Axcel Sildenafil

Axcel Sildenafil

sildenafil

Manufacturer:

Kotra Pharma

Distributor:

Kotra Pharma
Concise Prescribing Info
Contents
Sildenafil citrate
Dosage/Direction for Use
Adult 50 mg approx 1 hr before sexual activity, may be increased to max dose 100 mg once daily or decreased to 25 mg once daily. CrCl <30 mL/min & hepatic impairment 25 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concurrent use w/ nitric oxide donors, organic nitrates or organic nitrites.
Special Precautions
Men w/ inadvisable sexual activity. CV status eg, MI, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischaemic attack, HTN; left ventricular outflow obstruction (eg, aortic stenosis, hypertrophic obstructive cardiomyopathy) or severely impaired autonomic control of BP. Non-arteritic anterior ischemic optic neuropathy (NAION). Diabetes, coronary artery disease, hyperlipidemia, smoking; retinitis pigmentosa; bleeding disorders or active peptic ulceration; anatomical penis deformation (eg, angulation, cavernosal fibrosis or Peyronie's disease); conditions predisposing to priapism (eg, sickle cell anemia, multiple myeloma or leukemia). Sudden visual & hearing loss. Concomitant use w/ α-blocker. May affect ability to drive & use machines. Not to be used in women & childn <18 yr. Elderly <50 yr.
Adverse Reactions
Headache, flushing & dyspepsia. Visual disturbance, dizziness, nasal congestion, diarrhoea, vomiting, eyelid swelling, eye pain & redness, epistaxis, muscle & back pain, skin rashes, UTI, syncope, cerebrovascular haemorrhage & transient ischaemic attack.
Drug Interactions
Potentiated hypotensive effects of organic nitrates. Enhanced hypotensive effect of nicorandil. Symptomatic hypotension w/ α-blockers. Reduced clearance w/ cimetidine, delavirdine, erythromycin, itraconazole, ketoconazole & HIV-PIs. Increased plasma conc by ritonavir & grapefruit juice. Decreased plasma conc by CYP3A4 inducers eg, rifampicin.
ATC Classification
G04BE03 - sildenafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
Form
Axcel Sildenafil tab 100 mg
Packing/Price
1 × 4's
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