Limenda vaginal suppositories №7

Description

Limenda Composition

active ingredients: 1 suppository contains 750 mg of metronidazole and 200 mg of miconazole nitrate
excipients: witepsol S55.

Limenda Dosage form

Vaginal suppositories.

Limenda Basic physical and chemical properties:

yellowish-white torpedo-shaped suppositories.

Pharmacological group

Antimicrobial and antiseptic agents used in gynecology. Combinations of imidazole derivatives. ATX code G01A F20.

Pharmacological properties

Pharmacodynamics.

Limenda is a combined antimicrobial drug, the action of which is due to metronidazole and miconazole, which are part of it.

Miconazole provides antifungal effect, and metronidazole causes an antibacterial and antichomonas drug effect. Miconazole nitrate is broad-spectrum and is particularly effective against pathogenic fungi, including C. albicans. In addition, miconazole nitrate is effective against gram-positive bacteria. Metronidazole is an antibacterial and antiprotozoal agent. It is effective against Gardnerella vaginalis and anaerobic bacteria including anaerobic streptococci and Trichomonas vaginalis.

Pharmacokinetics.

The absorption of miconazole nitrate through the vaginal wall is insignificant (about 1.4% of the dose). The bioavailability of metronidazole when administered vaginally is 20% compared to its bioavailability when administered orally. Miconazole nitrate is not detected in blood plasma with vaginal administration of Lemend’s suppositories. The equilibrium concentration of metronidazole in blood plasma is 1.6-7.2 mg / ml. Metronidazole is metabolized in the liver. Hydroxymetabolite is an active substance. The half-life of metronidazole is 6-11 hours. Approximately 20% of the dose is excreted in the urine unchanged.

Indications

For the local treatment of vaginal candidiasis, bacterial and trichomonas vaginitis and vaginitis caused by mixed infections.

Contraindications

Hypersensitivity to any of the active ingredients of the drug or to their derivatives, porphyria, epilepsy, severe liver dysfunction.

Interaction with other medicinal products and other types of interactions

Through the absorption of metronidazole, drug interaction reactions can be observed when used simultaneously with certain substances and drugs:

Alcohol: Interaction of metronidazole with alcohol can cause a reaction similar to that with disulfiram.

Oral anticoagulants may increase the anticoagulant effect.

Phenytoin: the concentration of phenytoin in the blood may increase, the concentration of metronidazole in the blood may decrease.

Phenobarbital: a decrease in the concentration of metronidazole in the blood.

Disulfiram: Central nervous system effects (psychotic reactions) may occur.

Cimetidine: the concentration in the blood of metronidazole may increase and the risk of neurotic symptoms may increase.

Lithium: There may be an increase in the toxic effects of lithium.

Astemizole and terfenadine: metronidazole and miconazole slow down the metabolism of these drugs and increase their plasma concentration.

An effect on the concentration of liver enzymes, glucose (hexokinase method), theophylline and procainamide was also observed.

Acenocoumarol, anisindione, dicumarol, fenindione, fenprocoumon warfarin: increase the risk of bleeding.

Amiodarone: increased risk of cardiotoxicity (prolonged QT interval, pirouette-type ventricular tachycardia, cardiac arrest).

Fluorouracil: Increased blood levels of fluorouracil and increased toxicity. Carbamazepine: an increase in the concentration of carbamazepine in the blood.

Cyclosporine: Increases the toxicity of cyclosporine.

Metronidazole can increase plasma levels of busulfan, which can lead to significant toxic effects of busulfan. It is necessary to monitor the level of prothrombin and INR (international normalized ratio) more often while using oral anticoagulants. It is recommended to adjust the dose of oral anticoagulants when using metronidazole and within 8 days after its cancellation.

Through the absorption of miconazole nitrate, drug interaction reactions can be observed when used simultaneously with certain substances and drugs.

Acenocoumarol, anisindione, dicumarol, fenindione, fenprocoumon warfarin: increased risk of bleeding.

Astemizole, cisapride and terfenadine: Miconazole slows down the metabolism of these drugs and increases their plasma concentrations.

Cyclosporine: increased risk of cyclosporine toxicity (renal dysfunction, cholestasis, paresthesia).

Fentanyl: enhancement or prolongation of the action of opioids (depression of the central nervous system, respiratory depression).

Phenytoin and phosphenytoin: increased risk of phenytoin toxicity (ataxia, hyperreflexia, nystagmus, tremor).

Carbamazepine decreases the metabolism of carbamazepine.

Glimepiride: increased hypoglycemic action.

Oxybutynin: an increase in the concentration of oxybutynin in plasma and an increase in its effect (dry mouth, constipation, headache).