Revatio POS Dosage & Drug Information

Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Sildenafil citrate

Indications/Uses

Paed patients 1-17 yr w/ pulmonary arterial HTN. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary HTN & pulmonary HTN associated w/ congenital heart disease.

Click to view Revatio POS detailed prescribing information

Dosage/Direction for Use

Paed 1-17 yr >20 kg 20 mg 3 times daily, ≤20 kg 10 mg 3 times daily. Patient receiving CYP3A4 inhibitors eg, erythromycin or saquinavir 20 mg (10 mg if by IV inj) twice daily. Patient receiving more potent CYP3A4 inhibitors eg, clarithromycin, telithromycin & nefazodone 20 mg (10 mg if by IV inj) once daily.

Click to view Revatio POS detailed prescribing information

Overdosage

View Revatio POS overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Co-administration w/ nitric oxide donors (eg, amyl nitrate) or nitrates; PDE-5 inhibitors w/ guanylate cyclase stimulators (eg, riociguat); most potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir). Loss of vision in 1 eye due to non-arteritic anterior ischaemic optic neuropathy. Recent history of stroke or MI. Severe hypotension (BP <90/50 mmHg) at initiation. Severe hepatic impairment.

Click to view Revatio POS detailed prescribing information

Special Precautions

Patients w/ hypotension, fluid depletion, severe left ventricular outflow obstruction or autonomic dysfunction; veno-occlusive disease; bleeding disorders or active peptic ulceration; anatomical deformation of the penis eg, angulation, cavernosal fibrosis or Peyronie's disease; sickle cell anaemia, multiple myeloma or leukaemia; hearing impairment. Prolonged erection (lasting >4 hr) & priapism. Serious CV events including MI, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, HTN & hypotension. Discontinue treatment immediately in the event of any sudden visual defect/loss. Co-administration w/ α-blockers; bosentan; vit K antagonists; other PDE-5 inhibitors. Not recommended in patients w/ hereditary degenerative retinal disorders eg, retinitis pigmentosa. May impair ability to drive & use machines. Not recommended for women of childbearing potential. Not to be used in pregnant women. Lactation.

Click to view Revatio POS detailed prescribing information

Use In Pregnancy & Lactation

Click to view Revatio POS detailed prescribing information

Adverse Reactions

Influenza; insomnia; headache; visual disturbance/impairment, blurred vision; flushing; epistaxis, cough; nasal congestion; diarrhoea, dyspepsia; myalgia, back pain, pain in extremity; pyrexia.

Click to view Revatio POS detailed prescribing information

Drug Interactions

CYP3A4 (major route) & 2C9 (minor route) inhibitors may reduce sildenafil clearance & inducers may increase sildenafil clearance. Decreased exposure w/ CYP3A4 inducers eg, bosentan, carbamazepine, phenytoin, phenobarb, St. John's wort, rifampicin. Increased AUC w/ CYP3A4 inhibitors eg, saquinavir, erythromycin, clarithromycin, telithromycin, nefazodone. Increased exposure w/ β-blockers. Concomitant use w/ grapefruit juice is not recommended. Potential serious interaction w/ nicorandil. Potentiate the hypotensive effects of nitrates. May lead to symptomatic hypotension w/ α-blockers. Increased AUC of bosentan. Additive systemic BP lowering effect w/ riociguat. Increased C_max & AUC w/ ritonavir. Increased plasma conc w/ cimetidine.

Click to view Revatio POS detailed prescribing information

Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Revatio POS detailed prescribing information

Storage

View Revatio POS storage conditions for details to ensure optimal shelf-life.

Description

View Revatio POS description for details of the chemical structure and excipients (inactive components).

Action

View Revatio POS mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Other Antihypertensives

ATC Classification

C02KX - Antihypertensives for pulmonary arterial hypertension ; Used in the treatment of pulmonary arterial hypertension.

Regulatory Classification

Presentation/Packing

Form

Revatio POS powd for oral susp 10 mg/mL

Packing/Price

112 mL x 1's (Rp6,399,812/boks)

Revatio POS

sildenafil

Manufacturer:

Pfizer