These highlights do not include all the information needed to use JALYN safely and effectively. See full prescribing information for JALYN.JALYN (dutasteride and tamsulosin hydrochloride) CapsulesInitial U.S. Approval: 2010
JALYN™ (dutasteride and tamsulosin hydrochloride) Capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
The recommended dosage of JALYN is 1 capsule (0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride) taken once daily approximately 30 minutes after the same meal each day.
The capsules should be swallowed whole and not chewed or opened. Contact with the contents of the JALYN capsule may result in irritation of the oropharyngeal mucosa.
JALYN should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [see Warnings and Precautions (5.2), Drug Interactions (7.1), Clinical Pharmacology (12.3)] .
Renal Impairment: No dosage adjustment is necessary for patients with moderate to severe renal impairment (10≤ CL <30 mL/min/1.73 m). However, there are no data of JALYN or its individual components in patients with end-stage renal disease [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
Hepatic Impairment: No dosage recommendation can be made due to the absence of data in patients with hepatic impairment [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
Elderly: No dosage adjustment is necessary [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
JALYN Capsules, containing 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride, are oblong, hard-shell capsules with a brown body and an orange cap imprinted with “GS 7CZ” in black ink.
JALYN is contraindicated for use in:
As with other alpha-adrenergic antagonists, orthostatic hypotension (postural hypotension, dizziness, and vertigo) may occur in patients treated with tamsulosin-containing products, including JALYN, and can result in syncope. Patients starting treatment with JALYN should be cautioned to avoid situations where syncope could result in an injury [see Adverse Reactions (6.1)].
Strong Inhibitors of CYP3A4: Tamsulosin-containing products, including JALYN, should not be coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole) as this can significantly decrease tamsulosin metabolism and increase tamsulosin exposure [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].
Inhibitors of CYP2D6 and Moderate Inhibitors of CYP3A4: Tamsulosin-containing products, including JALYN, should be used with caution when coadministered with moderate inhibitors of CYP3A4 (e.g., erythromycin), when coadministered with strong (e.g., paroxetine) or moderate (e.g., terbinafine) inhibitors of CYP2D6, or in patients known to be poor metabolizers of CYP2D6 as there is a potential for significant increase in tamsulosin exposure [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].
Cimetidine: Caution is advised when tamsulosin-containing products, including JALYN, are coadministered with cimetidine [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].
Other Alpha-adrenergic Antagonists: Tamsulosin-containing products, including JALYN, should not be coadministered with other alpha-adrenergic antagon
