Tadalafil

Tadalafil is used to treat erectile dysfunction in men. It increases blood flow to the penis to help men get an erection. It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited. Tadalafil may be taken on an empty stomach or with a meal. It should be strictly taken as advised by your doctor. The medicine will only help you to get an erection if you are sexually stimulated. You should take it about one hour before you plan to have sex. The amount of time it takes to work varies from person to person, but it normally takes between 30 minutes and one hour. Only take it if you need it and it has been prescribed to you by a doctor. The most common side effects of this medicine are flushing, headache, blurred vision, muscle pain, stomach upset, and rash. Talk to your doctor if the side effects bother you or will not go away. This medicine is not intended for use by women and men should avoid using any other medicines to treat impotence without talking to a doctor. It can be dangerous to take it along with medicines called nitrates (often given for chest pain). Do not take this medicine if you have severe heart or liver problems, if you have recently had a stroke or heart attack or if you have low blood pressure. Let your doctor know if you suffer from these or any other health problems before taking it. You should not drive if this medicine makes you feel dizzy. Avoid drinking alcohol while taking this medicine as it can lead to side effects. Tadalafil is a phosphodiesterase (PDE-5) inhibitor. It works in erectile dysfunction by increasing blood flow to the penis by relaxing the muscles in penile blood vessels.

• Erectile dysfunction

Tadalafil is a phosphodiesterase type-5 inhibitor.

Adult Dose: Oral Erectile dysfunction Adult: 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 IntimateTM dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability. Benign Prostatic Hyperplasia Treatment of signs and symptoms of benign prostatic hyperplasia (BPH); daily use also indicated for treatment of patients with both BPH and erectile dysfunction BPH: 5 mg PO once daily BPH with erectile dysfunction: 5 mg PO once daily, taken at approximately same time each day without regard to timing of sexual activity With finasteride for BPH: tadalafil 5 mg plus finasteride 5 mg PO once daily for 1 week; may be increased to 40 mg/day on basis of tolerability Hepatic impairment (erectile dysfunction) Mild-to-moderate (Child-Pugh class A or B): Not to exceed 10 mg PO once daily Severe (Child-Pugh class C): Not recommended Hepatic impairment (pulmonary arterial hypertension) Mild-to-moderate (Child-Pugh class A or B): Consider starting dosage of 20 mg PO once daily Severe (Child-Pugh class C): Avoid use Renal Dose: Renal impairment (erectile dysfunction) Mild (CrCl >51 mL/min): No dosage adjustment needed Moderate (CrCl 30-50 mL/min): Not to exceed 5 mg PO once daily initially; maximum dosage, 10 mg PO q48hr Severe (CrCl <30 mL/min and on hemodialysis): Not to exceed 5 mg PO q72hr Renal impairment (pulmonary arterial hypertension) Mild-to-moderate (CrCl 31-80 mL/min): 20 mg PO once daily initially; may be increased to 40 mg once daily on basis of tolerability Severe (CrCl <30 mL/min and on hemodialysis): Avoid use

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Tadalafil may be taken with or without food, but it is better to take it at a fixed time.

If you miss a dose of Tadalafil, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

Common: • Headache • Blurred vision • Muscle pain • Nasal congestion (stuffy nose) • Flushing (sense of warmth in the face, ears, neck and trunk) • Nosebleeds

[UNSAFE] Tadalafil may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur. You have been prescribed Tadalafil for the treatment of erectile dysfunction. It is best to take it an hour before sexual intercourse. But, you can take it anytime between 30 minutes and 4 hours before sexual activity. Do not take it more than once a day. It may also be used for treating the urinary symptoms of an enlarged prostate gland (benign prostatic hyperplasia). It may cause dizziness or blurred vision. Do not drive or do anything requiring concentration until you know how it affects you. Avoid drinking alcohol as it can reduce your ability to get an erection and can make dizziness worse. Seek medical attention if the erection persists for more than 4 hours after sexual intercourse. Do not use Tadalafil if you have recently taken nitrates (medicines used in angina or chest pain), if you have had a heart attack in the past 3 months, or stroke or heart failure in the past 6 months.

Concurrent use of organic nitrates, nitrates and nitric oxide donors. Men with cardiac disease for whom sexual activity is inadvisable. Recent MI (within 90 days) or stroke (within last 6 mth), hypotension (<90/50 mm Hg), unstable angina, heart failure, uncontrolled arrhythmias or hypertension.

Concurrent use increased risk of hypotension with beta-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: Enhanced hypotensive effect with nitrates and nicorandil.

[UNSAFE] It is unsafe to consume alcohol with Tadalafil.

[SAFE IF PRESCRIBED] Tadalafil is generally considered safe to use during pregnancy. Animal studies have shown low or no adverse effects to the developing baby; however, there are limited human studies.

[CONSULT YOUR DOCTOR] Information regarding the use of Tadalafil during breastfeeding is not available. Please consult your doctor.

[CAUTION] Tadalafil should be used with caution in patients with kidney disease. Dose adjustment of Tadalafil may be needed. Please consult your doctor. [CAUTION] Tadalafil should be used with caution in patients with liver disease. Dose adjustment of Tadalafil may be needed. Please consult your doctor. Use of Tadalafil is not recommended in patients with severe liver disease.

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