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Indications/Uses
For the treatment of asymptomatic and symptomatic Trichomoniasis infection due to susceptible anaerobic, giardiasis (Gardia intestinalis), vaginalis and other protozoa including Entamoeba histolytica and live abscess.
Dosage/Direction for Use
Metronidazole is given in dose of 400 to 800 mg three day by mouth for 5-10 days.
Children: aged 1-3 years: may be given one-quarter; aged 3-7 years: one third; aged 7-10 years: one half-life the adult alternatively; 35 to 50 mg/kg body weight daily in divided does has been suggested or as prescribed by physician.
Children: aged 1-3 years: may be given one-quarter; aged 3-7 years: one third; aged 7-10 years: one half-life the adult alternatively; 35 to 50 mg/kg body weight daily in divided does has been suggested or as prescribed by physician.
Administration
Tab: Should be taken with food. Susp: Should be taken on an empty stomach: Take at least 1 hr before meals.
Contraindications
Lactation.
Warnings
Metronidazole has been shown to be carcinogenic in mice and possibly carcinogenic in rats. Unnecessary use of the drug should be avoided.
Special Precautions
Metronidazole should be used with great care in patients with blood dyscrasias or with active disease of the central nervous system. All patients receiving Metronidazole for more than 10 days should be monitored and treatment discontinued if signs of peripheral neuropathy or CNS toxicity develop. Doses should be reduced in patients with severe liver disease.
It is suggested that the use of Metronidazole should be avoided during pregnancy, especially the first trimester and especially high-dose regimens. Some authorities consider that women taking Metronidazole should not breast-feed their babies.
It is suggested that the use of Metronidazole should be avoided during pregnancy, especially the first trimester and especially high-dose regimens. Some authorities consider that women taking Metronidazole should not breast-feed their babies.
Adverse Reactions
The adverse effects of Metronidazole are generally dose-related. The most common are gastrointestinal disturbances, especially nausea and unpleasant metallic taste; nausea is sometimes accompanied by headache, anorexia and vomiting. Diarrhea, dry mouth a furred tongue, glossitis and stomatitis may also occur. There have been rare reports of antibiotic-associated colitis associated with metronidazole.
Peripheral neuropathy, usually presenting as numbness or tingling in the extremities and epileptiform seizures are serious adverse effects on the nervous system that have been associated especially with high doses of Metronidazole or prolonged treatment. Weakness, dizziness, ataxia, drowsiness, insomnia and change in mood or mental state as depression or confusion have also been reported.
Temporary moderate leucopenia may occur in some patients receiving Metronidazole. Skin rashes and pruritus occur occasionally and anaphylaxis has been reported rarely. Other side effects including urethral discomfort and darkening of the urine. Raised liver enzyme values have occasionally been reported. Thrombophlebitis may follow the intravenous administration of Metronidazole.
Studies have shown Metronidazole to be mutagenic carcinogenic in some animals.
Peripheral neuropathy, usually presenting as numbness or tingling in the extremities and epileptiform seizures are serious adverse effects on the nervous system that have been associated especially with high doses of Metronidazole or prolonged treatment. Weakness, dizziness, ataxia, drowsiness, insomnia and change in mood or mental state as depression or confusion have also been reported.
Temporary moderate leucopenia may occur in some patients receiving Metronidazole. Skin rashes and pruritus occur occasionally and anaphylaxis has been reported rarely. Other side effects including urethral discomfort and darkening of the urine. Raised liver enzyme values have occasionally been reported. Thrombophlebitis may follow the intravenous administration of Metronidazole.
Studies have shown Metronidazole to be mutagenic carcinogenic in some animals.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacokinetics: Metronidazole is readily absorbed following administration by mouth and bioavailability approaches 100%. Peak plasma concentrations of approximately 5 and 10 μg per mL are within 1 to 2 hours after single doses of 250 and 500 respectively. Some accumulation and consequently higher concentrations occur when multiple doses are given. Absorption may be delayed, but is not reduced over all by administration with food.
Following the intravenous administration of metronidazole, peak-steady steady state plasma concentrations of about 25 μg per mL with trough concentrations of about 18 μg per mL have been reported in patients given a loading dose of 15 mg per kg body weight followed by 7.5 mg per kg every 6 hours. The bioavailability of Metronidazole from rectal suppositories is 60 to 80%; peak plasma concentrations are half those with equivalent oral doses and occur after about 5 to 12 hours. Absorption from vaginal pessaries has been reported to be poor.
Metronidazole is widely distributed. It appears in most body tissue and fluid bile, bone, breast milk, cerebral abscesses, saliva, seminal fluid and vaginal secretions and achieves concentrations similar to those in plasma. No more than 20% is bound to plasma proteins.
The elimination half-life of Metronidazole is about 8 hours; that of the hydroxy metabolite is slightly longer. The half-life of Metronidazole is reported to be longer in neonates and in patients with severe liver disease; that of hydroxy metabolite is prolonged patients with renal failure.
Following the intravenous administration of metronidazole, peak-steady steady state plasma concentrations of about 25 μg per mL with trough concentrations of about 18 μg per mL have been reported in patients given a loading dose of 15 mg per kg body weight followed by 7.5 mg per kg every 6 hours. The bioavailability of Metronidazole from rectal suppositories is 60 to 80%; peak plasma concentrations are half those with equivalent oral doses and occur after about 5 to 12 hours. Absorption from vaginal pessaries has been reported to be poor.
Metronidazole is widely distributed. It appears in most body tissue and fluid bile, bone, breast milk, cerebral abscesses, saliva, seminal fluid and vaginal secretions and achieves concentrations similar to those in plasma. No more than 20% is bound to plasma proteins.
The elimination half-life of Metronidazole is about 8 hours; that of the hydroxy metabolite is slightly longer. The half-life of Metronidazole is reported to be longer in neonates and in patients with severe liver disease; that of hydroxy metabolite is prolonged patients with renal failure.
MedsGo Class
Other Antiprotozoal Agents / Other Antibiotics
Features
Brand
Medgyl
Full Details
Dosage Strength
125 mg / 5 ml
Drug Ingredients
- Metronidazole
Drug Packaging
Suspension 60ml
Generic Name
Metronidazole
Dosage Form
Suspension
Registration Number
DR-XY18460
Drug Classification
Prescription Drug (RX)