JALYN Rx

Indications for JALYN:

Benign prostatic hyperplasia (BPH).

Adult Dose for JALYN:

Swallow whole. Take ½ hour after same meal each day. 1 capsule daily.

Children's Dose for JALYN:

Not applicable.

Pharmacological Class:

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

Contraindications:

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

Warnings/Precautions:

Not for use in preventing prostate cancer. 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 surgery (intraoperative floppy iris syndrome possible). Poor metabolizers (low CYP2D6 activity). Sulfa allergy. Avoid donating blood until at least 6 months after last dose.

Interactions:

Concomitant strong inhibitors of CYP3A4 (eg, ketoconazole): not recommended; caution with strong CYP2D6 inhibitors (eg, paroxetine). Do not use with other alpha-blockers. Potentiated by cimetidine. Dutasteride may be potentiated by moderate CYP3A4/5 inhibitors (eg, diltiazem, erythromycin). Tamsulosin may be potentiated by a concomitant combination of CYP3A4 and CYP2D6 inhibitors (eg, terbinafine). 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