Jalyn (Dutasteride / Tamsulosin Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

JALYN™ (dutasteride and tamsulosin hydrochloride) Capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

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≤ CL_cr <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.

HOW SUPPLIED/STORAGE AND HANDLING

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. They are available in bottles with child-resistant closures as follows:

Bottle of 30 (NDC 0173-0809-13).

Bottle of 90 (NDC 0173-0809-59).

Store at 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature]. Capsules may become deformed and/or discolored if kept at high temperatures.

Dutasteride is absorbed through the skin. JALYN Capsules should not be handled by women who are pregnant or who may become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus [see Warnings and Precautions].