Genesis Tablets (Finasteride Tablets USP)

Product Specifications: Genesis Tablets USP

Genesis Tablets mg: Each filmcoated tablet contains Finasteride USP

Product contains Lactose

Description:

Genesis Tablets(Finasteride) tablets feature finasteride as the active ingredient, a synthetic 4azasteroid compound Finasteride is a specific inhibitor of steroid Type II 5reductase, an enzyme converting testosterone into
5adihydrotestosterone (DHT)

Pharmaceutical Form:

Film Coated Tablet Clinical Particulars:

Therapeutic Indications:

 Genesis (Finasteride) is indicated for the treatment of male pattern hair loss (androgenetic
alopecia) in MEN ONLY Posology and Method of Administration:

 Recommended dose: One tablet (1 mg) once daily by mouth  Continued use for
three months or more is necessary before benefits are observed  Withdrawal of treatment
leads to the reversal of effects within 12 months

Contraindications:

•  Finasteride is contraindicated in women, especially during pregnancy
•  Hypersensitivity to any component of the medication
• Special Warnings and Precautions for Use:
•  Exposure of Women: Risk to Male Fetus
•  Effects on Prostate Specific Antigen (PSA)
•  Increased Risk of High Grade Prostate Cancer with 5αReductase Inhibitors
•  Pediatric Patients: Not indicated for use
•  Effects on Fertility
•  Breast Cancer Risk
•  Mood Alterations

Interaction with Other Medicinal Products:

 No interactions of clinical importance identified

 Finasteride does not appear to affect the cytochrome P450linked drug metabolizing enzyme system

 Use in Specific Populations:

•  Pregnancy Category X
•  Nursing Mothers: Not indicated for use in women
•  Pediatric Use: Not established
•  Geriatric Use: Efficacy not established in the elderly
•  Renal Impairment: No dosage adjustment necessary
•  Hepatic Impairment: Caution advised

Pharmacological Properties:

Mechanism of Action:

 Inhibits human Type 2 5αreductase, blocking the conversion of testosterone to DHT

Pharmacodynamics Properties:

 Rapid reduction in serum DHT concentration

 No clinically meaningful changes in hormone levels

Pharmacokinetic Properties:

 Bioavailability: Approximately 80%

 Maximum plasma concentrations reached in about two hours

 Metabolism: Extensively metabolized in the liver

 Excretion: 57% in feces, 39% in urine

Undesirable Effects:

•  Common: Impotence, decreased libido
•  Uncommon: Erectile dysfunction, ejaculation disorder
•  Rare: Breast tenderness, enlargement
•  Not Known: Hypersensitivity reactions, mood alterations

Over dosage:

 No specific treatment recommended based on available data

Storage:

•  Do not store above 30 °C
•  Keep away from moisture, light, and reach of children

Instructions:

 To be sold on the prescription of a registered Healthcare practitioner only

 Read the contents cautiously before use This package insert is regularly and timely updated