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CIPROFLOXACIN TABLETS 250 mg

(CIPROFLOXACIN TABLETS B.P.)

CIPROFLOXACIN TABLETS 500 mg

Antibacterial Tablets for Oral use.

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Composition
Each fim coated tablet contains :
Ciprofloxacin Hydrochloride B.P. equivalent to Ciprofloxacin : 500 mg
Colour : Titanium Dioxide

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Indications
Lower Respiratory Tract Infections Urinary Tract Infections Skin and Soft Tissue Infections Gastro-intestinal Infections Bone Infections Gonorrhoea

Dosage and Administration

The ideal therapeutic regimens for each indication have not been established. Effective regimens for different infections vary from use of a single dose of 250 mg to 750 mg three times a day for several months.

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

Respiratory tract infections: 250-500 mg twice daily. Usual duration of treatment: 7-14 days.

Urinary tract infections: 250-500 mg twice daily. Usual duration of treatment: 7-14 days.

Prostatitis: 500 mg twice daily. Usual duration of treatment: up to 28 days.

Gonorrhoea: acute uncomplicated 250-500 mg as a single dose.

Severe gastroenteritis: 500 mg twice daily. Usual duration of treatment: 3-7 days.

Skin and soft tissue infections: 500 mg twice daily. Usual duration of treatment: 5-10 days.


Children and adolescents (5-17 years):
Acute pulmonary exacerbation of cystic fibrosis caused by Pseudomonas aeruginosa: 40 mg/kg/24 h, divided in two doses i.e. 20 mg/kg/ twice daily (maximum 1500 mg daily). Usual duration of treatment: 10-14 days.

Or as directed by the Physician.

Administration:
The tablets are to be swallowed with liquid. They can be taken at any time regardless of meals. Ingestion on an empty stomach accelerates the absorption of the active substance. Dairy products with a high calcium content (milk, yoghurt) may reduce ciprofloxacin absorption.


CONTRAINDICATIONS:

Ciprofloxacin is contra-indicated in children under 18 years and growing adolescents (except where the benefits of treatment outweigh the risks).It is also contra-indicated in patients with Hypersensitivity to Ciprofloxacin & other quinolone antibiotics.

WARNINGS & PRECAUTIONS:

Ciprofloxacin should be used with cautions in patients with epilepsy or a history of CNS disorders. Crystalluria has been observed in association with ciprofloxacin use. Patients on ciprofloxacin should therefore be well hydrated and must avoid excessive alkalinity of the urine.

DRUG-INTERACTIONS:

When Ciprofloxacin Tablet is given concomitantly with food, there is a delay in the absorption of the drug. Concurrent administration of antacids containing magnesium hydroxide or aluminium hydroxide may reduce the bioavailability of ciprofloxacin by as much as 90%. The serum concentrations of ciprofloxacin and metronidazole were not altered when these two drugs were given concomitantly. Concomitant administration of ciprofloxacin with theophylline decreases the clearance of theophylline resulting in elevated serum theophylline levels and increased risk of a patient developing CNS or other adverse reactions. Ciprofloxacin also decreases caffeine clearance and inhibits the formation of paraxanthine after caffeine administration.

PREGNANCY AND LACTATION:

Ciprofloxacin should not be given to pregnant women. Clinical experience of use of ciprofloxacin in pregnant women is limited. Ciprofloxacin should not be taken by lactating mothers since quinolones administered at therapeutic doses are excreted in breast milk in quantities that can be expected to affect the infant.

UNDESIRABLE EFFECTS:

Nausea, headache, vomiting, diarrhoea, restlessness, abdominal pain, skin rash, dizziness and arthralgia.

OVERDOSE AND TREATMENT:

In the event of acute, excessive oral overdosage, reversible renal toxicity has been reported. Therefore, apart from routine emergency measures, it is recommended to monitor renal function and to administer Mg - or Ca-containing antacids which reduce the absorption of ciprofloxacin. Only a small amount of ciprofloxacin (<10%) is removed from the body after haemodialysis or peritoneal dialysis. Treatment should be symptomatic and supportive.

PHARMACOLOGICAL ACTION:

Ciprofloxacin is a synthetic, fluorinated 4-quinolone antimicrobial agent.It has broad antimicrobial activity and is effective, after oral administration, for the treatment of a wide variety of infectious diseases. The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase, needed for the synthesis of bacterial DNA. It has in vitro bactericidal activity against a wide range of gram-negative and gram-positive organisms.

PHARMACOKINETICS:

Ciprofloxacin is well absorbed and peak serum levels are obtained within 1 - 3 hours after oral dosing. The absolute oral bioavailability is approximately 70% with no substantial loss by first pass metabolism. Food does not impair oral absorption, but may delay the time to peak serum concentrations. Distribution of ciprofloxacin is wide and the volume of distribution high, indicating extensive tissue penetration. Ciprofloxacin is present in lung, skin, fat, muscle, cartilage and bone. It is also present in active form in the saliva, nasal and bronchial secretions, sputum, skin blister fluid, lymph, peritoneal fluid, prostatic secretions, cerebrospinal fluid and the aqueous humor. High concentrations are achieved in bile. Protein binding is low and ranges from 20 to 40%. Ciprofloxacin is eliminated principally by urinary excretion, but non-renal excretion may account for about a third of elimination and includes hepatic metabolism, biliary excretion and possibly transluminal secretions across the intestinal mucosa. Elimination occurs primarily by the kidneys and mainly during the first 12 hours after dosing. Excretion is virtually complete after 24 hours; about 40% to 50% is excreted in urine as unchanged drug and about 15% as metabolites. Renal clearance is approximately 300 mL/minute. The elimination half-life of unchanged ciprofloxacin is 3 - 5 hours. The elimination kinetics are linear; after repeated dosing at 12 hourly intervals and once steady state has been reached no accumulation occurs.

STORAGE INSTRUCTIONS:

Store below 25°C , in a dry place.

NATURE AND CONTENTS OF CONTAINER:

10 Blisters containing 10 tablets each, are packed in a Primary carton along with the Pack Insert.






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