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Introduction About BOZETAN 125MG TABLET
BOZETAN 125MG TABLET contains Bosentan which belongs to the group of medicines called Endothelin receptor antagonists. BOZETAN 125MG 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.
BOZETAN 125MG 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.
BOZETAN 125MG 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 BOZETAN 125MG TABLET, inform your doctor if you are planning to father a child, and/or have kidney problems (such as impaired renal function).
BOZETAN 125MG 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.
BOZETAN 125MG 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 BOZETAN 125MG 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 BOZETAN 125MG TABLET
- Manage pulmonary artery hypertension
- Manage digital ulcers (that occurs due to scleroderma) in affected individuals
How BOZETAN 125MG TABLET Works
BOZETAN 125MG 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 BOZETAN 125MG TABLET
Take BOZETAN 125MG 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 BOZETAN 125MG TABLET
Common
- headache
- oedema (swelling of legs & ankles)
- flushed appearance/redness of skin
- signs of hypersensitivity reactions (immune mediated allergic reaction) such as skin inflammation, itching, and/or rashes
- gastroesophageal reflux disease (acid reflux)
- diarrhoea
- syncope (fainting)
- palpitations (fast/irregular heartbeats)
- low blood pressure
- nasal congestion
Rare
- signs of anaphylactic reaction (life threatening allergic reaction) such as skin rash, nausea, difficulty in breathing, and/or shock
- cirrhosis/scarring of the liver
- liver failure.
Stop taking BOZETAN 125MG TABLET and consult your doctor immediately if you experience any of the following side effects:
- signs of abnormal/impaired liver function such as nausea, fever, pain in the stomach, jaundice (yellowing of the skin/whites of eyes), dark-coloured urine, itching, lethargy/fatigue, and/or flu-like symptoms such as joint & muscle pain with fever
How To Manage Side Effects
Headache:
If BOZETAN 125MG 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 BOZETAN 125MG 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
BOZETAN 125MG 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 BOZETAN 125MG TABLET. Consult your doctor before taking the medicine.
Breastfeeding
BOZETAN 125MG 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 BOZETAN 125MG TABLET.
Kidney
BOZETAN 125MG TABLET should be used with caution in patients with kidney problems such as impaired renal function. Consult your doctor before taking the medicine.
Liver
BOZETAN 125MG TABLET is not recommended for use in patients with liver problems. Consult your doctor before taking the medicine.
Allergy
Do not take BOZETAN 125MG TABLET if you are allergic to Bosentan, and/or any other ingredients of the medicine.
Others
Before taking BOZETAN 125MG TABLET, inform your doctor if you:
- are planning to father a child (since this medicine may lower the sperm count).
Use in Paediatrics:
BOZETAN 125MG TABLET is recommended for use in children and adolescents (aged 1 year and above) to manage only pulmonary hypertension. It is not recommended for use to manage systemic sclerosis and ongoing digital ulcer disease in affected children. Consult your doctor before administering the medicine to the child.
Use in Geriatrics:
BOZETAN 125MG TABLET should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before taking the medicine.
Interactions
A. Drug-Drug interactions:
Before taking BOZETAN 125MG 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 BOZETAN 125MG TABLET, consult your doctor immediately or visit the nearby hospital to manage overdose symptoms.
Synopsis
| Drug | : | Bosentan |
| Pharmacological Category | : | Endothelin receptor antagonists |
| Therapeutic Indication | : | Pulmonary artery hypertension, Digital ulcers (due to scleroderma) |
| Dosage Forms | : | Tablet |
More Information
- Keep BOZETAN 125MG TABLET out of reach of children
- Do not store BOZETAN 125MG TABLET above 30 °C
FAQs About BOZETAN 125MG TABLET
What is BOZETAN 125MG TABLET used for?
BOZETAN 125MG 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 BOZETAN 125MG TABLET?
The most common side effects of taking BOZETAN 125MG 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 BOZETAN 125MG TABLET works?
BOZETAN 125MG 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 BOZETAN 125MG TABLET should be taken?
Take BOZETAN 125MG 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 BOZETAN 125MG TABLET be used in pregnant women?
No, BOZETAN 125MG 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 BOZETAN 125MG 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
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