Regulatory Information
ACCORD HEALTHCARE PRIVATE LIMITED
ACCORD HEALTHCARE PRIVATE LIMITED
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**DOSAGE AND ADMINISTRATION** The recommended dosage is one 5 mg tablet daily with or without food. Dosage in renal insufficiency No adjustment in dosage is required in patients with varying degrees of renal insufficiency (creatinine clearances as low as 9 mL/min) as pharmacokinetic studies did not indicate any change in the disposition of finasteride. Dosage in the elderly No adjustment in dosage is required although pharmacokinetic studies indicated the elimination of finasteride is somewhat decreased in patients more than 70 years of age.
ORAL
Medical Information
**INDICATIONS** FINAINTAS tablets are indicated for the treatment and control of benign prostatic hyperplasia (BPH) and for the prevention of urologic events as it: - May reduce the risk of acute urinary retention - May reduce the risk of surgery including transurethral resection of the prostate (TURP) and prostatectomy. FINAINTAS tablets causes regression of the enlarged prostate, improves urinary flow and improves the symptoms associated with BPH. Patients with an enlarged prostate are the appropriate candidates for therapy with FINAINTAS tablets.
**CONTRAINDICATIONS** Finasteride is not indicated for use in women or children. Finasteride is contraindicated in the following: - Hypersensitivity to any component of this product. - Pregnancy – Use in women when they are or may potentially be pregnant (See PRECAUTIONS: PREGNANCY and EXPOSURE TO FINASTERIDE – RISK TO MALE FETUS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
G04CB01
finasteride
Manufacturer Information
ACCORD HEALTHCARE PRIVATE LIMITED
Intas Pharmaceuticals Limited
Active Ingredients
Documents
Package Inserts
Finaintas 5 Tablet PI.pdf
Approved: June 29, 2022