Introduction About BOSENTAN 62.5 TABLET

BOSENTAN 62.5 TABLET contains Bosentan which belongs to the group of medicines called Endothelin receptor antagonists. BOSENTAN 62.5 TABLET is used to manage pulmonary arterial hypertension in affected individuals which is a disease that occurs due to high blood pressure in blood vessels that carry blood from heart to the lungs.

BOSENTAN 62.5 TABLET is also used in adults to reduce digital ulcers (sores on the fingers and toes) that occurs due to scleroderma which is a chronic disease that cause skin to become thick and hard.

BOSENTAN 62.5 TABLET is not recommended for use in patients allergic to Bosentan. It is also not recommended for use in patients suffering from liver problems.

Before taking BOSENTAN 62.5 TABLET, inform your doctor if you are planning to father a child, and/or have kidney problems (such as impaired renal function).

BOSENTAN 62.5 TABLET is generally not recommended for use during pregnancy and in women planning for pregnancy since the medicine may cause harm to the unborn child. It is also not recommended for use in breastfeeding women since it is not known whether the medicine may pass through breastmilk.

BOSENTAN 62.5 TABLET is recommended for use in children and adolescents (aged 1 year and above) to manage only pulmonary hypertension and is not indicated for use to manage systemic sclerosis and digital ulcer disease in affected children. The medicine is advised to be used with caution in elderly patients (aged 65 years/above) after consulting the doctor.

The most common side effects of taking BOSENTAN 62.5 TABLET are headache, oedema (swelling of legs & ankles), flushing/redness of skin, diarrhoea, low blood pressure, and/or nasal congestion. Consult your doctor if any of these symptoms worsen.

Uses Of BOSENTAN 62.5 TABLET

• Manage pulmonary artery hypertension
• Manage digital ulcers (that occurs due to scleroderma) in affected individuals

How BOSENTAN 62.5 TABLET Works

BOSENTAN 62.5 TABLET works by blocking the action of endothelin-1 hormone (chemical that cause vasoconstriction) which leads to relaxation and widening of blood vessel wall resulting in reduced pressure on the blood vessel wall and managing pulmonary hypertension in affected individuals.

How to use BOSENTAN 62.5 TABLET

Take BOSENTAN 62.5 TABLET as advised by your physician. 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, body weight and disease condition.

Side Effects Of BOSENTAN 62.5 TABLET

How To Manage Side Effects

Headache:

If BOSENTAN 62.5 TABLET causes headache, then take rest and drink plenty of fluids. Try to avoid drinking alcohol. Ask your doctor to recommend a painkiller. Headaches should usually go away after the first week of taking BOSENTAN 62.5 TABLET. If it lasts more than a week or becomes severe, then consult your doctor.

Diarrhea:

Drink plenty of water and stay hydrated. Try to avoid taking any medicine on your own to manage diarrhea. Consult your doctor if the symptom worsens.

Warning & Precautions

Pregnancy

BOSENTAN 62.5 TABLET is generally not recommended for use during pregnancy and in women planning for pregnancy since the medicine may cause harm to the unborn child. Women of child-bearing potential should use effective contraceptive measures to manage accidental pregnancy while in management with BOSENTAN 62.5 TABLET. Consult your doctor before taking the medicine.

Breastfeeding

BOSENTAN 62.5 TABLET is not recommended for use in breastfeeding women since it is not known whether the medicine may pass through breastmilk. Consult your doctor before taking the medicine.

Driving and Using Machines

Do not drive/operate any machines if you feel dizzy or experience blurred vision after taking BOSENTAN 62.5 TABLET.

Kidney

BOSENTAN 62.5 TABLET should be used with caution in patients with kidney problems such as impaired renal function. Consult your doctor before taking the medicine.

Liver

BOSENTAN 62.5 TABLET is not recommended for use in patients with liver problems. Consult your doctor before taking the medicine.

Allergy

Do not take BOSENTAN 62.5 TABLET if you are allergic to Bosentan, and/or any other ingredients of the medicine.

Interactions

A. Drug-Drug interactions:

Before taking BOSENTAN 62.5 TABLET, inform your doctor if you are taking any of the following medicine:

• ciclosporin A (used after transplants and to manage psoriasis)
• sirolimus, tacrolimus (medicines used after transplants to manage organ rejection)
• glibenclamide (used to manage diabetes)
• rifampicin (use to manage tuberculosis)
• fluconazole, ketoconazole (medicines used to manage fungal infections)
• nevirapine (used to manage HIV infection)
• warfarin (used to manage blood clots)
• other medicine used to manage pulmonary hypertension (Ex. sildenafil, tadalafil)
• simvastatin (used to manage hypercholesterolaemia)
• hormonal contraceptives (used to manage pregnancy)

Overdosage:

If you or anyone else accidentally take too much of BOSENTAN 62.5 TABLET, consult your doctor immediately or visit the nearby hospital to manage overdose symptoms.

Synopsis

More Information

• Keep BOSENTAN 62.5 TABLET out of reach of children
• Do not store BOSENTAN 62.5 TABLET above 30 °C

FAQs About BOSENTAN 62.5 TABLET

What is BOSENTAN 62.5 TABLET used for?

BOSENTAN 62.5 TABLET is used to manage pulmonary arterial hypertension in affected individuals which is a disease that occurs due to high blood pressure in blood vessels that carry blood from heart to the lungs. It is also used in adults to reduce digital ulcers (sores on the fingers and toes) that occurs due to scleroderma which is a chronic disease that cause skin to become thick and hard in affected individuals.

What are the side effects of taking BOSENTAN 62.5 TABLET?

The most common side effects of taking BOSENTAN 62.5 TABLET are headache, oedema (swelling of legs & ankles), flushing/redness of skin, diarrhoea, low blood pressure, and/or nasal congestion. Contact your doctor if any of these symptoms worsen.

How BOSENTAN 62.5 TABLET works?

BOSENTAN 62.5 TABLET works by blocking the action of endothelin-1 hormone (chemical that cause vasoconstriction) which leads to relaxation and widening of blood vessel wall resulting in reduced pressure on the blood vessel wall and managing pulmonary hypertension in affected individuals.

How BOSENTAN 62.5 TABLET should be taken?

Take BOSENTAN 62.5 TABLET as advised by your physician. 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, body weight and disease condition.

Can BOSENTAN 62.5 TABLET be used in pregnant women?

No, BOSENTAN 62.5 TABLET is generally not recommended for use during pregnancy and in women planning for pregnancy since the medicine may cause harm to the unborn child. Women of child-bearing potential should use effective contraceptive measures to manage accidental pregnancy while in management with BOSENTAN 62.5 TABLET. Consult your doctor before taking the medicine.

References

1. Angela Cheng-Lai, James Nawarskas, William H. Frishman. Vasodilators. Current Cardiovascular Drugs. Fourth edition. 2005. Page – 327.

2. J Dingemanse, P L M van Giersbergen. Influence of severe renal dysfunction on the pharmacokinetics and metabolism of bosentan, a dual endothelin receptor antagonist. NIH National Library of Medicine. National Center for biotechnology information. PubMed.gov. July 2002. [Accessed on 29th April 2022] https://pubmed.ncbi.nlm.nih.gov/12139208/

3. Accord Healthcare Limited. Electronic Medicines Compendium (EMC). [Revised in September 2022] [Accessed on 29th April 2022] https://www.medicines.org.uk/emc/files/pil.8409.pdf

Useful Diagnostic Tests

• Echocardiogram
• Right heart catheterization