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Silatio

Silatio

sildenafil

Manufacturer:

Unison

Distributor:

Health Alliance
Concise Prescribing Info
Contents
Sildenafil citrate
Indications/Uses
Pulmonary arterial HTN (WHO functional class II & III) in adult patients, to improve exercise capacity.
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Dosage/Direction for Use
Adult 20 mg tds. Patients already receiving CYP3A4 inhibitors eg, erythromycin or saquinavir Consider downward dose adjustment to 20 mg bd. Patients co-administered w/ more potent CYP3A4 inhibitors eg, clarithromycin, telithromycin & nefazodone Consider downward dose adjustment to 20 mg once daily. Renal impairment Consider downward dose adjustment to 20 mg bd. Hepatic impairment (Child-Pugh class A and B) Consider downward dose adjustment to 20 mg bd.
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Overdosage
View Silatio overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients who have loss of vision in 1 eye because of non-arteritic anterior ischaemic optic neuropathy (NAION). Severe hepatic impairment, recent history of stroke or MI, severe hypotension (BP <90/50 mmHg) at initiation. Co-administration w/ nitric oxide donors (eg, amyl nitrite) or nitrates in any form; guanylate cyclase stimulators eg, riociguat; most potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir).
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Special Precautions
Retinitis pigmentosa; vasodilatory action; CV risk factors; priapism; vaso-occlusive crises in patients w/ sickle cell anemia; visual events; α-blockers; bleeding disorders; vit K antagonists; veno-occlusive disease; galactose intolerance; use of sildenafil w/ bosentan; concomitant use w/ other PDE5 inhibitors. Pregnancy & lactation.
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Adverse Reactions
Headache; flushing; diarrhea, dyspepsia; pain in extremity. Cellulitis, flu, bronchitis, sinusitis, rhinitis, gastroenteritis; anemia; fluid retention; insomnia, anxiety; migraine, tremor, paresthesia, burning sensation, hypoesthesia; retinal hemorrhage, visual impairment, vision blurred, photophobia, chromatopsia, cyanopsia, eye irritation, ocular hyperemia; vertigo; epistaxis, cough, nasal congestion; gastritis, GERD, hemorrhoids, abdominal distension, dry mouth; alopecia, erythema, night sweats; myalgia, back pain; pyrexia.
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Drug Interactions
Effects of other medicinal products on sildenafil: Ambrisentan, iloprost; other PDE5 inhibitors; CYP3A4 substrates & the combination of CYP3A4 substrates & β-blockers; ketoconazole & itraconazole; ritonavir; bosentan; carbamazepine, phenytoin, phenobarb, St. John's wort & rifampicin; saquinavir; erythromycin; azithromycin; cimetidine; clarithromycin, telithromycin & nefazodone; grapefruit juice; nicorandil. Effects of sildenafil on other medicinal products: Bosentan; amlodipine; doxazosin; nitric oxide donors or nitrates in any form; riociguat.
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Storage
View Silatio storage conditions for details to ensure optimal shelf-life.
Description
View Silatio description for details of the chemical structure and excipients (inactive components).
Action
View Silatio mechanism of action for pharmacodynamics and pharmacokinetics details.
MIMS Class
Other Antihypertensives
ATC Classification
G04BE03 - sildenafil ; Belongs to the class of drugs used in erectile dysfunction.
C02KX - Antihypertensives for pulmonary arterial hypertension ; Used in the treatment of pulmonary arterial hypertension.
Presentation/Packing
Form
Silatio FC tab 20 mg
Packing/Price
10 × 10's
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