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Gynomax

Gynomax

Manufacturer:

Exeltis Ilac San Ve Tic AS

Distributor:

Exeltis
Concise Prescribing Info
Contents
Tinidazole 300 mg, tioconazole 200 mg, lidocaine 100 mg
Indications/Uses
Candidal vulvovaginitis caused by Candida albicans, bacterial vaginosis caused by Gardnerella vaginalis & anaerobic bacteria, trichomonal vaginitis caused by Trichomonas vaginalis, & mixed vag infections.
Dosage/Direction for Use
Adult & elderly >65 yr Insert 1 supp high into the vag at night for 3 days.
Contraindications
Hypersensitivity to tioconazole, tinidazole, lidocaine or their derivatives. Patients w/ organic neurologic disorders; current picture or history of blood dyscrasia. 1st trimester of pregnancy. Lactation.
Special Precautions
Not to be swallowed or applied by other routes. Administration during menstruation is not recommended. Transient leukopenia & neutropenia may develop. Warn patients not to take alcohol during therapy & for 3 days after end of a treatment course. Should not be used in virgins & in young girls who are not sexually mature. Must not be used w/ contraceptive diaphragms & condoms or other vag products (eg, tampon, douche or spermicide) during treatment. Sexual partners w/ Trichomonas vaginalis should be treated at the same time. Patients w/ CV disorders; hepatic &/or renal failure. Avoid pregnancy. Usage during 2nd & 3rd trimesters must be evaluated according to benefits/risks ratio; not to be used during pregnancy unless clearly necessary. Should not be used in childn <12 yr.
Adverse Reactions
Weakness, fatigue, malaise, headache, dizziness; metallic/bitter taste, nausea, anorexia, loss of appetite, flatulence, dyspepsia, abdominal cramp, epigastric discomfort, vomiting, constipation; darkened urine.
Drug Interactions
Tinidazole: Increased bleeding risk w/ acenocoumarol, anisindione, dicoumarol, phenindione, phenprocoumon, warfarin. Decreased efficacy w/ cholestyramine; CYP3A4 inducers. Increased plasma conc w/ cimetidine; ketoconazole. Increased levels of cyclosporine; tacrolimus. CNS-related effects (eg, psychotic reactions) w/ disulfiram. Increased plasma levels of fluorouracil & signs of a potential fluorouracil intoxication (granulocytopenia, anemia, thrombocytopenia, stomatitis, vomiting). Increased toxicity of fosphenytoin &/or decreased plasma conc of tinidazole w/ fosphenytoin. Increased plasma conc of lithium & signs of lithium intoxication (weakness, shaking, polydipsia, confusion). Decreased plasma conc w/ phenobarb; rifampin. Increased potential phenytoin intoxication &/or decreased plasma conc of tinidazole w/ phenytoin. Increased risk of adverse reactions w/ CYP3A4 inhibitors eg, cimetidine & ketoconazole. Tioconazole: Increased plasma conc & decreased clearance of oxycodone. Lidocaine: Decreased plasma clearance w/ propranolol; cimetidine. Increased lidocaine toxicity w/ antiarrhythmic products. Decreased plasma level of phenytoin or barbiturates.
MIMS Class
Preparations for Vaginal Conditions
ATC Classification
G01AF20 - combinations of imidazole derivatives ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.
Presentation/Packing
Form
Gynomax vag supp
Packing/Price
3's
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