RiteMED Finasteride

Finasteride Tablets BP 5 mg: Blue coloured, circular, biconvex beveled edged film coated tablets, debossed with 'E' on one side and '61' on the other side.
Each film-coated tablet contains: Finasteride 5 mg.
Excipients/Inactive Ingredients: Lactose Monohydrate, Microcrystalline Cellulose, Sodium Starch Glycolate, Pregelatinised Starch, Docusate Sodium, Magnesium Stearate and Opadry Blue.

5-Alpha Reductase Inhibitor.
Pharmacology: Pharmacodynamics: Finasteride is a competitive inhibitor of human 5α-reductase, an intracellular enzyme which metabolizes testosterone into the more potent androgen, dihydrotestosterone (DHT). In benign prostatic hyperplasia (BPH), enlargement of the prostate gland is dependent upon the conversion of testosterone to DHT within the prostate. Finasteride is highly effective in reducing circulating and intraprostatic DHT. Finasteride has no affinity for the androgen receptor.
Pharmacokinetics: Finasteride is absorbed following oral administration, and peak plasma concentrations are achieved in 1 to 2 hours. The mean terminal half-life is about 6 hours in patients under 60 years of age but may be prolonged to about 8 hours in those 70 years of age or older.

Finasteride is indicated for the treatment and control of benign prostatic hyperplasia (BPH) in patients with an enlarged prostate to: Cause regression of the enlarged prostate, improve urinary flow and improve the symptoms associated with BPH.
Reduce the incidence of acute urinary retention and the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.

The recommended adult dose is one 5 mg tablet daily, with or without food.
Finasteride can be administered alone or in combination with the alpha-blocker doxazosin.
Although early improvement in symptoms may be seen, treatment for at least six months may be necessary to assess whether a beneficial response has been achieved. Thereafter, treatment should be continued long term.
No dosage adjustment is required in the elderly or in patients with varying degrees of renal insufficiency (creatinine clearances as low as 9 mL/min).

No specific treatment of overdosage with Finasteride is recommended.

Hypersensitivity to any component of this product; women who are or may potentially be pregnant; children.

Finasteride should be used with caution in men with hepatic impairment. When used for benign prostatic hyperplasia, finasteride should be used with caution in men at risk of obstructive uropathy. Patients should be evaluated for prostatic carcinoma before and during therapy. Use of finasteride decreases concentrations of serum markers of prostate cancer such as prostate specific antigen (PSA) by up to 50% even when cancer is present, and reference values should be adjusted accordingly; the ratio of free to total PSA (percent free PSA) remains constant. Studies in animals suggest finasteride could produce feminisation (hypospadias) of a male fetus if used in pregnant women; therefore its use is contraindicated in women who are or may become pregnant. In addition, it is recommended that women in this category should not handle crushed or broken finasteride tablets. Finasteride has been detected in semen, therefore use of a condom is recommended if the patient's sexual partner is, or may become, pregnant.
Effects on ability to drive and use machines: None known.

Pregnancy: Finasteride is contraindicated in women who are or may potentially be pregnant. Because of the ability of Type II 5α-reductase inhibitors to inhibit testosterone to dihydrotestosterone, these drugs, including finasteride, may cause abnormalities of the external genitalia of a male foetus when administered to a pregnant woman.
Lactation: Finasteride is not indicated during lactation.

The most commonly reported adverse effects of finasteride are decreased libido, impotence, ejaculation disorders, and reduced volume of ejaculate.
Breast tenderness and enlargement (gynaecomastia) may occur, and there have been reports of hypersensitivity reactions such as swelling of the lips and face, pruritus, urticaria, and rashes. Testicular pain has also been reported.
Finasteride is well tolerated, adverse reactions usually have been mild and transient.

No clinically important drug interactions have been identified. Finasteride does not appear to significantly affect the cytochrome P450-linked drug metabolizing enzyme system. Compounds which have been tested in man include propranolol, digoxin, glibenclamide, warfarin, theophylline, and antipyrine and no clinically meaningful interactions were found.
Other concomitant therapy: Although specific interaction studies were not performed in clinical studies, Finasteride was used concomitantly with ACE inhibitors, alpha-blockers, beta-blockers, calcium channel blockers, cardiac nitrates, diuretics, H2 antagonists, HMG-CoA reductase inhibitors.
Non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin and paracetamol, quinolones and benzodiazepines without evidence of clinically significant adverse interactions.

Store at temperatures not exceeding 30°C.

Drugs for Bladder & Prostate Disorders

G04CB01 - finasteride ; Belongs to the class of testosterone-5-alpha reductase inhibitors. Used in the treatment of benign prostatic hypertrophy.

Rx