A selection of JALYN® safety information for your patients. Full important safety information can be found here.
Contraindications
Pregnancy. Dutasteride use is contraindicated in females who are pregnant. (4, 5.6, 8.1)•Patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema, urticaria, pruritus, respiratory symptoms) to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin, or any component of JALYN®. (4)
Precautions
Orthodontic 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)].
Drug-Drug Interactions
Strong Inhibitors of Cytochrome P450 (CYP) 3A4
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)].
Moderate Inhibitors of CYP3A4, Inhibitors of CYP2D6, or a Combination of Both CYP3A4 and CYP2D6 Inhibitors
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) inhibitors of CYP2D6, a combination of both CYP3A4 and CYP2D6 inhibitors, or in patients known to be poor metabolizers of CYP2D6, as there is a potential for significant increase in tamsulosin exposure [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].
Cimetidine
Caution is advised when tamsulosin-containing products, including JALYN®, are coadministered with cimetidine [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].
Other Alpha-adrenergic Antagonists
Tamsulosin-containing products, including JALYN®, should not be coadministered with other alpha-adrenergic antagonists because of the increased risk of symptomatic hypotension.
Phosphodiesterase-5 (PDE-5) Inhibitors
Caution is advised when alpha-adrenergic–antagonist-containing products, including JALYN®, are coadministered with PDE-5 inhibitors. Alpha-adrenergic antagonists and PDE-5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these 2 drug classes can potentially cause symptomatic hypotension.
Warfarin
Caution should be exercised with concomitant administration of warfarin and tamsulosin-containing products, including JALYN® [see Drug Interactions (7.2), Clinical Pharmacology (12.3)].
This is not a complete list of JALYN® safety information. For the full list, click here.