Firide

Finasteride.

Each tablet contains Finasteride 1 mg or 5 mg, respectively.

Pharmacology: Pharmacodynamics: Finasteride is a synthetic 4-azasteroid compound, competitively and specifically inhibits 5α-reductase (type II), an isoenzyme that metabolizes testosterone into dihydrotestosterone (DHT).
1 mg: The inhibition blocks the peripheral conversion of testosterone to DHT, leading to significant reduction in serum and tissue DHT. Finasteride increases hair growth and slows hair loss.
5 mg: DHT is the potent androgen responsible for the development and enlargement of the prostate gland. In benign prostatic hyperplasia (BPH), Finasteride decreases serum and tissue DHT. Finasteride had no affinity for the androgen receptor.
Pharmacokinetics: Food does not affect the bioavailability of Finasteride. It is about 90% bound to plasma protein. Finasteride crosses the blood-brain barrier. It is metabolized in the liver, primarily by the cytochrome P450 CYP3A4, and excreted in urine (39%) and feces (57%) as metabolites.
1 mg: The mean bioavailability of Finasteride was 65%.
5 mg: The mean bioavailability of Finasteride was 63%.

1 mg: Finasteride is indicated for the treatment of male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss.
Finasteride is not indicated in women and children.
Finasteride is not effective in postmenopausal women with androgenetic alopecia.
5 mg: FIRIDE is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: Improve symptoms; Reduce the risk of acute urinary retention; Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
FIRIDE administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression in BPH (a confirmed ≥4 point increase in AUA symptom score).
FIRIDE is not indicated for use in women and children.

Finasteride is recommended only for use in men.
Finasteride may be taken with or without food.
Renal impairment: No dosage adjustment is necessary.
Hepatic impairment: Use with caution (Finasteride is metabolized extensively in the liver).
1 mg: Adult (male): The recommended dosage is 1 tablet (1 mg) orally daily.
In general, daily use for 3 months or more is necessary before increased hair growth and/or prevention of further hair loss is observed. Continued use is recommended to obtain maximum benefit. Withdrawal of treatment leads to reversibility of effect within 12 months.
5 mg: Adult (Males): BPH: Oral: 5 mg (1 tablet) once daily (either as a single agent or in combination with doxazosin).
Elderly: No dosage adjustment is necessary.

Overdose and treatment: Patients have received single dose of Finasteride up to 400 mg and multiple doses of Finasteride up to 80 mg/day for 3 months without adverse effects. There is no specific treatment of overdosage with Finasteride.

Hypersensitivity to Finasteride or any component of the formulation.
Women or children, especially in pregnant woman or may become pregnant. Women of childbearing age should avoid contact with crushed or broken tablets because of the possibility of absorption of Finasteride. Finasteride may cause abnormalities of the external genitalia of a male fetus.

Use with caution in patients with hepatic dysfunction; Finasteride is extensively metabolized in the liver.
1 mg: Oral Finasteride therapy has been associated with reductions (from 0.7 to 0.5 ng/ml) in serum prostate specific antigen (PSA) at 12^th month in men 18-41 years of age receiving the drug at a dosage of 1 mg daily for male pattern hair loss. When oral Finasteride 1 mg daily is used for treatment of male pattern hair loss in older men who also have BPH, PSA reductions of approximately 50% have been demonstrated. Such reductions should be consideration when interpreting serum PSA value in men receiving Finasteride.
5 mg: Patients with large residual urinary volume and/or severity diminished urinary flow should be carefully monitored for obstructive uropathy. These patients may not be candidates for Finasteride therapy.
Effect on PSA and prostate cancer detection: Finasteride did not appear to alter the rate of prostate cancer detection in BPH. Other urological diseases (including prostate cancer) should be ruled out before initiating therapy with Finasteride (in BPH management) and periodically thereafter. Digital rectal examination as well as other evaluations for prostate cancer are recommended. Serum Prostate Specific Antigen (PSA) is also used for prostate cancer detection. For BPH, a minimum of 6 months of treatment may be necessary to determine whether an individual will respond to Finasteride.
Use of Finasteride in BPH decreases PSA concentrations by approximately 50% even when cancer is present. To interpret serial PSAs, a new PSA baseline should be established ≥6 months after treatment initiation and PSA monitored periodically thereafter. A reduction in baseline PSA concentration by approximately 50% within 6 months of therapy is indicative of efficacy. In typical patients treated with Finasteride ≥6 months, PSA values should be doubled for comparison with normal ranges in untreated men.
Finasteride does not interfere with free PSA levels. If percent free PSA (the ratio of free to total PSA) is used as an aid in the detection of prostate cancer, no adjustment to its value is necessary. The percent free PSA remains constant.
Use in Pregnancy: Finasteride is contraindicated in women who are or may become pregnant. Pregnant women are advised to avoid contact with crushed or broken tablets. Active ingredient of crushed or broken tablets can be absorbed through the skin and the subsequent potential risk of abnormalities in the external genitalia of a male fetus.

Finasteride is contraindicated in women who are or may become pregnant. Pregnant women are advised to avoid contact with crushed or broken tablets. Active ingredient of crushed or broken tablets can be absorbed through the skin and the subsequent potential risk of abnormalities in the male fetus.
Finasteride is not indicated in women. It is not known whether Finasteride is excreted in human breast milk.

Finasteride is well tolerated.
The adverse effects may occur: Immune system disorders: hypersensitivity reactions such as swelling of the lips and face, pruritus, urticaria and rashes, angioedema (including swelling of the lips, tongue, throat and face).
Psychiatric disorders: depression, decreased libido that continued after discontinuation of treatment.
Reproductive system and breast disorders: sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after discontinuation of treatment, testicular pain, male infertility and/or poor seminal quality. Normalization or improvement of seminal quality has been reported after discontinuation of Finasteride. breast tenderness and enlargement (gynaecomastia).
1 mg: Adverse reactions of Finasteride 1 mg usually have been mild, generally have not required discontinuation of therapy.
The most commonly reported adverse effects of Finasteride 1 mg are decreased libido, erectile dysfunction and reduced volume of ejaculate. The adverse events of Finasteride 1 mg were resolved both in men after discontinuation and in men who continue the therapy.
The incidence of these side effects decreased to 0.3% or less by the fifth year of treatment with Finasteride 1 mg.
5 mg: The most commonly reported adverse effects of Finasteride are impotence, decreased libido, erectile dysfunction, ejaculation disorders and reduced volume of ejaculate.

No drug interactions of clinical importance have been identified including effects on drug metabolism by the Cytochrome P450 enzyme system. The drugs that have been tested have included glyburide, antipyrine, propranolol, digoxin, theophylline and warfarin. In addition, although specific interaction studies were not performed, no evidence of clinically significant adverse interactions were observed when Finasteride was used concomitantly with acetaminophen (for 5 mg only), ACE-inhibitors, α-blockers, β-blockers, calcium channel blockers, diuretics, cardiac nitrates, NSAIDs, benzodiazepines, quinolones, H₂-antagonists and HMG-CoA reductase inhibitors.

Store below 30°C and protect from light.

Drugs for Bladder & Prostate Disorders / Other Dermatologicals

G04CB01 - finasteride ; Belongs to the class of testosterone-5-alpha reductase inhibitors. Used in the treatment of benign prostatic hypertrophy.
D11AX10 - finasteride ; Belongs to the class of other dermatologicals.

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