Mavifrem Cream 30gr Disposable Vaginal Applicator
Contains: Clindamycin, Ketoconazole
Vaginal antifungal and antibiotic
( Clindamycin and ketoconazole)
Each vaginal tablet contains:
Clindamycin phosphate equivalent to 100 mg
Ketoconazole 400 mg
Excipient c.b.p. 1 tablet.
Each 100 g of vaginal cream contains:
Clindamycin phosphate equivalent to 2 g
Ketoconazole 8 g
Excipient c.b.p. 100 g .
Each applicator with 5 g of cream containing 100 mg of clindamycin, and 400 mg of ketoconazole .
Each tablet contains:
Clindamycin phosphate equivalent to 100 mg
Ketoconazole 800 mg
Excipient c.b.p. 1 tablet.
INDICATIONS: MAVIFEM * is indicated for the treatment of bacterial vaginosis caused by Gardnerella vaginalis, Mobiluncus spp and other anaerobic bacteria such as Bacteroides fragilis , as well as in mixed vaginitis ( candidiasis and bacterial ) and vaginal candidiasis. Also is indicated as a preventive of premature rupture of membranes in pregnant women with vaginosis. Having the same clinical and bacteriological efficacy presentations 6 D and 3 D.
Pharmacokinetics MAVIFEM * is clindamycin plus ketoconazole , an association that provides comprehensive coverage of antibacterial and antifungal action , particularly effective in cases of mixed vaginal infections ( candidiasis and bacterial ) which are one of the most common causes of vaginitis in women in adulthood.
Clindamycin : The antimicrobial spectrum of clindamycin covers most aerobic Gram positive cocci including Staphylococcus aureus , Streptococcus pyogenes , Streptococcus viridans and Streptococcus pneumoniae. It is active against most anaerobic and microaereofílicos negative microorganisms and gram- positive bacteria , including Bacteroides fragilis , Bacteroides melaninogenicus , Mobiluncus spp , Actinomyces , Eubacterium , Fusobacterium , Propionibacterium , Peptococcus , Peptostreptococcus , Prevotella , Veillonella , Clostridium perfringens , Clostridium tetani , Corynebacterium diphtheriae and Mycoplasma . Some strains of Neisseria gonorrhoeae Haemophilus influenzaey may be inhibited by clindamycin. Clindamycin is active in vitro and in vivo , and such action is primarily bactericidal . Clindamycin concentrations between 0.04 to 0.4 mg / mL , inhibited most deStaphylococcus susceptible strains , Streptococcus , Corynebacterium diphtheriae , and Actinomyces , and the minimal inhibitory concentration for most bacteria and anaerobic microaereofílicas is 0.1 to 4 mg / mL .
Clindamycin phosphate is inactive until hydrolyzed to give free clindamycin. Clindamycin act on bacteria by inhibiting protein synthesis , it binds to the 50 S subunit of the ribosome and acts in two ways : by preventing the binding of the amino - transfer RNA to the ribosome complex , and inhibiting the translocation mechanism .
Clindamycin applied topically has a very poor rate of systemic absorption of the serum concentrations are ( 0-3 ng / mL ) there is no data available on blood concentrations when administered vaginally. Lacking systemic absorption administered vaginally, clindamycin is not metabolized and eliminated by the mechanisms of self-purification of vagina.
Ketoconazole is a synthetic imidazole derivative , whose primary pharmacological action is antifungal , but also has in vitro activity against some Gram -positive bacteria , including Staphylococcus aureus and S. epidermidis. Its action mainly fungicide out against Candida albicans, with a minimum inhibitory concentration ranging between 1 and 16 mg / mL . Ketoconazole has shown efficacy in the treatment of vaginal candidiasis, vaginal either topical or oral therapy, and to date , has not been demonstrated in vitro and in vivo development of fungal resistance.
Ketoconazole has fungicide to produce distortion of cell morphology by modification of the membrane and increased permeability of the vital elements escape action, which results in metabolic disorders and cellular necrosis of fungi. This action is performed because ketoconazole inhibits citocrómicas P450 enzymes in fungi and prevents the conversion of lanosterol to ergosterol in the fungal cell membrane .
In addition , inhibits cytochrome oxidase C - peroxidase enzymes. Moreover, low concentrations of ketoconazole ( 0.01 mg / mL ) Candida albicansforme prevent pseudohyphae , and this effect increases phagocytosis by polymorphonuclear fungus since these more easily phase cells phagocytose yeast mycelial phase .
The pharmacokinetics of ketoconazole information available locally applied vaginally, indicating that systemic absorption is negligible . By this route of administration, peak plasma concentration ranging from undetectable to 20.7 ng / mL is reached. Because ketoconazole vaginally applied hardly reach the circulation , and does not undergo biotransformation is eliminated by the self-purifying mechanisms of the vagina. Concentrations of 800 mg of ketoconazole FEMISAN * 3 D do not alter their clinical and microbiological effectiveness , only accelerate the clinical response to 3 days.
CONTRAINDICATIONS : Known hypersensitivity to the components of the formula.
WARNINGS: Prolonged use of any medicine topically can cause hypersensitivity. During pregnancy, should be used in preference FEMISAN * Tablets or cream without using the applicator.
RESTRICTIONS OF USE DURING PREGNANCY AND LACTATION : There are no restrictions on use during pregnancy and lactation.
ADVERSE REACTIONS : * MAVIFEM , exclusively for its topical action , is free of undesirable systemic side effects. However, it can cause in susceptible individuals , dryness of the vaginal mucosa, vulvar irritation and itching , which disappear with cessation of treatment .
DRUG INTERACTIONS : No described .
CHANGES IN RESULTS OF LABORATORY TESTS : No reported .
PRECAUTIONS IN RELATION TO EFFECTS Carcinogenesis, Mutagenesis , Impairment of Fertility : Toxicity of clindamycin and ketoconazole vaginally is irrelevant, since the drugs have no significant absorption. In vitro studies using clindamycin and ketoconazole have shown that drugs are mutagenic . In long-term studies in rats and mice , both clindamycin and ketoconazole have not been shown to be carcinogenic , teratogenic, or effects on fertility.
DOSAGE AND ADMINISTRATION: The usual dose of MAVIFEM * 6 D is one tablet or applicator with 5g of deep vaginal cream once a day , preferably at bedtime , for 6 consecutive days . FEMISAN * 3 D one tablet deep vaginally once a day at bedtime for 3 days. The shape of both tablets as 3 6 D D are pyriform borderless injuring the vaginal wall.
MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR ACCIDENTAL INGESTION : Not informed about the occurrence of overdose with this product .
Presentation MAVIFEM vaginal cream * is box tube 30g vaginal cream and six disposable applicators , wherein an applicator 5 g of cream containing 100 mg of clindamycin with 400 mg of ketoconazole .
RECOMMENDED STORAGE: Store at room temperature not more than 30 ° C.
- Drug Name: MAVIFEM
- Comparable drug patent: FEMISAN
- Active ingredient: Clindamycin / Ketoconazole
- Presentation: VAGINAL CREAM
- Concentration: 2mg/8mg
- Laboratory MAVI
- CASE: WITH 30GR 6 DISPOSABLE VAGINAL APPLICATOR
- Made in: Mexico