Ametrol-VT Vaginal Tablet

Metronidazole + Miconazole Nitrate

Indications

Vaginal treatment of female urogenital trichomonas infection, prevention & local therapy of candidiasis.

Pharmacology

Metronidazole is converted to reduction products that interact with DNA to cause destruction of helical DNA structure and strand leading to a protein synthesis inhibition and cell death in susceptible organisms. It is active against most anaerobic protozoa, some gm+ve, gm-ve and facultative anaerobes.

Miconazole inhibits ergosterol synthesis thus damaging fungal cell wall membrane and increases its permeability, allowing leakage of nutrients.

Dosage & Administration

In trichomoniasis, concurrently with oral metronidazole treatment and 1 vaginal tablet should be inserted high up into the vagina once a day (preferably before going to bed at night) for 10 days. Long-term recovery may be expected only is response to the simultaneous oral treatment of both partners.

In candidiasis or other fungal infections, 1 vaginal tablet has to be inserted high up into the vagina for 10 days. The vaginal tablet should be slightly moistened before application.

* চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন‘

Interaction

Metronidazole: Disulfiram-like reaction with alcohol. Increased oral anticoagulant effect, blood levels of phenytoin, lithium toxicity, plasma cone of astemizole & terfenadine; blood cone of carbamazepine. Decreased blood levels with phenobarb. Risk of CNS-related effects (eg psychotic reactions) with disulfiram. Increased blood levels & neurologic effects with cimetidine. May increase blood levels & toxicity of fluorouracil; toxicity of cyclosporine. Increased cardiotoxicity with amiodarone. Interference with blood levels of liver enzymes, glucose (hexokinase method), theophylline & procainamide. Decreased levels with phenytoin.

Miconazole: Increased risk of bleeding with acenocoumarol, anisindione, dicumarol, phenindione, phenprocoumon, warfarin; plasma cone & exposure to oxybutinin.

May increase risk of phenytoin, phosphenytoin, cyclosporine, trimetrexate toxicity & cardiotoxicity with pimozide. May inhibit metabolism of astemizole, cisapride & terfenadine. Reduced carbamazepine metabolism. Increased or prolonged effects of opioid (fentanyl). May cause hypoglycemia with glimepiride. Reduced clearance & increased plasma cone of oxycodone. May increase bioavailability of tolterodine (in patients with deficient CYP2D6 activity).

Contraindications

Hypersensitivity; hepatic impairment (oral gel). Porphyria.

Side Effects

Nausea, vomiting, febrile reactions, rash, drowsiness, diarrhoea, anorexia and flushing, hepatitis. Local irritation and sensitisation, contact dermatitis.

Pregnancy & Lactation

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Precautions & Warnings

For external use only; discontinue if sensitization or irritation occurs. Pregnancy and lactation

Therapeutic Class

Drugs used in Vaginal and Vulval condition