Generic
Tadalafil
69 brands available in the market
At a glance
Tadalafil is a PDE5 inhibitor used for erectile dysfunction (ED), benign prostatic hyperplasia (BPH), and combined ED+BPH. It increases blood flow by inhibiting PDE5 and raising cGMP in the corpus cavernosum.
Description
Tadalafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. PDE5 inhibition increases cGMP in smooth muscle cells, causing smooth muscle relaxation and increased blood flow into the corpus cavernosum, producing erection. PDE5 is also present in prostate and bladder smooth muscle; its inhibition relaxes these muscles, improving voiding.
Indications
- Erectile Dysfunction (ED)
- Benign Prostatic Hyperplasia (BPH)
- Both ED and BPH symptoms
Therapeutic class
Drugs for Erectile Dysfunction
Pharmacological class
PDE5 Inhibitor
Pharmacology
Tadalafil inhibits PDE5, increasing cGMP in smooth muscle cells of the corpus cavernosum, causing smooth muscle relaxation and increased blood flow for erection. In the prostate and bladder, PDE5 inhibition relaxes smooth muscle, improving blood flow and widening the bladder neck for better voiding.
Mechanism of action
Relaxes smooth muscle and increases blood flow by inhibiting PDE5 and raising cGMP.
Dosage
Adult Dose (Oral):
- ED (as needed): Start 10 mg; adjust 5-20 mg based on need; max once daily
- ED (daily): Start 2.5 mg/day; may increase to 5 mg/day
- BPH: 5 mg/day (same time each day)
- ED+BPH: 5 mg/day
- Hepatic impairment (ED): Mild-moderate: max 10 mg/day; severe: do not use
Administration
- Take with or without food
- Daily dose: Take at the same time each day
- As needed: Take before sexual activity
Missed dose
If you miss a dose, take it as soon as you remember; if almost time for the next dose, skip it; do not double the dose.
Side effects
Common Side Effects:
- Headache, dyspepsia
- Back pain, myalgia
- Nasopharyngitis, nasal congestion
Rare:
- Vision changes, sudden vision loss
- Hearing loss
- Stevens-Johnson syndrome
- Angina, stroke, MI
Precautions & warnings
- Do not use with nitrates (isosorbide, nitroglycerin) – severe hypotension
- Recent MI (within 90 days) or stroke (within 6 months)
- Uncontrolled hypertension, uncontrolled arrhythmias
- Caution in severe hepatic or renal impairment
Contraindications
- Concurrent use of organic nitrates, nitric oxide donors
- Cardiac disease where sexual activity is inadvisable
- Recent MI (90 days) or stroke (6 months)
- Hypotension (<90/50), uncontrolled arrhythmias
Drug interactions
- Nitrates and nicorandil: Enhanced hypotensive effect (potentially fatal)
- Beta-blockers: Increased hypotension risk
- CYP3A4 inhibitors (ketoconazole, protease inhibitors): Increase tadalafil levels
- CYP3A4 inducers (rifampicin, carbamazepine): Decrease levels
Food interactions
Alcohol is unsafe with Tadalafil (increased hypotension and dizziness).
Use in pregnancy
Use in Pregnancy: Generally safe; animal studies show low or no adverse effects; limited human data; consult your doctor.
Pregnancy Category: D — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Information not available; consult your doctor.
Pediatric use
Safety and efficacy not established in children
Geriatric use
Caution required in elderly patients (dose adjustment)
Renal / hepatic impairment
Renal Impairment: Mild (CrCl >51): no dose adjustment; Moderate (CrCl 30-50): max 5 mg/day initially; Severe (CrCl <30): max 5 mg/72hr; consult your doctor.
Hepatic Impairment: Mild-moderate: caution (max 10 mg for ED); severe: do not use; consult your doctor.
Overdose effects
Overdose may increase side effects; provide symptomatic treatment; do not use nitrates.
Storage conditions
Store in a dry place, away from light and heat; keep out of reach of children.
Chemical structure
Tadalafil