Sildera

Sildera

sildenafil

Manufacturer:

Atlantic Lab

Distributor:

Atlantic Pharma

Marketer:

Atlantic Pharma
Concise Prescribing Info
Contents
Sildenafil citrate
Indications/Uses
Dosage/Direction for Use
Adult Usual dose: 50 mg, 1 hr before sexual intercourse. Max: 100 mg. Elderly >65 yr & patients w/ renal (CrCl <30 mL/min) or hepatic impairment (Child-Pugh Class A & B), patients stable on α-blockers Initially 25 mg. Concomitant use w/ potent CYP3A4 inhibitors Starting dose: 25 mg, PI Max: 25 mg every 48 hr.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ organic nitrates in any form eg, nitroglycerin, isosorbide dinitrate.
Special Precautions
Patients w/ left ventricular outflow obstruction (aortic stenosis or hypertrophic obstructive cardiomyopathy). Concurrent use w/ α-adrenergic antagonist therapy or substantial ethanol consumption. Patients should be hemodynamically stable prior to initiating therapy at the lowest possible dose. Patients w/ hypotension (<90/50 mmHg); uncontrolled HTN (>170/110 mmHg); life-threatening arrhythmias, stroke or MI w/in the last 6 mth; cardiac failure or CAD causing unstable angina; anatomical deformation of the penis (angulation, cavernosal fibrosis or Peyronie's disease) & those w/ conditions which may predispose them to priapism (eg, sickle cell anaemia, multiple myeloma, leukemia); retinitis pigmentosa; genetic disorders of retinal phosphodiesterases; bleeding disorders or w/ active PUD. Consider CV status prior to initiating treatment. Nonarteritic anterior ischemic optic neuropathy. History of vision loss. May cause dose-related impairment of color discrimination. Concomitant use w/ strong CYP3A4 inhibitors or α-blockers. Renal or hepatic dysfunction. Pregnancy & lactation. Elderly.
Adverse Reactions
Headache, flushing & dyspepsia. Visual disturbances eg, blurred vision, photophobia, chromatopsia, cyanopsia, eye irritation, pain & redness of the eyes. Dizziness, insomnia, anxiety, vertigo, epistaxis, nasal congestion, pyrexia & GI disturbances eg, diarrhoea & vomiting. Priapism; skin rashes, erythema, alopecia, limb &/or back pain, myalgia, facial oedema, fluid retention, paraesthesia, & UTI. Dyspnoea, cough, rhinitis, sinusitis, bronchitis & cellulitis. Sudden decrease or loss of hearing. Anaemia, leucopenia, gynaecomastia, urinary frequency or incontinence, haematuria & seizures. Cerebrovascular haemorrhage & transient ischaemic attacks. Palpitations, syncope, HTN, hypotension, & serious CV events including MI, arrhythmias, tachycardia, unstable angina & sudden cardiac death.
Drug Interactions
May increase the levels/effects of α1-blockers, amyl nitrate, antihypertensive, bosentan, HMG-CoA reductase inhibitors, phosphodiesterase 5 inhibitors, vasodilators (organic nitrates). Increased sildenafil levels/effects by antifungal agents (azole derivatives, systemic), conivaptan, moderate & strong CYP3A4 inhibitors, dasatinib, macrolide antibiotics, PI, sapropterin. May decrease sildenafil levels/effects by bosentan, strong CYP3A4 inducers, deferasirox, etravirine, herbs (CYP3A4 inducers), peginterferon α-2b; high-fat meal; St. John's wort. May increase serum conc & toxicity w/ grapefruit juice.
ATC Classification
G04BE03 - sildenafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
Form
Sildera tab 100 mg
Packing/Price
1 × 4's
Form
Sildera tab 50 mg
Packing/Price
1 × 4's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in