Zenavil

Zenavil

tadalafil

Manufacturer:

Medochemie

Distributor:

Medochemie
Concise Prescribing Info
Contents
Tadalafil
Indications/Uses
Erectile dysfunction; signs & symptoms of benign prostatic hyperplasia (BPH) in adult males.
Dosage/Direction for Use
Erectile dysfunction 10 mg prior to anticipated sexual activity as needed. Patient whom tadalafil 10 mg does not produce adequate effect Max daily dose: 20 mg. May be taken from 30 min to 36 hr pior to sexual activity. Patient who anticipate a frequent use of Zenavil (ie, at least 2x wkly) 2.5 mg once daily at approx same time every day w/o regard to timing of sexual activity. BPH 5 mg at approx same time every day. Therapy initiated w/ finasteride: 5 mg at approx same time every day up to 26 wk. Erectile dysfunction & BPH 5 mg at approx same time every day w/o regard to timing of sexual activity. Moderate renal impairment (CrCl 31-50 mL/min) Initially 5 mg once daily. Max dose: 10 mg not more than once in every 48 hr. Severe renal impairment (CrCl <30 mL/min or on hemodialysis) Max dose: 5 mg not more than once in every 72 hr. Hepatic impairment 10 mg prior to anticipated sexual activity. Patient taking CYP3A4 inhibitors (eg, ketoconazole or ritonavir) Max dose: 10 mg not to exceed once every 72 hr when used as needed. Max once daily dose: 2.5 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ cardiac disease for whom sexual activity is inadvisable (eg, MI w/in the last 90 days, unstable angina or angina occuring during sexual intercourse, NYHA 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 vision loss in one eye because of non-arteritic anterior ischaemic optic neuropathy. Concomitant use w/ any form of organic nitrate.
Special Precautions
Take a medical history & physical exam to diagnose erectile dysfunction or BPH prior to treatment. Consider CV status prior to treatment initiation for erectile dysfunction. Assess for CV conditions & examine to rule out presence of prostate carcinoma prior to treatment initiation for BPH. Patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy. Possible serious CV events including MI, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischaemic attacks, chest pain, palpitations & tachycardia. Concomitant use w/ α1-blockers may lead to symptomatic hypotension. May decrease BP; consider possible dose adjustment of antihypertensive therapy. Discontinue use in case of sudden visual defect. Not recommended in patients w/ known hereditary degenerative retinal disorders including retinitis pigmentosa. Patients who experience erections lasting ≥4; may result to penile tissue damage & permanent loss of potency if priapism is not treated immediately. Patients w/ anatomical deformation of penis (eg, angulation, cavernosal fibrosis or Peyronie's disease) or in those who have predisposing conditions to priapism (eg, sickle cell anaemia, multiple myeloma or leukaemia). Concomitant use w/ potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazone & erythromycin); other PDE5 inhibitors or other treatments for erectile dysfunction. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Possible dizziness; may affect the ability to drive & use machines. Not recommended in patients w/ severe renal impairment. Severe hepatic impairment. Not indicated for women. Not to be used in childn <18 yr.
Adverse Reactions
Headache; flushing; nasal congestion; dyspepsia; back pain, myalgia, pain in extremity.
Drug Interactions
Increased AUC & Cmax w/ selective CYP3A4 inhibitor (eg, ketoconazole). Increased AUC w/ ritonavir. May increase plasma conc w/ other PIs (eg, saquinavir) & other CYP3A4 inhibitors (eg, erythromycin, clarithromycin, itraconazole & grapefruit juice). Possible interaction mediated by transporter (eg, P-glycoprotein) inhibition. Reduced AUC w/ rifampicin. May decrease plasma conc w/ other CYP3A4 inducers (eg, phenobarb, phenytoin & carbamazepine). May augment the hypotensive effects of nitrates. Increased BP-lowering effect of doxazosin. Additive systemic BP-lowering effect w/ riociguat. Small increase in heart rate w/ theophylline. Increased oral bioavailability of ethinylestradiol & terbutaline.
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
Zenavil FC tab 20 mg
Packing/Price
1 × 4's
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