Prosta-One

A white round film-coated tablet plain on both sides.
Each film-coated tablet contains: Finasteride USP 5 mg.

Testosterone 5 Alpha-Reductase Inhibitor.
Pharmacology: Pharmacodynamics: Finasteride is synthetic 4-azasteroid compound. Finasteride is an inhibitor of Type II 5-alpha reductase, an intracellular enzyme which metabolises testosterone into the more potent androgen dihydrotestosterone (DHT). Finasteride has no affinity for the androgen receptor.
The development of the prostate hyperplasia (BHP) is dependent upon the conversion of testosterone to DHT within the prostate.
Finasteride reduces circulating and intraprostatic DHT. Within 24 hours after oral administration of Finasteride there is a significant reduction in circulating DHT levels as a result of the inhibition of 5-alpha reductase.
Pharmacokinetics: Following an oral dose of C-Finasteride in humans, the bioavailability is approximately 80% and is not affected by food.
Maximum Finasteride plasma concentrations are reached about 2 hours after dosing and the absorption is complete after 6 to 8 hours. Protein binding is approximately 93%, plasma clearance about 165 mL/min and the volume of distribution, 76 litres. Finasteride displays a mean plasma.
Elimination half-life of approximately 6 hours (4-12 hours) in subjects 46-60 years of age and approximately 8 hours in men 70 years of age and older.
Two metabolites of Finasteride have been identified which possess only a small fraction of the 5-alpha reductase inhibitory activity of Finasteride. 36% of the dose is excreted in the urine in the form of metabolites and 57% of the total dose is excreted in the feces.

Finasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarge prostate to: Improve urinary flow and improve the symptoms associated with BPH by causing regression of enlarge prostate.
Decrease the incidence of surgery including transurethral resection of the prostate (TURP) and prostatectomy.

It is given orally in a dose of 5 mg daily in the management of benign prostatic hyperplasia to cause regression of the enlarged prostate and to improve symptoms; it may reduce the need for surgery. Response may be delayed and treatment may be required for 6 months or more to assess whether benefit has been achieved. Finasteride is given orally in a dose of 1 mg daily. In general, use for 3 months or more is required before benefit is seen.

No specific treatment of overdosage with Finasteride is recommended.
Treatment is symptomatic and supportive.

Hypersensitivity to any of the components of Finasteride.
Pregnancy (see Use in Pregnancy, Lactation and Exposure to Finasteride (by pregnant women): Risk to Male Fetus under Use in Pregnancy & Lactation).
Finasteride is not indicated for pediatric use.

Serum Prostate Specific Antigens (S-PSA) levels decrease on patients treated with Finasteride.
Use in Pregnancy: Finasteride is contraindicated for use in women when they are or may potentially be pregnant as it may cause abnormalities of the external genitalia of a male fetus when administered to a pregnant woman. It is not known whether Finasteride is excreted in breast milk.

General: The beneficial response of Finasteride may not be manifested immediately and thus patients with large residual urine volume and/or severely diminished urinary flow should be monitored carefully for obstructive uropathy.
Since serum markers of prostate cancer may be reduced in patients taking Finasteride, such malignancies should be excluded before treatment of benign prostatic hyperplasia is initiated.
Effects on PSA and prostate cancer detection: No clinical benefit has been demonstrated in patients with prostate cancer treated with Finasteride.
Digital rectal examination as well as other evaluation for prostate cancer are recommended prior to initiating therapy with Finasteride and periodically thereafter.
Serum prostate-specific antigen (S-PSA) is also used for the prostate cancer detection.
Generally as baseline S-PSA greater than 10 ng/mL prompts further evaluation and consideration of biopsy; for S-PSA levels between 14 and 10 ng/mL, further evaluation is advisable. The medical practitioner should be aware that the baseline S-PSA <4 ng/mL does not exclude prostate cancer.
Finasteride cause a decrease in S-PSA concentrations even in the presence of prostate cancer. The reduction of levels in patients with BPH treated with Finasteride should be considered when evaluating S-PSA data and does not rule out concomitant prostate cancer.
Patients treated with Finasteride who have a sustained S-PSA levels should be carefully evaluated.

Use in pregnancy: Finasteride is contraindicated in pregnancy.
Because of the ability of Type II 5-alpha reductase inhibitors to inhibit conversion of testosterone to dihydrotestosterone, these drug, including Finasteride, may cause abnormalities of the external genitalia of a male fetus when administered to pregnant woman.
Lactation: It is not known if Finasteride is excreted in human milk.
Exposure to Finasteride (by pregnant women): Risk to Male Fetus: Finasteride tablets are film-coated and will prevent contamination with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.
Pregnant women should not handle crushed or broken Finasteride tablets because of the possibility of absorption of Finasteride and the subsequent potential risk to male fetus.
In addition, since Finasteride is present in semen, male patients should wear a condom or otherwise avoid exposure of female sexual partners at risk of becoming pregnant.

Reproductive system and breast disorders: Less frequent: Impotence, decreased libido, decreased volume of ejaculate, ejaculation disorder, gynecomastia (breast tenderness and enlargement).
Incidence unknown: Testicular pain.
Skin and subcutaneous tissue disorders: Less frequent: Skin rash.
Other: Less frequent: Hypersensitivity reactions including pruritus, urticaria and swelling of the lips and face.

Prostatic volume is correlated with a patient's age whereas serum prostate serum antigen (S-PSA) concentration is correlated with a patient's age and prostatic volume. When S-PSA laboratory determinations are evaluated, consideration should be given to the fact that S-PSA levels decrease in patients treated with Finasteride. S-PSA levels decrease rapidly within the first months of therapy, after which time, S-PSA levels stabilize to a new baseline. The post treatment baseline approximates half of the pre-treatment value. This decrease is predictable over the entire-range of S-PSA values, although it may vary in individual patients. Therefore, in typical patients treated with Finasteride for six months or more S-PSA values should be doubled for comparison to normal ranges in untreated men. There is considerable overlap in S-PSA levels among men with and without prostate cancer. Therefore BHP, S-PSA values within the normal reference range, prostate cancer should not be ruled out regardless of Finasteride treatment. The ability of S-PSA to distinguish between BHP and cancer is not adversely affected by treatment with Finasteride.
Laboratory Test Findings: Consideration should be given to the fact that S-PSA levels are decreased in the patients treated with Finasteride when S-PSA laboratory test determinations are evaluated.
Drug Interactions: No interactions of clinical importance have been identified.
Finasteride does not appear to significantly affect the cytochrome P450-linked drug metabolising enzyme system.
Compounds tested in men included digoxin, propranolol, warfarin, glibenclamide and theophylline and no clinically meaningful interactions were found.
Other Concomitant Therapy: Finasteride has been used concomitantly with ACE-Inhibitors, paracetamol, acetylsalicylic acid, alpha-blockers, cardiac nitrates, diuretics, H₂-antagonist, HMG-CoA reductase Inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), 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.

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