Volibris

Volibris

ambrisentan

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Ambrisentan
Indications/Uses
Pulmonary arterial hypertension (PAH) in adults classified as WHO functional class II & III.
Dosage/Direction for Use
5 mg once daily, may be increased to 10 mg daily. In combination w/ tadalafil 10 mg once daily.
Administration
May be taken with or without food: Swallow whole, do not chew/crush/split tab.
Contraindications
Hypersensitivity to ambrisentan & soya. Idiopathic pulmonary fibrosis w/ or w/o secondary pulmonary HTN. Baseline values of hepatic aminotransferases ≥3x ULN. Severe hepatic impairment w/ or w/o cirrhosis. Women of childbearing potential who are not using reliable contraception. Pregnancy & lactation.
Special Precautions
Hypersensitivity to ambrisentan & soya. Not recommended in patients w/ clinically significant anaemia. Not to be initiated in patients w/ ALT &/or AST baseline values >3x ULN. Peripheral oedema; pulmonary veno-occlusive disease. Patients w/ WHO functional class IV PAH. Monitor liver function, Hb &/or haematocrit levels during treatment. Concomitant use w/ rifampicin. May cause allergic reaction due to azo colouring agent. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive or operate machinery. Not to be initiated in severe hepatic impairment. Severe renal impairment. Not to be initiated in women of childbearing potential. Childn & adolescents <18 yr.
Adverse Reactions
Headache; peripheral oedema, fluid retention. Anaemia; dizziness; palpitation; dyspnoea, nasopharyngitis, nasal congestion; nausea, diarrhoea; fatigue. Flushing; vomiting; chest pain/discomfort. Cardiac failure; hypotension; epistaxis; abdominal pain, constipation; asthenia. Hypersensitivity; blurred vison, visual impairment; tinnitus; syncope; rash.
Drug Interactions
Increased exposure w/ cyclosporine A. Transient increased exposure w/ rifampicin. Caution in co-administration w/ other targeted PAH treatments eg, prostanoids & soluble guanylate cyclase stimulators.
MIMS Class
Other Antihypertensives
ATC Classification
C02KX02 - ambrisentan ; Belongs to the class of other antihypertensives. Used in the treatment of pulmonary arterial hypertension.
Presentation/Packing
Form
Volibris FC tab 10 mg
Packing/Price
30's
Form
Volibris FC tab 5 mg
Packing/Price
30's
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