PT Indofarma-Ciprofloxacin

PT Indofarma-Ciprofloxacin



PT Indofarma


Full Prescribing Info
Each film-coated tablet contains ciprofloxacin hydrochloride monohydrate equivalent to 250 mg or 500 mg ciprofloxacin.
Pharmacology: Pharmacodynamics: Ciprofloxacin, a quinolone group of synthesized antibacterial agents, inhibits DNA topoisomerase commonly referred to as DNA-gyrase in susceptible organisms. It does not result in parallel resistance to other noncarboxylate antibiotics. It is effective against organisms resistant to other antibiotics, such as aminoglycosides, penicillins, cephalosporins, and tetracyclines. Ciprofloxacin is effective against gram-negative and gram-positive organisms.
Ciprofloxacin is suitable for treating infections caused by ciprofloxacin-sensitive pathogens e.g. urinary tract infections except prostatitis, urethritis, and cervicitis gonorrhoea; respiratory tract infections except pneumonia caused by streptococcus; skin and soft-tissue infections; bone and joint infections; gastrointestinal tract infections, including typhoid fever and paratyphoid.
Dosage/Direction for Use
Urinary tract infections: mild, 250 mg twice daily; severe, 500 mg twice daily.
Respiratory tract, bone, joint, skin and soft-tissue infections: mild, 500 mg twice daily; severe, 750 mg twice daily.
Gastrointestinal tract infections: 500 mg twice daily.
Acute gonorrhoea: a single dose, 250 mg daily.
Impaired renal function: If the "Creatinine Clearance" is less than 20 ml/min, the daily recommended dose is 500 mg or 250 mg if it is administered twice daily.
The duration of treatment depends upon the severity of infection. Generally, ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared. The usual duration is 7-14 days. Bone and joint infections may require treatment for 4 to 6 weeks or longer.
Patients who are hypersensitive to ciprofloxacin or other quinolone chemotherapeutics. It must not be prescribed for pregnant women or nursing mother, children and growing children.
Special Precautions
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 ciprofloxacin. Symptoms may occur soon after initiation of ciprofloxacin and may be irreversible. Ciprofloxacin should be discontinued immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation.
Vision disorders: If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.
Ciprofloxacin is used with caution in patients with renal insufficiency, elderly patients, epileptic patients, patients with central nervous system disorders.
To avoid crystalluria, patients should be instructed to drink enough water.
Don't operate motor, vehicle or machinery during use of the drug, especially to drink with alcohol.
Use In Pregnancy & Lactation
This drug is contraindicated in pregnant women or nursing mother.
Side Effects
Effects on gastrointestinal tract: nausea, diarrhoea, vomiting, dyspepsia, abdominal pain, flatulence and anorexia.
Effects on the nervous system: dizziness, headache, tiredness, rarely visual disturbance. Nervous system disorders (frequency not known): peripheral neuropathy (that may be irreversible) and polyneuropathy.
Effects on the blood: eosinophilia, leukocytopenia, leukocytosis, anemia. Hypersensitivity reactions: skin reactions e.g. rashes. Patients with renal impaired liver functions the drug can increase transaminase serum level. Please consult to the physician if negative effects occur.
Drug Interactions
Antacids containing aluminium hydroxide or magnesium hydroxide reduce the uptake (absorption) of ciprofloxacin. Concurrent administration of ciprofloxacin and theophylline can cause an undesirable increase in the theophylline plasma concentration. On concurrent administration of theophylline, therefore, it is necessary to determine the serum theophylline concentration at brief intervals. Should not be given together with probenecid and coumarin anticoagulants.
Store below 30°C and dry place.
MIMS Class
ATC Classification
J01MA02 - ciprofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
FC tab 250 mg x 50's. 500 mg x 5's.
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