Antibiotic Case No 10 . Fluoroquinolones Antibiotic

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Antibiotic Case No 10 . Fluoroquinolones Antibiotic

Fluoroquinolones:-

1.Ciprofloxacin:-

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

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

Beuflox 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 Beuflox are obtained in serum and body tissues as well as in the urine following administration by mouth, Beuflox 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 Beuflox combined with its enhanced antibacterial activity (including antipseudomonal activity), enables Beuflox 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. Beuflox 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 Tablet:-Beuflox 500mg (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 Tablet:-Beuflox 500mg (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.

Administration

Instruction for the use of Ciprofloxacin IV infusion-

Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
Do not use if the solution is cloudy or a precipitate is present.
Do not use flexible bags in series connections.
Close flow control clamp of administration set.
Remove cover from port at bottom of bag.
Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
Suspend bag from hanger.
Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
Open flow control clamp to expel air from set.Close clamp.
Regulate rate of administration with flow control clamp.

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

Concurrent administration of Beuflox should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Beuflox. Beuflox should not be taken concurrently with milk or other dairy products, since absorption of Beuflox may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Beuflox.

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

Patients with a history of hypersensitivity to Ciprofloxacin or to other quinolones.

Side Effects Tablet:-Beuflox 500mg (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

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.

Precautions & Warnings Tablet:-Beuflox 500mg (AS A Ciprofloxacin AS A 4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs).

It should be used with caution in patients with suspected or known CNS disorders such as arteriosclerosis or epilepsy or other factors which predispose to seizures and convulsion.

Beuflox may be taken with or without meals and to drink fluids liberally.
Concurrent administration of Beuflox should be avoided with magnesium / aluminium antacids, or sucralfate or with other products containing calcium, iron and zinc. These products may be taken two hours after or six hours before Beuflox.
Beuflox should not be taken concurrently with milk or yogurt alone, since absorption of Beuflox may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the Beuflox absorption.

Use in Special Populations

Although effective in clinical trials, Beuflox is not a drug of first choice in pediatric population.

Overdose Effects

Overdose following Beuflox administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

Therapeutic Class Tablet:-Beuflox 500mg (AS A Ciprofloxacin AS A 4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs).

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

2.Delafloxacin:-

IV Infusion 2. Delameg 300 mg/vial (AS A Delafloxacin 4-Quinolone preparations).

Indications of IV Infusion:- Delameg 300 mg/vial (AS A Delafloxacin 4-Quinolone preparations).

Acute Bacterial Skin and Skin Structure Infections: Delameg is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, Enterococcus faecalis, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

Community-Acquired Bacterial Pneumonia: Delameg is indicated in adults for the treatment of community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible [MSSA] isolates only), Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Chlamydia pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae.

Pharmacology of IV Infusion:- Delameg 300 mg/vial (AS A Delafloxacin 4-Quinolone preparations).

Delafloxacin inhibits the activity of bacterial DNA topoisomerase IV and DNA gyrase (topoisomerase II). This interferes with bacterial DNA replication by preventing the relaxation of positive supercoils introduced as part of the elongation process. The resultant strain inhibits further elongation. Delafloxacin exerts concentration-dependent bacteriocidal activity.

The antibacterial activity of delafloxacin appears to best correlate with the ratio of area under the concentration-time curve of free delafloxacin to minimal inhibitory concentration (fAUC/MIC) for Gram-positive organisms such as Staphylococcus aureus and Gram-negative organisms such as Escherichia coli based on animal models of infection.

Dosage & Administration of IV Infusion:- Delameg 300 mg/vial (AS A Delafloxacin 4-Quinolone preparations).

Route of administration: Intravenous (IV) Injection

Hepatic Impairment: No dosage adjustment is necessary for Delaflox (Delafloxacin) in patients with hepatic impairment.

Renal Impairment: Dosage adjustment is required for patients with severe renal impairment (eGFR 15-29 mL/min/1.73m2). In patients with severe renal impairment or ESRD (eGFR of < 15 mL/min/1.73 m2), accumulation of the intravenous vehicle, sulfobutylether-β-cyclodextrin (SBECD) occurs. Serum creatinine levels should be carefully monitored in patients in such case. If serum creatinine level increases, consider switching to oral Delafloxacin. Discontinue Delafloxacin if eGFR decreases to < 15 mL/min/1.73 m2.

Interaction of IV Infusion:- Delameg 300 mg/vial (AS A Delafloxacin 4-Quinolone preparations).

With medicine: Do not administer Delameg for Injection with any solution containing multivalent cations (e.g. calcium and magnesium) through the same intravenous line. Do not co-infuse Delameg for Injection with other medications. With food & others: Not applicabl

Contraindications of IV Infusion:- Delameg 300 mg/vial (AS A Delafloxacin 4-Quinolone preparations).

Delafloxacin is contraindicated in patients with known hypersensitivity to Delafloxacin or any of the fluoroquinolone class of antibacterial drugs. Discontinue Delafloxacin at the first appearance of a skin rash or any other sign of hypersensitivity

Side Effects of IV Infusion:- Delameg 300 mg/vial (AS A Delafloxacin 4-Quinolone preparations).

Common Side Effects: The most common side effects of Delaflox include nausea, diarrhea, headache, transaminase elevations and vomiting.

Pregnancy & Lactation

The limited available data with Delafloxacin use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriages. There are no data available on the presence of Delafloxacin in human milk, the effects on the breast-fed infant or the effects on milk production.

Precautions & Warnings of IV Infusion:- Delameg 300 mg/vial (AS A Delafloxacin 4-Quinolone preparations).

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy and CNS effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). Discontinue Delameg immediately at the first signs or symptoms of any serious adverse reaction

Fluoroquinolones have been associated with an increased risk of tendinitis and tendon rupture in all ages. Tendinitis or tendon rupture can occur, within hours or days of starting a fluoroquinolone, or even several months after completion of fluoroquinolone therapy. Tendinitis and tendon rupture can occur bilaterally. Discontinue Delameg immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon.

Fluoroquinolones have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including Delameg. Discontinue Delameg immediately if the patient experiences symptoms of peripheral neuropathy.

Fluoroquinolones, including Delameg, have been associated with an increased risk of psychiatric adverse reactions. Toxic psychosis; hallucinations or paranoia; depression or suicidal thoughts or acts; delirium, disorientation, confusion or disturbances in attention; anxiety, agitation or nervousness; insomnia or nightmares; memory impairment may occur. Discontinue Delameg immediately if the patient experiences symptoms.

Fluoroquinolones have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (including pseudotumor cerebri), dizziness and tremors. Discontinue Delameg immediately if the patient experiences symptoms.

Fluoroquinolones have neuromuscular blocking activity and may cause muscle weakness in persons with myasthenia gravis. Avoid Delameg in patients with known history of myasthenia gravis.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, have been reported in patients receiving fluoroquinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticarial and itching. Discontinue Delameg at the first appearance of a skin rash or any other sign of hypersensitivity.

Clostridium difficile-associated diarrhea (CDAD) has been reported in users of nearly all systemic antibacterial drugs, including Delameg, with severity ranging from mild diarrhea to fatal colitis.

Increased risk of aortic aneurysm and dissection have been reported within two months following use of fluoroquinolones, particularly in elderly patients.

Fluoroquinolones have been associated with disturbances of blood glucose, including symptomatic hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent or with insulin. In these patients, careful monitoring of blood glucose is recommended. Severe cases of hypoglycemia resulting in coma or death have been reported with other fluoroquinolones. If a hypoglycemic reaction occurs, discontinue Delameg immediately.

Delameg can make you feel dizzy and lightheaded. Do not drive, operate machinery or do other activities that require mental alertness or coordination until you know how Delameg affects you.

Use in Special Populations of IV Infusion:- Delameg 300 mg/vial (AS A Delafloxacin 4-Quinolone preparations).

Use in children & adolescents: It is not known if Delameg is safe and effective in people under 18 years of age and use in people under 18 years of age is not recommended.

Geriatric use: Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone. Caution should be used when prescribing Delameg to elderly patients especially those on corticosteroids. If any symptoms of tendinitis or tendon rupture occur, then discontinuation of Delameg is recommended. Case of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients were reported. Caution should be used when prescribing Delameg to elderly patients.

Overdose Effects of IV Infusion:- Delameg 300 mg/vial (AS A Delafloxacin 4-Quinolone preparations).

Treatment of overdose with Delameg should consist of observation and general supportive measures. Hemodialysis found to remove about 19% of Delameg and 56% of Sulfobutylether-β-cyclodextrin after IV administration of Delameg.

Therapeutic Class of IV Infusion:- Delameg 300 mg/vial (AS A Delafloxacin 4-Quinolone preparations).

4-Quinolone preparations

3.Gemifloxacin.

Tablet 3:-

Facticin 320mg (AS A Gemifloxacin 4-Quinolone preparations).

Indications

Facticin is indicated for the treatment of the following bacterial infections in adults caused by sensitive organisms as follows-

Acute bacterial exacerbation of chronic bronchitis: caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.
Community-acquired pneumonia (of mild to moderate severity): caused by Streptococcus pneumoniae (including multi-drug resistant strains), Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.

Pharmacology Facticin 320mg (AS A Gemifloxacin 4-Quinolone preparations).

Gemifloxacin is a fluoroquinolone antibiotic. It is bactericidal with minimum bactericidal concentrations. Gemifloxacin acts by inhibiting DNA synthesis through inhibition of the bacterial type II topoisomerases, DNA gyrase, and/or topoisomerase IV (TOPO IV) which are both essential for bacterial growth.

Gemifloxacin is rapidly absorbed after oral administration. It is widely distributed throughout the body. Studies in healthy subjects showed that gemifloxacin is distributed rapidly into target tissues and body fluids such as the lung (epithelial lining fluid, alveolar macrophages, bronchial tissue) and nasal secretions.

Following oral administration of gemifloxacin, approximately 36% and 61% of the dose is excreted in the urine and feces, respectively, as unchanged drug and metabolites. AUC values were generally only slightly higher (approx. 10%) in women than in men. No dose adjustment is required based on gender

Dosage & Administration Facticin 320mg (AS A Gemifloxacin 4-Quinolone preparations).

Acute bacterial exacerbation of chronic bronchitis: 320 mg once daily for 5 days.

Community-acquired pneumonia (Mild to moderate severity):

Due to known or suspected S. pneumoniae, H. influenzae, M. pneumoniae, or C. pneumoniae infection: One 320 mg tablet daily for 5 days.
Due to known or suspected multi-drug resistant Streptococcus pneumoniae, K.pneumoniae, or M. catarrhalis infection: One 320 mg tablet daily for 7 days.

Interaction Facticin 320mg (AS A Gemifloxacin 4-Quinolone preparations).

Facticin absorption is significantly reduced when aluminium or magnesium containing antacids and iron salts are concomitantly administered. Facticin should be taken at least 2 hours before or 3 hours after these agents. Facticin should be taken at least 2 hours before sucralfate administration. No clinically significant interactions have been observed when Facticin was co-administered with omeprazole theophylline, digoxin, warfarin and oral contraceptives.

Contraindications Facticin 320mg (AS A Gemifloxacin 4-Quinolone preparations).

Known hypersensitivity to Gemifloxacin and other quinolones, Patients who have previously suffered tendon damage with fluoroquinolones. Gemifloxacin should not be used in children under 18 years of age.

Side Effects Facticin 320mg (AS A Gemifloxacin 4-Quinolone preparations).

The general adverse events include abdominal pain, diarrhea, headache, nausea, rash and vomiting. Some side effects have been infrequently reported such as fungal overgrowth in body, dizziness and insomnia, urticaria, pruritis and a maculopapular erythmatous skin rash.

Pregnancy & Lactation Facticin 320mg (AS A Gemifloxacin 4-Quinolone preparations).

Gemifloxacin should not be used in pregnant or lactating women. The safety and efficacy of Gemifloxacin in pregnant or lactating women have not been established.

Precautions & Warnings

For patients with severe impairment of renal function, alteration of the dosage regimen to 160 mg once daily is necessary. Adequate hydration of patients receiving Facticin should be maintained to prevent the formation of a highly concentrated urine and crystalluria. Facticin may cause dizziness; if this occurs, patients should not operate an automobile or machinery or engage in activities requiring mental alertness or co-ordination.

Tendinitis and tendon ruptures may occur in any age group during treatment with quinolones, including Facticin, but particularly in elderly patients or when corticosteroids are being co-administered. Facticin should be discontinued if tendinitis is suspected or at the first sign of pain or inflammation and the affected limb should be rested. In clinical studies with Facticin a small mean increase in QTc interval was observed. Facticin should be used with caution in patients predisposed to QTc interval prolongation or in patients taking other medications that are known to prolong the QTc interval. Facticin should be used with caution in patients with epilepsy.

Use in Special Populations

Renal impairment: Dose adjustment in patients with mild/moderate renal impairment is not required. Some modification of dosage is recommended for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:

Creatinine Clearance (>40 ml/min): See usual dosage
Creatinine Clearance (<40 ml/min): 160 mg once daily
Patients on haemodialysis or continuous ambulatory peritoneal dialysis therapy should receive 160 mg once daily.

Hepatic impairment: Facticin may be given to patients with hepatic impairment, with no requirement for dose adjustment.

Elderly patients: Dose adjustment is not required.

Overdose Effects

No specific antidote is known. Dialysis does not remove Facticin sufficiently to be useful in overdose. In the event of acute oral overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage; the patient should be carefully observed, treated symptomatically and adequate hydration should be maintained.

Therapeutic Class Facticin 320mg (AS A Gemifloxacin 4-Quinolone preparations).

4-Quinolone preparations

4.Levofloxacin.

Tablet 4.Levoflox 500mg (AS A Levofloxacin Hemihydrate 4-Quinolone preparations).

Indications of Tablet:-Levoflox 500mg (AS A Levofloxacin Hemihydrate 4-Quinolone preparations).

Levoflox is indicated for the treatment of mild, moderate and severe infections caused by susceptible strains of the designated micro-organisms in the condition listed below:

Acute maxillary sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
Acute bacterial exacerbation of chronic bronchitis due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
Community-acquired pneumonia due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.
Uncomplicated & complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.
Acute pyelonephritis caused by Escherichia coli.
Uncomplicated & complicated skin and soft tissue infections including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to Staphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis or Enterococcus faecalis.
Enteric infections caused by Enterobacter sp., Escherichia coli, Campylobacter sp., Vibrio cholerae, Shigella sp., Salmonella sp.

Description of Tablet:-Levoflox 500mg (AS A Levofloxacin Hemihydrate 4-Quinolone preparations).

Levoflox is a synthetic, broad-spectrum, third-generation fluoroquinolone derivative antibacterial agent for oral administration. Chemically levofloxacin is a chiral fluorinated carboxyquinolone.

Pharmacology of Tablet:-Levoflox 500mg (AS A Levofloxacin Hemihydrate 4-Quinolone preparations).

Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibiotic. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.

Dosage of Tablet:-Levoflox 500mg (AS A Levofloxacin Hemihydrate 4-Quinolone preparations).

The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or 2 hours after eating.

Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.

Adults:

Acute sinusitis: 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days
Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (Uncomplicated), 750 mg once daily for 5 days (Complicated)
Community-acquired pneumonia: 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days
Uncomplicated urinary-tract infections: 250 mg once daily for 3 days
Complicated urinary-tract infections and acute pyelonephritis: 250 mg once daily for 7-10 days
Uncomplicated skin and soft-tissue infections: 500 mg once daily for 7-10 days.
Complicated skin and soft-tissue infections: 750 mg once daily for 7-14 days.
Enteric fever: 500 mg once daily for 7-14 days.
Diarrhea, cholera, shigellosis & enteritis: Mild to moderate case: 500 mg (single dose). Moderate to sever case: 500 mg once daily for 3 days

Children:

Children 6 months to <5 years: 10 mg/kg every 12 hours.
Children >5 years: 10 mg/kg every 24 hours

In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

Administration of Tablet:-Levoflox 500mg (AS A Levofloxacin Hemihydrate 4-Quinolone preparations).

Instructions for the Use of Levofloxacin Infusion-

Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution.
Do not use if the solution is cloudy or a precipitate is present.
Do not use flexible containers in series connections.
Close flow control clamp of administration set.
Remove cover from port at bottom of container.
Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
Suspend container from hanger.
Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levoxin Injection.
Open flow control clamp to expel air from set. Close clamp.
Regulate rate of administration with flow control clamp.

Interaction of Tablet:-Levoflox 500mg (AS A Levofloxacin Hemihydrate 4-Quinolone preparations).

No quinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Antacids, Iron and Adsorbents reduce absorption of Levoflox. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.

Contraindications of Tablet:-Levoflox 500mg (AS A Levofloxacin Hemihydrate 4-Quinolone preparations).

Levofloxacin is contraindicated in patients with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.

Side Effects of Tablet:-Levoflox 500mg (AS A Levofloxacin Hemihydrate 4-Quinolone preparations).

Levoflox is generally well tolerated. However, a few side-effects can usually be seen. There is a risk of retinal detachment. Other side-effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side-effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.

Pregnancy & Lactation of Tablet:-Levoflox 500mg (AS A Levofloxacin Hemihydrate 4-Quinolone preparations).

Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Precautions & Warnings of Tablet:-Levoflox 500mg (AS A Levofloxacin Hemihydrate 4-Quinolone preparations).

The following measures should be taken during administration of Levoflox:

Levoflox Injection should only be administered by slow intravenous infusion over a period of 60 or 90 minutes depending on the dosage.
While administrating Levoflox, adequate amount of water should be taken to avoid concentrated form of urine.
Dose adjustment should be exercised during Levoflox administration in presence of renal insufficiency.

Overdose Effects of Tablet:-Levoflox 500mg (AS A Levofloxacin Hemihydrate 4-Quinolone preparations).

Levoflox exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.

Therapeutic Class of Tablet:-Levoflox 500mg (AS A Levofloxacin Hemihydrate 4-Quinolone preparations).

4-Quinolone preparations

5.Moxifloxacin:-

Tablet 5. Visomox 400mg (AS A Moxifloxacin Hydrochloride AS A 4-Quinolone preparations).

Indications of Tablet:-Visomox 400mg (AS A Moxifloxacin Hydrochloride AS A 4-Quinolone preparations).

Visomox tablet is indicated for the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community acquired pneumonia, uncomplicated & complicated skin and skin structure infections, complicated intra-abdominal infections and pelvic inflammatory disease.

Pharmacology of Tablet:-Visomox 400mg (AS A Moxifloxacin Hydrochloride AS A 4-Quinolone preparations).

Moxifloxacin is a 4th generation synthetic broad spectrum, fluoroquinolone class of antibacterial drug. It has activity against a wide range of gram-positive, gram-negative, anaerobic and atypical bacteria including Mycoplasma pneumoniae. It acts by inhibiting topoisomerase II (DNA gyrase) and topoisomerase IV which are necessary for bacterial DNA replication, transcription & repair.

Dosage & Administration of Tablet:-Visomox 400mg (AS A Moxifloxacin Hydrochloride AS A 4-Quinolone preparations).

Acute bacterial sinusitis: 400 mg once daily 7-10 days.
Acute bacterial exacerbation of chronic bronchitis: 400 mg once daily 5-10 days.
Community-acquired pneumonia: 400 mg once daily 7-14 days.
Uncomplicated skin and skin structure infections: 400 mg once daily 7 days.
Complicated skin and skin structure infections: 400 mg once daily 7-21 days.
Complicated intra-abdominal infections: 400 mg once daily 5-14 days.
Pelvic inflammatory disease: 400 mg once daily 14 days.

Interaction of Tablet:-Visomox 400mg (AS A Moxifloxacin Hydrochloride AS A 4-Quinolone preparations).

Visomox absorption is decreased when administered with antacids, sucralfate, multivitamins, and multivalent cations (e.g. iron or zinc). Visomox may enhance the risk of convulsions with NSAIDs and bleeding with warfarin. So concomitant use of Visomox with them should be avoided.

Contraindications of Tablet:-Visomox 400mg (AS A Moxifloxacin Hydrochloride AS A 4-Quinolone preparations).

It is contraindicated in patients with a history of hypersensitivity to Moxifloxacin or other quinolones.

Side Effects of Tablet:-Visomox 400mg (AS A Moxifloxacin Hydrochloride AS A 4-Quinolone preparations).

Common side effects of Visomox include nausea, vomiting, diarrhea, headache and dizziness.

Pregnancy & Lactation

US FDA pregnancy category C. Moxifloxacin is not recommended during pregnancy & lactation.

Precautions & Warnings

Visomox may cause an increased risk of tendinitis and tendon rupture. It should be discontinued if pain or inflammation in a tendon occurs. It should not be used in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients with receiving Class IA or Class III antiarrhythmic agents

Use in Special Populations of Tablet:-Visomox 400mg (AS A Moxifloxacin Hydrochloride AS A 4-Quinolone preparations).

Renal or hepatic impaired patients: No dose adjustment is necessary for patients with renal or hepatic impairment.

Pediatric patients: Safety and effectiveness of Visomox in pediatric patients and adolescent less than 18 years of age have not been established.

Therapeutic Class of Tablet:-Visomox 400mg (AS A Moxifloxacin Hydrochloride AS A 4-Quinolone preparations).

4-Quinolone preparations

6.Norfloxacin:- Only Vetenary drug

7.Ofloxacin:-

Tablet 7.Rutix 400mg (AS A Ofloxacin AS A 4-Quinolone preparations, Aural Anti-bacterial preparations).

Indications of Tablet:-Rutix 400mg (AS A Ofloxacin AS A 4-Quinolone preparations, Aural Anti-bacterial preparations).

Rutix tablets are indicated for the treatment of adults with mild to moderate infections caused by susceptible strains.

Lower Respiratory Tract: Acute bacterial exacerbation of chronic bronchitis lung abscess, pneumonia.
Gastrointestinal Tract: Enteric fever, shigellosis.
Multi-drug-resistant Tuberculosis.
Skin and skin structures: Uncomplicated skin and skin structure infections.
Sexually Transmitted Diseases: Acute, Uncomplicated urethral and cervical gonorrhoea. Nongonococcal urethritis and cervicitis.
Mixed infections of the urethra and cervix.
Urinary tract: Uncomplicated Urinary Tract Infections, Complicated urinary tract infections.

Rutix Eye & Ear Drops is indicated in-

Eye: It is indicated for the treatment of external ocular infections such as acute & sub-acute conjunctivitis, keratitis, kerato-conjunctivitis, blepharo-conjunctivitis, blepharitis, corneal ulcer and pre-operative prophylaxis in ocular surgery.
Ear: It is indicated for the treatment of external ear infections (otitis externa) and certain middle ear infections (otitis media).

Pharmacology of Tablet:-Rutix 400mg (AS A Ofloxacin AS A 4-Quinolone preparations, Aural Anti-bacterial preparations).

Ofloxacin containing ofloxacin is a synthetic 4-fluoroquinolone antibacterial agent with bactericidal activity against a wide range of Gram-negative and Gram-positive organisms. Ofloxacin is thought to exert bactericidal effect by inhibiting DNA gyrase, an essential enzyme that is a critical catalyst in the duplication, transcription and repair of bacterial DNA. Following oral administration ofloxacin is rapidly and well absorbed from G.I. tract. The bioavailability of ofloxacin in the tablet formulation is almost 100%. It is widely distributed into body tissues and fluid. The half-life is about 4.6 to 6.9 hours. Up to 80% of an oral dose of ofloxacin is eliminated in the urine as the parent compound within 48 hour.

Dosage & Administration of Tablet:-Rutix 400mg (AS A Ofloxacin AS A 4-Quinolone preparations, Aural Anti-bacterial preparations).

General dosage recommendations: The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200 mg to 800 mg daily. Up to 400 mg may be given as a single dose, preferably in the morning, larger doses should be given as two divided doses. Ofloxacin tablets should be swallowed with liquid; they should not be taken within two hours of intake of magnesium/aluminium containing antacids or iron preparations since reduction of absorption of ofloxacin can occur.

Enteric fever: For adults 200 mg, every 12 hours, for 5 days. For children 15 mg/kg/day in 2 divided doses for 3 days.
Shigellosis: 400 mg single dose.
Multi-drug-resistant tuberculosis: 400 mg twice daily along with conventional anti-tuberculosis drugs.
Lower respiratory tract infection: 400 mg daily, increasing, if necessary, to 400 mg twice daily.
Uncomplicated Urinary Tract Infections: A single dose of 200/400 mg.
Uncomplicated urethral and cervical gonorrhoea: A single dose of 400 mg.
Non-gonococcal urethral and cervicitis: 400 mg daily in single or divided doses.
Complicated Urinary Tract Infection: 200/400 mg/day for 7 days.
Impaired liver function: The excretion of ofloxacin may be reduced inpatients with severe hepatic dysfunction.
Children: Ofloxacin is usually not indicated for use in children or growing adolescents.
Elderly: No adjustment of dosage is required in the elderly.

Ofloxacin Eye & Ear Drops-

Eye: Instill 1 drop in the affected eye(s) every 2 to 4 hours for the first two days and then 4 times daily. The length of treatment should not exceed ten days.
Ear: Instill 1-2 drops in the affected ear(s) twice daily or as needed.

Interaction of Tablet:-Rutix 400mg (AS A Ofloxacin AS A 4-Quinolone preparations, Aural Anti-bacterial preparations).

Antacids containing magnesium, aluminium or calcium may decrease absorption of Rutix. Iron or Zinc may decrease oral absorption of Rutix.

Contraindications of Tablet:-Rutix 400mg (AS A Ofloxacin AS A 4-Quinolone preparations, Aural Anti-bacterial preparations).

Ofloxacin should not be used in-patients with known hypersensitivity to 4-fluoroquinolone antibacterials. It is contraindicated in-patients with a history of epilepsy or with a lowered seizure threshold. Ofloxacin is usually contraindicated in children or growing adolescents and in pregnant or breast feeding women.

Side Effects of Tablet:-Rutix 400mg (AS A Ofloxacin AS A 4-Quinolone preparations, Aural Anti-bacterial preparations).

Rutix tablet is generally well tolerated and clinical side-effects of Rutix has been quite low. Among the adverse effects gastrointestinal and central nervous systems’ reactions are common. Nausea, rash, vomiting, abdominal pain, diarrhoea and gastrointestinal distress are the gastrointestinal adverse effects. Common central nervous system reactions are headache, dizziness and insomnia.

Eye: Transient ocular irritation, burning, stinging, redness, itching or photophobia have been reported.

Ear: Mild irritation or mild discomfort in the ear may occur. Symptoms of an allergic reaction include rash, itching, swelling or trouble breathing.

Pregnancy & Lactation of Tablet:-Rutix 400mg (AS A Ofloxacin AS A 4-Quinolone preparations, Aural Anti-bacterial preparations).

The safety of ofloxacin during pregnancy has not been established. Ofloxacin may enter breast milk but data are not available.

Precautions & Warnings of Tablet:-Rutix 400mg (AS A Ofloxacin AS A 4-Quinolone preparations, Aural Anti-bacterial preparations).

Patients being treated with Rutix should not expose themselves unnecessarily to strong sunlight and should avoid UV rays. Caution is recommended if the drug is to be used in psychotic patients or in-patients with a history of psychiatric disease.

Prolonged use of eye drops & ear drops may result in overgrowth of non-susceptible organisms and secondary infection respectively.

Therapeutic Class of Tablet:-Rutix 400mg (AS A Ofloxacin AS A 4-Quinolone preparations, Aural Anti-bacterial preparations).

4-Quinolone preparations, Aural Anti-bacterial preparations

Raiyyan Tahsan Date:28-01-2025 Tuesday Time:12-24-55 PM

Raiyyan Tahsan

Raiyyan Tahsan