No adverse effects were observed in a study in which tadalafil was administered orally at
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 SummaryCIALIS 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. 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 UseCIALIS is 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 CIALIS 0.3 mg/kg, CIALIS 0.6 mg/kg, or placebo daily for 48 weeks failed to demonstrate any benefit of treatment with CIALIS 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. 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 CIALIS for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with CIALIS (2.5% of patients) [see Adverse Reactions (6.1)]. doses of 60, 200, and 1000 mg/kg/day to juvenile rats on postnatal days 14 to 90.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Super Active | 20mg | 10 Pills | 55.64€ 52.99€ | |
| Cialis Original | 20mg | 76 + 4 Pills | 319.19€ 303.99€ | |
| Cialis Black | 80mg | 20 Pills | 71.83€ 68.41€ | |
| Cialis Generic | 2.5mg | 30 + 4 Pills | 51.95€ 49.48€ | |
| Cialis Generic | 60mg | 120 + 8 Pills | 240.18€ 228.74€ | |
| Cialis Super Active | 20mg | 180 + 20 Pills | 521.59€ 496.75€ | |
| Cialis Generic | 20mg | 20 Pills | 54.72€ 52.11€ | |
| Cialis Professional | 20mg | 10 Pills | 48.29€ 45.99€ | |
| Cialis Generic | 20mg | 30 + 4 Pills | 68.05€ 64.81€ | |
| Cialis Soft Tabs | 20mg | 20 + 2 Pills | 66.98€ 63.79€ | |
| Cialis Professional | 40mg | 90 + 2 Pills | 348.59€ 331.99€ | |
| Cialis Generic | 5mg | 360 + 10 Pills | 268.08€ 255.31€ | |
| Cialis Super Active | 20mg | 20 + 4 Pills | 92.35€ 87.95€ | |
| Cialis Original | 20mg | 48 + 4 Pills | 224.69€ 213.99€ | |
| Cialis Generic | 20mg | 180 + 10 Pills | 254.09€ 241.99€ | |
| Cialis Generic | 20mg | 10 Pills | 31.49€ 29.99€ | |
| Cialis Professional | 20mg | 180 + 4 Pills | 423.11€ 402.96€ |
The highest plasma tadalafil exposures (AUC) achieved
No dose adjustment is warranted based on age alone. However, a greater sensitivity to medications in some older individuals should be considered. [see Clinical Pharmacology (12.3)].8.6 Hepatic ImpairmentIn clinical pharmacology studies, tadalafil exposure (AUC) in 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. There are no available data for doses higher than 10 mg of tadalafil in patients with hepatic impairment. Insufficient data are available for subjects with generic cialis 5 mg severe hepatic impairment (Child-Pugh Class C).
[see Dosage and Administration (2.6) and Warnings and Precautions (5.8)].8.7 Renal ImpairmentIn clinical pharmacology studies using single-dose tadalafil (5 to 10 mg), tadalafil exposure (AUC) doubled in subjects with creatinine clearance 30 to 80 mL/min. 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 or 20 mg tadalafil. 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. Hemodialysis (performed between 24 and 30 hours post-dose) contributed negligibly to tadalafil or metabolite elimination. In a clinical pharmacology study (N=28) at a dose of 10 mg, back pain was reported as a limiting adverse event in male patients with creatinine clearance 30 to 50 mL/min. were approximately 10-fold that observed at the MRHD.
Of the total number of subjects in ED clinical studies of tadalafil, approximately
| Step | Description | Notes |
|---|---|---|
| Take dose as directed | 1 tablet per day or as prescribed | Follow medical advice |
| Time to effect | 30-60 minutes after ingestion | Varies individually |
| Duration of effect | Up to 36 hours | Longer-lasting than some alternatives |
| Avoid alcohol | Alcohol can decrease effectiveness and increase side effects | Limit intake during use |
19 percent were 65 and over, while approximately 2 percent were 75 and over.
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)]. CIALIS is 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 CIALIS 0.3 mg/kg, CIALIS 0.6 mg/kg, or placebo daily for 48 weeks failed to demonstrate any benefit of treatment with CIALIS on a range of assessments of muscle strength and performance. In clinical pharmacology studies, tadalafil exposure (AUC) in
| Medication Type | Possible Interaction | Warning Level |
|---|---|---|
| Nitrates | Severe hypotension risk | High |
| Blood pressure meds | Enhanced effect, risk of hypotension | Moderate |
| Blood thinners | Increased bleeding risk | Moderate |
| CYP3A4 inhibitors | Prolonged drug effects | Moderate |
subjects with mild or moderate hepatic impairment (Child-Pugh Class
The reduced exposure of tadalafil with the coadministration of rifampin or other CYP3A4 inducers can be anticipated to decrease the efficacy of CIALIS for once daily use; the magnitude of decreased efficacy is unknown. Cytochrome P450 Substrates — CIALIS 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. 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. 8 USE IN SPECIFIC POPULATIONS 8.1 PregnancyRisk SummaryCIALIS (tadalafil) is not indicated for use in females.There are no data with the use of CIALIS 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 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. A or B) was comparable to exposure in healthy subjects when a dose of 10 mg was administered.
[see Dosage and Administration (2.6) and Warnings and Precautions (5.8)].
Tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats. CIALIS 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. 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. Based 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. In clinical pharmacology studies using single-dose tadalafil (5 to 10 mg), tadalafil
At a dose of 5 mg, the incidence and severity of back pain was not significantly different than in the general population. In patients on hemodialysis taking 10- or 20-mg tadalafil, there were no reported cases of back pain. [see 25mg cialis Dosage and Administration (2.6) and Warnings and Precautions (5.7)]. CIALIS (tadalafil) is not indicated for use in females. There are no data with the use of CIALIS 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). Animal 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. 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. This gives approximately 16 and 10 fold exposure multiples, respectively, of the human AUC for the MRHD of 20 mg. exposure (AUC) doubled in subjects with creatinine clearance 30 to 80 mL/min.