Tadalafil 20 mg to 40 mg Given Every Second Day Is Effective in Secondary Pulmonary Hypertensio

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%). (1.1)DOSAGE AND ADMINISTRATIONDOSAGE FORMS AND STRENGTHSTablets (not scored): 20 mg (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSHypotension: Carefully consider whether patients with certain underlying cardiovascular disease could be adversely affected by vasodilatory effects of tadalafil. 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.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Do not use nitrates within 48 hours of the last dose of tadalafil tablets. Tadalafil tablets potentiates the hypotensive effect of nitrates. This potentiation is thought to result from the combined effects of nitrates and tadalafil tablets on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)].4.2 Concomitant Guanylate Cyclase (GC) StimulatorsCoadministration of GC stimulator such as riociguat with tadalafil tablets is contraindicated. Tadalafil tablets may potentiate the hypotensive effects of GC stimulators.4.3 Hypersensitivity ReactionsTadalafil tadalafil pills tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil (tadalafil tablets or CIALIS). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions (6.2)].

Can you skip a day of tadalafil daily?

Tadalafil tablet is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. This potentiation is thought to result from the combined effects of nitrates and tadalafil tablets on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)]. Coadministration of GC stimulator such as riociguat with tadalafil tablets is contraindicated. Tadalafil tablets may potentiate the hypotensive effects of GC stimulators. Tadalafil tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil (tadalafil tablets or CIALIS). (5.4)Concomitant PDE5 inhibitors: Avoid use with CIALIS or other PDE5 inhibitors.

(5.5)Prolonged erection: Advise patients to seek emergency treatment if an erection lasts greater than 4 hours. (5.6)ADVERSE REACTIONSThe most common adverse reaction is headache. (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Ajanta Pharma USA Inc.

Important Safety Information for ambrisentan and tadalafil in the European Union

Hypotension: Carefully consider whether patients with certain underlying cardiovascular disease could be adversely affected by vasodilatory effects of tadalafil. Effects on the eye: Sudden loss of vision could be a sign of non-arteritic ischemic optic neuropathy (NAION) and may be permanent. Hearing impairment: Cases of tadalafil 2 5 mg sudden decrease or loss of hearing have been reported with CIALIS. Concomitant PDE5 inhibitors: Avoid use with CIALIS or other PDE5 inhibitors. Prolonged erection: Advise patients to seek emergency treatment if an erection lasts greater than 4 hours.

3. Do you take other medications?

The most common adverse reaction is headache. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE1.1 Pulmonary Arterial Hypertension2 DOSAGE AND ADMINISTRATION2.1 Pulmonary Arterial Hypertension2.2 Dose Adjustment in Renal Impairment2.3 Dose Adjustment in Hepatic Impairment2.4 Dose Adjustment for Use with Ritonavir3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Concomitant Organic Nitrates4.2 Concomitant Guanylate Cyclase (GC) Stimulators4.3 Hypersensitivity Reactions5 WARNINGS AND PRECAUTIONS5.1 Hypotension5.2 Worsening Pulmonary Vascular Occlusive Disease5.3 Visual Loss5.4 Hearing Impairment5.5 Combination with Other PDE5 Inhibitors5.6 Prolonged Erection6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Nitrates7.2 Alpha-Blockers7.3 Antihypertensives7.4 Alcohol7.5 CYP3A Inhibitors/Inducers8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.3 Females and Males of Reproductive Potential8.4 Pediatric Use8.5 Geriatric Use8.6 Renal Impairment8.7 Hepatic Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES14.1 Tadalafil tablets for Pulmonary Arterial Hypertension14.2 Long-Term Treatment of Pulmonary Arterial Hypertension16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. Sections or subsections omitted from the full prescribing information are not listed. 1 INDICATIONS AND USAGE 1.1 Pulmonary Arterial HypertensionTadalafil Tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. at 1-855-664-7744 or FDA at 1-800-FDA-1088 or IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 10/2025 Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Hypotension: Carefully consider whether patients with certain underlying cardiovascular disease could be adversely affected by vasodilatory effects of tadalafil. Effects on the eye: Sudden loss of vision could be a sign of non-arteritic ischemic optic neuropathy (NAION) and may be permanent. Hearing impairment: Cases of tadalafil 2 5 mg sudden decrease or loss of hearing have been reported with CIALIS. Concomitant PDE5 inhibitors: Avoid use with CIALIS or other PDE5 inhibitors. Prolonged erection: Advise patients to seek emergency treatment if an erection lasts greater than 4 hours. The most common adverse reaction is headache. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE1.1 Pulmonary Arterial Hypertension2 DOSAGE AND ADMINISTRATION2.1 Pulmonary Arterial Hypertension2.2 Dose Adjustment in Renal Impairment2.3 Dose Adjustment in Hepatic Impairment2.4 Dose Adjustment for Use with Ritonavir3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Concomitant Organic Nitrates4.2 Concomitant Guanylate Cyclase (GC) Stimulators4.3 Hypersensitivity Reactions5 WARNINGS AND PRECAUTIONS5.1 Hypotension5.2 Worsening Pulmonary Vascular Occlusive Disease5.3 Visual Loss5.4 Hearing Impairment5.5 Combination with Other PDE5 Inhibitors5.6 Prolonged Erection6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Nitrates7.2 Alpha-Blockers7.3 Antihypertensives7.4 Alcohol7.5 CYP3A Inhibitors/Inducers8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.3 Females and Males of Reproductive Potential8.4 Pediatric Use8.5 Geriatric Use8.6 Renal Impairment8.7 Hepatic Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES14.1 Tadalafil tablets for Pulmonary Arterial Hypertension14.2 Long-Term Treatment of Pulmonary Arterial Hypertension16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. Sections or subsections omitted from the full prescribing information are not listed. 1 INDICATIONS AND USAGE 1.1 Pulmonary Arterial HypertensionTadalafil Tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.

• Tadalafil 40mg is available in some countries only as a prescription medication.
• Use with caution in patients with retinal disorders or retinitis pigmentosa.
• Be aware of possible side effects like dizziness, visual disturbances, or flushing.
• Do not use this medication if you have recently had a stroke or heart attack.
• Tadalafil 40mg can help improve quality of life for men with ED.
• Always discuss your full medical history with your healthcare provider beforehand.

Tadalafil Tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.

Possible Alternatives to Tadalafil

Drug information

2 DOSAGE AND ADMINISTRATION 2.1 Pulmonary Arterial HypertensionThe recommended dose of tadalafil tablets is 40 mg (two 20 mg tablets) taken once daily with or without food.

3. Competitive Pricing for Distributors & Importers

Tadalafil Tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. 2 DOSAGE AND ADMINISTRATION 2.1 Pulmonary Arterial HypertensionThe 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 ImpairmentMild (creatinine clearance 51 mL/min to 80 mL/min) or moderate (creatinine clearance 31 mL/min to 50 mL/min): Start dosing at 20 mg once daily. Increase to 40 mg once daily based on individual tolerability.Severe (creatinine clearance less than 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 ImpairmentMild 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 RitonavirCo-administration of tadalafil tablets in Patients on RitonavirIn patients receiving ritonavir for at least one week, start tadalafil tablets at 20 mg once daily.

CAUTION & SCHEDULE:

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 tabletsAvoid 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 tadalafil weekend pill (7.5) and Clinical Pharmacology (12.3)]. 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 ImpairmentMild (creatinine clearance 51 mL/min to 80 mL/min) or moderate (creatinine clearance 31 mL/min to 50 mL/min): Start dosing at 20 mg once daily. Increase to 40 mg once daily based on individual tolerability.Severe (creatinine clearance less than 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 ImpairmentMild 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 RitonavirCo-administration of tadalafil tablets in Patients on RitonavirIn patients receiving ritonavir for at least one week, start tadalafil tablets at 20 mg once daily.

Administration Instructions for Tadalafil

Dividing the dose (40 mg) over the course of the day is not recommended. Mild (creatinine clearance 51 mL/min to 80 mL/min) or moderate (creatinine clearance 31 mL/min to 50 mL/min): Start dosing at 20 mg once daily. Increase to 40 mg once daily based on individual tolerability. Severe (creatinine clearance less than 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)]. 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.

Tadalafil strengths

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)]. 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. Co-administration of Ritonavir in Patients on Tadalafil tablets Avoid use of tadalafil tablets during the initiation of ritonavir. 4 CONTRAINDICATIONS 4.1 Concomitant Organic NitratesTadalafil tablet is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. 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 tabletsAvoid 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 tadalafil weekend pill (7.5) and Clinical Pharmacology (12.3)]. 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. Mild (creatinine clearance 51 mL/min to 80 mL/min) or moderate (creatinine clearance 31 mL/min to 50 mL/min): Start dosing at 20 mg once daily. Increase to 40 mg once daily based on individual tolerability. Severe (creatinine clearance less than 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)]. 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)]. 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. Co-administration of Ritonavir in Patients on Tadalafil tablets Avoid use of tadalafil tablets during the initiation of ritonavir. 4 CONTRAINDICATIONS 4.1 Concomitant Organic NitratesTadalafil tablet 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 tadalafil tablets. Tadalafil tablets potentiates the hypotensive effect of nitrates. This potentiation is thought to result from the combined effects of nitrates and tadalafil tablets on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)].4.2 Concomitant Guanylate Cyclase (GC) StimulatorsCoadministration of GC stimulator such as riociguat with tadalafil tablets is contraindicated. Tadalafil tablets may potentiate the hypotensive effects of GC stimulators.4.3 Hypersensitivity ReactionsTadalafil tadalafil pills tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil (tadalafil tablets or CIALIS).

8.3 Females and Males of Reproductive Potential

5 WARNINGS AND PRECAUTIONS 5.1 HypotensionTadalafil tablets 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 DiseasePulmonary 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 LossWhen 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 (PDE-5) inhibitors, including tadalafil.

STORAGE & DOSAGE:

Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions (6.2)]. Tadalafil tablet is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently.

• Do not take Tadalafil 40mg if you are on medications containing nitrates.
• Follow the prescribed dosing schedule strictly for safety and effectiveness.
• The medication may cause a sudden drop in blood pressure in some users.
• Inform your doctor about all health conditions before starting Tadalafil.
• Do not take more than one dose per day to avoid overdose risks.
• Use this medication responsibly to manage ED effectively and safely.

This potentiation is thought to result from the combined effects of nitrates and tadalafil tablets on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)]. Coadministration of GC stimulator such as riociguat with tadalafil tablets is contraindicated. Tadalafil tablets may potentiate the hypotensive effects of GC stimulators. Tadalafil tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil (tadalafil tablets or CIALIS). 5 WARNINGS AND PRECAUTIONS 5.1 HypotensionTadalafil tablets 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.

Is it safe to take tadalafil daily?

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%). (1.1)DOSAGE AND ADMINISTRATIONDOSAGE FORMS AND STRENGTHSTablets (not scored): 20 mg (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSHypotension: Carefully consider whether patients with certain underlying cardiovascular disease could be adversely affected by vasodilatory effects of tadalafil. 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.

How does Cialis work?

(5.4)Concomitant PDE5 inhibitors: Avoid use with CIALIS or other PDE5 inhibitors. (5.5)Prolonged erection: Advise patients to seek emergency treatment if an erection lasts greater than 4 hours. (5.6)ADVERSE REACTIONSThe most common adverse reaction is headache. (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Ajanta Pharma USA Inc. at 1-855-664-7744 or FDA at 1-800-FDA-1088 or IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 10/2025 Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. 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 DiseasePulmonary 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 LossWhen 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 (PDE-5) inhibitors, including tadalafil.