cephalosporins).

Cefazolin is contraindicated in patients with known allergy to the Cephalosporin group of Antibiotics.

Side Effects of IM/IV Injection :-Zolibac 1gm/vial AS A (Cefazolin Sodium First generation Cephalosporins).

Common side effects include:Injection site reactions (pain, swelling, skin rash, or a hard lump), diarrhea, stomach pain, stomach cramps, nausea, vomiting, loss of appetite, skin rash or itching, hives, white patches or sores inside the mouth or on the lips, vaginal itching or discharge,heartburn, gas,rectal itching,confusion, weakness, hypotension, drowsiness, headache and allergic reactions.

Pregnancy & Lactation of IM/IV Injection :-Zolibac 1gm/vial AS A (Cefazolin Sodium First generation Cephalosporins).

Pregnancy Category B. Cefazolin is present in very low concentrations in the milk of nursing mothers.Caution should be exercised when Cefazolin is administered to a nursing woman.

3.CEFADROXIL*******

Capsule :-Fodexil 500/1000 mg (AS A Cefadroxil Monohydrate AS A First generation Cephalosporins).

Indications of Capsule :-Fodexil 500/1000 mg (AS A Cefadroxil Monohydrate AS A First generation Cephalosporins).

Fodexil is indicated in the treatment of the following infections.

Streptococcal pharyngitis and tonsillitis
Bronchopneumonia, bacterial pneumonia
Uncomplicated urinary tract infections: pyelonephritis, cystitis
Skin and soft tissue infections: abscesses, furunculosis, impetigo, erysipelas, pyoderma, lymphadenitis.

Pharmacology Capsule :-Fodexil 500/1000 mg (AS A Cefadroxil Monohydrate AS A First generation Cephalosporins).

Cefadroxil inhibits bacterial cell wall synthesis by binding to 1 or more of the penicillin-binding proteins (PBPs) which in turn inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis and arresting cell wall assembly resulting in bacterial cell death.

Dosage & Administration Capsule :-Fodexil 500/1000 mg (AS A Cefadroxil Monohydrate AS A First generation Cephalosporins).

The dosage of Cefadroxil depends on the susceptibility of the pathogens, the severity of the disease and on the clinical status of the patient (renal and hepatic function).

Streptococcal pharyngitis and tonsillitis–

Adult and adolescents >40 kg with normal renal function: 1000 mg once a day over at least 10 days. Dosage may be decreased.
Children <40 kg with normal renal function: 30 mg/kg/day once a day over at least 10 days.

Bronchopneumonia, bacterial pneumonia, Urinary tract infections, Skin & soft tissue infections–

Adult and adolescents >40 kg with normal renal function: 1000 mg twice a day.
Children <40 kg with normal renal function: 30-35 mg/kg/day divided into two daily doses.

Children may benefit of increased posology up to 100 mg/kg/day. Depending on the severity of the infection, adults may require increased posology. The dosage maximum is 4 g per day. Chronic urinary tract infection may require a prolonged and intensive treatment with continued testing of susceptibility and clinical monitoring. Cefadroxil 500 mg is not recommended for infants and children under 6 years. For younger children and children with a body weight <40 kg, liquid dosage oral form is recommended.

Renal impairment patients: In patients with renal impairment, the dose should be adjusted according to creatinine clearance rates to prevent accumulation of cefadroxil. In patients with creatinine clearance of 50 ml/min or less, the following reduced dosage schedule is recommended as a guideline.

Creatinine clearance 50-25 ml/min/1.73 m2: 500 mg-1000 mg every 12 hours
Creatinine clearance 25-10 ml/min/1.73 m2: 500 mg-1000 mg every 24 hours
Creatinine clearance 10-0 ml/min/1.73 m2: 500 mg-1000 mg every 36 hours
Children (<40 kg) with renal impairment: Cefadroxil is not indicated in children suffering from renal insufficiency and children requiring haemodialysis.
Dosage for haemodialysis patients: Haemodialysis eliminates 63% of 1000 mg of cephalosporin after 6 to 8 hours of haemodialysis. Elimination half-time of cephalosporin is about 3 hours during dialysis. Patients with haemodialysis receive one additional dose ofcefadroxil 500 mg-1000 mg at the end of the haemodialysis.

Hepatic impairment: No adjustment of posology is necessary.

Elderly: As cefadroxil is excreted by renal route, the dosage should be adjusted if necessary as described under impaired renal function.

Mode of administration: Bioavailability is not affected by food and cefadroxil may be taken with meals or on an empty stomach. In case of gastro-intestinal disturbances, it may be administered with food.

Duration of therapy: Treatment should be applied for 2 to 3 further days after regression of the acute clinical symptoms or evidence of bacterial eradication has been obtained. In infections caused by Streptococcus pyogenes up to 10 days treatment may be considered.

Side Effects Capsule :-Fodexil 500/1000 mg (AS A Cefadroxil Monohydrate AS A First generation Cephalosporins).

Infections and infestations: Uncommon side effects are Vaginal mycoses, thrush. Blood and lymphatic system disorders: Rare side effects are eosinophilia, thrombocytopenia, leucopenia, neutropenia, agranulocytosis and very rarely occurs haemolytic anemia.

Immune system disorders: Rarely occur serum sickness-like reactions, Very rarely occur immediate allergic reaction (anaphylactic shock).

Nervous system disorders: Very rare side effects are Headache, sleeplessness, dizziness, nervousness.

Gastrointestinal disorders: Common side effects are nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, glossitis and very rarely occurs Pseudomenbranous colitis.

Hepatobiliary disorders: Rarely occurs cholestase and idiosyncratic hepatic failure.

Skin and subcutaneous tissue disorders: Pruritus, rash, allergic exanthema, urticaria are common side effects. Very rarely occurs stevens Johnson syndrom and erythema multiforma.

Musculoskeletal and connective tissue disorders: Rarely occur arthralgia. Renal and urinary disorders: Rarely occurInterstitial nephritis.

General disorders: Fever is rare and fatigue is very rare.

Pregnancy & Lactation Capsule :-Fodexil 500/1000 mg (AS A Cefadroxil Monohydrate AS A First generation Cephalosporins).

Although animal studies and clinical experience have not shown any evidence of teratogenicity, the safe use during pregnancy has not been established. Cefadroxil is present in low concentrations in breast milk; sensitization, diarrhoea or colonization of the infants’ mucosa with fungi are possible. The use of cefadroxil during pregnancy and in lactating mothers should therefore be handled very strictly.

4. CEPHALEXIN******

Capsule 1:-Cefex 500 mg (AS A Cephalexin AS A First generation Cephalosporins).

Indications of Capsule :-Cefex 500 mg (AS A Cephalexin AS A First generation Cephalosporins).

Cefex is indicated for the treatment of the following infections when caused by susceptible organisms.

Respiratory tract infections: Acute and chronic bronchitis and infected bronchiectasis.
Genito-urinary tract infections: Acute and chronic nephritis, cystitis, urethritis and prostatitis, prophylaxis of recurrent urinary tract infections.
Skin and soft tissue infections: Caused by staphylococci and/or streptococci.
Ear, Nose and Throat infections: Otitis media, mastoiditis, sinusitis, follicular tonsillitis and pharyngitis.
Bone infections: Caused by staphylococci and/or P. mirabilis.

Pharmacology of Capsule :-Cefex 500 mg (AS A Cephalexin AS A First generation Cephalosporins).

Cephalexin is a semisynthetic analogue of Cephalosporin C. It kills bacteria by interfering in the synthesis of the bacterial cell wall. Peptidoglycan is a heteropolymeric structure that provides the cell wall with mechanical stability. The final stage in the synthesis of peptidoglycan involves the completion of the cross-linking and the terminal glycine residue of the Pentaglycine Bridge is linked to the fourth residue of the pentapeptide (d-alanin). The transpeptidase enzyme that performs this step is inhibited by penicillins and cephalosporins. As a result the bacterial cell wall is weakened, the cell swells and then ruptures. Cephalexin is a first generation cephalosporin that is active by mouth.

Dosage & Administration of Capsule :-Cefex 500 mg (AS A Cephalexin AS A First generation Cephalosporins).

Adult:

The usual dose is 250 mg to 500 mg every 6 hour.
For skin and soft tissue infections, streptococcal pharyngitis and uncomplicated cystitis, in patients over 15 years of age: 500 mg of the drug may be administered every 12 hour.
In severe or deep seated infections the dose can be increased up to 3 g to 6 g daily.

Children: The dosage range is 25-100 mg/kg/day in divided doses to a maximum of 4 g daily

Children’s Weight Recommended Dose:

10 kg (22 Ibs): 62.5 mg to 125 mg qid or 125 mg to 250 mg bid
20 kg (44 Ibs): 125 mg to 250 mg qid or 250 mg to 500 mg bid
40 kg (88 Ibs): 250 mg to 500 mg qid or 500 mg to 1 g bid

For streptococcal pharyngitis, skin and soft tissue infections and in patients over 1 year of age the total daily dose may be divided and administered every 12 hour. In the therapy of otitis media 75-100 mg/kg/day in four divided doses may be required. In the treatment of β haemolytic streptococcal infections a therapeutic dosage of the drug should be given at least for 10 days.

Pregnancy & Lactation of Capsule :-Cefex 500 mg (AS A Cephalexin AS A First generation Cephalosporins).

Pregnancy Category B. Cefalexin may be used during pregnancy when it is considered essential. Cefalexin is found in the milk of nursing mothers, hence caution should be taken when it is administered to nursing mothers.

Side Effects of of Capsule :-Cefex 500 mg (AS A Cephalexin AS A First generation Cephalosporins).

Side effects include nausea, vomiting, diarrhoea and abdominal discomfort. Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment. Skin rash, angio oedema, rise in serum aminotransferases, eosinophilia, neutropenia have been reported very rarely. Superinfection with resistant micro organisms, particularly candida may follow the treatment.

5.CEPHALOTHIN:N/A

6.CEPHAPIRIN:N/A

7.CEPHRADINE********

Capsule 1:-Lebac 500mg (AS A Cephradine 500mg AS A First generation Cephalosporins).

Indications of Capsule :-Lebac 500mg (AS A Cephradine 500mg AS A First generation Cephalosporins).

Lebac is indicated for the treatment of infections caused by sensitive Gram-positive and Gram-negative bacteria. These include-

Undesirable Upper respiratory tract infections: sinusitis, pharyngitis, tonsillitis, laryngo-tracheo bronchitis and otitis media, and also
Lower respiratory tract infections: bronchitis (acute and chronic), lobar pneumonia and bronchopneumonia.
Urinary tract infections: cystitis, urethritis and pyelonephritis.
Skin and soft tissue infections: abscess, cellulitis, furunculosis and impetigo.

The following microorganisms are susceptible, in vitro to Lebac:

Gram-positive: Staphylococci (both penicillin sensitive and resistant strains and penicillinase-producing species), Streptococci, Streptococci pyogenes (beta haemolytic), Streptococcus pneumonia.
Gram-negative: Escherichia coli, Klebsiella spp, Proteus mirabilis, Haemophilus influenza, Shigella spp, Salmonella spp (including Salmonella typhi), Neisseria spp Many strains of E.coli and Staphylococcus aureus that produce the enzyme penicillinase and thus are ampicillin resistant, are susceptible to Lebac which is unaffected by this enzyme.

Pharmacology of Capsule :-Lebac 500mg (AS A Cephradine 500mg AS A First generation Cephalosporins).

Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.

Dosage & Administration of Capsule :-Lebac 500mg (AS A Cephradine 500mg AS A First generation Cephalosporins).

For oral administration–
Adults:

Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.

Children:

Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
Maximum daily dosage: 4 gm

Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.

For injectable administration–

Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.

Interaction of of Capsule :-Lebac 500mg (AS A Cephradine 500mg AS A First generation Cephalosporins).

The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.

Contraindications of Capsule :-Lebac 500mg (AS A Cephradine 500mg AS A First generation Cephalosporins).

Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.

Side Effects of Capsule :-Lebac 500mg (AS A Cephradine 500mg AS A First generation Cephalosporins).

Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.

Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
Psychiatric disorders- Unknown: Confusion, sleep disturbances
Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
Renal and urinary disorders- Unknown: Reversible interstitial nephritis
Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.

Pregnancy & Lactation of Capsule :-Lebac 500mg (AS A Cephradine 500mg AS A First generation Cephalosporins).

Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.

8.CEFOXITIN ******:-N/A

9.CEFOTETAN :-N/A

10.CEFMETAZOLE:-N/A

11. CEFPROZIL:N/A

12.CEFACLOR*********

Capsule 1:-Oticlor 500mg (AS A Cefaclor Monohydrate AS A Second generation Cephalosporins).

Indications of Capsule :-Oticlor 500mg (AS A Cefaclor Monohydrate AS A Second generation Cephalosporins).

Oticlor is indicated for the treatment of the following infections:

Respiratory tract infections, including pneumonia, bronchitis, caused by Streptococcus Pneumoniae, Haemophilus Influenzae, and Streptococcus Pyogenes
Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, Staphylococci, and Streptococcus pyogenes
Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes
Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative Staphylococci
Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes.

Pharmacology of Capsule :-Oticlor 500mg (AS A Cefaclor Monohydrate AS A Second generation Cephalosporins).

Cefaclor is a second generation cephalosporin antibiotic which has stability against b-lactamase inactivation and possesses a broad spectrum of activity. Cefaclor is active against the following organisms in vitro: Alpha and beta haemolytic Streptococci, Staphylococci; including coagulase-positive, coagulase negative and penicillinase-producing strains, Streptococcus pneumoniae, Streptococcus pyogenes (Group A b-haemolytic Streptococci), Branhamella catarrhalis, Escherichia coli, Proteus mirabilis, Klebsiella species Haemophilus influenzae, including ampicillin-resistant strains. Cefaclor is generally effective in the eradication of Streptococci from the nasopharynx.

Dosage & Administration of Capsule :-Oticlor 500mg (AS A Cefaclor Monohydrate AS A Second generation Cephalosporins).

Capsule: Adult dose: The usual dose is 250 mg every 8 hourly. For severe infections or those caused by less susceptible organisms, doses may be doubled with a maximum dosage of 4 g/day. In case of β-hemolytic Streptococcal infections, therapy should be administered for at least 10 days.

Powder for suspension & Pediatric drops: Children: The usual daily dosage for paediatric patients over 1 month is 20 mg/kg/day in divided doses every 8 hours. In serious infections such as otitis media and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1 g/day. Safety and effectiveness of Cefaclor for use in infants less than 1 month of age have not been established.

<1 year (9 kg):

Powder for suspension: ½ tsp three times daily
Pediatric drops: 0.625 ml three times daily

1-5 years (9 kg-18 kg):

Powder for suspension: 1 tsp three times daily
Pediatric drops: 1.25 ml three times daily

Over 5 years:

Powder for suspension: 2 tsp three times daily

In renal impairment: Cefaclor may be administered in the presence of impaired renal function. Dose adjustments for patients with moderate or sever renal impairment are not usually required.

In patients undergoing haemodialysis: Haemodialysis shortens serum half-life by 25-30%. In patients undergoing haemodialysis, a predialysis loading dose of 250 mg-1 g is recommended. A maintaining dose of 250-500 mg every 6 hourly during interdialytic period may be used.

Geriatric use: Clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Side Effects of Capsule :-Oticlor 500mg (AS A Cefaclor Monohydrate AS A Second generation Cephalosporins).

Gastro-intestinal symptoms may occur include diarrhea, nausea and vomiting in some patients receiving Oticlor. As with some penicillins and some other Cephalosporins, transient hepatitis and cholestatic jaundice have been reported rarely. Fever, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, hemorrhage, elevated LDH and pancytopenia may occur.

Pregnancy & Lactation of Capsule :-Oticlor 500mg (AS A Cefaclor Monohydrate AS A Second generation Cephalosporins).

There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Small amounts of Cefaclor have been detected in mother’s milk. The effect on nursing infants is not known. Caution should be exercised when Cefaclor is administered to a nursing woman.

13.CEFUROXIME*******

Tablet 1:-Cefotil 500 mg As a Cefuroxime Axetil AS A (Second generation Cephalosporins)

Indications of Tablet :-Cefotil 500 mg As a Cefuroxime Axetil AS A (Second generation Cephalosporins)

It is indicated for the treatment of infections caused by sensitive bacteria.

Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli
Acute bacterial exacerbation of chronic bronchitis and Secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
Skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
Urinary tract infections caused by E.coli or Klebsiella pneumoniae.
Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.

Pharmacology of Tablet :-Cefotil 500 mg As a Cefuroxime Axetil AS A (Second generation Cephalosporins)

Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.

Dosage of Tablet :-Cefotil 500 mg As a Cefuroxime Axetil AS A (Second generation Cephalosporins)

Tablet or Suspension-

Adolescents and adults (13 years and older)-

Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
Uncomplicated Gonorrhoea: 1000 mg Single dose
Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
Acute otitis media: 30 mg/kg/day b.i.d for 10 days
Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
Impetigo: 30 mg/kg/day b.i.d for 10 days

Parenteral-

Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
Children (above 3 months of age): 30 – 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
Neonate: 30 – 100 mg/kg/day given in 2 or 3 equally divided doses.
Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)
In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).

In Meningitis:

Adult: 3 gm IV injection three times daily.
Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.

In bone and joint infections:

Adult: 1.5 gm IV injection four times daily.
Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.

Side Effects of Tablet :-Cefotil 500 mg As a Cefuroxime Axetil AS A (Second generation Cephalosporins)

Adverse effects to Cefotil have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.

Pregnancy & Lactation of Tablet :-Cefotil 500 mg As a Cefuroxime Axetil AS A (Second generation Cephalosporins)

US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.

14 mCEFTIBUTEN

Tablet 1:-Cefamax 400 (Ceftibuten Dihydrate AS A Third generation Cephalosporins).

Indications of Tablet 1:-Cefamax 400 (Ceftibuten Dihydrate AS A Third generation Cephalosporins).

Cefamax is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.

Acute Bacterial Exacerbations of Chronic Bronchitis: Due to Haemophilus influenzae (including β-lactamase producing strains), Moraxella catarrhalis (including (β-lactamase producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).
Acute Bacterial Otitis Media: Due to Haemophilus influenzae (including β-lactamase producing strains), Moraxella catarrhalis (including β-lactamase producing strains) or Streptococcus pyogenes.
Pharyngitis and Tonsillitis: Due to Streptococcus pyogenes.

Pharmacology of Tablet :-Cefamax 400 (Ceftibuten Dihydrate AS A Third generation Cephalosporins).

Ceftibuten is the dihydrate salt of Ceftibuten, is a semi-synthetic Cephalosporin antibiotic for oral administration. Ceftibuten exerts its bactericidal action by binding to essential target proteins of the bacterial cell wall. This binding leads to inhibition of cell-wall synthesis.

Dosage & Administration of Tablet :-Cefamax 400 (Ceftibuten Dihydrate AS A Third generation Cephalosporins).

Otitis Media-

Adult Dosage: 400 mg orally every 24 hours for 10 days
Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Tonsillitis/Pharyngitis-

Adult Dosage: 400 mg orally every 24 hours for 10 days
Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Bronchitis-

Adult Dosage: 400 mg orally every 24 hours for 10 days
Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 days

Cystitis-

Adult Dosage: 400 mg orally every 24 hours for 7 days
Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 7 days

Pneumonia-

Adult Dosage: 200 mg orally every 12 hours for 7 to 14 days
Pediatric Dosage: >12 years: 200 mg orally every 12 hours for 7 to 14 days

Sinusitis-

Adult Dosage: 400 mg orally every 24 hours for 10 to 14 days
Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 to 14 days

Urinary tract Infection-

Adult Dosage: 400 mg orally every 24 hours for 10 days
Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Side Effects of Tablet :-Cefamax 400 (Ceftibuten Dihydrate AS A Third generation Cephalosporins).

Nausea, headache, diarrhea, dyspepsia, dizziness, abdominal pain, vomiting.

Pregnancy & Lactation of Tablet :-Cefamax 400 (Ceftibuten Dihydrate AS A Third generation Cephalosporins).

Pregnancy Category B. There are no controlled data on the use of Ceftibuten in pregnant women. Ceftibuten should be used in pregnancy only when the benefit clearly outweighs the risk. It is not known whether Ceftibuten (recommended dosage) is excreted in human milk. Because many drugs are excreted in human milk, caution should be excercised when Ceftibuten is administered to nursing women.

15. CEFTRIAXONE ******

IM Injection 1:-Ceftron 500mg/vial (As a Ceftriaxone Sodium 500mg/vial AS A Third generation Cephalosporins).

Indications of IM Injection :-Ceftron 500mg/vial (As a Ceftriaxone Sodium 500mg/vial AS A Third generation Cephalosporins).

Ceftron injection is indicated for the treatment of the following major infections:

Lower respiratory tract infections
Acute Bacterial Otitis Media
Skin and skin structure infections
Urinary tract infections
Gonorrhea
Bacterial Septicemia
Bone and joint infections
Meningitis
Prevention of postoperative infections
Perioperative prophylaxis of infections associated with surgery

Pharmacology of IM Injection :-Ceftron 500mg/vial (As a Ceftriaxone Sodium 500mg/vial AS A Third generation Cephalosporins).

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

Dosage of IM Injection :-Ceftron 500mg/vial (As a Ceftriaxone Sodium 500mg/vial AS A Third generation Cephalosporins).

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
Uncomplicated gonococcal infections: 250 mg IM as a single dose
Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

Side Effects of IM Injection :-Ceftron 500mg/vial (As a Ceftriaxone Sodium 500mg/vial AS A Third generation Cephalosporins).

Ceftron is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

Pregnancy & Lactation of IM Injection :-Ceftron 500mg/vial (As a Ceftriaxone Sodium 500mg/vial AS A Third generation Cephalosporins).

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

16 CEFOTAXIME ******

IM/IV Injection 1:-Cefotime 1gm/10ml (AS A Cefotaxime Third generation Cephalosporins).

Indications of IM/IV Injection :-Cefotime 1gm/10ml (AS A Cefotaxime Third generation Cephalosporins):-

Cefotime is indicated for the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity: Septicemia, Respiratory Tract Infections such as acute or chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess and postoperative chest infections, Urinary Tract Infections such as acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria Soft-tissue Infection such as cellulitis, peritonitis and wound infections, Bone and Joint Infections such as osteomyelitis, septic arthritis, Obstetric and gynecological infections: such as pelvic inflammatory disease, Gonorrhea particularly when penicillin has failed or is unsuitable Other Bacterial Infections: meningitis and other sensitive infections suitable for parenteral antibiotic therapy.

Prophylaxis: The administration of Cefotime prophylactically may reduce the incidence of certain post operative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated or in clean operation where infection would have serious effects.

Pharmacology of IM/IV Injection 1:-Cefotime 1gm/10ml (AS A Cefotaxime Third generation Cephalosporins).

Cefotaxime binds to 1 or more of the penicillin binding proteins (PBPs) which inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting biosynthesis and arresting cell wall assembly resulting in bacterial cell death. Cefotaxime is a broad spectrum bactericidal 3rd generation parenteral cephalosporin antibiotic. Cefotaxime is exceptionally active against gram-negative organisms sensitive or resistant to first or second generation cephalosporins. It is similar to other cephalosporins in activity against gram-positive bacteria.

Dosage & Administration of IM/IV Injection :-Cefotime 1gm/10ml (AS A Cefotaxime Third generation Cephalosporins).

Adults: The recommended dosage for mild to moderate infections is 1 gm every 12 hourly. However, dosage may be varied according to the severity of infection, sensitivity of causative organisms and condition of the patient. In severe infections dosage may be increased up to 12 gm daily given in 3 or 4 divided doses. For infections caused by sensitive Pseudomonas spp. daily doses of greater than 6 gm will usually be required

Children: The usual dosage range is 100-150 mg/kg/day in 2 to 4 divided doses. However, in very severe infections doses of up to 200 mg/kg/day may be required.

Neonates: The recommended dosage is 50 mg/kg/day in 2 to 4 divided doses. In severe infections 150-200 mg/kg/day, in divided doses, have been given.

Dosage in gonorrhoea: 500 mg as a single dose.

Side Effects IM/IV Injection :-Cefotime 1gm/10ml (AS A Cefotaxime Third generation Cephalosporins).

Adverse reactions to Cefotime have occurred relatively infrequently and have generally been mild and transient. Effects reported include candidiasis, rashes, fever, transient rises in liver transaminase and/or alkaline phosphatase and diarrhoea. As with all cephalosporins, pseudomembranous colitis may rarely occur during treatment. If this occurs the drug should be stopped and specific treatment instituted.As with other cephalosporins, changes in renal function have been rarely observed with high doses of Cefotime. Administration of high doses of cephalosporins particularly in patients with renal insufficiency may result in encephalopathy. Hypersensitivity reactions have been reported, these include skin rashes, drug fever and very rarely anaphylaxis.

Pregnancy & Lactation of M/IV Injection 1:-Cefotime 1gm/10ml (AS A Cefotaxime Third generation Cephalosporins):-

Although studies in animals have not shown any adverse effect on the developing foetus, the safety of Cefotaxime in human pregnancy has not been established. Consequently, Cefotaxime should not be administered during pregnancy especially during first trimester, without carefully weighing the expected benefit against possible risks. Cefotaxime is excreted in the milk.

17.CEFTAZIDIME

IM/IV Injection 1:-Sidobac 1gm/vial (As a Ceftazidime Pentahydrate As a Third generation Cephalosporins).

Indications of IM/IV Injection :-Sidobac 1gm/vial (As a Ceftazidime Pentahydrate As a Third generation Cephalosporins).

Sidobac Injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:

Lower Respiratory Tract Infections, including pneumonia, caused by Pseudomonas aeruginosa and other Pseudomonas spp., Haemophilus influenzae, including ampicillin-resistant strains; Klebsiella spp.; Enterobacter spp.; Proteus mirabilis; Escherichia coli; Serratia spp.; Citrobacter spp.; Streptococcus pneumoniae; and Staphylococcus aureus (methicillin susceptible strains).

Skin and Skin Structure Infections caused by Pseudomonas aeruginosa; Klebsiella spp.; Escherichia coli; Proteus spp., including Proteus mirabilis and indole-positive Proteus, Enterobacter spp.; Serratia spp.; Staphylococcus aureus (methicillin susceptible strains); and Streptococcus pyogenes (group A beta-hemolytic streptococci).

Urinary Tract Infections, both complicated and uncomplicated, caused by Pseudomonas aeruginosa; Enterobacter spp.; Proteus spp., including Proteus mirabilis and indole-positive Proteus, Klebsiella spp.; and Escherichia coli.

Bacterial Septicemia caused by Pseudomonas aeruginosa, Klebsiella spp., Haemophilus influenzae, Escherichia coli, Serratia spp., Streptococcus pneumoniae and Staphylococcus aureus (methicillin susceptible strains).

Bone and Joint Infections caused by Pseudomonas aeruginosa, Klebsiella spp., Enterobacter spp., and Staphylococcus aureus (methicillin susceptible strains).

Gynecologic Infections, including endometritis, pelvic cellulitis, and other infections of the female genital tract caused by Escherichia coli.

Intraabdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella spp., and Staphylococcus aureus (methicillin susceptible strains) and polymicrobial infections caused by aerobic and anaerobic organisms and Bacteroides spp.

Central Nervous System Infections, including meningitis, caused by Haemophilus influenzae and Neisseria meningitidis, Pseudomonas aeruginosa and Streptococcus pneumoniae.

Pharmacology of IM/IV Injection :-Sidobac 1gm/vial (As a Ceftazidime Pentahydrate As a Third generation Cephalosporins).

Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for parenteral administration. Ceftazidime is bactericidal in action exerting its effect by inhibition of enzymes responsible for cell-wall synthesis. A wide range of gram-negative organisms is susceptible to ceftazidime in vitro, including strains resistant to gentamicin and other aminoglycosides. In addition, ceftazidime has been shown to be active against gram-positive organisms. It is highly stable to most clinically important beta-lactamases, plasmid or chromosomal, which are produced by both gram-negative and gram-positive organisms and, consequently, is active against many strains resistant to ampicillin and other cephalosporins.

Dosage of IM/IV Injection :-Sidobac 1gm/vial (As a Ceftazidime Pentahydrate As a Third generation Cephalosporins).

The usual adult dosage is 1 gram administered intravenously or intramuscularly every 8 to 12 hours. The dosage and route should be determined by the susceptibility of the causative organisms, the severity of infection and the condition, and renal function of the patient.

Ceftazidime is to be used by the parenteral route, the dosage depending upon the severity, sensitivity & type of infections and the age, weight & renal function of the patient.

Adults: The adult dosage range for ceftazidime is 1 to 6 gm per day 8 or 12 hourly (IM/IV) in the majority of infections, 1 gm 8 hourly or 2 gm 12 hourly should be given.

In urinary tract infections and many less serious infections: 500 mg or 1 gm 12 hourly is usually adequate.
In severe infections, especially immunocompromised patients, including those with neutropenia: 2 gm 8 or 12 hourly should be administered. When used as a prophylactic agent in prostatic surgery 1 gm should be given at the induction of anesthesia. A second dose should be considered at the time of catheter removal.

Elderly: In view of the reduced clearance of Ceftazidime in acutely ill elderly patients, the daily dosage should not normally exceed 3 gm, especially in those over 80 years of age.

Cystic fibrosis: In fibrocystic adults with normal renal function who have pseudomonal lung infections, high doses of 100 to 150 mg/kg/day as three divided doses should be used.

Infants and Children: The usual dosage range for children aged over two months is 30 to 100 mg/kg/day, given as two or three divided doses. Doses up to 150 mg/kg/day (maximum 6 gm daily) in three divided doses may be given to infected immunocompromised or fibrocystic children or children with meningitis.

Neonates and Children up to 2 months of age: The usual dosage range is 25 to 60 mg/kg/day as two divided doses.

Side Effects of IM/IV Injection :-Sidobac 1gm/vial (As a Ceftazidime Pentahydrate As a Third generation Cephalosporins).

The most common side-effects are local reactions following IV injection and allergic and gastrointestinal reactions. Hypersensitivity reactions are pruritus, rash, and fever. Angioedema and anaphylaxis have been reported very rarely. Gastrointestinal symptoms are diarrhea, nausea, vomiting, and abdominal pain. Central nervous system reactions included headache, dizziness, and paresthesia.

Pregnancy & Lactation of IM/IV Injection :-Sidobac 1gm/vial (As a Ceftazidime Pentahydrate As a Third generation Cephalosporins).

Pregnancy: No adequate and well-controlled studies in pregnant women have been conducted with Ceftazidime. Because animal reproduction studies are not always predictive of human response this drug should be used during pregnancy only if clearly needed.

Lactation: Ceftazidime is excreted in human milk in low concentrations. Because many drugs are excreted in human milk and because the safety of the component of the injections in nursing infants has not been established, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

18. CEFPODOXIME*******

Tablet 1:-Ximeprox 200 mg (AS A Cefpodoxime Proxetil Third generation Cephalosporins).

Indications of Tablet :-Ximeprox 200 mg (AS A Cefpodoxime Proxetil Third generation Cephalosporins):-

Ximeprox is indicated for the treatment of infections caused by susceptible microorganism, listed below:

Acute otitis media caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenza, Moraxella catarrhalis (including beta-lactamase producing strains).
Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
Acute maxillary sinusitis caused by Haemophilus influenzae (including beta-lactamase producing strains), Streptococcus pneumoniae and Moraxella catarrhalis.
Community acquired pneumonia caused by S. pneumoniae or H. influenza (including beta-lactamase-producing strains).
Acute bacterial exacerbation of chronic bronchitis caused by S. pneumoniae, H. influenzae (non-beta-lactamase-producing strains only), or M. catarrhalis.
Skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes.
Uncomplicated urinary tract infections caused by E. coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus.
Uncomplicated gonorrhea caused by Neisseria gonorrhoeae (including penicillinase-producing strains).
Rectal gonococcal infections in women due to Neisseria gonorrhoeae (including penicillinase-producing strains).

Pharmacology of Tablet :-Ximeprox 200 mg (AS A Cefpodoxime Proxetil Third generation Cephalosporins):-

Cefpodoxime is an oral 3rd generation cephalosporin, which has good stability to beta lactamases and activity against Gram negative and Gram positive bacteria. It is indicated for the treatment of infections either before the infecting organism has been identified. It is a prodrug its active metabolite is Cefpodoxime. Approximately 29 to 33% of Cefpodoxime excreted unchanged in the urine in 12 hours.

Cefpodoxime is indicated for the treatment of patients infected with susceptible strains of microorganisms which include a wide range of gram-positive & gram-negative bacteria. As it is highly stable in presence of β-lactamase enzyme, so it is more effective against gram-positive bacteria than other 3rd generation oral cephalosporins. The susceptible organisms include gram-positive bacteria eg. S. aureus (including penicillinase producing strains), S. saprophyticus, S. pneumoniae, S. pyogenes, S. agalactiae, P. magnus and gram-negative bacteria eg. E. coli, K. pneumoniae, H. influenzae (including β-lactamase producer & Ampicillin resistant strains), M. catarrhalis, N. gonorrhoeae (including penicillinase producing strains), P. mirabilis, C. diversus, H. parainfluenzae, K. oxytoca, P. vulgaris, P. rettgeri.

Dosage & Administration of Tablet :-Ximeprox 200 mg (AS A Cefpodoxime Proxetil Third generation Cephalosporins):-

Adults and Adolescents (13 years and older)-

Pharyngitis/tonsillitis: 100 mg 12 hourly, 5 to 10 days
Acute maxillary sinusitis: 200 mg 12 hourly, 10 day
Community-acquired pneumonia: 200 mg 12 hourly, 14 days
Acute bacterial exacerbations of chronic bronchitis: 200 mg 12 hourly, 10 days
Skin and skin structure: 400 mg 12 hourly, 7 to 14 days
Uncomplicated urinary tract infection: 100 mg 12 hourly, 7 days
Uncomplicated gonorrhea: single dose of 200 mg
Rectal gonococcal infections in women: single dose of 200 mg

Infants and Pediatric Patients (2 months to 12 years)-

Acute otitis media: 5 mg/kg body weight 12 hourly, 5 days
Pharyngitis /tonsillitis: 5 mg/kg body weight 12 hourly, 5 to 10 days
Acute maxillary sinusitis: 5 mg/kg body weight 12 hourly, 10 days

Patients with renal dysfunction: For patients with severe renal impairment (creatinine clearance <30ml/min) the dosing intervals should be increased to 24 hourly.

Patients with liver cirrhosis: Cefpodoxime Proxetil pharmacokinetics in cirrhotic patients are similar to those in healthy subjects. Dose adjustment is not necessary in this population.

Side Effects of Tablet :-Ximeprox 200 mg (AS A Cefpodoxime Proxetil Third generation Cephalosporins):-

Ximeprox has very few side effects. The side effects include diarrhea, nausea, skin & vaginal fungal infection, abdominal pain, headache, chest pain, myalgia, dyspepsia, dizziness, vertigo, cough etc. In children incidence of fungal skin rash is more than adults.

Pregnancy & Lactation of Tablet :-Ximeprox 200 mg (AS A Cefpodoxime Proxetil Third generation Cephalosporins):-

Cefpodoxime was neither teratogenic nor embryocidal in animal trial. There is, however, no adequate and well-controlled study of Cefpodoxime Proxetil use in pregnant woman. The drug should be used during pregnancy only if clearly needed. Because Cefpodoxime is excreted in human milk, a decision should be made wheather to discontinue breast-feeding or to discontinue the drug.

19.CEFIXIME***********

Capsule 1:-Cef-3 DS (Cefixime Trihydrate AS A Third generation Cephalosporins).

Indications

Cef-3 DS is an orally active cephalosporin antibiotic which has marked in-vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organism. It is indicated for the treatment of the following acute infections when caused by susceptible microorganisms.

Upper Respiratory Tract Infections (URTI): e.g. otitis media; and other URTI where the causative organism is known or suspected to be resistant to other commonly used antibiotics, or where treatment failure may carry significant risk. Lower Respiratory Tract Infections-e.g. bronchitis.

Urinary Tract Infections: e.g. cystitis, cystourethritis, pyelonephritis. Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumonia, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Moraxella catarrhalis (beta-lactamase positive and negative) and Enterobacter species. Cef-3 DS is highly stable in the presence of beta-lactamase enzymes.

Pharmacology

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

Dosage & Administration

Absorption of Cefixime is not significantly modified by the presence of food. The usual course of treatment is 7 days. This may be continued for up to 14 days if required.

Adults and children over 10 years: The recommended adult dosage is 200-400 mg daily according to the severity of the infection, given either as a single dose or in two divided doses.

Elderly: Elderly patients may be given the same dose as recommended for adults. Renal function should be assessed and dosage should be adjusted in severe renal impairment.

Children: The recommended dosage for children is 8 mg/kg/day administered as a single dose or in two divided doses. As a general guide for prescribing in children the following daily doses in terms of volume of suspension are suggested:

6 months up to 1 year: 3.75 ml daily
Children 1-4 years: 5 ml daily
Children 5-10 years: 10 ml daily

In typhoid: the recommended children dose is 5 mg/kg body weight twice daily for 10-14 days.

Children weighing more than 50 kg or older than 10 years: Should be treated with the recommended adult dose 200-400 mg daily depending on the severity of infection.

Children aged less than 6 months: The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

Dosage in Renal Impairment: Cefixime may be administered in the presence of impaired renal function. Normal dose and schedule may be given in patients with creatinine clearances of 20 ml/min or greater. In patients whose creatinine clearance is less than 20 ml/min, it is recommended that a dose of 200 mg once daily should not be exceeded. The dose and regimen for patients who are maintained on chronic ambulatory peritoneal dialysis or haemodialysis should follow the same recommendation as that for patients with creatinine clearances of less than 20 ml/min.

Side Effects

Cef-3 DS is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self limiting in nature. Gastrointestinal disturbances: The most frequent side-effects seen with Cef-3 DS are diarrhoea and stool changes; diarrhoea has been more commonly associated with higher doses. Other gastrointestinal side-effects seen less frequently are nausea, abdominal pain, dyspepsia, vomiting and flatulence. Pseudomembraneous colitis has been reported. Central nervous system: headache and dizziness. Hypersensitivity reactions: allergies in the form of rash, pruritis, urticaria, drug fever and arthralgia have been observed. These reactions usually subsided upon discontinuation of therapy. Hematological and clinical chemistry: thrombocytopenia, leukopenia and eosinophilia have been reported. These reactions were infrequent and reversible. Mild transient change in liver and renal function tests have been observed. Miscellaneous: other possible reactions include genital pruritis and vaginitis.

Pregnancy & Lactation

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

20.CEFDINIR

Capsule 1:-Efdinir 300mg (AS A Cefdinir AS A Third generation Cephalosporins).

Indications of Capsule :-Efdinir 300mg (AS A Cefdinir AS A Third generation Cephalosporins):-

Efdinir is indicated in-

Community Acquired Pneumonia,
Acute Exacerbations of Chronic Bronchitis,
Acute Maxillary Sinusitis,
Pharyngitis/Tonsillitis,
Acute Bacterial Otitis Media and
Uncomplicated Skin and Skin Structure Infections.

Pharmacology of Capsule :-Efdinir 300mg (AS A Cefdinir AS A Third generation Cephalosporins):-

Cefdinir is a semisynthetic third generation oral cephalosporin antibotic. It has a broad spectrum bactericidal activity against a wide range of common pathogens, including b-lactamase producing strains like Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae, Moraxella catarrhalis, E. coli, Klebsiella pneumoniae, and Proteus mirabilis. As with other cephalosporins, bactericidal activity of Cefexta results from inhibition of cell wall synthesis.

Dosage & Administration:- The total daily dose for all infections is 600 mg. The dosage schedule is given in the following:-

Type of infection	Dosage	Duration
Acute Exacerbations of Chronic Bronchitis	300 mg two times daily or 600 mg once daily	5 to 10 days
Pharyngitis/Tonsillitis
Acute Bacterial Otitis Media
Acute Maxillary Sinusitis	300 mg two times daily or 600 mg once daily	10 days
Community Acquired Pneumonia	300mg two times daily	10 days
Uncomplicated Skin and Skin Structure Infections	300mg two times daily	10 days

Powder for Oral Suspension: The total daily dose for all infections is 14 mg/kg body weight up to a maximum dose of 600 mg per day. The dosage schedule of oral suspension for pediatric patients as follows:


Type of infection	Dosage	Duration
Acute Bacterial Otitis Media	7mg/kg two times or 14 mg/kg once daily	5 to 10 days
Phayngitis/Tonsilitis
Acute Maxillary Sinusitis	7mg/kg two times or14 mg/kg once daily	10 days
Uncomplicated Skin and Skin Structure Infections	7mg/kg two times daily	10 days

Direction for Reconstitution of Powder for Suspension: Shake the bottle well so that powder does not clog. Add 40 ml (8 x 5 ml spoonful) boiled and cooled water with the provided 5ml spoon to the bottle. Shake well until all powder is dispersed. Reconstituted suspension should be used within 10 days of preparation if kept at room temperature or within 14 days if kept in a refrigerator. Shake the bottle well before use.

Side Effects of Capsule :-Efdinir 300mg (AS A Cefdinir AS A Third generation Cephalosporins):-

Common side effects are Diarrhea, Vaginal moniliasis, Nausea & Vomiting, Headache, Rash etc.

Pregnancy & Lactation of Capsule :-Efdinir 300mg (AS A Cefdinir AS A Third generation Cephalosporins):-

Its pregnancy category is B. But there are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. After administration of single 600 mg doses Cefdinir was not detected in the breast milk.

21.CEFEPIME

IV Injection 1:-Ceftipime (AS A Cefepime Hydrochloride AS A Fourth generation Cephalosporins).

Indications of IV Injection :-Ceftipime (AS A Cefepime Hydrochloride AS A Fourth generation Cephalosporins):-

Ceftipime is indicated for the treatment of the following infections caused by susceptible strains of the microorganisms:

Pneumonia (moderate to severe): caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.
Febrile Neutropenia: Ceftipime as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients.
Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis): caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms.
Uncomplicated Skin and Skin Structure Infections: caused by Staphylococcus aureus (methicillin- susceptible strains only) or Streptococcus pyogenes.
Complicated Intra-abdominal Infections (used in combination with metronidazole): caused by Escherichia coli, viridians group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.
Pharmacology of IV Injection :-Ceftipime (AS A Cefepime Hydrochloride AS A Fourth generation Cephalosporins):-
Cephalosporins are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillins). Cephalosporins disrupt the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity, especially in Gram-positive organisms. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin binding proteins (PBPs).

Dosage & Administration of IV Injection :-Ceftipime (AS A Cefepime Hydrochloride AS A Fourth generation Cephalosporins):-

Cefepime should be administered intravenously over approximately 30 minutes.

Moderate to Severe Pneumonia due to S. pneumoniae, *P. aeruginosa, K. pneumoniae, or Enterobacter species: 1-2 gm IV 12 hourly for 10 days.
Empiric therapy for febrile neutropenic patients: 2 gm IV 8 hourly for 7** days.
Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis*: 0.5-1 gm IV/IM*** 12 hourly for 7-10 days.
Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae*: 2 gm IV 12 hourly for 10 days.
Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes: 2 gm IV 12 hourly for 10 days.
Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa, K. pneumoniae, Enterobacter species, or B. fragilis: 2 gm IV 12 hourly for 7-10 days.

Note:
*including cases associated with concurrent bacteremia.
**or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re evaluated frequently.
*** IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTls due to E. coli when the IM route is considered to be a more appropriate route of drug administration.

Side Effects of IV Injection :-Ceftipime (AS A Cefepime Hydrochloride AS A Fourth generation Cephalosporins):-

Ceftipime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.

Pregnancy & Lactation of IV Injection :-Ceftipime (AS A Cefepime Hydrochloride AS A Fourth generation Cephalosporins):-

Pregnancy Category B. There are, however, no adequate and well-controlled studies of cefepime use in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefepime is excreted in human breast milk in very low concentrations (0.5 pg/ml). Caution should be exercised when cefepime is administered to a nursing woman.

22. CEFPIROME:N/A

23 CEFTAROLINE

IV Infusion 1:-Ceftalin 600 mg/vial AS A Ceftaroline Fosamil AS A unspecified.

Indications of IV Infusion :-Ceftalin 600 mg/vial AS A Ceftaroline Fosamil AS A unspecified.

Ceftalin is indicated for the treatment of the following infections caused by susceptible isolates of the designated microorganisms:

Complicated skin and soft tissue infections (cSSTI)
Community-acquired pneumonia (CAP)

Ceftalin is indicated in neonates, infants, children, adolescents and adults.

Pharmacology of IV Infusion :-Ceftalin 600 mg/vial AS A Ceftaroline Fosamil AS A unspecified.

Ceftaroline is a cephalosporin with activity against Gram-positive and Gram-negative bacteria. In vitro studies have shown that ceftaroline is bactericidal, due to inhibition of bacterial cell wall synthesis by binding to penicillin binding proteins (PBPs). Ceftaroline is also active against methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-nonsusceptible Streptococcus pneumoniae (PNSP) due to its affinity for the altered PBPs found in these organisms.

Dosage & Administration of IV Infusion :-Ceftalin 600 mg/vial AS A Ceftaroline Fosamil AS A unspecified.

The recommended durations of treatment are 5-14 days for Complicated skin and soft tissue infections (cSSTI) and 5-7 days for Community-acquired pneumonia (CAP).

Dosage in adults with normal renal function, creatinine clearance CrCl>50 ml/min:


Indications	Posology (mg/infusion)	nfusion time (minutes)/Frequency
Standard dose^a: Complicated skin and soft tissue infections (cSSTI) Community-acquired pneumonia (CAP)	600 mg	5-60^b/every 12 hour
High dose^b: cSSTI confirmed or suspected to be caused by S. aureus with an MIC = 2 mg/L or 4 mg/L to ceftaroline^c	600 mg	120/every 8 hours

a. For patients with supranormal renal clearance receiving the standard dose, an infusion time of 60 minutes
may be preferable.

b. Infusion times of less than 60 minutes and high dose recommendations are based on pharmacokinetic and
pharmacodynamic analyses only.

c. For treatment of S. aureus for which the ceftaroline MIC is ≤1 mg/L, the standard dose is recommended.

24. CEFTOBIPROLE:N/A

25..Clidamycin************

Capsule 1:-Clindacin 300mg (AS A Clidamycin As a Macrolides).

Indications of Capsule :-Clindacin 300mg (AS A Clidamycin As a Macrolides).

Clindacin has been shown to be effective in the treatment of the following infections when caused by susceptible anaerobic bacteria or susceptible strains of gram positive bacteria such as Streptococci, Staphylococci and Pneumococci; Upper respiratory infections, Lower respiratory infections, Skin and soft tissue infections, Bone and joint infections, Pelvic infections, Intra-abdominal infections, Septicemia and endocarditis, Dental infections. As an alternative therapy when used in combination with quinine or amodiaquine for the treatment of multi-drug resistant Plasmodium falciporum infection.

Description of Capsule :-Clindacin 300mg (AS A Clidamycin As a Macrolides).

Clindacin is a lincosamide antibiotic used in the treatment of infections caused by susceptible microorganisms. Clindacin is a semisynthetic antibiotic derived from lincomycin.

Aerobic gram-positive cocci, including: Staphylococcus aureus, Staphylococcus epidermidis (penicillinase and non-penicillinase producing strains), Streptococci, Pneumococci.

Anaerobic gram-negative bacilli, including: Bacteroides species, Fusobacterium species.

Anaerobic gram-positive non-spore forming bacilli, including: Propionibacterium species, Eubacterium species, Actinomyces species.

Anaerobic and microaerophilic gram-positive cocci, including: Peptococcus species, Peptostreptococcus species, Microaerophilic streptococci, C. perferinges

Dosage & Administration of Capsule :-Clindacin 300mg (AS A Clidamycin As a Macrolides).

Dosage of Clindamycin Capsule:

Serious Infections: 150 mg-300 mg every six hours.
More severe infections: 300 mg-450 mg every six hours.

To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC₉₀ for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:

Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-

Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
More severe infections: 1200-2700 mg/day in 2-4 equal doses.
For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.

Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):

20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

Side Effects of Capsule :-Clindacin 300mg (AS A Clidamycin As a Macrolides).

The adverse effects have been reported with the use of Clindacin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.

Pregnancy & Lactation of Capsule :-Clindacin 300mg (AS A Clidamycin As a Macrolides).

Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.

এই গুলি প্রেগন্যান্সিতে দেওয়া যাবে-

Note : সব cephalosporin pregnancy তে দেওয়া যাবে, Category -B

C অক্ষর দিয়ে শুরু তবে প্রেগন্যান্সিতে দেওয়া যাবেনা এমন এন্টিবায়োটিক ৩ টা.

1. Ciprofloxacin

Tablet 1:- Aprocin 500 mg (AS A Ciprofloxacin AS A 4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs).

Indications Tablet :- Aprocin 500 mg (AS A Ciprofloxacin AS A 4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs).

Aprocin is indicated for the treatment of single infection or mixed infections caused by two or more susceptible organisms. It can also be used for infections caused by organisms resistant to other antibiotics including Aminoglycosides, Penicillins and Cephalosporins.

As antibacterial concentrations of Aprocin are obtained in serum and body tissues as well as in the urine following administration by mouth, Aprocin has been suggested for use in the treatment of a wide range of infections caused by susceptible organisms including infections of the urinary, respiratory and gastrointestinal tracts, gonorrhoea and septicaemia. The extensive tissue penetration of Aprocin combined with its enhanced antibacterial activity (including antipseudomonal activity), enables Aprocin to be used alone (pending sensitivity results) or in combination with an Aminoglycoside or with beta lactam antibiotics for instance when severe neutropenia is present or with an antibiotic active against anaerobes where the presence of bacteroides fragilis is suspected. Aprocin is indicated for the treatment of the following infections caused by sensitive bacteria:

Severe systemic infections: e.g. septicaemia, bacteraemia, peritionitis, infections in immunosuppressed patients with haematological or solid tumors and in patients in intensive care unit with specific problems such as infected burns.
Respiratory tract infections: Lobar and bronchopneumonia, acute and chronic bronchitis, acute exacerbation of cystic fibrosis, bronchiectasis, empyema.
Urinary tract infections: Uncomplicated and complicated urethritis, cystitis, pyelonephritis, prostatitis, epididymitis.
Skin and soft tissue infections: e.g. infected ulcers, wound infections, abscesses, cellulitis, otitis externa, erysipelas, infected burns.
Gastro-intestinal infections: e.g. enteric fever, infective diarrhea.
Infection of the biliary tract: e.g. cholangitis, cholecystitis, empyema of the gall bladder.
Intra abdominal infections: e.g. peritonitis, intra abdominal abscesses.
Bone and joint infection: Osteomyelitis, septic arthritis.
Pelvic infections: e.g. salpingitis, endometritis, pelvic inflammatory diseases.
Eye, ear, nose and throat infections: e.g. otitis media, sinusitis, mastoiditis, tonsillitis.
Gonorrhoea: Including urethral, rectal and pharyngeal gonorrhoea caused by beta-lactamase producing organisms or organisms moderately sensitive to penicillin.

Pharmacology of Tablet :- Aprocin 500 mg (AS A Ciprofloxacin AS A 4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs).

Ciprofloxacin is a synthetic quinolone anti-infective agent. Ciprofloxacion has broad spectrum of activity. It is active against most gram negative aerobic bacteria including Enterobacteriaceae and Pseudomonas aeruginosa. Ciprofloxacin is also active against gram-positive aerobic bacteria including penicillinase producing, non penicillinase producing, and methicillin resistant staphylococci, although many strains of streptococci are relatively resistant to the drug. The bactericidal action of Ciprofloxacin results from interference with the enzyme DNA gyrase needed for the synthesis of bacterial DNA. Following oral administration it is rapidly and well absorbed from the G.I. tract. It is widely distributed into the body tissues and fluids. The half life is about 3.5 hours. About 30% to 50% of an oral dose of Ciprofloxacin is excreted in the urine within 24 hours as unchanged drug and biologically active metabolites.

Dosage of Tablet :- Aprocin 500 mg (AS A Ciprofloxacin AS A 4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs).

General dosage recommendations: The dosage of the Ciprofloxacin is determined by the severity and type of infection, the sensitivity of the causative organism(s) and the age, weight and renal function of the patient.

Adults: The dosage range for adults is 100-750 mg twice daily.

In infections of the lower and upper urinary tract (depending on severity): 250-500 mg twice daily.

In respiratory tract infections: 250-500mg twice daily for both upper and lower respiratory tract infections, depending on the severity. For the treatment of known Streptococcus pneumonia infection, the recommended dosage is 750 mg twice daily.

In gonorrhea: A single dose of 250 or 500 mg.

In the majority other infections: 500-750 mg twice daily should be administered.

Cystic fibrosis: In adults with pseudomonal infections of the lower respiratory tract , the normal dose is 750 mg twice daily. As the pharmacokinetics of Ciprofloxacin remain unchanged in patients with cystic fibrosis, the low body weight of these patients would be fallen into consideration when determining dosage.

Impaired renal function: Dosage adjustment is not usually required except in patients with several renal impairment. (serum creatinine >265 micro mol/l or creatinine clearance <20 ml/minute). If adjustment is necessary, this may be achieved by reducing the total daily dose by half, although monitoring of drug serum levels provide the most reliable basis for dose adjustment.

Elderly: Although higher Ciprofloxacin serum levels are found in the elderly, no adjustment of dosage is necessary.

Adeloscents and children: As with other drugs in its class, Ciprofloxacin has been shown to cause arthropathy in weight bearing joints of immature animals. Although the relevance of this to man is unknown, its use in children, growing children and growing adolescents is not recommended. However, where the benefit of using Ciprofloxacin is considered to outweigh the potential risk, the dosage should be 7.5-15 mg/kg/day depending upon the severity of infection, administered in two divided doses.

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings.

For acute infections: The usual treatment period is 5 to 10 days with Ciprofloxacin tablets. Generally treatment should be continued for three days after the signs and symptoms of the infection have disappeared.

Extended-release tablet:

In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.
Side Effects of Tablet :- Aprocin 500 mg (AS A Ciprofloxacin AS A 4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs).
Gastrointestinal disturbances e.g. nausea, diarrhoea, vomiting, dyspepsia, abdominal pain. Disturbances of the central nervous system e.g. headache, dizziness, tiredness, confusion, convulsion & risk of retinal detachment. Hypersensitivity reactions e.g. skin rash (very rarely Stevens-Johnson syndrome and toxic epidermal necrolysis), pruritus and possible systemic reactions. The other less reported reactions are joint pain, mild photosensitivity and transient increase in liver enzymes (particularly in patients with previous liver damage), serum bilirubin, urea or creatinine levels. Risk of hypoglycemia & mental health adverse effects.
Pregnancy & Lactation of Tablet :- Aprocin 500 mg (AS A Ciprofloxacin AS A 4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs).
Reproduction studies performed in mice, rats and rabbits using parenteral and oral administration did not reveal any evidence of teratogenicity, impairment of fertility or impairment of peri/post natal development. However as with other quinolones, Ciprofloxacin has been shown to cause arthropathy in immature animals and therefore its use during pregnancy is not recommended. Studies in rats have indicated that Ciprofloxacin is secreted in milk, administration to nursing mothers is thus not recommended.

2. Chloramphenicol

Capsule 1:-Chlorool 250mg (AS A Chloramphenicol AS A Macrolides).

Indications of Capsule :-Chlorool 250mg (AS A Chloramphenicol AS A Macrolides).

Chlorool is an antibiotic that is clinically useful for, and should be reserved for, serious infections caused by organisms susceptible to its antimicrobial effects when less potentially hazardous therapeutic agents are ineffective or contraindicated. However, Chlorool may be chosen to initiate antibiotic therapy on the clinical impression that one of the conditions below is believed to be present. In vitro sensitivity tests should be performed concurrently so that the drug may be discontinued as soon as possible if less potentially dangerous agents are indicated by such tests. The decision to continue use of Chlorool, rather than another antibiotic when both are suggested by in vitro studies to be effective against a specific pathogen, should be based upon severity of the infection, susceptibility of the pathogen to the various antimicrobial drugs, and the efficacy of the various drugs in the infection

Pharmacology of Capsule :-Chlorool 250mg (AS A Chloramphenicol AS A Macrolides).

In vitro, chloramphenicol exerts mainly a bacteriostatic effect on a wide range of Gram-negative and Gram positive bacteria and is active against rickettsiae, the lymphogranuloma-psittacosis group and Vibrio cholerae. It is particularly active against Salmonella typhi and Haemophilus influenzae. The mode of actions is through interference or inhibition of protein synthesis in intact cells and cell-free systems. Antagonism has been demonstrated in vitro between chloramphenicol, erythromycin, clindamycin and lincomycin. Chloramphenicol is rapidly absorbed from the GI tract. Chloramphenicol palmitate is hydrolyzed in the GI tract and is absorbed as free chloramphenicol.

Following oral administration of a single one gram dose of chloramphenicol base to healthy adults, average peak plasma chloramphenicol concentrations of about 11 mcg/ml were attained with 1-3 hours. Cumulative dosing gave a peak of 18 mcg/ml after the fifth dose of one gram, every 6 hours. Mean serum levels were 8-14 mcg/ml over a 48 hour period.

Most of the drug is excreted in the urine. Despite the small proportion of unchanged drug excreted in the urine, the concentration of free chloramphenicol in the urine is relatively high. From 8% to 12% of the antibiotic is excreted as free chloramphenicol. The remainder is excreted as inert metabolites, mainly glucuronate. Small amounts of active drug are found in bile and feces. Chloramphenicol diffuses rapidly, but its distribution is not uniform. Highest concentrations are found in liver and kidney, and lowest concentrations are found in brain and cerebrospinal fluid (CSF). Chloramphenicol enters CSF even in the absence of meningeal inflammation, appearing in concentrations about half of those found in the blood.

Dosage & Administration of Capsule :-Chlorool 250mg (AS A Chloramphenicol AS A Macrolides).

Chloramphenicol, like other potent drugs, should be prescribed at recommended doses known to have therapeutic activity. Inhibition of the majority of sensitive organisms may be expected at concentrations of 5 to 20 mcg/ml. The desired concentration of active drug in serum should fall within this range over most of the treatment period. Dosage of 50 mg/kg/day divided into 4 doses at intervals of 6 hours will usually achieve and sustain levels of this order.

Except in certain circumstances (e.g. premature infants and neonates and individuals with hepatic or renal impairment) lower doses may not achieve these concentrations. Close observation of the patient should be maintained and in the event of any adverse reactions, dosage should be reduced or the drug discontinued, if other factors in the clinical situation permit.

Adults: should receive 50 mg/kg/day in divided doses [approximately one 250 mg capsule per each 4.5 kg (10 lbs) of body weight or one 500 mg capsule per each 9 kg (20 lbs) of body weight] in divided doses at 6 hour intervals. In exceptional cases, patients with infections due to moderately resistant organisms may require increased dosage up to 100 mg/kg/day to achieve serum levels inhibiting the pathogen, but these high doses should be decreased as soon as possible.

Adults with impairment of hepatic or renal function, or both, may have reduced ability to metabolize and excrete the drug. In instances of impaired metabolic processes, dosages should be adjusted accordingly.

Pediatric patients: Dosage of 50 mg/kg/day divided at 6 hour intervals is effective against most susceptible organisms. Severe infections (eg., bacteremia or meningitis), especially when adequate cerebrospinal fluid concentrations are desired, may require dosage up to 100 mg/kg/day; however, it is recommended that dosage be reduced to 50 mg/kg/day as soon as possible. Children with impaired hepatic or renal function may retain excessive amounts of the drug.

Newborn infants: A total of 25 mg/kg/day in 4 equal doses at 6-hour intervals usually produces and maintains concentrations in serum and tissues adequate to control most infections for which the drug is indicated.

3.. Clarithromycin

Tablet 1:-Klarix 500mg (AS A Clarithromycin Macrolides).

Indications of Tablet :-Klarix 500mg (AS A Clarithromycin Macrolides).

Klarix is indicated for the treatment of-

Acute bacterial exacerbation of chronic bronchitis in adults
Acute maxillary sinusitis
Community-acquired pneumonia
Pharyngitis or tonsillitis
Uncomplicated skin and skin structure infections
Acute otitis media in pediatric patients
Treatment and prophylaxis of disseminated mycobacterial infections
Helicobacter pylori infection and duodenal ulcer disease in adults

Pharmacology of Tablet :-Klarix 500mg (AS A Clarithromycin Macrolides).

Clarithromycin acts by inhibiting microsomal protein synthesis in susceptible organisms mainly by binding to the donor site on the 50S subunit of the bacterial ribosome and preventing translocation to that site. Clarithromycin is active against most Gram-positive bacteria and Chlamydia, some Gram-negative bacteria and Mycoplasmas. Clarithromycin’s activity is the same as, or greater than, that of Erythromycin in vitro against most Gram-positive bacteria. Clarithromycin is more acid-stable than Erythromycin and therefore, is better tolerated. Clarithromycin has twice the activity of Erythromycin against H. influenzae. Most species of Gram-negative bacteria are resistant to Clarithromycin because of failure to penetrate the target.

Dosage & Administration of Tablet :-Klarix 500mg (AS A Clarithromycin Macrolides).

Adults:

Acute bacterial exacerbation of chronic bronchitis: 250 mg to 500 mg every 12 hours for 7 to 14 days.
Acute maxillary sinusitis: 500 mg every 12 hours for 14 days.
Community-acquired pneumonia: 250 mg every 12 hours for 7 to 14 days.
Pharyngitis or tonsillitis: 250 mg every 12 hours for 10 days.
Uncomplicated skin and skin structure infections: 250 mg every 12 hours for 7 to 14 days.
Treatment and prophylaxis of disseminated Mycobacterium avium disease: 500 mg every 12 hours until the patient is considered at low risk of disseminated infection.

Combination dosing regimens for H. pylori infection:

Triple therapy: Clarithromvcin/lansoprazole/amoxicillin: The recommended adult dosage is 500 mg clarithromycin, 30 mg lansoprazole and 1 g amoxicillin, all given every 12 hours for 10 or 14 days.

Triple therapy: Clarithromycin/omeprazole/amoxicillin: The recommended adult dosage is 500 mg clarithromycin, 20 mg omeprazole and 1 g amoxicillin; all given every 12 hours for 10 or 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 or 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: Clarithromycin/omeprazole: The recommended adult dosage is 500 mg clarithromycin given every 8 hours and 40 mg omeprazole given once every morning for 14 days. An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Children: The recommended daily dosage is 15 mg/kg/day divided every 12 hours for 10 days. For treatment and prophylaxis of mycobacterial infections in pediatric patients, the recommended dose is 7.5 mg/kg every 12 hours up to 500 mg every 12 hours.

Renal and hepatic impairment: Clarithromycin is principally excreted via the liver and kidney. Clarithromycin may be administered without dosage adjustment to patients with hepatic impairment and normal renal function. However, in the presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosaqe or prolonqed dosinq intervals may be appropriate.

Side Effects of Tablet :-Klarix 500mg (AS A Clarithromycin Macrolides).

Klarix is generally well tolerated. Side effects include nausea, vomiting, diarrhoea and abdominal pain. Stomatitis and glossitis have also been reported. Other side effects include headache, allergic reactions ranging from urticaria and mild skin reactions to anaphylaxis. Taste perversion may occur. There have been reports of transient central nervous system side effects including anxiety, dizziness, insomnia and hallucination.

Pregnancy & Lactation of Tablet :-Klarix 500mg (AS A Clarithromycin Macrolides).

The drug may be used in neonates and children in appropriate doses. Breast milk from mothers receiving Clarithromycin should not be given to infants until treatment is completed. There is as yet little experience in the treatment of pregnant patients and Clarithromycin is not recommended.

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Raiyyan Tahsan Date:28-12-2024 Saturday Time:-11-11-55 Pm

Raiyyan Tahsan

Raiyyan Tahsan