The following adverse reactions have been identified during post-approval use of the individual components of JALYN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to drug exposure.

Dutasteride:

Immune System Disorders: Hypersensitivity reactions, including rash, pruritus, urticaria, localized edema, serious skin reactions, and angioedema.

Tamsulosin:

Immune System Disorders: Hypersensitivity reactions, including rash, urticaria, pruritus, angioedema, and respiratory problems.

Cardiac Disorders: Palpitations.

Skin Disorders: Skin desquamation.

Gastrointestinal Disorders: Constipation, vomiting.

Reproductive System and Breast Disorders: Priapism.

Vascular Disorders: Hypotension.

Ophthalmologic Disorders: During cataract surgery, a variant of small pupil syndrome known as Intraoperative floppy iris syndrome (IFIS) associated with alpha-adrenergic antagonist therapy [see Warnings and Precautions (5.8)].

There have been no drug interaction studies using JALYN. The following sections reflect information available for the individual components.

Dutasteride: Dutasteride is extensively metabolized in humans by the CYP3A4 and CYP3A5 isoenzymes. The effect of strong CYP3A4 inhibitors on dutasteride has not been studied [see Clinical Pharmacology (12.3)].

Tamsulosin: Strong and Moderate Inhibitors of CYP3A4 or CYP2D6: Tamsulosin is extensively metabolized, mainly by CYP3A4 or CYP2D6.

Concomitant treatment with ketoconazole (a strong inhibitor of CYP3A4) resulted in increases in the C and AUC of tamsulosin by factors of 2.2 and 2.8, respectively [see Warnings and Precautions (5.2), Clinical Pharmacology (12.3)] . The effects of concomitant administration of a moderate CYP3A4 inhibitor (e.g., erythromycin) on the pharmacokinetics of tamsulosin have not been eva luated [see Warnings and Precautions (5.2), Clinical Pharmacology (12.3)]. Concomitant treatment with paroxetine (a strong inhibitor of CYP2D6) resulted in increases in the C and AUC of tamsulosin by factors of 1.3 and 1.6, respectively [see Warnings and Precautions (5.2), Clinical Pharmacology (12.3)]. A similar increase in exposure is expected in poor metabolizers (PM) of CYP2D6 as compared to extensive metabolizers (EM). Since CYP2D6 PMs cannot be readily identified and the potential for significant increase in tamsulosin exposure exists when tamsulosin 0.4 mg is coadministered with strong CYP3A4 inhibitors in CYP2D6 PMs, tamsulosin 0.4 mg capsules should not be used in combination with strong inhibitors of CYP3A4 (e.g., ket