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Endobloc T Kit

Ambrisentan · Tadalafil

Lower pulmonary artery pressure and improve exercise capacity in pulmonary arterial hypertension

Active ingredients
Ambrisentan · Tadalafil
Route
Oral use
Form
Tablet
Strengths
5mg + 20mg

Prescription and consultation requirements for Endobloc T Kit vary by destination and are determined by the fulfilment partner.

Endobloc T Kit details

Therapeutic class
Endothelin receptor antagonists; Phosphodiesterase type 5 inhibitors
Pharmacological class
Endothelin A receptor antagonist; Phosphodiesterase-5 inhibitor
Dosage forms
Tablet
Administration route
Oral use
Supply category
Prescription-only medicine (POM)
Manufacturer
Cipla
Storage instructions
Store at room temperature below 30°C. Protect from light and moisture.
Age restrictions
Safety and efficacy in children and adolescents not established.
Contraindications

hypersensitivity to ambrisentan, tadalafil or any excipient; pregnancy; females of childbearing potential not using effective contraception; breast-feeding; severe hepatic impairment; idiopathic pulmonary fibrosis with or without secondary pulmonary hypertension; concomitant use with nitrates; concomitant use with riociguat; known hereditary degenerative retinal disorders including retinitis pigmentosa; history of non-arteritic anterior ischaemic optic neuropathy; severe hypotension at baseline; left ventricular outflow obstruction; heart failure with reduced ejection fraction

Precautions and warnings

haemoglobin and haematocrit monitoring due to risk of anaemia; fluid retention and peripheral oedema; pulmonary veno-occlusive disease; hepatic transaminase monitoring; idiosyncratic hepatic injury; cardiovascular effects and hypotension; priapism; sudden decrease or loss of hearing; caution in renal impairment; contraindicated in pregnancy with mandatory pregnancy testing programme

Minor side effects

headache; peripheral oedema; nasal congestion; sinusitis; flushing; dizziness; fatigue; nausea; indigestion; back pain; muscle aches

Moderate side effects

anaemia; hepatic transaminase elevations; hepatotoxicity; priapism; sudden hearing loss; visual field defects; non-arteritic anterior ischaemic optic neuropathy; hypotension; syncope; palpitations

Serious side effects

priapism, requires immediate medical attention; sudden hearing loss, requires immediate medical attention; non-arteritic anterior ischaemic optic neuropathy, requires immediate medical attention; severe hypotension, requires immediate medical attention; hepatotoxicity, requires immediate medical attention

Patient summary

Lower pulmonary artery pressure and improve exercise capacity in pulmonary arterial hypertension

Mechanism of action

Endobloc T Kit contains two active medicines that work together to treat pulmonary arterial hypertension. Ambrisentan is an endothelin receptor antagonist that blocks the action of endothelin, a naturally occurring substance that causes narrowing of blood vessels in the lungs. By blocking endothelin receptors, it helps relax and widen the pulmonary arteries. Tadalafil is a phosphodiesterase-5 inhibitor that increases levels of cyclic guanosine monophosphate in the smooth muscle of pulmonary blood vessels, promoting relaxation and increased blood flow. Together, these two mechanisms reduce the pressure in the pulmonary arteries and decrease the workload on the heart.

Drug interactions

nitrates; riociguat; alpha-blockers; antihypertensives; strong CYP3A4 inhibitors; CYP3A4 inducers; ciclosporin; ketoconazole; rifampicin

Pregnancy and breastfeeding

Endobloc T Kit is contraindicated in pregnancy due to the potential for fetal harm. Ambrisentan has been shown to cause teratogenic effects. Females of childbearing potential must use effective contraception and undergo monthly pregnancy testing during treatment. Breast-feeding is contraindicated.