Sildegra

Sildegra

sildenafil

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Sildenafil
Indications/Uses
Dosage/Direction for Use
Adult Recommended dose: 50 mg as needed to be taken approx 1 hr before sexual activity. May be increased to 100 mg or decreased to 25 mg. Max dose: 100 mg daily. Max dosing frequency: Once daily. Patient w/ severe renal impairment (CrCl <30 mL/min) & hepatic impairment (eg, cirrhosis) Consider 25 mg dose. Patient receiving concomitant therapy w/ ritonavir Max single dose: 25 mg in 48-hr period. Patient receiving concomitant treatment w/ CYP3A4 inhibitors (eg, erythromycin, saquinavir, ketoconazole, itraconazole) & elderly Starting dose: 25 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concurrent administration (either regularly or intermittently) w/ nitric oxide donors, organic nitrates or any of its form. Co-administration w/ guanylate cyclase stimulators (eg, riociguat). Hypotension (BP <90/50 mmHg), recent history of stroke or MI, known hereditary degenerative retinal disorders (eg, retinitis pigmentosa). Patients w/ severe CV disease (eg, established cardiac failure & unstable angina); visual loss in 1 eye due to non-arteritic anterior ischaemic optic neuropathy (NAION). Severe hepatic impairment.
Special Precautions
Obtain medical history, physical exam & CV status prior to treatment initiation. Patients w/ left ventricular outflow obstruction (eg, aortic stenosis, hypertrophic obstructive cardiomyopathy), rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of BP. Risk of serious CV events including MI, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack. Coadministration w/ α-blocker may lead to symptomatic hypotension. Patients w/ anatomical penis deformation (eg, angulation, cavernosal fibrosis or Peyronie's disease); retinitis pigmentosa; bleeding disorders or active peptic ulceration; resting HTN (BP >170/110) or history of cardiac failure or CAD causing unstable angina; predisposing conditions to priapism (eg, sickle cell anaemia, multiple myeloma or leukaemia) or suffered life-threatening arrhythmia w/in the last 6 mth. Discontinue use if sudden visual or hearing loss occurs. Do not use in patients w/ history of NAOIN; increased risk of NAOIN recurrence. Provide immediate medical assistance in case of prolonged erections >4 hr & priapism; may result to penile tissue damage & permanent potency loss if not treated immediately. Potentiated antiaggregatory effect of Na nitroprusside. Not recommended to use in combination w/ other PDE5 inhibitors, pulmonary arterial HTN treatments or other treatments for erectile dysfunction. Possible dizziness & altered vision; may affect the ability to drive & use machines. Not indicated for women & childn <18 yr.
Adverse Reactions
Headache. Dizziness; blurred vision, visual disturbance, cyanopsia; hot flush, flushing; nasal congestion; nausea, dyspepsia.
Drug Interactions
Reduced clearance when co-administered w/ CYP3A4 inhibitors (eg, ketoconazole, erythromycin, cimetidine). Increased plasma conc when co-administered w/ cimetidine. Increased AUC when co-administered w/ erythromycin. Increased Cmax & AUC when co-administered w/ saquinavir & ritonavir. Grapefruit juice may increase sildenafil plasma levels. Decreased AUC & Cmax when co-administered w/ bosentan. Rifampin may greatly decrease sildenafil plasma conc. Potentiated hypotensive effects of acute & chronic nitrates. Concomitant administration w/ α-blockers (eg, doxazosin) may lead to symptomatic hypotension. Increased bosentan AUC & Cmax.
MIMS Class
Drugs for Erectile Dysfunction & Ejaculatory Disorders
ATC Classification
G04BE03 - sildenafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
Form
Sildegra tab 100 mg
Packing/Price
4's
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