Antibiotic Case No 15.Third Generation Cephalosporins Antibiotic.

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Antibiotic Case No 15.Third Generation Cephalosporins Antibiotic.

There are 10 Component Preparation in this Third Generation Cephalosporins Antibiotic are:-

1.Cefdinir.

2.Cefditoren.

3.Cefixime Trihydrate.

4.Cefoperazone Sodium. :-(Only Injection).

5.Cefotaxime. :-(Only Injection).

6.Cefpodoxime Proxetil.

7. Cefpodoxime Proxetil+Clavulanic Acid.

8.Ceftazidime Pentahydrate. (Only Injection)

9.Ceftibuten Dihydrate.

10.Ceftriaxone Sodium. (Only Injection)

Descriptation:-

1.Cefdinir:-

Indications of Cefdinir:-

Cefdinir 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 Cefdinir:-

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 Cefdinir:-

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

Type of infectionDosageDurationAcute Exacerbations of Chronic Bronchitis300 mg two times daily or 600 mg once daily5 to 10 daysPharyngitis/TonsillitisAcute Bacterial Otitis MediaAcute Maxillary Sinusitis300 mg two times daily or 600 mg once daily10 daysCommunity Acquired Pneumonia300mg two times daily10 daysUncomplicated Skin and Skin Structure Infections

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.

Interaction Cefdinir:-

Antacids: Cefdinir should be taken at least 2 hours interval of antacid administration.

Iron supplement: Cefdinir should be taken at least 2 hours interval of iron supplement administration.

Probencid: It inhibits the renal excretion of cefdinir.

Contraindications

Cefdinir is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.

Side Effects Cefdinir:-

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

Pregnancy & Lactation Cefdinir:-

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.

Precautions & Warnings Cefdinir:-

Cefdinir, as with other broad-spectrum antibiotics, should be prescribed with caution in individuals with a history of colitis. In patients with transient or persistent renal insufficiency (creatinine clearance <30 ml/min), the total daily dose of Cefdinir should be reduced.

Therapeutic Class Cefdinir:-

Third generation Cephalosporins

1.Cefdinir:-

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

Syrup 2. Efdinir 125mg/5ml 60ml Bottle (AS A Cefdinir AS A Third generation Cephalosporins).

2.Cefditoren:-

Descriptation:-

Indications of Cefditoren:-

Cefditoren is indicated for the treatment of mild to moderate infections in adults and adolescents (12 years of age or older) which are caused by susceptible strains of the designated microorganisms in the conditions listed below:

Acute Bacterial Exacerbation of Chronic Bronchitis
Community Acquired Pneumonia
Pharyngitis
Tonsillitis
Uncomplicated Skin and Skin-Structure Infections

Pharmacology of Cefditoren:-

Cefditoren is a preparation of Cefditoren Pivoxil which is a broad spectrum third generation cephalosporin antibiotic. Cefditoren is a prodrug which is hydrolyzed by esterases during absorption, and the drug is distributed in the circulating blood as active Cefditoren. Cefditoren has antibacterial activity against gram-positive and gram-negative pathogens. The bactericidal activity of Cefditoren results from the inhibition of cell wall synthesis via affinity for penicillin- binding proteins (PBPs). Cefditoren is stable in the presence of a variety of ß-lactamases, including penicillinases and some cephalosporinases.

Dosage & Administration of Cefditoren:-

Cefditoren should be taken after meals.

Community-Acquired Pneumonia: 400 mg twice daily for 14 days.
Acute Exacerbation of Chronic Bronchitis: 400 mg twice daily for 10 days.
Pharyngotonsillitis and Acute Sinusitis: 200 mg twice daily for 10 days.
Uncomplicated Skin and Soft Structure Infections: 200 mg twice daily for 10 days.

Interaction of Cefditoren:-

Antacids and Famotidine (intravenous administration) reduced the oral absorption of Cefditoren. As with other ß-lactam antibiotics, co-administration of probenecid with Cefditoren Pivoxil resulted in an increase in the plasma exposure of Cefditoren. Multiple doses of Cefditoren had no effect on the pharmacokinetics of ethinyl estradiol, the estrogenic component in most oral contraceptives.

Contraindications of Cefditoren:-

Cefditoren is contraindicated in patients with known allergy to the cephalosporin class of antibiotics or any of its components. Cefditoren contain sodium caseinate, a milk protein. Patients with milk protein hypersensitivity (not lactose intolerance) should not be administered Cefditoren.

Side Effects of Cefditoren:-

The most common side effects of Cefditoren are diarrhea, nausea, headache, abdominal pain, vaginal moniliasis, dyspepsia, vomiting, abnormal dreams, allergic reaction, anorexia, constipation, dizziness, dry mouth and fever.

Pregnancy & Lactation of Cefditoren:-

Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. Cefditoren should be used during pregnancy only if clearly needed. Animal studies show that Cefditoren excreted in breast milk. Caution should be exercised when Cefditoren is administered to nursing women.

Precautions & Warnings of Cefditoren:-

Cefditoren is not recommended when prolonged antibiotic treatment is necessary, since other pivalate-containing compounds have caused clinical manifestations of carnitine deficiency when used over a period of months. Prescribing Cefditoren in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Use in Special Populations of Cefditoren:-

Children: Use of Cefditoren is not recommended for pediatric patients less than 12 years of age. The safety and efficacy of Cefditoren tablets in this population, including any effects of altered carnitine concentration, have not been established.

Geriatric: No dose adjustments are necessary in geriatric patients with normal (for their age) renal function.

Patients with renal insufficiency: No dose adjustment is necessary for patients with mild renal impairment (ClCr: 50-80 mL/min/1.73 m2). It is recommended that not more than 200 mg BID be administered to patients with moderate renal impairment (ClCr: 30-49 mL/min/1.73 m2) and 200 mg QD be administered to patients with severe renal impairment (ClCr: <30 mL/min/1.73 m2 ). The appropriate dose in patients with end-stage renal disease has not been determined.

Patients with hepatic disease: No dose adjustments are necessary for patients with mild or moderate hepatic impairment.

Overdose Effects of Cefditoren:-

Information on Cefditoren overdosage in humans is not available. However, with other ß-lactam antibiotics, adverse effects following overdosage have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. Hemodialysis may aid in the removal of Cefditoren from the body, particularly if renal function is compromised.

Therapeutic Class of Cefditoren:-

Third generation Cephalosporins

2.Cefditoren:-

Tablet 1.Editoren 200mg (AS A Cefditoren AS A Third generation Cephalosporins).

Tablet 2. Editoren 400 mg (AS A Cefditoren AS A Third generation Cephalosporins).

3.Cefixime Trihydrate:-

Descriptation:-

Indications of Cefixime Trihydrate:-

Cefixime Trihydrate 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. Cefixime is highly stable in the presence of beta-lactamase enzymes.

Pharmacology of Cefixime Trihydrate:-

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 of Cefixime Trihydrate:-

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.

Interaction of Cefixime Trihydrate:-

In common with other cephalosporins, increases in prothrombin times have been noted in a few patients. Care should therefore be taken in patients receiving anticoagulant therapy.

Contraindications of Cefixime Trihydrate:-

Patients with known hypersensitivity to cephalosporin antibiotics.

Side Effects of Cefixime Trihydrate:-

Cefixime 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 Cefixime 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 of Cefixime Trihydrate:-

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.

Precautions & Warnings of Cefixime Trihydrate:-

Cefixime should be given with caution to patients who have shown hypersensitivity to other drugs. Cephalosporin should be given with caution to penicillin-sensitive patients, as there is some evidence of partial cross-allergenicity between the penicillins and the cephalosporins. Patients have had severe reactions (including anaphylaxis) to both classes of drugs. If an allergic effect occurs with Cefixime, the drug should be discontinued and the patient treated with appropriate agents if necessary. Cefixime should be administered with caution in patients with markedly impaired renal function. Treatment with broad spectrum antibiotics alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of antibiotic-associated diarrhoea. Use in pregnancy and lactation: There are no adequate and well-controlled studies in pregnant women. Cefixime should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.

Overdose Effects of Cefixime Trihydrate:-

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

Therapeutic Class of Cefixime Trihydrate:-

Third generation Cephalosporins

3.Cefixime Trihydrate:-

Capsule 1.Cef-3 200mg (AS A Cefixime Trihydrate AS A Third generation Cephalosporins).

Capsule 2.Cef-3 DS 400mg (AS A Cefixime Trihydrate AS A Third generation Cephalosporins).

Syrup 3. Cef-3 100mg/5ml 30/50/75 ml Bottle, (AS A Cefixime Trihydrate AS A Third generation Cephalosporins).

Syrup 4. Cef-3 Forte 200mg/5ml 50 ml Bottle, (AS A Cefixime Trihydrate AS A Third generation Cephalosporins).

Pediatric Drops 5. Cef-3 25mg/ml 21ml Bottle (AS A Cefixime Trihydrate AS A Third generation Cephalosporins).

Pediatric Drops 6. Cef-3 100mg/ml 20 ml Bottle (AS A Cefixime Trihydrate AS A Third generation Cephalosporins).

4.Cefoperazone Sodium:-(Only Injection).

Indications of Cefoperazone Sodium:-

Cefoperazone is indicated for the treatment of the following infections when caused by susceptible organisms: Respiratory Tract Infections, Peritonitis & Other Intra-abdominal Infections, Bacterial Septicemia, Skin and Skin Structures Infections, Pelvic Inflammatory Disease, Endometritis & Other Infections of the Female Genital Tract, Urinary Tract Infections, Enterococcal Infections etc.

Pharmacology of Cefoperazone Sodium:-

Cefoperazone is a bactericidal Cephalosporin antibiotic which is resistant to most beta-lactamases and active against a wide range of aerobic & anaerobic, Gram positive & Gram negative bacteria. The bactericidal action of Cefoperazone results from the inhibition of bacterial cell wall synthesis. Cefoperazone has a high degree of stability in the presence of beta-lactamases produced by most Gram negative pathogens. Cefoperazone is usually active against organisms which are resistant to other beta-lactam antibiotics because of beta-lactamase production.

Dosage & Administration of Cefoperazone Sodium:-

Cefoperazone Sodium can be administered by IM or IV injection (following dilution).

Adult: 2 to 4 grams per day administered in equally divided doses every 12 hours. In severe infections or infections caused by less sensitive organisms, the total daily dose and/or frequency may be increased. Patients have been successfully treated with a total daily dosage of 6-12 grams divided into 2,3, or 4 administrations ranging from 1.5 to 4 grams per dose. When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days.

Contraindications of Cefoperazone Sodium:-

Cefoperazone is contraindicated in patients with known allergy to the Cephalosporin-class of antibiotics.

Side Effects of Cefoperazone Sodium:-

Hypersensitivity: As with all Cephalosporins, hypersensitivity manifested by skin reactions (1 patient in 45), drug fever (1 in 260), or a change in Coombs’ test (1 in 60) has been reported. These reactions are more likely to occur in patients with a history of allergies, particularly to Penicillin.

Pregnancy & Lactation of Cefoperazone Sodium:-

Pregnancy Category B.This drug should be used during pregnancy only if clearly needed. Only low concentrations of Cefoperazone is excreted in human milk. Although Cefoperazone passes poorly into breast milk of nursing mothers, caution should be exercised when Cefoperazone is administered to a nursing woman.

Precautions & Warnings of Cefoperazone Sodium:-

Cefoperazone is extensively excreted in bile. The serum half-life of Cefoperazone is increased 2-4 fold in patients with hepatic disease and/or biliary obstruction. In general, total daily dosage above 4 gm should not be necessary in such patients. If higher dosages are used, serum concentrations should be monitored.

Use in Special Populations of Cefoperazone Sodium:-

Children use: Safety and effectiveness in children have not been established.

Geriatric use: Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Therapeutic Class of Cefoperazone Sodium:-

Third generation Cephalosporins

4.Cefoperazone Sodium:-(Only Injection).

Injection 1.Cefazone 1gm/vial IM/IV 1gm vial (AS A Cefoperazone Sodium AS A Third generation Cephalosporins).

Injection 2.Cefazone 2gm/vial IM/IV 2ml / vial (AS A Cefoperazone Sodium AS A Third generation Cephalosporins).

Injection 3.Cefaking 500mg /vial IM/IV 500mg / vial (AS A Cefoperazone Sodium AS A Third generation Cephalosporins).

5.Cefotaxime:- :-(Only Injection).

Descriptation:-

Indications of Cefotaxime:-

Cefotaxime 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 gynaecological infections: such as pelvic inflammatory disease, Gonorrhoea 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 Cefotaxime 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 Cefotaxime:-

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 Cefotaxime:-

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.

Interaction of Cefotaxime:-

Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.

Contraindications of Cefotaxime:-

Cefotaxime is contraindicated in patients who have shown hypersensitivity to cefotaxime or the cephalosporin group of antibiotics.

Side Effects of Cefotaxime:-

Adverse reactions to Cefotaxime 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 Cefotaxime. 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 Cefotaxime:-

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.

Precautions & Warnings of Cefotaxime:-

Cefotaxime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Because high and prolonged antibiotic concentrations can occur from usual doses in patients with transient or persistent reduction of urinary output because of renal insufficiency, the total daily dosage should be reduced when Cefotaxime is administered to such patients. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organism. There is no clinical evidence supporting the necessity of changing the dosage of Cefotaxime in patients with even profound renal dysfunction.

Use in Special Populations of Cefotaxime:-

Dosage in renal impairment: Because of extra-renal elimination, it is only necessary to reduce the dosage of Cefotaxime in severe renal failure (GFR<5 ml/min = serum creatinine approximately 751 micromol/litre). After an initial loading dose of 1 gm, daily dose should be halved without change in the frequency of dosing. In all other patients, dosage may require further adjustment according to the course of infection and the general condition of the patient.

Therapeutic Class of Cefotaxime:-

Third generation Cephalosporins

5.Cefotaxime:- :-(Only Injection).

Injection 1.Cefotime IM/IV 250mg/5ml 250mg vial (AS A Cefotaxime AS A Third generation Cephalosporins).

Injection 2.Cefotime IM/IV 500mg/10ml 500mg vial (AS A Cefotaxime AS A Third generation Cephalosporins).

Injection 3. Cefotime IM/IV 1gm/10ml 1gm Vial (AS A Cefotaxime AS A Third generation Cephalosporins).

6.Cefpodoxime Proxetil:-

Descriptation:-

Indications of Cefpodoxime Proxetil:-

Cefpodoxime 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 Cefpodoxime Proxetil:-

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 Cefpodoxime Proxetil:-

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.

Interaction of Cefpodoxime Proxetil:-

Antacids: Concomitant administration of high doses of antacids (sodium bicarbonate and aluminium hydroxide) or H 2 blockers reduce peak plasma level by 24% to 42% and the extent of absorption by 27% to 32%, respectively.

Probenecid: Renal excretion of cefpodoxime was inhibited by probenecid and resulted in an approximately 31% increase in AUC.

Nephrotoxic drugs: Close monitoring of renal function is advised when Cefpodoxime Proxetil is administered concomitantly with compounds of known nephrotoxic potential.

Contraindications of Cefpodoxime Proxetil:-

Cefpodoxime Proxetil is contraindicated in patients with a known allergy to Cefpodoxime or to the cephalosporin group of antibiotics.

Side Effects of Cefpodoxime Proxetil:-

Cefpodoxime 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 Cefpodoxime Proxetil:-

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.

Precautions & Warnings of Cefpodoxime Proxetil:-

In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime Proxetil should be reduced. Cefpodoxime, like other cephalosporins, should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other broad spectrum antibiotics, prolonged use of Cefpodoxime Proxetil may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient’s condition is essential.

Therapeutic Class of Cefpodoxime Proxetil:-

Third generation Cephalosporins

6.Cefpodoxime Proxetil:-

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

Tablet 2.Ximeprox 100mg (AS A Cefpodoxime Proxetil AS A Third generation Cephalosporins).

Syrup 3.Ximeprox 40mg/5ml 50ml/100ml Bottle (AS A Cefpodoxime Proxetil AS A Third generation Cephalosporins).

Syrup 4.Ximeprox DS 80mg/5ml 50ml Bottle (AS A Cefpodoxime Proxetil AS A Third generation Cephalosporins).

Pediatric Drops 5. Ximeprox 20mg/ml 15ml Bottle (AS A Cefpodoxime Proxetil AS A Third generation Cephalosporins).

7. Cefpodoxime Proxetil+Clavulanic Acid:-

Descriptation:-

Indications of Cefpodoxime Proxetil+Clavulanic Acid:-

It is indicated in the following infections –

Acute bacterial exacerbation of chronic bronchitis
Acute community acquired pneumonia
Pharyngitis or tonsillitis
Skin and soft tissue infections
Urinary tract infections
Uncomplicated gonorrhea
Acute maxillary sinusitis

Pharmacology of Cefpodoxime Proxetil+Clavulanic Acid:-

Cefpodoxime is a third generation semi-synthetic Cephalosporin, exhibits activity against several Gram positive as well as Gram negative microorganisms. This compound is also stable in beta lactamase environment. Cefpodoxime exhibits exceptional activity against methicillin susceptible Staphylococci, Streptococcus pneumoniae, Haemophilus influenzae, Neisseria spp. and Moraxella catarrhalis.

Clavulanic acid is a natural inhibitor of beta lactamase which are produced by Streptomyces clavuligerus. It binds to beta lactamase moieties and inactivates them, thus restricting the Cefpodoxime destruction.

Dosage & Administration of Cefpodoxime Proxetil+Clavulanic Acid:-

For adults (Age 12 years and older):

Acute bacterial exacerbation of chronic bronchitis: 1 tablet 12 hourly for 10 days
Acute community acquired pneumonia: 1 tablet 12 hourly for 14 days
Pharyngitis or tonsillitis: ½ tablet 12 hourly for 5 to 10 days
Skin and soft tissue infections: 2 tablet 12 hourly for 7 to 14 days
Urinary tract infections: ½ tablet 12 hourly for 7 days
Uncomplicated gonorrhea: Single dose
Acute maxillary sinusitis: 1 tablet 12 hourly for 10 days

For children: Children 2 months to 12 years- 10 mg/kg/day in divided dose, every 12 hours.

Interaction of Cefpodoxime Proxetil+Clavulanic Acid:-

Concomitant administration of Cefpodoxime at high doses with antacids or H2 blockers reduces peak plasma levels of Cefpodoxime.

Contraindications of Cefpodoxime Proxetil+Clavulanic Acid:-

Cefpodoxime is contraindicated in patients with known hypersensitivity to Cephalosporins.

Side Effects of Cefpodoxime Proxetil+Clavulanic Acid:-

Cefpodoxime is well tolerated. Most common gastrointestinal adverse effects are diarrhea, vomiting and abdominal pain.

Pregnancy & Lactation of Cefpodoxime Proxetil+Clavulanic Acid:-

US FDA pregnancy category of Cefpodoxime & Clavulanic Acid 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. Cefpodoxime have been shown to be excreted in human milk. So, caution should be exercised when Cefpodoxime is administered to a nursing woman.

Precautions & Warnings of Cefpodoxime Proxetil+Clavulanic Acid:-

Cefpodoxime should be administered with caution to patients receiving concurrent treatment with diuretics.

Therapeutic Class of Cefpodoxime Proxetil+Clavulanic Acid:-

Third generation Cephalosporins

7. Cefpodoxime Proxetil+Clavulanic Acid:-

Tablet 1.Duo-5 200mg+125mg (AS A (Cefpodoxime Proxetil+Clavulanic Acid) AS A

Third generation Cephalosporins).

Tablet 2.Duo-5 LS (100mg+62.5 mg) (AS A (Cefpodoxime Proxetil+Clavulanic Acid) AS A

Third generation Cephalosporins).

8.Ceftazidime Pentahydrate:- (Only Injection)

Descriptation:-

Indications of Ceftazidime Pentahydrate:-

Ceftazidime 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 Ceftazidime Pentahydrate:-

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 Ceftazidime Pentahydrate:-

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.

Administration of Ceftazidime Pentahydrate:-

Ceftazidime may be given intravenously or by deep IM injection into a large muscle mass such as the upper outer quadrant of the gluteus maximus or lateral proof of the thigh. Intra-arterial administration should be avoided. For IV/IM administration, Ceftazidime should be reconstituted with the supplied Sterile Water for Injection.

Contraindications of Ceftazidime Pentahydrate:-

Ceftazidime is contraindicated in patients who have shown hypersensitivity to Ceftazidime or the cephalosporin group of antibiotics.

Side Effects of Ceftazidime Pentahydrate:-

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 Ceftazidime Pentahydrate:-

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.

Precautions & Warnings of Ceftazidime Pentahydrate:-

The total daily dosage should be reduced when Ceftazidime is administered to patients with renal insufficiency. Ceftazidime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Use in Special Populations of Ceftazidime Pentahydrate:-

Impaired Renal Function: Ceftazidime is excreted by the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function (glomerular filtration rate <50 mL/min), it is recommended that the dosage of ceftazidime be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1 gram of Ceftazidime may be given. An estimate of GFR should be made to determine the appropriate maintenance dosage.

Dosage in peritoneal dialysis: Ceftazidime may also be used in peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD). As well as using Ceftazidime intravenously, it can be incorporated into the dialysis fluid (usually 125 to 250 mg for 2L of dialysis fluid).

Impaired Hepatic Function: No adjustment in dosage is required for patients with hepatic dysfunction.

Overdose Effects of Ceftazidime Pentahydrate:-

Ceftazidime overdosage has occurred in patients with renal failure. Reactions have included seizure activity, encephalopathy, asterixis, neuromuscular excitability, and coma. Patients who receive an acute overdosage should be carefully observed and given supportive treatment.

Therapeutic Class of Ceftazidime Pentahydrate:-

Third generation Cephalosporins

8.Ceftazidime Pentahydrate:- (Only Injection)

Injection 1.Tazid IM/IV 250mg/vial 250mg vial (AS A Ceftazidime Pentahydrate AS A Third generation Cephalosporins).

Injection 2.Tazid IM/IV 500mg/vial 500 mg vial (AS A Ceftazidime Pentahydrate AS A Third generation Cephalosporins).

Injection 3.Tazid IM/IV 1gm/vial 1gm vial (AS A Ceftazidime Pentahydrate AS A Third generation Cephalosporins).

9.Ceftibuten Dihydrate:-

Descriptation:-

Indications of Ceftibuten Dihydrate:-

Ceftibuten 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 Ceftibuten Dihydrate:-

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 Ceftibuten Dihydrate:-

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

Interaction of Ceftibuten Dihydrate:-

Theophylline & Antacid do not alter the pharmacokinetic profile of Ceftibuten. Ranitidine increases the Cmax & AUC of Ceftibuten.

Contraindications of Ceftibuten Dihydrate:-

Ceftibuten is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Side Effects of Ceftibuten Dihydrate:-

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

Pregnancy & Lactation of Ceftibuten Dihydrate:-

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.

Precautions & Warnings of Ceftibuten Dihydrate:-

As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. The dose of Ceftibuten may require adjustment in patients with varying degrees of renal insufficiency. Ceftibuten should be prescribed with caution to individuals with a history of gastrointestinal disease, particularly colitis.

Use in Special Populations of Ceftibuten Dihydrate:-

Renal Impairment-

CrCl 5 to 29 ml/min: 2.25 mg/kg or 100 mg orally once a day
CrCl 30 to 49 ml/min: 4.5 mg/kg or 200 mg orally once a day

Hepatic Impairment: Dose adjustment is not necessary.

Therapeutic Class of Ceftibuten Dihydrate:-

Third generation Cephalosporins

Reconstitution

The small bottle contains purified water and large bottle contains granules
Pour the purified water completely into large bottle
Tighten the cap of large bottle and shake the bottle for at least one minute
Use a measuring cup or dropper for reconstituted suspension

Prepared suspension to be consumed within 14 days of preparation if kept in a refrigerator. Shake the bottle well each time before use.

9.Ceftibuten Dihydrate:-

Capsule 1.Zoventa 200mg (AS A (Ceftibuten Dihydrate) AS A Third generation Cephalosporins).

Capsule 2.Zoventa 400 mg (AS A (Ceftibuten Dihydrate) AS A Third generation Cephalosporins).

Syrup 3. Zoventa 90mg/5ml 60ml Bottle (AS A (Ceftibuten Dihydrate) AS A Third generation Cephalosporins).

Syrup 4. Zoventa 180mg/5ml 60ml Bottle (AS A (Ceftibuten Dihydrate) AS A Third generation Cephalosporins).

10.Ceftriaxone Sodium:- (Only Injection)

Descriptation:-

Indications of Ceftriaxone Sodium:-

Ceftriaxone 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 Ceftriaxone Sodium:-

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 Ceftriaxone Sodium:-

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.

Administration of Ceftriaxone Sodium:-

Preparation of Solutions for Intramuscular / Intravenous Injections:

For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Interaction of Ceftriaxone Sodium:-

No drug interactions have been reported.

Contraindications of Ceftriaxone Sodium:-

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

Side Effects of Ceftriaxone Sodium:-

Ceftriaxone 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 Ceftriaxone Sodium:-

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.

Precautions & Warnings of Ceftriaxone Sodium:-

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

Use in Special Populations of Ceftriaxone Sodium:-

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

Overdose Effects of Ceftriaxone Sodium:-

There is no specific antidote. Treatment of overdosage should be symptomatic.

Therapeutic Class of Ceftriaxone Sodium:-

Third generation Cephalosporins

10.Ceftriaxone Sodium:- (Only Injection)

Injection 1.Ceftron IM 250mg/vial 250mg vial (AS A (Ceftriaxone Sodium )AS A Third generation Cephalosporins).

Injection 2.Ceftron IM 500mg/vial 500 mg vial (AS A (Ceftriaxone Sodium )AS A Third generation Cephalosporins).

Injection 3.Ceftron IM 1gm/vial 1gm vial (AS A (Ceftriaxone Sodium )AS A Third generation Cephalosporins).

Injection 4.Ceftron IV 250 mg /vial 250mg vial (AS A (Ceftriaxone Sodium )AS A Third generation Cephalosporins).

Injection 5.Ceftron IV 500 mg /vial 500 mg vial (AS A (Ceftriaxone Sodium )AS A Third generation Cephalosporins).

Injection 6.Ceftron IV 1gm /vial 1gm vial (AS A (Ceftriaxone Sodium )AS A Third generation Cephalosporins).

Injection 7.Ceftron IV 2gm /vial 2gm vial (AS A (Ceftriaxone Sodium )AS A Third generation Cephalosporins).

Raiyyan Tahsan Date:-31-01-2025 Friday Time:1-11-45 Pm