Cipex

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Indication: Cipex is used in adults for the treatment of urinary tract infections, lower respiratory tract infections, skin and soft tissue infections, bone and joint infections and G.I. infections, caused by susceptible gram-negative and gram-positive aerobic bacteria. It is also used for the treatment of uncomplicated gonorrhea caused by penicillinase producing Neisseria gonorrhoeae.

Composition:

Cipex 250 Tablet: Each film coated Tablet contains ciprofloxacin hydrochloride USP 291.106 mg equivalent to ciprofloxacin 250 mg.

Cipex 500 Tablet: Each film coated Tablet contains ciprofloxacin hydrochloride USP 582.212 mg equivalent to ciprofloxacin 500 mg.

Cipex 60 ml Granules for Suspension: Each 5 ml contains ciprofloxacin hydrochloride USP equivalent to ciprofloxacin 250 mg.

Therapeutic Class: Antibiotic

Generic Name: Ciprofloxacin HCI USP

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Description

Pharmacology: Cipex contains Ciprofloxacin, which is a synthetic quinolone anti-infective agent. Ciprofloxacin 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 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.

Dose and Administration: Cipex may be given orally without regard to meals. Patients receiving Cipex should be well hydrated and should be instructed to drink fluids liberally. Because of the risk of crystalluria, it is recommended that the usual dosage of the drugs should not be exceeded. For the treatment of urinary tract infections, the usual adult oral dosage of Cipex for mild to moderate infections is 250 mg every 12 hours and the usual adult dosage for complicated infections, caused by organisms not highly susceptible to drug is 500 mg every 12 hours. The usual adult oral dosage of Cipex for infections diarrhea is 500 mg every 12 hours. The usual adult dosage for mild to moderate lower respiratory tract, skin and soft tissue or bone and joint infections is 500 mg every 12 hours; a dosage of 750 mg every 12 hours may be needed especially in bone and joint infections. Contraindication: Patients with a history of hypersensitivity to Ciprofloxacin or to other quinolones.

Warning and Precaution: 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.

Side effects:

a) Common: Side effects include nausea and other gastrointestinal disturbances, headache, dizziness and skin rashes.

b) Rare: Crystalluria has occurred with high doses.

Use in Pregnancy & Lactation: Not to be used in pregnancy and nursing stage

Use in children & adolescents: Though not recommended for the children where benefit out-weighs risk, a dosage of 7.5-15 mg/kg/day in two divided can be given.

Drug interactions:

a) Medicine: Ciprofloxacin may be taken with or without meals and to drink fluids liberally. Concurrent administration of ciprofloxacin should be avoided with magnesium/aluminum antacids or sucralfate or with other products containing calcium, iron or zinc. These products may be taken two hours after or six hours before ciprofloxacin.

b)With Food and others: Ciprofloxacin should not be taken concurrently with milk or yogurt alone, since absorption of ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the ciprofloxacin absorption.

Overdose: Dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment, crystalluria, haematuria.

Storage: Store below 30°C, protected from light & moisture. Keep away from the reach of the children.

Packing:

Cipex 250 Tablet: Each box containing 3 x10’s tablets in blister pack.

Cipex 500 Tablet: Each box containing 3 x10’s tablets in blister pack. Cipex 60 ml Granules for Suspension: Each bottle contains granules for preparation of 60 ml Suspension.

Additional information

Weight

250 mg, 500 mg, 60 ml

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