DOSAGE AND ADMINISTRATION
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 Drug Interactions (7.1), Clinical Pharmacology]
Dosage Adjustment in Specific Populations
Renal Impairment: No dosage adjustment is necessary for patients with moderate to severe renal impairment (10≤ CLcr <30 mL/min/1.73 m2). However, there are no data of JALYN or its individual components in patients with end-stage renal disease [see Use in Specific Populations Clinical Pharmacology].
Hepatic Impairment: No dosage recommendation can be made due to the absence of data in patients with hepatic impairment [see Use in Specific Populations Clinical Pharmacology].
Elderly: No dosage adjustment is necessary [see Use in Specific Populations Clinical Pharmacology].
DOSAGE FORMS AND STRENGTHS
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.