TADALAFIL

TADALAFIL- tadalafil tablet
Torrent Pharmaceuticals Limited

1 INDICATIONS AND USAGE

1.1 Pulmonary Arterial Hypertension

Tadalafil tablets are 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 DOSAGE AND ADMINISTRATION

2.1 Pulmonary Arterial Hypertension

The recommended dose of Tadalafil tablets 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 Dose Adjustment in 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 <30 mL/min and on hemodialysis): Avoid use of tadalafil tablets because of increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis [see Use in Specific Populations ( 8.6)] .

2.3 Dose Adjustment in 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 tablets [see Use in Specific Populations ( 8.7)] .

2.4 Dose Adjustment for Use with Ritonavir

Co-administration of Tadalafil Tablets in Patients on Ritonavir

In patients receiving ritonavir for at least one week, start tadalafil tablets at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability [see Drug Interactions ( 7.5) and Clinical Pharmacology ( 12.3)] .

Co-administration of Ritonavir in Patients on Tadalafil Tablets

Avoid use of tadalafil tablets during the initiation of ritonavir. Stop tadalafil tablets at least 24 hours prior to starting ritonavir. After at least one week following the initiation of ritonavir, resume tadalafil tablets at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability [see Drug Interactions ( 7.5) and Clinical Pharmacology ( 12.3)] .

3 DOSAGE FORMS AND STRENGTHS

20 mg, yellow colored, oval shaped, biconvex beveled edge, film coated tablets with debossing “N9” on one side and plain on other side.

4 CONTRAINDICATIONS

4.1 Concomitant Organic Nitrates

Tadalafil 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 lst dose of tadalafil. Tadalafil potentiates the hypotensive effect of nitrates. This potentiation is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway [see Clinical Pharmacology ( 12.2)] .

4.2 Concomitant Guanylate Cyclase (GC) Stimulators

Coadministration of GC stimulators, such as riociguat with tadalafil is contraindicated. Tadalafil may potentiate the hypotensive effects of GC stimulators.

4.3 Hypersensitivity Reactions

Tadalafil is contraindicated in patients with a known serious hypersensitivity to tadalafil (Tadalafil tablets). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions ( 6.2)] .

5 WARNINGS AND PRECAUTIONS

5.1 Hypotension

Tadalafil has vasodilatory properties that may result in transient decreases in blood pressure. Prior to prescribing tadalafil tablets, carefully consider whether patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects. Patients with preexisting hypotension,with autonomic dysfunction, with left ventricular outflow obstruction, may be particularly sensitive to the actions of vasodilators.

5.2 Worsening Pulmonary Vascular Occlusive Disease

Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of tadalafil tablets to patients with veno-occlusive disease, administration of tadalafil tablets to such patients is not recommended. Should signs of pulmonary edema occur when tadalafil tablets are administered, the possibility of associated PVOD should be considered.

5.3 Visual Loss

When used to treat erectile dysfunction, non–arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including permanent loss of vision, has been reported postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including tadalafil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking. Based on published literature, the annual incidence of NAION is 2.5 to 11.8 cases per 100,000 in males aged ≥50 in the general population. An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, typical of erectile dysfunction treatment, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period. The results suggest an approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34). A similar study reported a consistent result, with a risk estimate of 2.27 (95% CI 0.99, 5.20). Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies.

Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.

5.4 Hearing Impairment

Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in patients taking tadalafil. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions ( 6.2)] .

5.5 Combination with Other PDE5 Inhibitors

Tadalafil is also marketed for erectile dysfunction. The safety and efficacy of taking tadalafil tablets together with another PDE5 inhibitors has not been studied. Inform patients taking tadalafil tablets not to take other PDE5 inhibitors.

5.6 Prolonged Erection

There have been reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Patients who have conditions that might predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease) are at an increased risk. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention.

6 ADVERSE REACTIONS

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)]

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