However, a greater sensitivity to medications in some older individuals should be considered

8.2 Lactation

Midazolam or Lovastatin) - Tadalafil had no significant effect on exposure (AUC) to midazolam or lovastatin.P-glycoprotein (e.g. Digoxin) - Coadministration 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. Nitrates - Administration of tadalafil tablets to patients who are using any form of organic nitrate, is contraindicated. 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 coadministered with alpha-blockers.

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Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin, tamsulosin or alfuzosin [see Dosage and Administration (2.7), Warnings and Precautions (5.6), and Clinical Pharmacology (12.2)]. Antihypertensives - PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. Small reductions in blood pressure occurred following coadministration 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. 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)].

How does tadalafil work (mechanism of action)?

[See Dosage and Administration (2.7) and Warnings and Precautions (5.10)]. Nizatidine) - An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics. Cytochrome P450 Inhibitors - Tadalafil tablets are a substrate of and predominantly metabolized by CYP3A4. Studies female viagra uk 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. [see Clinical Pharmacology (12.3)].8.6 Hepatic ImpairmentIn clinical pharmacology studies, tadalafil exposure (AUC) in

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subjects with mild or moderate hepatic impairment (Child-Pugh Class A or B) was comparable to exposure in healthy subjects when a dose of 10 mg was administered.

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There are no available data for doses higher than 10 mg of tadalafil in patients with hepatic impairment.

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Insufficient data are available for subjects with severe hepatic impairment (Child-Pugh Class C) [see Dosage and Administration (2.6) and Warnings and Precautions (5.8)].8.7

Color Shade	Approximate Dose	Additional Features	Notes
Bright Yellow	100 mg	High concentration	Prescription-only
Pale Yellow	25 mg	Lower dose	Suitable for sensitive users
Deep Amber	50 mg	Standard dose	Most common

Renal ImpairmentIn clinical pharmacology studies using single-dose tadalafil (5 mg to 10 mg), tadalafil exposure (AUC) doubled in subjects with creatinine clearance 30mL/min.

17.4 Concomitant Use with Drugs Which Lower Blood Pressure

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. 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.

What are the most common side effects of tadalafil?

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 coadministration of rifampin or other CYP3A4 inducers can be anticipated to decrease the efficacy of tadalafil tablet for once daily use; the magnitude of decreased generic viagra sildenafil citrate 50 mg efficacy is unknown. Aspirin - Tadalafil did not potentiate the increase in bleeding time caused by aspirin. Cytochrome P450 Substrates - Tadalafil tablets are 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.

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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. 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. Midazolam or Lovastatin) - Tadalafil had no significant effect on exposure (AUC) to midazolam or lovastatin. 8 USE IN SPECIFIC POPULATIONS 8.1 PregnancyRisk SummaryTadalafil tablets are not indicated for use in females.There are no data with the use of tadalafil tablets in pregnant women to inform any drug-associated risks for adverse developmental outcomes. In animal reproduction studies, no adverse developmental effects were observed with oral administration of tadalafil to pregnant rats or mice during organogenesis at exposures up to 11 times the maximum recommended human dose (MRHD) of 20 mg/day (see Data).DataAnimal DataAnimal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given orally to pregnant rats or mice at exposures up to 11 times the maximum recommended human dose (MRHD) of 20 mg/day during organogenesis. In subjects with end-stage renal disease on hemodialysis, there was a two-fold increase in Cmax and 2.7- to 4.8-fold increase in AUC following single-dose administration of 10 mg or 20 mg tadalafil.

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

Exposure to total methylcatechol (unconjugated plus glucuronide) was 2- to 4-fold higher in subjects with renal impairment, compared to those with normal renal function.

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The highest plasma tadalafil exposures (AUC) achieved were approximately 10-fold that observed at the MRHD.8.5 Geriatric UseOf the total number of subjects in ED clinical studies of tadalafil, approximately 19 percent were 65 and over, while approximately 2 percent were 75 and over. Of the total number of subjects in BPH clinical studies of tadalafil (including the ED/BPH study), approximately 40 percent were over 65, while approximately 10 percent were 75 and over. In these clinical trials, no overall differences in efficacy or safety were observed between older (>65 and ≥75 years of age) and younger subjects (≤65 years of age). However, in placebo-controlled studies with tadalafil tablets for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were viagra cream treated with tadalafil tablets (2.5% of patients) [see Adverse Reactions (6.1)]. No dose adjustment is warranted based on age alone. Hemodialysis (performed between 24 hours and 30 hours post-dose) contributed negligibly to tadalafil or metabolite elimination.

7.2 Potential for Other Drugs to Affect Tadalafil Tablets

In a prenatal/postnatal developmental study in rats, postnatal pup survival decreased following maternal exposure to tadalafil doses greater than 10 times the MRHD based on AUC. Signs of maternal toxicity occurred at doses greater than 16 times the MRHD based on AUC. Surviving offspring had normal development and reproductive performance.In another rat prenatal and postnatal development study at doses of 60, 200, and 1000 mg/kg, a reduction in postnatal survival of pups was observed. The no observed effect level (NOEL) for maternal toxicity was 200 mg/kg/day and for developmental toxicity was 30 mg/kg/day. 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 tablets are 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.

What should I know about tadalafil before using it?

Tadalafil and/or its metabolites are present in the milk of lactating rats at concentrations approximately 2.4-fold greater than found in the plasma.8.3 Females and Males of Reproductive PotentialInfertilityBased on the data from 3 studies in adult males, tadalafil decreased sperm concentrations in the study of 10 mg tadalafil for 6 months and the study of 20 mg tadalafil for 9 months. This effect was not seen in the study of 20 mg tadalafil taken for 6 months. The clinical significance of the decreased sperm concentrations in the two studies is unknown. 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 tablets are not indicated for use in pediatric patients. Safety and efficacy in patients below the age of 18 years have not been established.A randomized, double-blind, placebo-controlled trial in pediatric patients (7 to 14 years of age) with Duchenne muscular dystrophy, who received tadalafil tablets 0.3 mg/kg, tadalafil tablets 0.6 mg/kg, or placebo dailyfor48 weeks failed to demonstrate any benefit of treatment with tadalafil tablets on a range of assessments of muscle strength and performance.Juvenile Animal StudyNo adverse effects were observed in a study in which tadalafil was administered orally at doses of 60, 200, and 1000 mg/kg/day to juvenile rats on postnatal days 14 to 90.