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JALYN
Benign prostatic hyperplasia/urinary retention
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Drug Name:

JALYN Rx

Generic Name and Formulations:
Dutasteride 0.5mg, tamsulosin HCl 0.4mg; caps.

Company:
GlaxoSmithKline

Therapeutic Use:

Indications for JALYN:

Benign prostatic hyperplasia (BPH). Limitations of use: not approved for preventing prostate cancer.

Adult:

Swallow whole. Take 1 cap daily approx. 30mins after the same meal each day.

Children:

Not applicable.

Contraindications:

Not for use in children. Pregnant women and those of childbearing potential should avoid handling caps. Pregnancy (Cat.X). Nursing mothers.

Warnings/Precautions:

Increased risk of high-grade prostate cancer. Monitor prostate specific antigen (PSA) values (set new baseline PSA after 3–6 months of treatment); double PSA levels to compare with normal values. Rule out prostate cancer and other urological disorders prior to treatment. Syncope. End-stage renal disease. Severe hepatic impairment. Cataract and glaucoma surgery (intraoperative floppy iris syndrome possible); do not initiate tamsulosin-containing products. Poor metabolizers (low CYP2D6 activity). Sulfa allergy. Avoid donating blood until at least 6 months after last dose.

Pharmacological Class:

Type I and II 5 alpha-reductase inhibitor + alpha-1A blocker.

Interactions:

Concomitant strong CYP3A4 inhibitors (eg, ketoconazole): not recommended. Caution with moderate CYP3A4 inhibitors (eg, erythromycin), strong (eg, paroxetine) or moderate (eg, terbinafine) CYP2D6 inhibitors, or a combination of both CYP3A4 and CYP2D6 inhibitors. Do not use with other alpha-blockers. Potentiated by cimetidine. Dutasteride may be potentiated by CYP3A4/5 inhibitors (eg, ritonavir, diltiazem, verapamil, erythromycin). Caution with PDE-5 inhibitors (may increase orthostatic hypotension). Monitor warfarin.

Adverse Reactions:

Ejaculation disorders, impotence, decreased libido, dizziness, breast disorders, orthostatic hypotension and/or syncope; rare: priapism.

How Supplied:

Caps—30, 90


Data provided by MPR.

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