Adult: For mixed infections caused by Trichomonas vaginalis and Candida albicans: Insert 1 vaginal tablet/ovule or 1 applicatorful of vaginal cream daily, preferably at bedtime, for 10 days. May repeat for 10 more days if infection is still not completely eliminated, oral metronidazole may be concomitantly given.
Hypersensitivity to metronidazole and other imidazoles and to nystatin. Lactation.
Patient with Cockayne syndrome, peripheral and central nervous system diseases, hepatic encephalopathy. Severe hepatic impairment. Pregnancy.
Significant: Central or peripheral neuropathy, dark urine discolouration; superinfection such as Clostridium difficile-associated diarrhoea and pseudomembranous colitis (prolonged use). Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, xerostomia, metallic taste. Nervous system disorders: Headache, dizziness. Reproductive system and breast disorders: Vaginal pruritus, burning and granular sensation and discharge; vaginitis UTI.
Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery. This drug decreases effectivity of condoms and diaphragms, if needed, use other forms of contraception. May cause dark urine discolouration. Avoid use of menstrual tampons and of soaps with an acidic pH.
Monitor LFT before, during and after treatment (until normal); total and differential leukocyte count before and after treatment; for signs and symptoms of peripheral or central neuropathy.
Metronidazole: Psychotic reactions with disulfiram. May cause toxicity of busulfan, 5-fluorouracil. May cause increased exposure to ciclosporin, lithium. Increased anticoagulant effect of warfarin. Decreased effectivity with phenobarbital, phenytoin. May diminished therapeutic effect of progesterone. May cause a disulfiram-like reaction with lopinavir.
Disulfiram-like reaction with alcohol.
Description: Metronidazole is a 5-nitroimidazole antiprotozoal agent. It binds to the deoxyribonucleic acid (DNA) of the causative organism causing disruption in its structure and thereby, inhibiting protein synthesis and causing apoptosis.
Nystatin is a polyene antifungal agent. It binds to the sterols of the fungal cell membrane thereby changing its permeability and causing leakage of cellular contents. Pharmacokinetics: Absorption: Metronidazole: Poorly absorbed after vaginal administration. Bioavailability: Approx 20-25%. Distribution: Metronidazole: Widely distributed in most body tissues and fluids e.g. bile, bone, cerebral abscess CSF, liver, saliva, seminal fluid, and vaginal secretions. Crosses the placenta and enters breast milk. Plasma protein binding: <20%. Metabolism: Metronidazole: Metabolised in the liver via oxidation and glucuronidation into metabolites including 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole and 2-methyl-5-nitroimidazole-1-acetic acid. Excretion: Metronidazole: Mainly via urine (60-80% as unchanged drug and metabolites; approx 20% of total as unchanged drug); faeces (6-15%). Elimination half-life: Approx 8 hours.