Metroren- 250 Tablets

PHARMACOLOGY
This nitro group of metronidazole is reduced in anaerobic bacteria and protozoa by the pyruvate phosphoroclastic reaction, in which the drug acts as a preferential electron acceptor. It has been assumed that the product of reduction of the nitro group of metronidazole interacts with the DNA with ultimate inhibition of nucleic acid synthesis and subsequent cell death. Moreover metronidazole has been shown to inhibit DNA synthesis and degrade existing DNA in Clostridium bifermentans.
PHARMACOKINETICS
Metronidazole is rapidly and almost completely absorbed on administration; peak plasma concentrations occur after 20 minutes to 3 hours. The half-life of metronidazole is 8.5 ± 2.9 hours. Metronidazole can be used in chronic renal failure; it is rapidly removed from the plasma by dialysis. Metronidazole is excreted in breast milk but the intake of a suckling infant of a mother receiving normal dosage would be considerably less than the therapeutic dosage for infants.
INDICATIONS
Symptomatic Trichoniasis, asymptomatic Trichomoniasis, intestinal amoebiasis, amoebic liver abscess, anaerobic bacterial infections, intra-abdominal infections, skin and skin structure infections, Central Nervous System (CNS) infections, lower respiratory tract infections, Endocarditis.
DOSAGE AND ADMINISTRATION
Trichomoniasis:
Adults: 250 mg every 8 hours for 7 days or 400-500 mg every 12 hours for 5-7 days or 2 g as a single dose.
Children:
1-3 years: 50 mg every 8 hours for 7 days
3-7 years: 100 mg every 12 hours
7-12 year: 100 mg every 8 hours
AMOEBIASIS
Adults:
For acute intestinal amoebiasis (acute amoebic dysentery): 750 mg orally three times daily for 5 to 10 days.
For amoebic liver abscess: 500 mg or 750 mg orally three times daily for 5 to 10 days.
Pediatric patients: 35 to 50 mg/kg/24 hours, divided into three doses, orally for 10 days.
Anaerobic Bacterial Infections
The usual adult oral dosage is 7.5 mg/kg every six hours (approx. 500 mg for a 70-kg adult).
A maximum of 4 g should not be exceeded during a 24-hour period.
SIDE EFFECTS
Nausea, vomiting, unpleasant taste, furred tongue, and gastrointestinal disturbances, rashes, rarely drowsiness, headache, dizziness, ataxia, darkening of urine, erythema multiforme, pruritus, urticaria, angioedema, and anaphylaxis; also reported abnormal liver function tests, hepatitis, jaundice, thrombocytopenia, aplastic anaemia, myalgia, arthralgia; on prolonged or intensive therapy peripheral neuropathy, transient epileptiform seizures, and leucopenia.
WARNINGS
Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paraesthesia of an extremity, have been reported in patients treated with metronidazole. Metronidazole should be administered with caution to patients with central nervous system diseases.
CONTRAINDICATIONS
Metronidazole is contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives. In patients with trichomoniasis,
metronidazole is contraindicated during the first trimester of pregnancy.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Patients should be warned about the potential for drowsiness, confusion, dizziness, hallucinations,
Convulsions or transient visual disorders, and advised not to drive or operate machinery if these symptoms occur.
PREGNANCY AND LACTATION
There is inadequate evidence of the safety of metronidazole in pregnancy, but it has been in wide use for many years without apparent ill consequence. Nevertheless metronidazole should not be given during pregnancy or during lactation unless the physician considers it essential; in these circumstances the short, high-dose regimens are not recommended.
PRESENTATION
Jar of 1000 Uncoated Tablets
Blister pack of 10×10 Tablets.
STORAGE
Store in a cool, dry place below 30oC
Protect from light, Keep out of reach of children.