Jalyn
INDICATIONS
Benign Prostatic Hyperplasia (BPH) Treatment
JALYN™ (dutasteride and tamsulosin hydrochloride) Capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
Limitations of Use
Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer.
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.
HOW SUPPLIED
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.
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 could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus [see WARNINGS AND PRECAUTIONS].
Jointly Manufactured by Catalent Pharma Solutions F-67930 Beinheim, France, D-73614 Schorndorf, Germany and Rottendorf Pharma GmbH, D-59320 Ennigerloh, Germany. Distributed by : Glaxo SmithKline, Research Triangle Park, NC 27709. Revised: Apr 2013
Last reviewed on RxList: 5/13/2013
This monograph has been modified to include the generic and brand name in many instances.
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