MACITENTAN - ORAL

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MACITENTAN - ORAL

PHONETIC PRONUNCIATION: (MA-si-TEN-tan)

COMMON BRAND NAME(S): Opsumit

GENERIC NAME(S): macitentan

Uses

USES: Macitentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). This condition is thought to be caused by increased levels of a certain natural substance (endothelin-1). This medication blocks the effects of endothelin-1, which helps decrease the blood pressure in the lungs, slow the worsening of symptoms from the disease, and improve your ability to exercise.


How to use MACITENTAN - ORAL

HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking macitentan and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the tablet whole. Do not split, crush, or chew the tablet. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets. Tell your doctor if your condition does not improve or if it worsens.

Side Effects

SIDE EFFECTS: Runny nose, sore throat, cough, headache, chills, or body aches may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: signs of low red blood cell count (such as unusual tiredness, rapid breathing, pale skin, shortness of breath, fast heartbeat), unusual weight gain, new or worsening swelling of the hands/ankles/feet. Macitentan may rarely cause serious liver disease. Tell your doctor right away if you have any symptoms of liver disease, including: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes/skin. Macitentan may decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking macitentan, tell your doctor or pharmacist if you are allergic to it; or to other endothelin receptor blockers (such as bosentan); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: anemia, other lung conditions (such as pulmonary veno-occlusive disease). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication must not be used during pregnancy. It may harm an unborn baby. See also Warning section. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets. It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Other medications can affect the removal of macitentan from your body, which may affect how macitentan works. Examples include azole antifungals (such as ketoconazole), cobicistat, macrolide antibiotics (such as clarithromycin), HIV protease inhibitors (such as ritonavir), rifamycins (such as rifampin), among others.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Images

OPSUMIT 10 MG TABLET
OPSUMIT 10 MG TABLET
OPSUMIT 10 MG TABLET
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OPSUMIT 10 MG TABLET
OPSUMIT 10 MG TABLET
OPSUMIT 10 MG TABLET
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white
shape
round
imprint
10

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Faq for MACITENTAN - ORAL

Macitentan is an oral medication used for the treatment of pulmonary arterial hypertension (PAH).

Macitentan works by blocking the effects of endothelin, a substance that can cause blood vessels to narrow and increase blood pressure in the lungs. By blocking endothelin, Macitentan helps to relax the blood vessels and improve blood flow in the lungs.

The common side effects of Macitentan include headache, nasopharyngitis (common cold symptoms), anemia, bronchitis, and swelling of the ankles, legs, and feet.

Macitentan is typically taken once daily, with or without food. It is important to take it at the same time each day. The tablet should be swallowed whole and not crushed, chewed, or split.

No, Macitentan should not be used during pregnancy as it may cause harm to the unborn baby. Pregnant women should discuss alternative options with their healthcare provider.

Yes, Macitentan can interact with certain medications such as anticoagulants, rifampin, or hormonal birth control pills. It is important to inform your healthcare provider about all the medications you are taking before starting Macitentan.

There are no specific restrictions on alcohol consumption while taking Macitentan. However, it is advisable to speak with your doctor regarding alcohol use as it may exacerbate certain side effects or interact with other medications you are taking.

The effects of Macitentan may not be immediately noticeable. It may take several weeks or months of treatment to experience the full benefits. It is important to continue taking the medication as prescribed by your doctor.

Macitentan is not approved for use in children. Its safety and effectiveness have not been established in pediatric patients.

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Warning

WARNING: Macitentan must not be used during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while taking this medication and for 1 month after treatment. Therefore, female patients must use reliable birth control during treatment and for 1 month after the end of treatment. Ask your doctor which forms of birth control to use while taking this medication. Female patients must take a pregnancy test before starting treatment and take a monthly pregnancy test during treatment. If you become pregnant or think you may be pregnant, tell your doctor right away. To receive this medication, all doctors, pharmacists, and female patients must understand, agree to, and carefully follow the requirements of the Opsumit REMS program developed by the FDA. These requirements apply to female patients in the United States only. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.