Manufacturer: Cipla Ltd
Salt Composition : Macitentan(10mg)
Opsutan Tablet is given alone or in combination with some other medicines. It should be taken with or without food. This medicine should be used regularly to get the most benefit from it. The dose and how often you take it depends on what you are taking it for. Your doctor will decide how much you need to improve your symptoms. You should take this medicine for as long as it is prescribed for you.
The most common side effects of this medicine include headache, swelling of the legs and ankles(edema), and inflammation of the airways. If these bother you or appear serious, let your doctor know. There may be ways of reducing or preventing them. Some serious side effects which mean your doctor should know immediately include Anemia (low number of red blood cells) and abnormal liver function such as nausea, vomiting, dark urine, fever, and dark urine. Your doctor might check you for blood tests to check for anemia and liver function.
Before taking this medicine, let your doctor know if you have liver dysfunctioning. Inform your doctor if you are pregnant or breastfeeding. Your doctor should also know about all other medicines you are taking as many of these may make this medicine less effective or change the way it works. You must avoid driving if this medicine makes you feel dizzy.
Opsutan Tablet is an endothelin receptor blocker. It blocks the action of endothelin (a natural substance) that causes blood vessels to narrow (constrict). This narrowing increases the pressure in the blood vessels of the lungs. Opsutan Tablet helps relax these blood vessels and increases the supply of blood to the lungs.
Macitentan has a median Tmax of 8h although some studies have found up to 30h at higher doses. Although the bioavailability has not been experimentally determined, pharmacokinetic modeling has estimated it at 74%. Food has not been found to have a significant effect on absorption.
Most side effects do not require any medical attention and disappear as your body adjusts to the medicine. Consult your doctor if they persist or if you’re worried about them
Common side effects of Opsutan
Headache
Bronchitis (inflammation of the airways)
Nasopharyngitis (inflammation of the throat and nasal passages)
Anemia (low number of red blood cells)
Urinary tract infection
Influenza
Opsumit is contraindicated during pregnancy and in women of childbearing potential who are not using reliable contraception (see section 4.3). The development of testicular tubular atrophy in male animals was observed after treatment with macitentan (see section 5.3).
Opsutan Tablet is highly unsafe to use during pregnancy. Seek your doctor's advice as studies on pregnant women and animals have shown significant harmful effects to the developing baby.
It is not known whether it is safe to consume alcohol with Opsutan Tablet. Please consult your doctor.
Opsutan Tablet is unsafe to use during breastfeeding. Data suggests that the drug may cause toxicity to the baby.
(macitentan) is indicated for long-term treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce morbidity in patients of WHO Functional Class II or III whose PAH is either idiopathic or heritable, or associated with connective tissue disease or congenital heart disease.
Other medications can affect the removal of macitentan from your body, which may affect how macitentan works. Examples include amiodarone, azole antifungals (such as fluconazole, ketoconazole), cobicistat, macrolide antibiotics (such as clarithromycin), rifamycins (such as rifampin), ritonavir, among others.
Do not chew, crush or break it. Opsutan Tablet may be taken with or without food, but it is better to take it at a fixed time.
Store below 30°C
If you miss a dose of Opsutan Tablet, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Consult a doctor before taking any medicines.
Your doctor has prescribed Opsutan Tablet to treat high pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries).
It helps improve your quality of life, exercising ability, and delay disease progression.
Notify your doctor if you are pregnant or planning to conceive or breastfeeding.
Your doctor may ask you to get routine blood tests done to check for anemia and to assess the functioning of your liver.
Do not drive or do anything requiring concentration until you know how Opsutan Tablet affects you.
Inform your doctor if you notice weight gain, swelling of your arms and legs, or difficulty breathing.
Inform your doctor if you notice yellowing of skin/eye, dark urine, or stomach pain.
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Opsutan Tablet may be taken with or without food, but it is better to take it at a fixed time.
Q. What is the recommendation for birth control while on Opsutan Tablet?
Females who are able to get pregnant should use 2 acceptable methods of birth control during treatment with Opsutan Tablet and 1 month of stopping it. This is because it takes some time to get the medicine flushed out of the body. If you have tubal sterilization, a progesterone implant, or have an IUD (intrauterine device), these methods can be used alone. Consult your doctor if you are not sure about the birth control method.
Q. How should Opsutan Tablet be taken?
The prescribed dose of Opsutan Tablet is advised to be taken once daily. It can be taken with or without food. It should be swallowed whole with water and not be crushed or chewed. For best results, it should be taken at the same time each day.
Q. Does Opsutan Tablet affect fertility?
There is some evidence that it may decrease fertility in men. It could also be a reason for decreased sperm count. Hence, before taking Opsutan Tablet, discuss with your doctor about the risks of taking Opsutan Tablet.
Q. While taking Opsutan Tablet do I need to get any tests done?
Your doctor will get blood tests done before and during the treatment. This is done to test whether you have anemia (reduced hemoglobin or decreased red blood cell count) and whether your liver is functioning properly.
