Maxlis

Maxlis

tadalafil

Manufacturer:

Simex
Concise Prescribing Info
Contents
Tadalafil
Indications/Uses
Erectile dysfunction in adult men (ED). 5 mg: Treatment of the signs & symptoms of benign prostatic hyperplasia (BPH) in adult men.
Dosage/Direction for Use
Erectile dysfunction Adult As needed dosing. Initially, 10 mg as a single dose taken at least 30 min before sexual activity. May be increased to 20 mg, or decreased to 5 mg depending on patient response & tolerability. Max dosing frequency: Once daily. Patients anticipating frequent use (eg, at least twice wkly) A regular once-daily regimen w/ the lowest dose may be considered suitable. Regular daily dosing: 5 mg once daily, taken at the same time each day. May be decreased to 2.5 mg once daily depending on patient response & tolerability. Alternatively, start w/ 2.5 mg once daily, taken at the same time each day. May be increased to 5 mg once daily according to efficacy & tolerability. Benign prostatic hyperplasia Adult 5 mg once daily, taken at the same time each day. Men being treated for both BPH & ED 5 mg once daily, taken at the same time each day w/o regard to the timing of sexual activity. Hepatic & severe renal impairment Max dose: 10 mg in divided doses.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients who are using any form of organic nitrate. Men w/ cardiac disease for whom sexual activity is inadvisable. Patients w/ MI w/in the last 90 days; unstable angina or angina occurring during sexual intercourse; NHYA class ≥2 heart failure in the last 6 mth; uncontrolled arrhythmias, hypotension (<90/50 mmHg) or uncontrolled HTN; stroke w/in the last 6 mth. Patients who have loss vision in 1 eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not w/ previous PDE5 inhibitor exposure.
Special Precautions
Not recommended for continuous daily use. Consider CV status of patients prior to initiating any treatment. Serious CV events including MI, sudden cardiac death, unstable angina pectoris, ventricular arrhythmias, stroke, transient ischemic attacks, chest pain, palpitations & tachycardia; sudden decrease or loss of hearing, which may be accompanied by tinnitus. Visual defects & cases of NAION. Seek immediate medical assistance if patients experience erections lasting ≥4 hr. May lead to symptomatic hypotension in combination w/ guanylate cyclase stimulators. Hepatic impairment. Not indicated for use by women. Not to be used in childn <18 yr.
Adverse Reactions
Headache, dyspepsia, back pain & myalgia.
Drug Interactions
Ketoconazole, ritonavir, saquinavir, erythromycin, clarithromycin, itraconazole, grape fruit juice, rifampicin, phenobarb, phenytoin, carbamazepine, nitrate, doxazosin.
MIMS Class
Drugs for Erectile Dysfunction & Ejaculatory Disorders
ATC Classification
G04BE08 - tadalafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
Form
Maxlis FC tab 20 mg
Packing/Price
1 × 4's (Rp260,000/boks)
Form
Maxlis FC tab 5 mg
Packing/Price
3 × 10's (Rp500,000/boks)
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