V 10 Pill: yellow, oval, 10mm

Detection in biological fluids
17.2 Guanylate Cyclase (GC) Stimulators
5.9 Counseling Patients About Sexually Transmitted Diseases
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Detection in biological fluids

Cytochrome P450 Substrates — Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolized by cytochrome P450 (CYP) isoforms. CYP2C9 (e.g., Warfarin) — Tadalafil had no significant effect on exposure (AUC) to S-warfarin or R-warfarin, nor did tadalafil affect changes in prothrombin time induced by warfarin. CYP3A4 (e.g., Midazolam or Lovastatin) — Tadalafil had no significant effect on exposure (AUC) to midazolam or lovastatin. P-glycoprotein (e.g., Digoxin)— Co-administration of tadalafil (40 mg once per day) for 10 days did not have a significant effect on the steady-state pharmacokinetics of digoxin (0.25 mg/day) in healthy subjects. 8 USE IN SPECIFIC POPULATIONS 8.1 PregnancyRisk SummaryTadalafil is not indicated for use in females.There are no data with the use of tadalafil in pregnant women to inform any drug-associated risks for adverse developmental outcomes.

What is tadalafil used for?

Surviving offspring had normal development and reproductive performance.In another rat prenatal and postnatal development study at doses of 60 mg/kg, 200 mg/kg, and 1,000 mg/kg, a reduction in postnatal survival of pups was observed. This gives approximately 16 and 10 fold exposure multiples, respectively, of the human AUC for the MRHD of 20 mg.Tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats.8.2 LactationRisk SummaryTadalafil is not indicated for use in females.There is no information on the presence of tadalafil and/or metabolites in human milk, the effects on the breastfed child, or the effects on milk production. There have been no studies evaluating the effect of tadalafil on fertility in men [see Clinical Pharmacology (12.2)].Based on studies in animals, a decrease in spermatogenesis was observed in dogs, but not in rats [see Nonclinical Toxicology (13.1)].8.4 Pediatric UseTadalafil is not indicated for use in pediatric patients. Safety and efficacy in patients below the age of 18 years have not been established.Juvenile Animal StudyNo adverse effects were observed in a study in which tadalafil was administered orally at doses of 60 mg/kg/day, 200 mg/kg/day, and 1000 mg/kg/day to juvenile rats on postnatal days 14 to 90.

Does tadalafil interact with foods or drinks?

In clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates. In a patient who has taken tadalafil, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of tadalafil before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see Dosage and Administration (2.7), Contraindications (4.1), and Clinical Pharmacology (12.2)].Alpha-Blockers — Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. Clinical pharmacology studies have been conducted with co-administration of tadalafil with doxazosin, tamsulosin or alfuzosin [see Dosage and Administration (2.7), Warnings and Precautions (5.6), and Clinical Pharmacology (12.2)].Anti-hypertensives — PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. Small reductions in blood pressure occurred following co-administration of tadalafil with these agents compared with placebo [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.2)].Alcohol — Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. Substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache.

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Tadalafil did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations [see Warnings and Precautions (5.9) and Clinical Pharmacology (12.2)].7.2 Potential for Other Drugs to Affect Tadalafil[see Dosage and Administration (2.7) and Warnings and Precautions (5.10)].Antacids — Simultaneous administration of an antacid (magnesium hydroxide/aluminum hydroxide) and tadalafil reduced the apparent rate of absorption of tadalafil without altering exposure (AUC) to tadalafil.H2 Antagonists (e.g., Nizatidine) — An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics.Cytochrome P450 Inhibitors — Tadalafil is a substrate of and predominantly metabolized by CYP3A4.

17.2 Guanylate Cyclase (GC) Stimulators

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Studies have shown that drugs that inhibit CYP3A4 can increase tadalafil exposure.CYP3A4 (e.g., Ketoconazole) — Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4, increased tadalafil 20 mg single-dose exposure (AUC) by 312% and Cmax by 22%, relative to the values for tadalafil 20 mg alone. Ketoconazole (200 mg daily) increased tadalafil 10 mg single-dose exposure (AUC) by 107% and Cmax by 15%, relative to the values for tadalafil 10 mg alone [see Dosage and Administration (2.7)].Although specific interactions have not been studied, other CYP3A4 inhibitors, such as erythromycin, itraconazole, and grapefruit juice, would likely increase tadalafil exposure.HIV Protease inhibitor — Ritonavir (500 mg or 600 mg twice daily at steady-state), an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil 20 mg single-dose exposure (AUC) by 32% with a 30% reduction in Cmax, relative to the values for tadalafil 20 mg alone.

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Ritonavir (200 mg twice daily), increased tadalafil 20-mg single-dose exposure (AUC) by 124% with no change in Cmax, relative to the values for tadalafil 20 mg alone.Although specific interactions have not been studied, other HIV protease inhibitors would likely increase tadalafil exposure [see Dosage and Administration (2.7)].Cytochrome P450 Inducers — Studies have shown that drugs that induce CYP3A4 can decrease tadalafil exposure.CYP3A4 (e.g., Rifampin) — Rifampin (600 mg daily), a CYP3A4 inducer, reduced tadalafil 10 mg single-dose exposure (AUC) by 88% and Cmax by 46%, relative to the values for tadalafil 10 mg alone. The reduced exposure of tadalafil with the co-administration of rifampin or other CYP3A4 inducers can be anticipated to decrease the efficacy of tadalafil for once daily use; the magnitude of decreased efficacy is unknown.7.3 Potential for Tadalafil to Affect Other DrugsAspirin — Tadalafil did not potentiate the increase in bleeding time caused by aspirin.Cytochrome P450 Substrates — Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolized by cytochrome P450 (CYP) isoforms. Studies have shown that tadalafil does not inhibit or induce P450 isoforms CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP2E1.CYP1A2 (e.g., Theophylline) — Tadalafil had no significant effect on the pharmacokinetics of theophylline. When tadalafil was administered to subjects taking theophylline, a small augmentation (3 beats per minute) of the increase in heart rate associated with theophylline was observed.CYP2C9 (e.g., Warfarin) — Tadalafil had no significant effect on exposure (AUC) to S-warfarin or R-warfarin, nor did tadalafil affect changes in prothrombin time induced by warfarin.CYP3A4 (e.g., Midazolam or Lovastatin) — Tadalafil had no significant effect on exposure (AUC) to midazolam or lovastatin.P-glycoprotein (e.g., Digoxin)— Co-administration of tadalafil (40 mg once per day) for 10 days did not have a significant effect on the steady-state pharmacokinetics of digoxin (0.25 mg/day) in healthy subjects.

Purpose	Recommended Dosage	Typical Onset	Duration of Effect	Notes
Erectile Dysfunction	50-100 mg	30-60 min	4-6 hours	Taken with water
Pulmonary Hypertension	25 mg	15-30 min	4 hours	Prescribed by doctor
Recreational Use	50-100 mg	30-60 min	4-6 hours	Off-label, caution advised

Nitrates — Administration of tadalafil to patients who are using any form of organic nitrate, is contraindicated. Alpha-Blockers — Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. Clinical pharmacology studies have been conducted with co-administration of tadalafil with doxazosin, tamsulosin or alfuzosin [see Dosage and Administration (2.7), Warnings and Precautions (5.6), and Clinical Pharmacology (12.2)]. Anti-hypertensives — PDE5 inhibitors, including tadalafil, are mild systemic vasodilators.

5.9 Counseling Patients About Sexually Transmitted Diseases

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Alcohol — Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. H2 Antagonists (e.g., Nizatidine) — An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics. Cytochrome P450 viagra 100mg Inhibitors — Tadalafil is a substrate of and predominantly metabolized by CYP3A4. CYP3A4 (e.g., Ketoconazole) — Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4, increased tadalafil 20 mg single-dose exposure (AUC) by 312% and Cmax by 22%, relative to the values for tadalafil 20 mg alone. Ketoconazole (200 mg daily) increased tadalafil 10 mg single-dose exposure (AUC) by 107% and Cmax by 15%, relative to the values for tadalafil 10 mg alone [see Dosage and Administration (2.7)].

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HIV Protease inhibitor — Ritonavir (500 mg or 600 mg twice daily at steady-state), an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil 20 mg single-dose exposure (AUC) by 32% with a 30% reduction in Cmax, relative to the values for tadalafil 20 mg alone. Cytochrome P450 Inducers — Studies have shown that drugs that induce CYP3A4 can decrease tadalafil exposure. CYP3A4 (e.g., Rifampin) — Rifampin (600 mg daily), a CYP3A4 inducer, reduced tadalafil 10 mg single-dose exposure (AUC) by 88% and Cmax by 46%, relative to the values for tadalafil 10 mg alone. The reduced exposure of tadalafil with the co-administration of rifampin or other CYP3A4 inducers can be anticipated to decrease the efficacy of tadalafil for once daily use; the magnitude of decreased efficacy is unknown. Aspirin — Tadalafil did not potentiate the increase in bleeding time caused by aspirin. Small reductions in blood pressure occurred following co-administration of tadalafil with these agents compared with placebo [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.2)]. Alcohol — Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. H2 Antagonists (e.g., Nizatidine) — An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics.

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Cytochrome P450 viagra 100mg Inhibitors — Tadalafil is a substrate of and predominantly metabolized by CYP3A4.

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CYP3A4 (e.g., Ketoconazole) — Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4, increased tadalafil 20 mg single-dose exposure (AUC) by 312% and Cmax by 22%, relative to the values for tadalafil 20 mg alone. Ketoconazole (200 mg daily) increased tadalafil 10 mg single-dose exposure (AUC) by 107% and Cmax by 15%, relative to the values for tadalafil 10 mg alone [see Dosage and Administration (2.7)]. HIV Protease inhibitor — Ritonavir (500 mg or 600 mg twice daily at steady-state), an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil 20 mg single-dose exposure (AUC) by 32% with a 30% reduction in Cmax, relative to the values for tadalafil 20 mg alone.

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Cytochrome P450 Inducers — Studies have shown that drugs that induce CYP3A4 can decrease tadalafil exposure. CYP3A4 (e.g., Rifampin) — Rifampin (600 mg daily), a CYP3A4 inducer, reduced tadalafil 10 mg single-dose exposure (AUC) by 88% and Cmax by 46%, relative to the values for tadalafil 10 mg alone. The reduced exposure of tadalafil with the co-administration of rifampin or other CYP3A4 inducers can be anticipated to decrease the efficacy of tadalafil for once daily use; the magnitude of decreased efficacy is unknown. Aspirin — Tadalafil did not potentiate the increase in bleeding time caused by aspirin.

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Precaution	Explanation	Risk if Ignored
Do not mix with nitrates	Can cause severe hypotension	Heart issues, fainting
Avoid heavy meals before intake	Delays absorption	Reduced effectiveness
Consult doctor if on other medications	Potential interactions	Adverse reactions
Do not exceed recommended dose	Overdose risk	Severe side effects

8 USE IN SPECIFIC POPULATIONS 8.1 PregnancyRisk SummaryTadalafil is not indicated for use in females.There are no data with the use of tadalafil in pregnant women to inform any drug-associated risks for adverse developmental outcomes. Surviving offspring had normal development and reproductive performance.In another rat prenatal and postnatal development study at doses of 60 mg/kg, 200 mg/kg, and 1,000 mg/kg, a reduction in postnatal survival of pups was observed. This gives approximately 16 and 10 fold exposure multiples, respectively, of the human AUC for the MRHD of 20 mg.Tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats.8.2 LactationRisk SummaryTadalafil is not indicated for use in females.There is no information on the presence of tadalafil and/or metabolites in human milk, the effects on the breastfed child, or the effects on milk production.

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Urogenital — priapism [see Warnings and Precautions (5.3)]. 7 DRUG INTERACTIONS 7.1 Potential for Pharmacodynamic Interactions with TadalafilNitrates — Administration of tadalafil to patients who are using any form of organic nitrate, is contraindicated. In clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates. In a patient who has taken tadalafil, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of tadalafil before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see Dosage and Administration (2.7), Contraindications (4.1), and Clinical Pharmacology (12.2)].Alpha-Blockers — Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers.

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Clinical pharmacology studies have been conducted with co-administration of tadalafil with doxazosin, tamsulosin or alfuzosin [see Dosage and Administration (2.7), Warnings and Precautions (5.6), and Clinical Pharmacology (12.2)].Anti-hypertensives — PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. Small reductions in blood pressure occurred following co-administration of tadalafil with these agents compared with placebo [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.2)].Alcohol — Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. Substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache. Tadalafil did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations [see Warnings and Precautions (5.9) and Clinical Pharmacology (12.2)].7.2 Potential for Other Drugs to Affect Tadalafil[see Dosage and Administration (2.7) and Warnings and Precautions (5.10)].Antacids — Simultaneous administration of an antacid (magnesium hydroxide/aluminum hydroxide) and tadalafil reduced the apparent rate of absorption of tadalafil without altering exposure (AUC) to tadalafil.H2 Antagonists (e.g., Nizatidine) — An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics.Cytochrome P450 Inhibitors — Tadalafil is a substrate of and predominantly metabolized by CYP3A4. Studies have shown that drugs that inhibit CYP3A4 can increase tadalafil exposure.CYP3A4 (e.g., Ketoconazole) — Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4, increased tadalafil 20 mg single-dose exposure (AUC) by 312% and Cmax by 22%, relative to the values for tadalafil 20 mg alone.

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Ketoconazole (200 mg daily) increased tadalafil 10 mg single-dose exposure (AUC) by 107% and Cmax by 15%, relative to the values for tadalafil 10 mg alone [see Dosage and Administration (2.7)].Although specific interactions have not been studied, other CYP3A4 inhibitors, such as erythromycin, itraconazole, and grapefruit juice, would likely increase tadalafil exposure.HIV Protease inhibitor — Ritonavir (500 mg or 600 mg twice daily at steady-state), an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil 20 mg single-dose exposure (AUC) by 32% with a 30% reduction in Cmax, relative to the values for tadalafil 20 mg alone. Ritonavir (200 mg twice daily), increased tadalafil 20-mg single-dose exposure (AUC) by 124% with no change in Cmax, relative to the values for tadalafil 20 mg alone.Although specific interactions have not been studied, other HIV protease inhibitors would likely increase tadalafil exposure [see Dosage and Administration (2.7)].Cytochrome P450 Inducers — Studies have shown that drugs that induce CYP3A4 can decrease tadalafil exposure.CYP3A4 (e.g., Rifampin) — Rifampin (600 mg daily), a CYP3A4 inducer, reduced tadalafil 10 mg single-dose exposure (AUC) by 88% and Cmax by 46%, relative to the values for tadalafil 10 mg alone. The reduced exposure of tadalafil with the co-administration of rifampin or other CYP3A4 inducers can be anticipated to decrease the efficacy of tadalafil for once daily use; the magnitude of decreased efficacy is unknown.7.3 Potential for Tadalafil to Affect Other DrugsAspirin — Tadalafil did not potentiate the increase in bleeding time caused by aspirin.Cytochrome P450 Substrates — Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolized by cytochrome P450 (CYP) isoforms. Studies have shown that tadalafil does not inhibit or induce P450 isoforms CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP2E1.CYP1A2 (e.g., Theophylline) — Tadalafil had no significant effect on the pharmacokinetics of theophylline. When tadalafil was administered to subjects taking theophylline, a small augmentation (3 beats per minute) of the increase in heart rate associated with theophylline was observed.CYP2C9 (e.g., Warfarin) — Tadalafil had no significant effect on exposure (AUC) to S-warfarin or R-warfarin, nor did tadalafil affect changes in prothrombin time induced by warfarin.CYP3A4 (e.g., Midazolam or Lovastatin) — Tadalafil had no significant effect on exposure (AUC) to midazolam or lovastatin.P-glycoprotein (e.g., Digoxin)— Co-administration of tadalafil (40 mg once per day) for 10 days did not have a significant effect on the steady-state pharmacokinetics of digoxin (0.25 mg/day) in healthy subjects. There have been no studies evaluating the effect of tadalafil on fertility in men [see Clinical Pharmacology (12.2)].Based on studies in animals, a decrease in spermatogenesis was observed in dogs, but not in rats [see Nonclinical Toxicology (13.1)].8.4 Pediatric UseTadalafil is not indicated for use in pediatric patients. Safety and efficacy in patients below the age of 18 years have not been established.Juvenile Animal StudyNo adverse effects were observed in a study in which tadalafil was administered orally at doses of 60 mg/kg/day, 200 mg/kg/day, and 1000 mg/kg/day to juvenile rats on postnatal days 14 to 90.