ALYQ

Over a dose range of 2.5 to 20 mg, tadalafil exposure (AUC) increases proportionally with dose in healthy subjects. In PAH patients administered between 20 and 40 mg of tadalafil, an approximately 1.5-fold greater AUC was observed indicating a less than proportional increase in exposure over the entire dose range of 2.5 to 40 mg. During tadalafil 20 and 40 mg once daily dosing, steady-state plasma concentrations were attained within 5 days, and exposure was approximately 1.3-fold higher than aft...

14.1 Tadalafil for Pulmonary Arterial Hypertension A randomized, double-blind, 16 week placebo-controlled study was conducted in 405 patients with pulmonary arterial hypertension, defined as a resting mean pulmonary artery pressure (mPAP) ≥25 mm Hg, pulmonary capillary wedge pressure (PCWP) ≤15 mm Hg, and pulmonary vascular resistance (PVR) ≥3 Wood units via right heart catheterization. Allowed background therapy included bosentan (maintenance dosing up to 125 mg twice daily) and chronic anticoagulation. The use of prostacyclin or analogue, L-arginine, phosphodiesterase inhibitor, or other chr...

The following serious adverse reactions are discussed elsewhere in the labeling: Hypotension [see Warnings and Precautions ( 5.1 )] Visual Loss [see Warnings and Precautions ( 5.3 ) and Patient Counseling Information ( 17 )] Hearing loss [see Warnings and Precautions ( 5.4 )] Priapism [see Warnings and Precautions ( 5.6 )] The most common adverse reaction is headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6...

Concomitant organic nitrates ( 4.1 ) Concomitant Guanylate Cyclase (GC) Stimulators ( 4.2 ) History of known serious hypersensitivity reaction to ALYQ ® or CIALIS ® ( 4.3 ) 4.1 Concomitant Organic Nitrates ALYQ ® is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. Do not use nitrates within 48 hours of the last dose of ALYQ ® . ALYQ ® poten...

Hypotension: Carefully consider whether patients with certain underlying cardiovascular disease could be adversely affected by vasodilatory effects of ALYQ ® . Not recommended in patients with pulmonary veno-occlusive disease. ( 5.1 , 5.2 ) Effects on the eye: Sudden loss of vision could be a sign of non-arteritic ischemic optic neuropathy (NAION) and may be permanent. ( 5.3 ) Hearing impairment: Cases of sudden decrease or loss of hearing have been reported with CIALIS ® . ( 5.4 ) Concomitant P...

7 DRUG INTERACTIONS 7.1 Nitrates Administration of nitrates within 48 hours after the last dose of ALYQ ® is contraindicated [see Contraindications ( 4.1 )] . 7.2 Alpha-Blockers PDE5 inhibitors, including ALYQ ® , and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be an...