Comment
Author: Admin | 2025-04-28
1. Indications and Usage for Alyq 1.1 Pulmonary Arterial Hypertension Tadalafil (PAH) is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). 2. Alyq Dosage and Administration 2.1 Pulmonary Arterial Hypertension The recommended dose of Tadalafil (PAH) is 40 mg (two 20 mg tablets) taken once daily with or without food. Dividing the dose (40 mg) over the course of the day is not recommended. 2.2 Use in Special Populations Renal Impairment Mild (creatinine clearance 51 to 80 mL/min) or moderate (creatinine clearance 31 to 50 mL/min): Start dosing at 20 mg once daily. Increase to 40 mg once daily based on individual tolerability. Severe (creatinine clearance [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6)]. Hepatic Impairment Mild or moderate (Child Pugh Class A or B): Because of limited clinical experience in patients with mild to moderate hepatic cirrhosis, consider a starting dose of 20 mg once per day. Severe (Child Pugh Class C): Patients with severe hepatic cirrhosis have not been studied. Avoid use of Tadalafil (PAH) [see Warnings and Precautions (5.4) and Use in Specific Populations (8.7)]. Geriatric Patients No dose adjustment is required in patients >65 years of age without renal impairment or hepatic impairment. 2.3 Use with Ritonavir Coadministration of Tadalafil (PAH) in Patients on Ritonavir In patients receiving ritonavir for at least one week, start Tadalafil (PAH) at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability [see Warnings and Precautions (5.2), Drug Interactions (7.2) and Clinical Pharmacology (12.3)]. Coadministration of Ritonavir in Patients on Tadalafil (PAH) Avoid use of Tadalafil (PAH) during the initiation of ritonavir. Stop Tadalafil (PAH) at least 24 hours prior to starting ritonavir. After at least one week following the initiation of ritonavir, resume Tadalafil (PAH) at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability [see Warnings and Precautions (5.2), Drug Interactions (7.2) and Clinical Pharmacology (12.3)]. 3. Dosage Forms and Strengths 20 mg, orange, oval-shaped, film-coated tablets (not scored) debossed with “TEVA” on one side and with “3334” on the other side. 4. Contraindications 4.1 Concomitant Organic Nitrates Do not use Tadalafil (PAH) in patients who are using any form of organic nitrate, either regularly or intermittently. Tadalafil (PAH) potentiates the hypotensive effect of nitrates. This potentiation is thought to result from the combined effects of nitrates and Tadalafil (PAH) on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)]. 4.2 Concomitant Guanylate Cyclase (GC) Stimulators Do not use
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