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Jalyn Generic Name & Formulations
Legal Class
Rx
General Description
Dutasteride 0.5mg, tamsulosin HCl 0.4mg; caps.
Pharmacological Class
Type I and II 5 alpha-reductase inhibitor + alpha-1A blocker.
How Supplied
Caps—30, 90
Manufacturer
Jalyn Indications
Indications
Benign prostatic hyperplasia (BPH).
Limitations of Use
Not approved for preventing prostate cancer.
Jalyn Dosage and Administration
Adult
Swallow whole. Take 1 cap daily approx. 30mins after the same meal each day.
Children
Not established.
Jalyn Contraindications
Contraindications
Pregnancy. Nursing mothers.
Jalyn Boxed Warnings
Not Applicable
Jalyn Warnings/Precautions
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. Pregnant women and those of childbearing potential should avoid handling caps.
Jalyn Pharmacokinetics
See Literature
Jalyn Interactions
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.
Jalyn Adverse Reactions
Adverse Reactions
Ejaculation disorders, impotence, decreased libido, dizziness, breast disorders, orthostatic hypotension and/or syncope; rare: priapism.
Jalyn Clinical Trials
See Literature
Jalyn Note
Not Applicable
Jalyn Patient Counseling
See Literature
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