Tadalafil

(tah da' la fil)

Molecule Info

 

Indication & Dosage

Oral  Erectile dysfunction  Adult: Initially, 10 mg at least 30 min before sexual activity once daily, up to 20 mg as single dose.  Max: Not more than once daily.  If used with potent inhibitors of CYP3A4, e. g.  azole antifungals or protease inhibitors: max 10 mg once every 72 hr.

CrCl

Dosage Recommendation

31-50

Initial dose at 5 mg/day.  Max: 10 mg/48hr

<30

Max: 5 mg/24hr.

Hepatic impairment: Mild-moderate hepatic impairment: Max dose 10 mg.  Severe hepatic impairment: Not recommended.

Administration

May be taken with or without food.

Contraindications

Concurrent use of organic nitrates, nitrates and nitric oxide donors.  Men with cardiac disease for whom sexual activity is inadvisable.  Recent MI or stroke, hypotension, unstable angina, heart failure, uncontrolled arrhythmias or hypertension.

Special Precautions

Hepatic or renal impairment; CV diseases; anatomical penile deformation; predisposition to priapism; child <18 yr.  Discontinue and seek medical advice if there is sudden vision loss or decreased vision in one or both eyes or tinnitus, dizziness or sudden loss or decrease in hearing, while taking Tadalafil.  Seek immediate medical advice if erection last > 4 hr.

Adverse Drug Reactions

Headache, dyspepsia, dizziness, flushing, swelling of eyelids, eye pain, conjunctival hyperemia, back pain, myalgia, visual disturbances, nasal congestion, sudden decrease or loss of hearing, tinnitus.  Potentially Fatal: Stevens-Johnson syndrome, exfoliative dermatitis, severe cardiovascular events e. g.  MI, stroke, sudden cardiac death;

Drug Interactions

Concurrent use increased risk of hypotension with α-blockers; increased risk of priapism with other drugs for erectile dysfunction, e. g.  alprostadil; increased heart rate with theophylline; decreased tadalafil serum concentration with CYP 3A4 inducers e. g.  rifampicin, efavirenz,carbamazepine, nevirapine, barbiturates, phenobarbital, phenytoin, ribabutin; increased tadalafil serum concentration with CYP3A4 inhibitors e. g.  azole antifungals, protease inhibitors, cimetidine, macrolides. Potentially Fatal: Concurrent use increased risk of hypotension with α-blockers; increased risk of priapism with other drugs for erectile dysfunction, e. g.  alprostadil; increased heart rate with theophylline; decreased tadalafil serum concentration with CYP 3A4 inducers e. g.  rifampicin, efavirenz,carbamazepine, nevirapine, barbiturates, phenobarbital, phenytoin, ribabutin; increased tadalafil serum concentration with CYP3A4 inhibitors e. g.  azole antifungals, protease inhibitors, cimetidine, macrolides.

Food Interaction

Concuurent use with grapefruit juice may increase tadalafil levels, while St John's wort may decrease tadalafil levels.

Pregnancy Category

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect that was not confirmed in controlled studies in women in the 1sttrimester.

Storage

Oral:  Store at 15-30°C.

Mechanism of Action

Tadalafil is a phosphodiesterase type-5 inhibitor. Onset: 30 min Duration: Up to 36 hr.  Absorption: Well absorbed.  Peak plasma concentrations reached within 2 hr.  Rate and extent of absorption not affected by food.  Distribution: Widely distributed into tissues.  94% bound to plasma proteins.  Metabolism: Metabolised in the liver mainly by the cytochrome P450 isoenzyme CYP3A4 to inactive metabolites.  Mean half-life is 17. 5 hr.  Excretion: Excreted mainly as metabolites, in the faeces, and to a lesser extent the urine.

ATC Classification

G04BE08 - tadalafil; Belongs to the class of drugs used in erectile dysfunction.

 

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Brands/Products Info


Total Products : 8        
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
ADAFIL 10 Beximco Pharmaceuticals Ltd Tadalafil INN 10mg Tablet 4's: 140.00 MRP
ADAFIL 20 Beximco Pharmaceuticals Ltd Tadalafil INN 10mg Tablet 4's: 240.00 MRP
INTIMATE 10- 10'S Square Pharmaceuticals Ltd. Tadalafil 10mg Tablet 2x5's: 351.10 MRP
INTIMATE 10- 4'S Square Pharmaceuticals Ltd. Tadalafil 10mg Tablet 1x4's: 140.44 MRP
INTIMATE 20 Square Pharmaceuticals Ltd. Tadalafil 20mg Tablet 1x4's: 240.72 MRP
INTIMATE 5- 10'S Square Pharmaceuticals Ltd. Tadalafil 5mg Tablet 2x5's: 180.50 MRP
INTIMATE 5- 4'S Square Pharmaceuticals Ltd. Tadalafil 5mg Tablet 1x4's: 72.20 MRP
Tadalis 10 Incepta Pharmaceuticals Limited Tadalafil INN 10mg Capsule 10x1's:MRP 350 Tk

Gen. MedInfo

Why is this medication prescribed?

Tadalafil is used to treat erectile dysfunction, and the symptoms of benign prostatic hyperplasia which include difficulty urinating, painful urination, and urinary frequency and urgency in adult men. Tadalafil is used to improve the ability to exercise in people with pulmonary arterial hypertension. Tadalafil is in a class of medications called phosphodiesterase inhibitors. It works to treat erectile dysfunction by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection. Tadalafil treats PAH by relaxing the blood vessels in the lungs to allow blood to flow more easily.

If you are taking tadalafil to treat erectile dysfunction, you should know that it does not cure erectile dysfunction or increase sexual desire. Tadalafil does not prevent pregnancy or the spread of sexually transmitted diseases such as human immunodeficiency virus .

How should this medicine be used?

Tadalafil comes as a tablet to take by mouth. It may be taken with or without food.

If you are taking tadalafil to treat erectile dysfunction, follow your doctor's directions and the guidelines in this paragraph. There are two different ways to take tadalafil, either daily or on an as needed basis. Talk to your doctor about which dosing schedule is right for you. Tadalafil is sometimes taken as needed, usually at least 30 minutes before sexual activity and not more often than once every 24 hours. Your doctor will help you decide the best time for you to take tadalafil before sexual activity. Tadalafil is also sometimes taken once a day every day without regard to timing of sexual activity. You may attempt sexual activity at any time between doses. If you are taking tadalafil on a regular schedule, take it at around the same time every day. If you have certain health conditions or are taking certain medications, your doctor may tell you to take tadalafil less often or may prescribe a lower dose to be taken once a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tadalafil exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you are taking tadalafil to treat PAH or BPH, follow your doctor's directions and the guidelines in this paragraph. You should take tadalafil one time a day.Take all of the tablets for your daily dose at one time each day; do not divide the tablets to take as separate doses. Take tadalafil at around the same time every day. If you are already taking medication to treat BPH, your doctor may tell you to stop taking your other medication at least one day before starting treatment with tadalafil. Follow your doctor's directions carefully, and ask your doctor or pharmacist to explain any part you do not understand.

If you are taking tadalafil for erectile dysfunction, your doctor will probably start you on an average dose of tadalafil and increase or decrease your dose depending on your response to the medication. Tell your doctor if tadalafil is not working well or if you are experiencing side effects.

If you are taking tadalafil for PAH, you should know that tadalafil controls PAH but does not cure it. Continue to take tadalafil even if you feel well. Do not stop taking tadalafil without talking to your doctor.

Please carefully read the manufacturer's information for the patient.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking tadalafil,
  • tell your doctor if you are allergic to tadalafil, any other medications, or any of the ingredients in tadalafil tablets. Ask your pharmacist for a list of the ingredients.
  • tell your doctor if you are taking or have recently taken nitrates such as isosorbide dinitrate , isosorbide mononitrate , and nitroglycerin . Nitrates come as tablets, sublingual  tablets, sprays, patches, pastes, and ointments. Ask your doctor if you are not sure whether any of your medications contain nitrates. Your doctor will probably tell you not to take tadalafil if you are taking nitrates.
  • tell your doctor if you are taking street drugs containing nitrates  such as amyl nitrate, butyl nitrate, or nitrite while taking tadalafil. Your doctor will probably tell you not to take tadalafil if you are taking street drugs containing nitrates.
  • you should know that tadalafil is available under the brand names Adcirca and Cialis. You should only be treated with one of these products at a time.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: alpha blockers such as alfuzosin , doxazosin , dutasteride , prazosin , silodosin , tamsulosin , and terazosin ; amiodarone ; certain antifungals such as fluconazole , griseofulvin , itraconazole , ketoconazole ,and voriconazole ; aprepitant ; bosentan ;carbamazepine ; clarithromycin ; diltiazem ; efavirenz ;erythromycin; HIV protease inhibitors including indinavir , nelfinavir ,and ritonavir , lovastatin ; medications for high blood pressure; nefazodone ; nevirapine ; other medications or treatments for erectile dysfunction; other medications or treatments for PAH; phenobarbital; phenytoin ; rifabutin ; rifampin ; sertraline ; telithromycin ; and verapamil . Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor what herbal products you are taking, especially St. John's wort.
  • tell your doctor if you smoke; if you have ever had an erection that lasted more than 4 hours; and if you have recently had diarrhea, vomiting, not been drinking enough fluids, or sweating a lot which may have caused dehydration ; any condition that affects the shape of the penis; diabetes; high cholesterol; high or low blood pressure; irregular heartbeat; a heart attack or heart failure; angina ; a stroke; ulcers in the stomach; a bleeding disorder; blood circulation problems; blood cell problems such as sickle cell anemia , multiple myeloma , or leukemia ; or heart, kidney, or liver disease. Also tell your doctor if you or any of your family members have or have ever had an eye disease such as retinitis pigmentosa  or if you have ever had sudden severe vision loss, especially if you were told that the vision loss was caused by a blockage of blood flow to the nerves that help you see.
  • if you are a woman and you are taking tadalafil to treat PAH, tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tadalafil, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tadalafil.
  • ask your doctor about the safe use of alcoholic beverages while you are taking tadalafil. Alcohol can make the side effects from tadalafil worse. Your doctor will tell you how much alcohol you may drink while you are taking this medication.
  • if you are taking tadalafil to treat erectile dysfunction, tell your doctor if you have ever been advised by a health care professional to avoid sexual activity for medical reasons or if you have ever experienced chest pain during sexual activity. Sexual activity may be a strain on your heart, especially if you have heart disease. If you experience chest pain, dizziness, or nausea during sexual activity, call your doctor immediately or get emergency medical treatment, and avoid sexual activity until your doctor tells you otherwise.
  • tell all your health care providers that you are taking tadalafil. If you ever need emergency medical treatment for a heart problem, the health care providers who treat you will need to know when you last took tadalafil.

What special dietary instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

What should I do if I forget a dose?

If you are taking tadalafil for erectile dysfunction on a regular schedule, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose or more than one dose per day to make up for a missed one.

If you are taking tadalafil for PAH or BPH, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Tadalafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
  • headache
  • indigestion or heartburn
  • nausea
  • diarrhea
  • flushing
  • pain in the stomach, back, muscles, arms, or legs
  • cough
  • sudden decrease or loss of vision
  • blurred vision
  • changes in color vision
  • sudden decrease or loss of hearing
  • ringing in ears
  • erection that lasts longer than 4 hours
  • dizziness
  • chest pain
  • hives
  • rash
  • difficulty breathing or swallowing
  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
  • blistering or peeling of skin
Some side effects can be serious. If you experience any of these symptoms, consult your doctor immediately or get emergency medical treatment.

Some patients experienced a sudden loss of some or all of their vision after they took tadalafil or other medications that are similar to tadalafil. The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication. If you experience a sudden loss of vision while you are taking tadalafil, call your doctor immediately or get emergency medical treatment. Do not take any more doses of tadalafil or similar medications such as sildenafil or vardenafil until you talk to your doctor.

Some patients experienced a sudden decrease or loss of hearing after they took tadalafil or other medications that are similar to tadalafil. The hearing loss usually involved only one ear and may not get better. It is not known if the hearing loss was caused by the medication. If you experience a sudden loss of hearing, sometimes with ringing in the ears or dizziness, while you are taking tadalafil, call your doctor immediately. Do not take any more doses of tadalafil or similar medications such as sildenafil or vardenafil until you talk to your doctor.

Tadalafil may cause other side effects. Consult your doctor if you have any unusual problems while taking this medication. 

 Ref. US Natl. Library of Medicine


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