Neo-Penotran Forte

Neo-Penotran Forte

Manufacturer:

Exeltis

Distributor:

DKLL

Marketer:

Exeltis
Concise Prescribing Info
Contents
Metronidazole 750 mg, miconazole nitrate 200 mg
Indications/Uses
Candidal vulvovaginitis due to Candida albicans, bacterial vaginosis, trichomonal vaginitis due to Trichomonas vaginalis & mixed vag infections.
Dosage/Direction for Use
Insert 1 supp high into the vag at night for 7 days. Recurrent cases Insert 1 supp at night for 14 days.
Contraindications
Hypersensitivity. Patients using alcohol during or w/in 3 days after treatment; disulfiram during treatment or w/in 2 wk. Porphyria, epilepsy, serious liver function disorders. 1st trimester of pregnancy. Pregnant women w/ trichomonal vaginitis in 1st trimester.
Special Precautions
Not to be swallowed or applied by other routes. Disulfiram-like reaction w/ alcohol intake. Peripheral neuropathy & convulsion w/ high doses & long term use. Not to be used in virgins & not sexually mature young girls. Not to be used w/ contraceptive diaphragms & preservatives; other vag products eg, tampon, douche or spermicide during treatment. Sexual partners w/ Trichomonas vaginalis should be treated at the same time. May affect ability to drive & use machines. Hepatic encephalopathy. Women of childbearing potential should avoid pregnancy w/ proper birth control method. Not to be used during 1st trimester of pregnancy. Discontinue lactation during treatment; restart lactation 24-28 hr after end of treatment. Not to be used in childn <18 yr.
Adverse Reactions
Vag discharge. Dizziness, headache; vaginitis, vulvovag irritation, pelvic discomfort.
Drug Interactions
Metronidazole: Alcohol intolerance (disulfiram-like reaction) w/ alcohol. Increased risk of cardiotoxicity w/ amiodarone. Inhibited metabolism & increased plasma conc of astemizole & terfenadine. Increased carbamazepine blood conc. Increased blood level & risk of neurologic side effects w/ cimetidine. Increased risk of cyclosporine toxicity. CNS related effects w/ disulfiram. Increased blood levels & toxicity of lithium; fluorouracil. Increased blood levels w/ phenytoin & oral anticoagulants. Decreased blood levels w/ phenobarb. Interference w/ blood levels of liver enzymes, glucose (hexokinase method), theophylline & procainamide. Miconazole nitrate: Increased bleeding risk w/ acenocoumarol, anisindione, dicumarol, phenindione, phenprocoumon & warfarin. Inhibited metabolism & increased plasma conc of astemizole, cisapride & terfenadine. Decreased carbamazepine metabolism. Increased cyclosporine toxicity risk. Increased or prolonged opioid effects of fentanyl. Increased toxicity of phenytoin, fosphenytoin; trimetrexate. Increased hypoglycemic action of glimepiride. Increased plasma conc or exposure to oxybutynin. Increased plasma conc & reduced clearance of oxycodone. Increased risk of cardiotoxicity w/ pimozide. Increased tolterodine bioavailability in patients w/ deficient CYP450 2D6 activity.
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
Neo-Penotran Forte pessary
Packing/Price
7's
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