FINCAR Tablet Ref.[50462] Active ingredients: Finasteride

Source: Web Search  Revision Year: 2019 

1. Indications and Usage

Benign prostatic hypertrophy only.

Limitations of use: Finasteride is not approved for the prevention of prostate cancer.

2. Dosage and Administration

FINCAR may be administered with or without meals.

Monotherapy

The recommended dose of FINCAR is one tablet (5 mg) once a day, with or without meals.

Combination with Alpha-Blocker

The recommended dose of FINCAR tablet is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin.

10. Overdosage

Patients have received single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for 3 months without adverse effects. Until further experience is obtained, no specific treatment for an overdose with finasteride can be recommended.

Significant lethality was observed in male and female mice at single oral doses of 1500 mg/m² (500 mg/kg) and in female and male rats at single oral doses of 2360 mg/m² (400 mg/kg) and 5900 mg/m² (1000 mg/kg), respectively.

16.2. Storage and Handling

Store at a room temperature below 30°C. Protect from light and keep container tightly closed. Women should not handle crushed or broken finasteride tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus.

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