INTRODUCTION

BOSENTAS 125MG contains Bosentan which belongs to the class of medicines called endothelin receptor antagonists. It is used to treat primary pulmonary arterial hypertension (PAH) and PAH caused by scleroderma (abnormal growth of the connective tissue) or congenital heart defects with shunts. PAH is a type of high blood pressure that affects the blood vessels of the lungs. It is characterized by severe narrowing of the blood vessels, resulting in high blood pressure in blood vessels (pulmonary arteries) that carry blood from heart to lungs. This increased pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult.

Bosentan blocks a hormone called endothelin-1 (ET-1), which causes blood vessels to narrow. It causes vasodilatation of pulmonary arteries, making it easier for the heart to pump blood through them. This lowers the increased blood pressure and relieves the associated symptoms. BOSENTAS 125MG can also be used to treat digital ulcers (sores on toes and fingers) in adult patients with scleroderma. Your doctor would suggest frequent blood test for you before and during the treatment, to access your liver function and to check for anemia. If the results are abnormal, your doctor will reduce your dose or stop bosentan treatment.

The most common side effects of taking this medicine are headache, edema, diarrhea, fainting and low blood pressure. Before taking this medicine, inform your doctor if you are pregnant or think you may be pregnant. Bosentan can cause harm to the unborn babies conceived before starting or during the treatment. Your doctor will advise you a suitable contraceptive method. It should be used in children only with PAH. Consult your doctor for advice before taking. It is not recommended for use in pediatric patients with systemic sclerosis and ongoing digital ulcer disease.

USES OF BOSENTAS 125MG

• Treats Pulmonary arterial hypertension (PAH)
• Treats digital ulcers (sores on toes and fingers)

HOW BOSENTAS 125MG WORKS

Bosentan is an endothelin receptor antagonist that effectively blocks a naturally occurring hormone called endothelin-1 (ET-1), which is responsible to cause narrowing of blood vessels. Through this action, bosentan induces vasodilatation of blood vessels (pulmonary arteries) that carry blood from heart to lungs, making it easier for the heart to pump blood through them. This lowers the increased blood pressure and relieves its associated symptoms.

DIRECTIONS FOR USE

Take this medicine as directed by your physician. It can be taken in the morning or evening with or without meals. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, weight and health condition. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results.

SIDE EFFECTS OF BOSENTAS 125MG

HOW TO MANAGE SIDE EFFECTS

Nausea or vomiting:

Try taking this medicine with, or just after meal. Stick to simple meals. Do not eat rich or spicy food.

Diarrhea:

Drink lots of fluids, such as water or juice, to avoid dehydration. Do not take any medicines without speaking to a doctor.

Stomach pain:

Try to rest and relax. You can eat and drink slowly or have smaller and frequent meals. Keeping a heat pad on your stomach may also help. If still pain persists, speak to your doctor.

WARNING & PRECAUTIONS

INTERACTIONS

Talk to your doctor, if you are taking,

• cyclosporine A (used to prevent graft rejection and to treat psoriasis)
• other medicines used to treat graft rejection (e.g. sirolimus or tacrolimus)
• other medications used to treat pulmonary hypertension (e.g. sildenafil and tadalafil)
• medicines used to treat fungal infection (e.g. fluconazole and ketoconazole)
• medicines used to treat HIV infection (e.g. nevirapine, lopinavir and ritonavir)
• glibenclamide (used to treat diabetes)
• rifampicin (used to treat tuberculosis)
• hormonal contraceptives (birth control pills)
• warfarin (used to thin blood)
• simvastatin (used to treat high blood cholesterol levels)

SYNOPSIS

MORE INFORMATION

Store at room temperature and keep out of reach of children.

FAQs ABOUT BOSENTAS 125MG

Can you take BOSENTAS 125MG with sildenafil?

No. Avoid concomitant use of sildenafil and bosentan, because it can increase the risks of side effects.

Can BOSENTAS 125MG be taken during pregnancy?

It is strictly not recommended for use in pregnant women, because it can cause harm to the unborn babies conceived before starting or during the treatment. Your doctor will advise you a suitable contraceptive method.

Can BOSENTAS 125MG be taken during breastfeeding?

No. This medicine is strictly not recommended for use in breastfeeding mothers, because it is not known whether this medicine passes into breast milk.

REFERENCES

1. Peter J. Barnes. Pulmonary Pharmacology. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York Mc Graw Hill Medical 2011. Page – 1059.

2. John R. Teerlink, Karen Sliwa, Lionel H. Opie. Heart Failure. Drugs for the heart. 8th Edition. 2013. Page – 229.

3. Gerald G. Briggs and Roger K. Freeman. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 462- 464.

4. Actelion. A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients with Mildly Symptomatic Pulmonary Arterial Hypertension (PAH). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on August 2011] [Accessed 4th November 2020] https://clinicaltrials.gov/ct2/show/NCT00091715

5. Eli Gabbay, John Fraser and Keith McNeil. Review of bosentan in the management of pulmonary arterial hypertension. NCBI; PMC US National Library of Medicine, National Institute of Health. December 2007. [Accessed 4th November 2020] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2350123/

6. Zentiva. Electronic Medicines Compendium (EMC); [Revised on June 2020] [Accessed 4th November 2020] https://www.medicines.org.uk/emc/files/pil.8909.pdf

7. Pharmadox Healthcare Ltd. Electronic Medicines Compendium (EMC); [Revised on June 2018] [Accessed 4th November 2020] https://www.medicines.org.uk/emc/files/pil.9821.pdf

USEFUL DIAGNOSTIC TESTS

• Transesophageal echocardiogram
• Pulmonary function test