Tadalafil is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
Tadalafil is indicated for the treatment of erectile dysfunction and the signs of benign prostatic hyperplasia (ED/BPH).
For Use as Needed:
- The recommended starting dose of Tadalafil for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity.
- The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients.
For Once Daily Use:
- The recommended starting dose of Tadalafil for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.
- The Tadalafil dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.
Patients with BPH or with ED and BPH-
- Intimate for once daily use for BPH: The recommended dose of Intimate for once daily use is 5 mg, taken at approximately the same time every day.
- Intimate for once daily use for ED+BPH: The recommended dose of Intimate for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.
Hypersensitivity Reactions: Tadalafil is contraindicated in patients with a known serious hypersensitivity to tadalafil. Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis.
Cardiovascular and cerebrovascular: Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations, and tachycardia, may occur. Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. Hypotension (more commonly reported when tadalafil is given to patients who are already taking antihypertensive agents), hypertension, and syncope.
Skin and subcutaneous tissues: hyperhidrosis (sweating).
Gastrointestinal: abdominal pain and gastroesophageal reflux.
Nervous system: migraine, transient global amnesia.
Respiratory system: epistaxis (nose bleed).
Special senses: blurred vision, nonarteritic anterior ischemic optic neuropathy, retinal vein occlusion, visual field defect.
Otologic: cases of sudden decrease or loss of hearing have been reported.