CIPROLEX

CIPROLEX

Commercial Name

CIPROLEX®

Generic Name

Ciprofloxacin USP

Composition

Ciprolex® 250 Tablet: Each film coated tablet contains Ciprofloxacin USP 250mg as Ciprofloxacin hydrochloride.
Ciprolex® 500 Tablet: Each film coated tablet contains Ciprofloxacin USP 500mg as Ciprofloxacin hydrochloride.

Description

Ciprolex® containing Ciprofloxacin is synthetic quinolone anti-infective agent. Ciprofloxacin has broad spectrum 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 staphylococci are relatively resistant to the drug. The bactericidal action of Ciprofloxacin result 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 oral dose of Ciprofloxacin is excreted in the urine with 24 hours as unchanged drug and biologically active metabolites.

Indication

Ciprolex® 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.T. infections, caused by susceptible gram negative and gram-positive aerobic bacteria. It is also used for the treatment of uncomplicated gonorrhoea caused by penicillinase producing Neisseria.

Dosage & Administration

Ciprolex® may be given orally without regard to meals. Patients receiving Ciprolex® 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 drug should not be exceeded. For the treatment of urinary tract infections, the usual adult dosage of Ciprolex® for mild to moderate infections is 250mg every 12 hours and the usual adult dosage for complicated infections, caused by organisms not highly susceptible to drug is 500mg every 12 hours.
The usual adult oral dosage of Ciprolex® for infectious diarrhoea is 500mg 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 750mg every 12 hours may be needed especially in bone and joint infections or when infections are severe or complicated. For the treatment of uncomplicated urethral, endocervical or rectal gonorrhoea caused by penicillinase producing strains of Neisseria gonorrhoea (PPNG) or non-penicillinase producing strains of the organism, adults should receive a single 500mg oral dose of Ciprolex® followed by oral doxycycline therapy for possible coexisting chlamydia infection. In the treatment of chancroid, 500mg orally twice daily for 3 days is required. The duration of therapy depends on the type and severity of infection and should be determined by thee clinical and bacteriologic response of the patients. For most infections, therapy should be continued for at least 48 hours after the patients become asymptomatic. The usual duration is 1-2 weeks but severe or complicated infections may require more prolonged therapy. Ciprolex® therapy may need to be continued for 4-6 weeks or longer for the treatment of bone and joint infections. Infectious diarrhoea generally is treated for 3-7 days, although less prolonged therapy may be adequate. Modification of the usual dosage of Ciprolex® generally is unnecessary in patients with creatinine clearance greater than 50ml/ minute. In patients with creatinine clearance of 50 ml/minute orless, doses and/or frequency of administration of Ciprolex® should be modified in response to degree of renal impairment and the site and severity of infection.
Adults with creatinine clearance of 30-50 ml/minute can receive 150-500 mg of Ciprolex® every 12 hours.
Adults with creatinine clearance of 5-29 ml/minute can receive 250-500 mg of Ciprolex® every 18 hours.

Contraindication

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

Precaution

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

Pregnancy and Lactation

Not to be used in pregnancy and nursing stage. Though not recommended for the children where benefit over weighs risk a dosage of 7.5-15 mg/kg/day in two divided doses can be given.

Side Effect

Adverse effects include nausea and other gastrointestinal disturbances, headache, dizziness and skin rashes. Crystalluria has occurred with high doses.

Overdose

N/A

Storage

Keep in a cool dry place and protect from light.
Keep out of reach of children.

Pack Size

Ciprolex® 250mg Tablet: Box containing 3×10’s in blister pack.
Ciprolex® 500mg Tablet: Box containing 2×10’s in blister pack.

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