Each soft gelatin capsule contains: Dutasteride 500 mcg.
PHARMACOLOGY: Inhibits the conversion of testosterone to 5-alpha-dihydrotestosterone, a potent androgen.
PHARMACODYNAMICS: Effect on 5a-Dihydrotestosterone and Testosterone: The maximum effect of daily doses of Dutasteride on the reduction of DHT is dose dependent and is observed within 1 to 2 weeks. After 1 and 2 weeks of daily dosing with Dutasteride 0.5 mg, median serum DHT concentrations were reduced by 85% and 90%, respectively.
Mechanism of Action: Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT). DHT is the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland. Testosterone is converted to DHT by the enzyme 5a-reductase, which exists as 2 isoforms, type 1 and type 2. The type 2 isoenzyme is primarily active in the reproductive tissues, while the type 1 isoenzyme is also responsible for testosterone conversion in the skin and liver.
Dutasteride is a competitive and specific inhibitor of both type 1 and type 2 5a-reductase isoenzymes, with which it forms a stable enzyme complex.
PHARMACOKINETICS: Absorption: Tmax is 2 to 3h; bioavailability is approximately 60%; administration with food, maximum serum concentrations were decreased by 10% to 15%.
Distribution: Vd is 300 to 500 L; highly protein bound (99%).
Metabolism: Metabolized by CYP3A4 and CYP3A5.
Elimination: Mainly excreted in feces (approximately 5% as unchanged dutasteride and approximately 40% as metabolites).
The half life is approximately 5 weeks.
Dutasteride is indicated in the treatment of symptomatic prostatic hyperplasia (BPH) in men with enlarged prostate to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of need for BPH-related surgery.
Adults: Dutasteride 500 mcg once daily.
Take one capsule daily, at the same time each day, with or without food. Swallow the medication whole, and bear in mind that it may take from three to six months to notice any improvement of symptoms.
General Advice: Administer with or without food.
Swallow capsules whole. Do not crush, cut or chew.
Do not use capsules that are cracked or leaking.
Symptoms of Dutasteride overdose are not known. If the patient suspect overdose, contact the local poison control center or emergency room immediately.
Pregnancy; women of childbearing potential; children; hypersensitivity to 5-alpha-reductase inhibitors or any component of the product.
Using Dutasteride may affect the results of the blood test used to detect prostate cancer. Inform the doctor before taking this test if the patient is using dutasteride.
Monitor: Perform digital rectal exams, as well as other evaluations for prostatic cancer prior to starting therapy and periodically thereafter.
Assess patient to rule out other urologic diseases prior to treatment. Carefully monitor patients with larger residual urine volume or severely diminished urinary flow for obstructive uropathy.
Blood donation: Men should not donate blood until at least 6 months after the last dose of dutasteride.
Handling capsules: Women who are pregnant or may be pregnant should not handle the capsules, Dutasteride is absorbed through the skin and could result in unintended fetal exposure. Women who are not pregnant should use caution whenever handling the capsules. If contact is made with leaking capsules, wash the contacted area immediately with soap and water.
Obstructive uropathy: Patients with large residual urine volume or severely diminished urinary flow may not be good candidate for therapy.
Prostate effects: Total serum Prostate-Specific Antigen PSA concentrations are decreased. Establish a new baseline PSA concentration after 3 to 6 months of treatment and use this new value to assess potentially cancer-related changes PSA. To interpret an isolated PSA value in a man treated with dutasteride for 6 months or more double the PSA value for comparison with normal values in untreated men.
Hepatic function: Use with caution.
Reproductive effects: Sperm control may be reduced in some patients.
Use in Pregnancy: Category X.
Use in Lactation: Undetermined.
Use in Children: Contraindicated for use in children. Safety and efficacy not established.
Pregnancy: Category X.
Lactation: Undetermined.
Reproductive effects: Sperm control may be reduced in some patients.
CNS: Decreased libido (3%).
Genitourinary: Impotence (5%); breast disorder including breast enlargement and breast tenderness, ejaculation disorder (1%).
Hypersensitivity: Allergic reactions including angioedema, localized edema, pruritus, rash, serious skin reactions, and urticaria (postmarketing).
If the patient think they are allergic to Dutasteride, consult a doctor before discontinuing its usage.
CYP3A4 inhibitors (eg, cimetidine, ciprofloxacin, diltiazem, ketoconazole, ritonavir, troleandomycin, verapamil).
Plasma concentrations of dutasteride may be elevated, increasing the risk of adverse reactions. Use with caution. However, the change in dutasteride exposure with co-administration of diltiazem or verapamil is not considered clinically important and no dosage adjustment is recommended.
Food: When dutasteride is taken with food, the dutasteride Cmax is reduced 10% to 15%. This reduction is not considered to be clinically important. Dutasteride may be taken with or without food.
Store at temperatures not exceeding 30°C.
G04CB02 - dutasteride ; Belongs to the class of testosterone-5-alpha reductase inhibitors. Used in the treatment of benign prostatic hypertrophy.
Dutride softgel cap 500 mcg
30's
Sign Out
