Metronidazole + Miconazole Nitrate
Therapeutic Class: Drugs used in Vaginal and Vulval condition
Indications:
Vaginal treatment of female urogenital trichomonas infection, prevention & local therapy of candidiasis.
Description:
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 in a 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.
Interaction:
Metronidazole: Disulfiram-like reaction with alcohol. The 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, diarrhea, anorexia and flushing, hepatitis. Local irritation and sensitization, 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 the 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
Indications:
Vaginal treatment of female urogenital trichomonas infection, prevention & local therapy of candidiasis.
Description:
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 in a 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.
Interaction:
Metronidazole: Disulfiram-like reaction with alcohol. The 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, diarrhea, anorexia and flushing, hepatitis. Local irritation and sensitization, 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 the 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
Storage:
Keep protected from light. Keep medicines out of the reach of children. Do not use it later than the date of expiry.
Keep protected from light. Keep medicines out of the reach of children. Do not use it later than the date of expiry.