Spedra賽倍達

Spedra

avanafil

Manufacturer:

Menarini-Von Heyden

Distributor:

Zuellig
/
Agencia Lei Va Hong

Marketer:

A. Menarini
Concise Prescribing Info
Contents
Avanafil
Indications/Uses
Erectile dysfunction in adult men.
Dosage/Direction for Use
Adult, elderly (≥65 yr) & patient w/ mild to moderate renal impairment (CrCl ≥30 mL/min) 100 mg as needed, approx 15-30 min before sexual activity. May be increased to max of 200 mg or decreased to 50 mg. Max frequency: Once daily. Patient w/ mild to moderate hepatic impairment (Child-Pugh class A or B) Initiate w/ min dose & adjust dose based on tolerance.
Administration
May be taken with or without food: Preferably taken w/o food for better absorption.
Contraindications
Hypersensitivity. Use of organic nitrate or nitric oxide donors (eg, amyl nitrite). Co-administration w/ guanylate cyclase stimulators eg, riociguat; potent CYP3A4 inhibitors (eg, ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir & telithromycin). Consider potential cardiac risk of sexual activity in patients w/ pre-existing CV disease. Patients w/ history of MI, stroke, or life-threatening arrhythmia w/in the last 6 mth; resting hypotension (BP <90/50 mmHg) or HTN (BP >170/100 mmHg); unstable angina, angina w/ sexual intercourse, or CHF (NYHA Class ≥2). Patients who have vision loss in 1 eye due to non-arteritic anterior ischemic optic neuropathy (NAION); known hereditary degenerative retinal disorders. Severe hepatic impairment (Child-Pugh C). Severe renal impairment (CrCl <30 mL/min).
Special Precautions
Consider CV status of patients prior to treatment initiation. Patients w/ left ventricular outflow obstruction eg, aortic stenosis & idiopathic hypertrophic subaortic stenosis. Use cautiously in patients w/ anatomical penile deformation (eg, angulation, cavernosal fibrosis, or Peyronie's disease), or conditions predisposing to priapism (eg, sickle cell anaemia, multiple myeloma or leukaemia); bleeding disorders or active peptic ulceration. Reports of visual defects & non-arteritic anterior ischaemic optic neuropathy. Decreased or sudden loss of hearing. Patients w/ erectile dysfunction due to spinal cord injury or other neurological disorders. Concomitant use w/ α-blockers; other prep for erectile dysfunction; alcohol. Minor influence on the ability to drive & use machines. Not indicated for use in women.
Adverse Reactions
Headache, flushing, nasal congestion.
Drug Interactions
Augmented hypotensive effects of nitrates; α-blockers (eg, doxazosin, tamsulosin); amlodipine & enalapril; alcohol. Increased exposure w/ strong CYP3A4 inhibitors eg, ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, saquinavir, nelfinavir, indinavir, atazanavir, & telithromycin; moderate CYP3A4 inhibitors eg, erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, & verapamil; grapefruit juice. May decrease efficacy w/ CYP3A4 inducers eg, bosentan, carbamazepine, efavirenz, phenobarb & rifampicin. Additive BP lowering effect w/ riociguat.
MIMS Class
Drugs for Erectile Dysfunction & Ejaculatory Disorders
ATC Classification
G04BE10 - avanafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
Form
Spedra tab 100 mg
Packing/Price
4's
Form
Spedra tab 200 mg
Packing/Price
4's
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