CIFGA

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COMPOSITION:
Ciprofloxacin....................................... 500 mg
Excipients.q.s...................................... 1 caplet
(Tapioca starch, sodium starch glycolate, ludipress, magnesium stearate, PVP K30, HPMC, PEG 6000, titanium dioxide, talc).
DOSAGE FORM: Film coated caplets.
PRESENTATION: Box of 2 blisters x 10 caplets.
PHARMACODYNAMICS: Cifga with the active ingredient ciprofloxacin is semi-synthetic broad-spectrum antibiotic and belongs to quinolones; it is also called DNA-gyrase inhibitor. Ciprofloxacin acts by inhibiting DNA gyrase, preventing bacterial chromosome replication that making bacteria not reproduce quickly. Ciprofloxacin is highly active against bacteria which are resistant to other antibiotic groups (aminoglycosides, cephalosporins, tetracyclines, penicillins...), and is evaluated as one of the most effective drug of the fluoroquinolon group.
PHARMACOKINETICS: Ciprofloxacin is well and rapidly absorbed from the gastrointestinal tract. Absorption of ciprofloxacin is delayed but is not affected significantly when ciprofloxacin is given concomitantly with food or antacids. The absolute bioavailability is about 70 to 80% and a peak serum concentration occurs 1 to 2 hours. The plasma half-life of ciprofloxacin ranged from 3.5 - 4.5 hrs in patients with normal renal function. Half-life may be prolonged in renal impairment and to some extent in the elderly. Ciprofloxacin is widely distributed and is present in high concentrations at the sites of infections (fluids and tissues). Generally, the drug penetrates well through in the body tissues, including cerebrospinal fluid. Ciprofloxacin crosses the placenta and is excreted in human milk. Relatively high concentrations of the drug are present in bile. Ciprofloxacin is mainly eliminated by the kidney.
INDICATIONS: Treatment of prostatitis, osteomyelitis, severe bacterial enteritis, septicemia.
Uncomplicated urinary tract infections
Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions (see Warnings and Precautions) and for some patients with uncomplicated urinary tract infection is self-limiting, reserve ciprofloxacin for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options.
Acute exacerbation of chronic bronchitis
Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions (see Warnings and Precautions) and for some patients with acute exacerbation of chronic bronchitis is self-limiting, reserve ciprofloxacin for treatment of acute exacerbation of chronic bronchitis in patients who have no alternative treatment options.
Acute bacterial sinusitis
Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions (see Warnings and Precautions) and for some patients with acute bacterial sinusitis is self-limiting, reserve ciprofloxacin for treatment of acute bacterial sinusitis in patients who have no alternative treatment options.
CONTRAINDICATIONS: Hypersensitivity to ciprofloxacin or other quinolones.
WARNINGS AND PRECAUTIONS:
Disabling and potentially irreversible serious adverse reactions including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects.
Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting ciprofloxacin. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.
Discontinue ciprofloxacin immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
The drug should be used with caution in patients with a history of epilepsy or CNS disorders, renal or hepatic impairment, glucose-6-phosphate dehydrogenase deficiency, myasthenia gravis. Long-term use of ciprofloxacin may cause a drug resistance; frequently monitor the patient and make an antibiotic regiment to adjust the therapy. Ciprofloxacin may cause a negative result in Mycobacterium tuberculosis test. The use of ciprofloxacin in children and adolescents should be limited.
PREGNANCY AND LACTATION:
Ciprofloxacin should only be administered to pregnant women with severe infections, if there are no alternative antibiotics. Ciprofloxacin should not be administered to nursing mothers since ciprofloxacin accumulates in breast milk and can reach a concentration which causes damage to children. If the mother is required to use ciprofloxacin, breast-feeding should be temporarily discontinued.
VEHICLE DRIVERS AND MACHINERY OPERATORS: Ciprofloxacin may cause dizziness or vertigo; so cautions should be taken when driving vehicle or operating machinery.
INTERACTIONS: Nonsteroidal anti-inflammatory drugs (including ibuprofen, indomethacin, etc.) enhance the adverse effects of ciprofloxacin. The simultaneous administration of ciprofloxacin and magnesium-, aluminium-containing preparations reduces the serum concentrations and the bioavailability of ciprofloxacin. Concomitant administration of ciprofloxacin and the antacids should be avoided. The antacids should be taken at least 2 - 4 hours before ciprofloxacin administration. The absorption of ciprofloxacin may be reduced by a half if concomitantly administered with cytotoxic agents (e.g. cyclophosphamide, vincristine, doxorubicin, cytosine arabinoside, mitozantrone). The simultaneous administration with didanosine may induce a significant decrease of ciprofloxacin concentrations. Ciprofloxacin should be taken at least two hours before or six hours after didanosine administration. Iron- (including fumarate, gluconate, and sulfate) or zinc-containing preparations significantly decrease the intestinal absorption of ciprofloxacin. Zinc-containing preparations give a less effect. Concomitant administration of ciprofloxacin and iron- and zinc-preparations is not recommended; the interval between doses is as far as possible. Sucralfate decreases the absorption of ciprofloxacin. Ciprofloxacin should be taken at least 2 - 6 before sucralfate administration. Concurrent administration of ciprofloxacin with theophylline may result in increased serum theophylline concentration and other adverse reactions. If concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage as appropriate. A transient rise in the concentration of serum creatinine was observed when ciprofloxacin and ciclosporin containing medicinal products were administered simultaneously. Therefore, it is frequently (twice a week) necessary to control the serum creatinine concentrations in these patients. Probenecid interferes with renal tubular secretion of ciprofloxacin and produces a decrease in the level of ciprofloxacin in the urine. Ciprofloxacin intensifies the action of warfarin in concurrent administration. Monitor prothrombin time and make an adjustment of anticoagulant doses.
ADVERSE EFFECTS: Frequent: nausea, vomiting, diarrhea, colic. A temporary increase in transaminases.
Less frequent: headache, fever, eosinophilia, anaemia, leukopenia. Tachycardia. Rash, itching, phlebitis. Joints pain, joint swelling.
Rare: anaphylactic reaction or anaphylaxis. Hemolytic anemia, leukocytosis, thrombocythemia, changes in prothrombin concentration, insomnia, depression. Vision, hearing, taste and smell disturbances. Pseudomembranous colitis. Mucocutaneous syndromes, Lyell's syndrome, erythema. Hepatitis, obstructive jaundice.  Joint pains, tendinitis (Achilles tendon) and paratenonitis. Renal impairment, interstitial nephritis. Photosensitivity  involving areas exposed to sunlight, difficulty in breathing, bronchospasm. Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: Apply these following methods in case of ingestion of a large dose: induction of emesis, gastric lavage, diuresis. Patients should be monitored carefully and given supportive treatment such as enough infusion.
DOSAGE & ADMINISTRATION: The drug should be orally taken with a lot of water and given 2 hours after meals.
Adults: 500 mg twice daily for 7-14 days.
Uncomplicated acute urinary tract infections: 250 mg twice daily for 3 days. Acute sinusitis: 500 mg twice daily for 10 days.
Or as directed by the physician.
Read the directions carefully before use.   Shelf-life: 36 months from the manufacturing date.
Consult the physician for more information.  Storage conditions: Store in dry places, not exceeding 30oC; protect from light.
This drug is for prescriptions only.   Specifications: Manufacturer's.

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