Tadalafil Medication Monograph

Written information about this prescription has been provided for you. Please read this information before you take the medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions at 888-689-2271

Información por escrito acerca de esta receta se le a presentado a usted. Favor de leer esta información antes de tomar el medicamento. Si usted tiene preguntas tocante esta receta, un farmacéutico estará presente durante horas de negocio para contestar sus preguntas

Complaints concerning the practice of pharmacy may be filed with the Texas State Board of Pharmacy at:

Quejas sobre la practica de farmacia pueden ser reportadas al Concilio Farmacia del Estado de Tejas:

William P. Hobby Building Ste. 3-600, 333 Guadalupe Street, Box 21

Austin, Texas 78701-3942 Tel: (512) 305-8000 www.tsbp.state.tx.us

 

Tadalafil is a phosphodiesterase type 5 (PDE-5) inhibitor that relaxes the smooth muscles in the body including those in the penis, bladder, prostate, and lungs. By relaxing the smooth muscles in the penis, blood is able to flow into the tissue more easily when sexual stimulation occurs

Indications: Tadalafil can be taken everyday to prevent symptoms of benign prostate hypertrophy (BPH) and erectile dysfunction (ED) or it can be taken as needed before intercourse for erectile dysfunction

Dosing (Adults): Erectile dysfunction: 10mg orally prior to anticipated sexual activity (dosing range: 5-20mg) – to be given as a single dose and not given more than once daily BHP:5 mg orally each day, may be taken at any time

Renal Dosing:

Crcl 31-50 ml/min: Initial dose 5mg once daily – maximum dose 10 mg every 48 hours

Crcl <30 ml/min or hemodialysis: maximum dose 5mg

Hepatic impairment:

Mild-to-moderate hepatic impairment (Child-Pugh class A or B): Do not exceed 10 mg once daily

Severe hepatic impairment: Use is not recommended

Contraindications: Serious hypersensitivity to tadalafil; concurrent use (regularly/intermittently) of organic nitrates in any form (eg, nitroglycerin, isosorbide dinitrate); concomitant use of riociguat (a guanylate cyclase stimulator)

Warnings/Precautions:

Anginal chest pain: Patients experiencing chest pain after administration should seek immediate medical attention

Color discrimination: May cause dose-related impairment of color discrimination

Hearing loss: Sudden decrease or loss of hearing has been reported rarely; hearing changes may be accompanied by tinnitus and dizziness. Seek medical assistance for sudden decrease in hearing or loss of hearing

Hypotension: Decreases in blood pressure may occur; Concurrent use with alpha-adrenergic antagonist therapy may cause symptomatic hypotension; patients should be hemodynamically stable prior to initiating therapy at the lowest possible dose. Patients should avoid or limit concurrent substantial alcohol consumption as this may increase the risk of symptomatic hypotension

Priapism: Painful erection >6 hours in duration has been reported (rarely). Seek medical assistance for erection lasting >4 hours. Use with caution in patients who have conditions which may predispose them to priapism

Vision loss: Vision loss (rare) may be a sign of nonarteritic anterior ischemic optic neuropathy (NAION). Discontinue therapy and seek medical assistance for sudden loss of vision in one or both eyes. Safety has not been evaluated in patients with known hereditary degenerative retinal disorders (eg, retinitis pigmentosa); use is not recommended

Drug Interactions::Alpha blockers: If stabilized on either alpha blockers or tadalafil therapy, initiate new therapy with the other agent at the lowest possible dose. CYP3A4 inhibitors: Dose reduction of tadalafil is recommended with strong CYP3A4 inhibitors. The dose of tadalafil should not exceed 10 mg, and tadalafil should not be taken more frequently than once every 72 hours. Some examples include: azole antifungals, clarithromycin, doxycycline, erythromycin, grapefruit juice, imatinib, isoniazid, nefazodone, protease inhibitors, etc.

Please speak with your doctor or pharmacist about other possible drug interactions as this list is not all-inclusive

Adverse Reactions: Flushing of the face, runny nose, headache, dizziness upon standing, upset stomach, back pain or muscle pain

Storage: Room temperature

Missed Dose: Take a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses

Patient Education:

What should I tell my doctor about before taking this medication?

Bleeding disorders, eye problems, history of or current heart problems, irregular heartbeat, liver problems, kidney problems, history of priapism (an erection lasting longer than 4 hours), other medications you take including those that are over-the-counter

Before taking this medication, your doctor must determine if your heart is healthy enough for sex

You cannot take this medication if you take nitrates

When and how do I take this medication?

Once daily tadalafil should be taken at the same time each day, without regard to sexual activity

As needed dose should be taken at least 2-3 hours prior to sexual activity

Effects of tadalafil can last up to 36 hours. You should not take tadalafil more often than prescribed

Tadalafil can be taken with or without food

What side effects should I call my doctor about right away?

Chest pain or pressure, a heartbeat that is very fast or does not feel normal, a very bad headache, extreme dizziness or passing out, hearing loss or ringing in ears, an erection lasting longer than 4 hour

What should I do if this medication does not produce the desired effect?

Tadalafil will not produce an erection without sexual stimulation. You must be aroused for tadalafil to work

Tadalafil takes >60 minutes to work depending on the formulation but some patients do not see full effect for >4 hours. You may need to wait longer to see an effect

This medication should be tried at least 3 different times (different days, at least 36 hours apart) before determining that it does not work for you