LAZARUS ®

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Tadalafil 20 mg
LIQUID GELCAPS
“THE RIGHT CHOICE TO STAY FIRM OVER TIME”

Indications:
Tadalafil is indicated for the treatment of erectile dysfunction (ED) and, alone or in combination with finasteride, for the treatment of benign prostatic hyperplasia (BPH). It is also indicated for the treatment of pulmonary arterial hypertension (PAH) either alone or in combination with macitentan or other endothelin-1 antagonists.

Dosage:
Erectile Dysfunction in Adult Men.

Generally, the recommended dose is 20 mg taken before anticipated sexual activity, with or without food.
For patients who anticipate frequent use of tadalafil (i.e., at least twice a week), a lower daily dose of tadalafil may be appropriate, considering both patient preference and the clinical judgment of the physician. For these patients, the recommended dose is 5 mg taken once daily, at approximately the same time each day. The dose may be reduced to 2.5 mg once daily, depending on patient tolerability.

Men with Renal Impairment:
No dose adjustment is required for patients with mild to moderate renal impairment. In patients with severe renal impairment, the maximum recommended dose is 10 mg. Daily administration of tadalafil is not recommended for patients with severe renal impairment.

Men with Hepatic Impairment:
The recommended dose for the treatment of erectile dysfunction with on-demand tadalafil is 10 mg taken before anticipated sexual activity, with or without food. Clinical data on the safety of tadalafil in patients with severe hepatic impairment (Child-Pugh classification grade C) are limited. If prescribed for this patient group, the physician should carefully assess the benefit/risk ratio for the patient. There are no available data on the administration of tadalafil doses greater than 10 mg in patients with hepatic impairment.

The daily administration regimen of tadalafil for the treatment of both erectile dysfunction and benign prostatic hyperplasia has not been studied in patients with hepatic impairment; therefore, if prescribed, the physician should carefully assess the benefit/risk ratio for the patient.

Men with Diabetes:
No dose adjustment is required for diabetic patients.

Contraindications:
Hypersensitivity to the active ingredient or any of the excipients.
During clinical trials, it was observed that tadalafil increased the hypotensive effect of nitrates. This is believed to be due to the combination of the effects of tadalafil and nitrates on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway. Therefore, tadalafil is contraindicated in patients taking any form of organic nitrate.
Tadalafil should not be used in men with heart disease for whom sexual activity is inadvisable. The physician should consider the potential cardiac risk of sexual activity in patients with a history of cardiovascular disease.
The following groups of cardiovascular patients were not included in clinical trials, and therefore the use of tadalafil is contraindicated in them:

•Patients who have had a myocardial infarction within the last 90 days.
•Patients with unstable angina or angina occurring during sexual activity.
•Patients with heart failure classified as New York Heart Association (NYHA) class II or higher in the last 6 months.
•Patients with uncontrolled arrhythmias, hypotension (blood pressure < 90/50 mm Hg), or uncontrolled hypertension.
•Patients who have had a stroke within the last 6 months.
Tadalafil is contraindicated in patients who have experienced vision loss in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether the episode occurred during previous exposure to a PDE5 inhibitor.
The concomitant administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may cause potentially symptomatic hypotension.

Presentations:
LAZARUS: Box containing 2 LIQUID CAPSULES

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