Registered Zambia · ZAMRA

Pulmofirst 125 tablets

Bosentan Monohydrate 129.08 mg

311/043 Tablet Uncoated 129.08 mg cardiovascular system INN generic

What it does

Bosentan is a medication that helps to relax blood vessels and improve blood flow.

Commonly used for: pulmonary hypertension (high blood pressure in the lungs), heart failure

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Registration & product details

Registration no.
311/043
Registration date
2024-06-08
Expiry date
2029-06-07
Status
Registered/Compliant
Active ingredient
Bosentan Monohydrate 129.08 mg
Dosage form
Tablet Uncoated
Strength
129.08 mg
Pack size
-
Therapeutic class
-
ATC class (WHO)
C02KX - Antihypertensives for pulmonary arterial hypertension
RxNorm RxCUI
75207
Manufacturer / MAH
Msn Laboratories
Country of origin
India
Manufacturer location
MSN Corporate, H. No. 2-91/10 & 11 /MSN, Kondapur, Laxmi Cyber City, Whitefields, Gachibowli, Hyderabad, Telangana 500084, India

Source: Zambia Medicines Regulatory Authority · fetched 2026-03-12 00:05:42 · updated 2026-09-17 03:38:00

Drug Interactions

137
Check interactions

Severe (30)

Anti-Androgens - decreases exposure

Bosentan is predicted to decrease the exposure to anti-androgens (darolutamide). Avoid.

Severe Theoretical

Antifungals,azoles - decreases exposure

Bosentan is predicted to decrease the exposure to antifungals, azoles (isavuconazole). Avoid.

Severe Theoretical

Antipsychotics, Second Generation - decreases exposure

Bosentan is predicted to decrease the exposure to antipsychotics, second generation (cariprazine). Avoid.

Severe Theoretical

Bosentan - increases exposure

Fluconazole is predicted to increase the exposure to endothelin receptor antagonists (bosentan). Avoid.

Severe Study

Bosentan - increases exposure

Voriconazole is predicted to increase the exposure to endothelin receptor antagonists (bosentan). Avoid.

Severe Theoretical

Moderate (19)

Amlodipine - decreases exposure

Bosentan is predicted to decrease the exposure to calcium channel blockers (amlodipine, felodipine, lacidipine, lercanidipine, nicardipine, nifedipine, nimodipine). Monitor and adjust dose.

Moderate Theoretical

Benzodiazepines - decreases concentration

Bosentan is predicted to decrease the concentration of benzodiazepines (midazolam). Monitor and adjust dose.

Moderate Theoretical

Bosentan - increases exposure

Roxadustat is predicted to increase the exposure to bosentan. Monitor adverse effects and adjust dose.

Moderate Study

Calcium Channel Blockers - decreases exposure

Bosentan is predicted to decrease the exposure to calcium channel blockers (amlodipine, felodipine, lacidipine, lercanidipine, nicardipine, nifedipine, nimodipine). Monitor and adjust dose.

Moderate Theoretical

Everolimus - decreases concentration

Bosentan is predicted to decrease the concentration of everolimus. Avoid or adjust dose.

Moderate Study

Unknown (88)

Acalabrutinib - decreases exposure

Bosentan is predicted to decrease the exposure to acalabrutinib.

Unknown Study

Anti-Androgens - decreases efficacy

Bosentan is predicted to decrease the efficacy of anti-androgens (cyproterone) with ethinylestradiol (co-cyprindiol). Use alternative methods during treatment with, and for 28 days after, the enzyme i

Unknown Study

Antiarrhythmics - decreases exposure

Bosentanispredictedtodecreasetheexposureto antiarrhythmics(dronedarone).rTheoretical

Unknown Theoretical

Atorvastatin - decreases exposure

Bosentan is predicted to decrease the exposure to statins (atorvastatin, simvastatin).

Unknown Study

Avacopan - decreases exposure

Bosentanispredictedtodecreasetheexposuretoavacopan. rTheoretical

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Zambia Medicines Regulatory Authority (Zambia). Always consult a qualified healthcare professional before using any medication.

About this medicine

Bosentan is a medication that helps to relax blood vessels and improve blood flow.

What it treats

  • pulmonary hypertension (high blood pressure in the lungs)
  • heart failure

How it works

It blocks certain receptors in the body that cause blood vessels to narrow, which helps to lower blood pressure.

Who it's for

This medication is for adults with specific types of high blood pressure affecting the lungs.

Drug class

Endothelin receptor antagonists

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Bosentan

BNF-referenced

Bosentan is an endothelin receptor antagonist used primarily in the treatment of pulmonary arterial hypertension (PAH), aimed at improving exercise capacity and delaying clinical worsening.

Indications

  • Pulmonary arterial hypertension
  • Idiopathic pulmonary arterial hypertension
  • Familial pulmonary arterial hypertension

Dosage

Children: Refer to the BNF for Children for specific dosing information for paediatric patients.

Adults: The typical initial dose for adults is 62.5 mg twice daily for 4 weeks, which may be increased to 125 mg twice daily based on clinical response.

Mechanism of action

Bosentan works by blocking the action of endothelin-1, a potent vasoconstrictor, thereby promoting vasodilation, reducing vascular resistance, and improving blood flow in the pulmonary and systemic circulation.

Pharmacodynamics

Bosentan leads to decreased pulmonary and systemic arterial pressures and increased cardiac output, which helps alleviate symptoms associated with pulmonary arterial hypertension.

Pharmacokinetics

Bosentan is absorbed orally with peak plasma concentrations occurring within 3 to 5 hours. It is extensively metabolized in the liver, primarily by CYP2C9 and CYP3A4. The elimination half-life is approximately 5 hours, and it is excreted mainly as metabolites in urine and feces.

Contra-indications

  • Conditions which increase risk of haemorrhage
  • Congenital or acquired valvular defects of the myocardium
  • Decompensated cardiac failure (unless under close medical supervision)
  • Pulmonary veno-occlusive disease
  • Severe arrhythmias
  • Severe coronary heart disease

Interactions

  • Fluconazole: Severe (increases exposure)
  • Voriconazole: Severe (increases exposure)
  • Endothelin receptor antagonists: Moderately decrease exposure to ciclosporin
  • Ciclosporin: Moderately increases the exposure to bosentan
  • Bosentan + anti-androgens: Severe (decreases exposure)
  • Bosentan + darolutamide: Severe (decreases exposure)
  • Bosentan + antifungals, azoles: Severe (decreases exposure)
  • Bosentan + isavuconazole: Severe (decreases exposure)
  • Bosentan + antipsychotics, second generation: Severe (decreases exposure)
  • Bosentan + cariprazine: Severe (decreases exposure)

Precautions

  • Hypotension (do not initiate if systolic blood pressure is low)
  • Avoid abrupt withdrawal due to risk of rebound pulmonary hypertension and hypertensive crisis

Pregnancy

Use if potential benefit outweighs risk.

Breast-feeding

Manufacturer advises avoid; no information available.

Storage

Store in a cool, dry place away from direct sunlight.

Formulations

  • Powder for solution for infusion
BNF for Children 2019-2020 p.143 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Bosentan

PubChem CID 104865

Molecular formula: C27H29N5O6S

Mechanism of action

Endothelin-1 (ET-1) is a neurohormone, the effects of which are mediated by binding to ET<sub>A</sub> and ET<sub>B</sub> receptors in the endothelium and vascular smooth muscle. It displays a slightly higher affinity towards ET<sub>A</sub> receptors than ET<sub>B</sub> receptors. ET-1 concentrations are elevated in plasma and lung tissue of patients with pulmonary arterial hypertension, suggesting a pathogenic role for ET-1 in this disease. Bosentan is a specific and competitive antagonist at endothelin receptor types ET<sub>A</sub> and ET<sub>B</sub>.

Pharmacodynamics

Bosentan belongs to a class of drugs known as endothelin receptor antagonists (ERAs). Patients with PAH have elevated levels of endothelin, a potent blood vessel constrictor, in their plasma and lung tissue. Bosentan blocks the binding of endothelin to its receptors, thereby negating endothelin's deleterious effects.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.