Drug Detail:Finasteride and tadalafil (Finasteride and tadalafil [ fin-as-ter-ide-and-ta-da-la-fil ])
Drug Class: Miscellaneous genitourinary tract agents
Usual Adult Dose for Benign Prostatic Hyperplasia
Usual dose: 1 capsule (containing finasteride 5 mg and tadalafil 5 mg) orally once daily
Duration of therapy: up to 26 weeks
Comment:
- To be taken at approximately the same time every day on an empty stomach.
Use: Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate
Renal Dose Adjustments
CrCl less than 50 mL/min: Not recommended
Liver Dose Adjustments
Mild to moderate liver dysfunction: Use with caution
Severe liver dysfunction (Child-Pugh C): Not recommended
Precautions
CONTRAINDICATIONS:
- Concomitant use of any form of organic nitrate, either regularly and/or intermittently
- Known hypersensitivity to finasteride, tadalafil, or to any ingredient of this product
- Pregnancy
- Concomitant use with a guanylate cyclase (GC) stimulator
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Hemodialysis: Not recommended
Other Comments
Administration advice:
- Only for oral administration in men.
- To be taken on an empty stomach.
Storage requirements:
- Store at room temperature between 20C and 25C (68F and 77F); excursions permitted to 15C to 30C (59F to 86F).
- Keep out of the reach of children.
General:
- Do not use this product for indications not described in the patient information leaflet.
Patient advice:
- Patient are advised to read FDA-approved patient labeling.
- Patients should never take this product with other nitrates or guanylate cyclase stimulator medicines.
- Reach out to health care provider or pharmacist if patients are not sure if any of their medicines are nitrates or guanylate cyclase stimulators.
- This product is contraindicated in pregnancy and not indicated for women. Do not handle crushed or open capsule during pregnancy as it may harm a male fetus.
- If symptoms such as chest pain, dizziness, or nausea are experienced during sex, stop sexual activity and seek immediate medical help.
- Patients are advised to visit their doctor regularly while undergoing treatment with this medication.
- Patients should inform their physician about any preexisting conditions and all their concomitant medicines including prescription and non-prescription medicines.
- Patients should always check with a health care provider before starting or stopping any concomitant medicines.
- Capsule should not be taken more than one time each day. Missed dose can be taken when remembered but should not exceed more than one capsule a day.
- Patients should be informed about common side effects to anticipate any actions needed during the treatment.
