Ciproflox Full Prescribing Information, Dosage & Side Effects

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Contents

Ciprofloxacin hydrochloride.

Description

Each tablet contains: Ciprofloxacin (as hydrochloride) 500 mg.

Action

Pharmacology: Pharmacokinetics: Ciprofloxacin HCl is readily absorbed from the gastro-intestinal tract. An approximate oral bioavailability of 70% and a peak plasma concentration of about 2.5 μg/mL is achieved after a 500-mg oral dose. Presence of food may delay the absorption. Reported plasma half-life is about 3.5 to 4.5 hours; half-life may be prolonged in severe renal failure. The drug is about 20-40% plasma protein-bound. Ciprofloxacin is widely distributed in the body. It is found in the CSF, it crosses the placenta and is distributed in breast milk. High concentrations are achieved in the bile. Principal means of excretion is through the urine; others are eliminated in the feces.

Indications/Uses

Ciprofloxacin HCl is used in the treatment of a wide range of infections including anthrax, biliary-tract infections, infected bites and stings, bone and joint infections, brucellosis, cat scratch disease, chancroid, exacerbations of cystic fibrosis, gastro-enteritis, gonorrhea, Legionnaire's disease, otitis externa, otitis media, peritonitis, Q fever, lower respiratory tract infections, septicaemia, skin and soft tissue infections, spotted fevers, typhoid and paratyphoid fever, typhus and urinary tract infections. Also used in the prophylaxis of meningococcal meningitis and surgical infection.

Dosage/Direction for Use

All doses to be taken 1 hour before or 2 hours after meals.
Usual dose: Adult: 250 to 750 mg (½ to 1½ tablets) twice daily depending on the severity and nature of infection.
Acute exacerbations of cystic fibrosis associated with P. aeruginosa infection: Adults and children over 5 years: 20 mg per kg body-weight twice daily, up to a maximum of 750 mg (1½ tablets) twice daily.
Gonorrhea: Adult: 250 or 500 mg (½ or 1 tablet) once daily.
Meningococcal meningitis prophylaxis: Adult: 500 mg (1 tablet) once daily.
Surgical infection prophylaxis: Adult: 750 mg (1½ tablets) as a single dose to be given 60 to 90 minutes before the procedure. Or as prescribed by a physician.

Contraindications

Ciprofloxacin HCl should not be given to children, adolescents, pregnant and lactating women because the drug has been shown to cause degenerative changes in weight-bearing joints, and tendon damage may occur. The drug should also be avoided in methicillin-resistant S. aureus infections because of the high level of resistance.

Special Precautions

Ciprofloxacin HCl should be given with caution in patients with epilepsy or a history of CNS disorders. Treatment should be withdrawn if tendon pain, inflammation, or rupture occur. Care is necessary if the drug is to be given to patients with impaired hepatic or renal function, glucose-6-phosphate dehydrogenase deficiency, or myeasthenia gravis. Adequate fluid intake should be maintained during treatment; excessive alkalinity of the urine avoided because of the risk of crystalluria. Exposure to strong sunlight and sunlamps should also be avoided. Patients are not advised to drive a vehicle or to operate machinery, especially when alcohol is also taken.

Use In Pregnancy & Lactation

Ciprofloxacin HCl should not be given to pregnant and lactating women because the drug has been shown to cause degenerative changes in weight-bearing joints, and tendon damage may occur.

Adverse Reactions

Gastro-intestinal effects: nausea, vomiting, diarrhea, abdominal pain, dyspepsia, rarely Pseudomembranous colitis.
CNS-related effects: headache, dizziness, restlessness, tremor, drowsiness, insomnia, nightmares, visual and other sensory disturbances and, more rarely, hallucinations, psychotic reactions, depression, convulsions, occasionally paraesthesia and peripheral neuropathy.
Dermatologic effects: rash, pruritus, rarely vasculitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity.
Hepatic effects: elevated liver enzyme values, jaundice, hepatitis.
Hematological effects: eosinophilia, leucopenia, thrombocytopenia, hemolytic anemia or agranulocytosis.
Others: transient increase in serum creatinine or blood urea nitrogen, occasionally acute renal failure, crystalluria, tachycardia.

View ADR Monitoring Form

Drug Interactions

Theophylline: Concurrent administration of Ciprofloxacin with Theophylline may lead to elevated serum concentrations and prolonged elimination half-life of Theophylline which may result to Theophylline-related adverse reactions.
Caffeine: Caffeine elimination half-life has been reported to be increased and clearance decreased by the concomitant administration of Ciprofloxacin.
Antacids containing Mg, Al or Ca: Concurrent administration of these antacids may substantially interfere with the absorption of Ciprofloxacin.
Phenytoin: Altered serum levels of Phenytoin have been reported in patients concomitantly receiving Ciprofloxacin.
Warfarin: Quinolones have been reported to enhance the effects of Warfarin and its derivatives.
Probenecid: Probenecid interferes with renal tubular secretion of Ciprofloxacin.

Storage

Store at temperatures not exceeding 30°C.

MIMS Class

Quinolones

ATC Classification

J01MA02 - ciprofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.

Regulatory Classification

Presentation/Packing

Tab 500 mg x 50's, 100's.

Ciproflox

ciprofloxacin

Manufacturer:

Sea King Pharma

Distributor:

Sea King Pharma