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JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE): FULL PRESCRIBING INFORMATION
INDICATIONS AND USAGE
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 8 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.
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.
Jalyn (Dutasteride, Tamsulosin Hydrochloride) is contraindicated for use in:
Pregnancy. In animal reproduction and developmental toxicity studies, dutasteride inhibited 22 development of male fetus external genitalia. Therefore, Jalyn may cause fetal harm when administered to a pregnant woman. If Jalyn (Dutasteride, Tamsulosin Hydrochloride) capsules are used during pregnancy, or if the patient becomes pregnant while taking this medication, the patient should be apprised of the potential hazard to the fetus.
Women of childbearing potential.
Patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to dutasteride, other 5 alpha-reductase inhibitors, tamsulosin, or any other component of Jalyn (Dutasteride and Tamsulosin).
Jalyn drug-drug interactions
Jalyn adverse reactions
Jalyn drug interactions
USE IN SPECIFIC POPULATIONS
Jalyn use in specific populations
Jalyn clinical pharmacology
PHARMACOKINETICS IN SPECIFIC POPULATIONS
Jalyn pharmacokinetics in specific populations
PHARMACOKINETICS OF DRUG INTERACTIONS
Jalyn pharmacokinetics for drug interactions
Jalyn nonclinical toxicology
Jalyn clinical studies
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).
Store at 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F). 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.
Manufactured and distributed by GlaxoSmithKline pharmaceutical company and its divisions.
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