Dutride

Dutride

dutasteride

Manufacturer:

Swati Spentose

Distributor:

Scriptmed

Marketer:

Ambica
Concise Prescribing Info
Contents
Dutasteride
Indications/Uses
Symptomatic prostatic hyperplasia (BPH) in men w/ enlarged prostate, reduce risk of acute urinary retention & risk of need for BPH-related surgery.
Dosage/Direction for Use
Adult 500 mcg once daily. Take at the same time each day.
Administration
May be taken with or without food: Swallow whole, do not crush/cut/chew.
Contraindications
Pregnancy, women of childbearing potential, childn, hypersensitivity.
Special Precautions
Perform evaluations for prostatic cancer (eg, digital rectal exams) prior to starting therapy & periodically thereafter. Assess patient to rule out other urologic diseases prior to treatment. Carefully monitor patients w/ larger residual urine vol or severely diminished urinary flow for obstructive uropathy. Establish a new baseline PSA conc after 3-6 mth of treatment & use the new value to assess potentially cancer-related changes PSA. May affect results of blood test used to detect prostate cancer. Men should not donate blood until at least 6 mth after last dose. Women who are pregnant or may be pregnant should not handle the cap, it can be absorbed through the skin & could result in unintended fetal exposure. Women who are not pregnant should use caution whenever handling the cap. If contact is made w/ leaking cap, wash the contacted area immediately w/ soap & water. Hepatic function. Reduced sperm control. Pregnancy & lactation. Contraindicated for use in childn.
Adverse Reactions
Decreased libido; Impotence, breast disorder including breast enlargement & tenderness, ejaculation disorder; Allergic reactions including angioedema, localized edema, pruritus, rash, serious skin reactions. Urticaria (postmarketing).
Drug Interactions
Increased dutasteride plasma conc w/ CYP3A4 inhibitors (eg, cimetidine, ciprofloxacin, diltiazem, ketoconazole, ritonavir, troleandomycin, verapamil).
MIMS Class
Drugs for Bladder & Prostate Disorders
ATC Classification
G04CB02 - dutasteride ; Belongs to the class of testosterone-5-alpha reductase inhibitors. Used in the treatment of benign prostatic hypertrophy.
Presentation/Packing
Form
Dutride softgel cap 500 mcg
Packing/Price
30's
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