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- PROSCAR TABLET 5 MG [SIN07513P]
PROSCAR TABLET 5 MG [SIN07513P]
Active ingredients: PROSCAR TABLET 5 MG
Product Info
PROSCAR TABLET 5 MG
[SIN07513P]
Product information
Active Ingredient and Strength | FINASTERIDE - 5 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | AIAC INTERNATIONAL PHARMA, LLC - PUERTO RICO |
Registration Number | SIN07513P |
Licence Holder | ORGANON SINGAPORE PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | G04CB01 |
INDICATIONS
PROSCAR is 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.
PROSCAR 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 PROSCAR.
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.
CONTRAINDICATIONS
PROSCAR is not indicated for use in women or children.
PROSCAR 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).
