Indication
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Medicine Overview
Adult Dose
| Clinical Information | Administration Information |
|---|---|
|
Indication: Benign Prostatic Hyperplasia Age: Adult |
Dose: Capsule – 5 mg/5 mg Frequency: once daily by mouth Duration: up to 26 weeks Note: Indicated to initiate treatment for signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Not recommended for greater than 26 weeks; incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and incremental benefit greater than 26 weeks is unknown. |
|
Indication: Benign Prostatic Hyperplasia Age: Adult Condition: Mild-to-moderate hepatic impairment (Child-Pugh A or B) |
Dose: Capsule – 5 mg/5 mg Note: Caution; finasteride extensively metabolized in liver. |
Child Dose
| Clinical Information | Administration Information |
|---|---|
|
Age: Child |
Dose: Form – Not specified Note: No approved pediatric dosage available |
Renal Dose
| Clinical Information | Administration Information |
|---|---|
|
Condition: Renal impairment CrCl less than 50 mL/min or on hemodialysis |
Dose: No dose recommendation Note: Not recommended; increased tadalafil exposure (AUC), limited clinical experience, and inability of dialysis to influence clearance |
Administration
Administer finasteride and tadalafil orally as a single fixed-dose combination capsule once daily at approximately the same time for up to 26 weeks. The medication must be taken on an empty stomach to ensure proper absorption. Capsules should be swallowed whole; do not crush or open them, especially since finasteride can be absorbed through the skin and is hazardous to pregnant women or those planning pregnancy. Use with caution in patients with mild to moderate hepatic or renal impairment, as dosage adjustments for the individual components may be necessary. It is contraindicated in patients using any form of organic nitrates or guanylate cyclase stimulators due to the risk of severe hypotension. Safety and efficacy have not been established in pediatric populations, and its use is restricted to adult men.
Side Effect
- Impotence (5.1-18.5%)
- Decreased libido (2.6-10%)
- Postural hypotension (9.1%)
- Dizziness (7.4%)
- Abnormal ejaculation (7.2%)
- Asthenia (5.3%)
- Decreased ejaculate volume (1.5-3.7%)
- Sexual function abnormal (2.5%)
- Gynecomastia (2.2%)
- Headache (2%)
- Breast enlargement (0.5-1.8%)
- Somnolence (1.7%)
- Peripheral edema (1.3%)
- Hypotension (1.2%)
- Rhinitis (1%)
- Headache (4.1%)
- Dyspepsia (2.4%)
- Back pain (2.4%)
- Nasopharyngitis (2.1%)
- Diarrhea (1.4%)
- Pain in extremity (1.4%)
- Myalgia (1.2%)
- Dizziness (1%)
- Body as a whole: Asthenia, face edema, fatigue, pain, peripheral edema
- Cardiovascular: Angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardia
- Digestive: Abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, gamma-glutamyl transpeptidase (GGTP) increased, loose stools, nausea, upper abdominal pain, vomiting, gastroesophageal reflux disease, hemorrhoidal hemorrhage, rectal hemorrhage
- Musculoskeletal: Arthralgia, neck pain
- Nervous: Dizziness, hypoesthesia, insomnia, paresthesia, somnolence, vertigo
- Renal and urinary: Renal impairment
- Respiratory: Dyspnea, epistaxis, pharyngitis
- Skin and appendages: Pruritus, rash, sweating
- Ophthalmologic: Blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increase, swelling of eyelids
- Otologic: Sudden decrease in or loss of hearing, tinnitus
- Urogenital: Erection increased, spontaneous penile erection
Drug Interaction
Drug Interaction
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Disease Interaction
Disease Interaction
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Pregnancy
Pregnancy
Lactation
Special Use
Precaution
Overdose
Pharmacology
Storage
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Data Sources
Clinical & regulatory information on this page is compiled from the following government sources:
DISCLAIMER: This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment.