ated with coadministered dutasteride and tamsulosin are ejaculation disorders, impotence, decreased libido, dizziness, and breast disorders. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 06/2011
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1 INDICATIONS AND USAGE
1.1 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.
1.2 Limitations of Use
Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer.
2 DOSAGE AND ADMINISTRATION
The recommended dosage of JALYN is 1capsule (0.5mg dutasteride and 0.4mg tamsulosin hydrochloride) taken once daily approximately 30minutes 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.
3 DOSAGE FORMS AND STRENGTHS
JALYN Capsules, containing 0.5mg dutasteride and 0.4mg tamsulosin hydrochloride, are oblong, hard-shell capsules with a brown body and an orange cap imprinted with “GS7CZ” in black ink.
4 CONTRAINDICATIONS
JALYN is contraindicated for use in:
Pregnancy. In animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. Therefore, JALYN may cause fetal harm when administered to a pregnant woman. If JALYN is used during pregnancy, or if the patient becomes pregnant while taking JALYN, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.6), Use in Specific Populations (8.1)].
Women of childbearing potential [see Warnings and Precautions (5.6), Use in Specific Populations (8.1)].
Pediatric patients [see Use in Specific Populations (8.4)].
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 [see Adverse Reactions (6.2)].
5 WARNINGS AND PRECAUTIONS
5.1 Orthostatic Hypotension
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)].
5.2 Drug-Drug Interactions
Strong Inhibitors of CYP3A4: Tamsulosin-containing products, including JALYN, should not be coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole) as this can significantly 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), strong (e.g., paroxetine) or moderate (e.g., terbinafine) inhibi |
