Microsoft word - metrogyl plus_insert_eng

The instruction on use of medicinal product

METROGYL® PLUS vaginal gel
International non-proprietary name: Metronidazole + Clotrimazole

Composition
Active ingredients: One gram of gel contains: Metronidazole 10 mg, Clotrimazole 20 mg.
Auxiliary substances: methylhydroxy benzoate, propylhydroxy benzoate, disodium edetate, carbomer-940,
benzyl alcohol, sodium hydroxide, purified water.
Pharmacotherapeutic group
Antimicrobial drug combination for topical administration.

ATC code: G01AF20
Pharmacological action
Pharmacodynamics
This is a combination formulation for intravaginal use and the effectiveness is based on the presence of two
components in the composition: metronidazole and clotrimazole.
Metronidazole has high activity against protozoa: Entamoeba histolytica, Giardia lamblia, Trichomonas
vaginalis as well as gram-negative anaerobes: Bacteroides fragilis, Fusobacterium spp., Prevotella (P.bivia,
P.buccae, P.disiens), Gardnerella vaginalis and some gram-positive micro-organisms: Clostridium
perfringens, Clostridium difficile, Peptococcus spp., Peptostreptococcus spp.
Clotrimazole is an imidazole derivative. It has fungicidal and bactericidal action. It retards the biosynthesis of
ergosterol, which regulates the permeability of the cellular wall in micro-organisms. The drug has high activity
against the following fungi: Blastomyces dermatitidis, Candida spp., Coccidioides immitis, Cryptococcus
neoformans, dermatophytes: Histoplasma capsulatum, Paracoccidioides brasiliensis, Sporothrix schenckii;
protozoa: Trichomonas vaginalis; gram-positive bacteria: Escherichia coli, Streptococcus spp.,
Staphylococcus spp., Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae.
Pharmacokinetics
After intravaginal application, metronidazole is absorbed systemically. The relative bioavailability of vaginal
gel is double that of a single dose of vaginal tablets of metronidazole. The drug passes into breast milk and a
majority of tissues; it passes through the haematoencephalic barrier and the placenta. The absorbed
metronidazole passes through the placenta and the hematoencephalic barrier. The time to reach maximum
concentration is 6-12 hours. Binding with plasma proteins is less than 20%. About 60-80% of the dose
having systemic action is excreted by the kidneys, while 6-15% of the dose having systemic action is
excreted by the intestines.

Indications
Bacterial vaginosis of different etiologies confirmed through clinical and micro-biological analyses; candidial
vulvitis and vulvovaginitis, urogenital trichomoniasis.

Contraindications
Hypersensitivity to components of the formulation;
Leucopoenia (including history of leucopoenia);
Organic disorders of the central nervous system (including epilepsy);
Hepatic insufficiency;
1st trimester of pregnancy.
Drug interaction
The drug induces intolerance for ethanol, like disulfiram.
It potentiates the action of indirect anticoagulants; not recommended in combination with non-depolarising
myorelaxants (vecuronium).
Simultaneous use with lithium formulations may increase the plasma concentration of lithium.
Phenobarbital accelerates metabolism of metronidazole through induction of microsomal enzymes in the
liver; cimetidine retards metabolism of the drug.
Amphotericin B, nystatin and natamycin reduce the efficacy of clotrimazole when used concurrently.
Avoid contact with the eyes.
Special warnings
The drug can be used in the second and third trimesters of pregnancy if strictly indicated and only under
medical supervision (without use of applicator). Breast feeding should be discontinued if the drug is used
during lactation. Only for intravaginal use. Sexual intercourse should be avoided during the course of
treatment!
Directions for use and dosage
Intravaginal. The recommended dose is 5 g (one full applicator) twice daily (morning and evening).
Adverse effects
Local reactions: burning sensation or frequent urination, vulvitis; burning sensation or irritation of the penis in
the sexual partner.
There may be development of systemic effects: dizziness, headache, nausea and spasmodic abdominal
pain.
Allergic reactions: skin rash, urticaria.
If any adverse side effects occur, discontinue the treatment and consult the physician.

Presentation
20g or 30g gel in aluminium or plastic laminated tube. One tube and applicator with PIL in cardboard
packing.
Storage conditions
Store at a temperature below 25ºС away from direct sunlight. Keep out of the reach of children.

Expiry date
2 years.
Do not use after expiry date.

Release form drugstores
Under the recipe.
Manufacturer:

Unique Pharmaceutical Laboratories
(Division of J.B.Chemicals and Pharmaceuticals Ltd)
India, Mumbai 400 030, Worli, Hind Cycle Road, Neelam Center
® - registered trade mark
«ТЕТRADA» LTD.
AZ1102; 14, 20Yanvar street; Baku, Azerbaijan
Tel.: (+994 12) 431-59-24, 431-05-41
Fax: (+994 12) 430-80-51
Е-mail: info@tetrada-az.com www.tetrada-az.com

Source: http://www.tetrada-az.com/eng/wp-content/uploads/2012/06/Metrogyl-Plus_insert_eng.pdf