TREPROSTINIL EXTENDED RELEASE - ORAL

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TREPROSTINIL EXTENDED RELEASE - ORAL

PHONETIC PRONUNCIATION: (tre-PROS-ti-nil)

COMMON BRAND NAME(S): Orenitram ER

GENERIC NAME(S): treprostinil diolamine

Uses

USES: This medication is used to treat a type of high blood pressure in the lungs (pulmonary arterial hypertension). Treprostinil helps to increase your ability to exercise. It works by relaxing and widening the blood vessels (arteries) in the lungs and other parts of the body so that blood can flow more easily. This medication belongs to a class of drugs known as vasodilators.


How to use TREPROSTINIL EXTENDED RELEASE - ORAL

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking treprostinil and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with food as directed by your doctor, usually twice daily (every 12 hours). In some cases, your doctor may direct you to take this medication three times daily (every 8 hours). Follow your doctor's instructions carefully. Swallow the medication whole. Do not crush or chew the tablets or use a tablet that is damaged or broken. Doing so can release all of the drug at once, increasing the risk of side effects. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Use this medication regularly to get the most benefit from it. Remember to take it at the same times each day. Do not stop taking this medication without consulting your doctor. Your condition may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased. Your doctor may direct you to use other medications in addition to treprostinil to treat your condition and to prevent problems. Use all prescribed medications exactly as directed. Tell your doctor if your condition does not improve or if it worsens.

Side Effects

SIDE EFFECTS: Headache, nausea, diarrhea, jaw pain, flushing, dizziness, and abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. 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: muscle cramps, weakness, unusual bleeding/bruising. 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 using treprostinil, tell your doctor or pharmacist if you are allergic to it; 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: liver disease, bleeding problems, a certain intestinal disorder (diverticulosis). This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. 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. Treprostinil may lower your blood pressure. Your doctor may also direct you to take other medications that may also lower your blood pressure (including "water pills"/diuretics such as furosemide, ACE inhibitors such as captopril, calcium channel blockers such as nifedipine, other vasodilators such as nitrates). Your doctor may also prescribe "blood thinners" (such as warfarin) to prevent blood clots. Treprostinil may increase your risk of bleeding if you take "blood thinners." Your doctor or pharmacist will monitor you for these possible drug interactions. Tell your doctor or pharmacist right away if you develop symptoms such as easy or unusual bleeding/bruising, severe dizziness, or fainting.

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. Symptoms of overdose may include: severe dizziness, fainting.

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Faq for TREPROSTINIL EXTENDED RELEASE - ORAL

Treprostinil Extended Release - Oral is a medication used to treat pulmonary arterial hypertension (PAH). It helps to relax and open up the blood vessels in the lungs, improving blood flow.

Treprostinil Extended Release - Oral should be taken as prescribed by your doctor. It is typically taken once daily, with or without food. Do not crush, chew, or split the capsules and swallow them whole.

Common side effects of Treprostinil Extended Release - Oral include headache, nausea, diarrhea, flushing, and jaw pain. However, it is important to seek medical attention if you experience severe side effects such as chest pain, shortness of breath, or signs of an allergic reaction.

It is not recommended to use Treprostinil Extended Release - Oral during pregnancy unless the potential benefits outweigh the risks. It is not known if the medication passes into breast milk, so consulting with your doctor is advised before breastfeeding while using this medication.

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.

Treprostinil Extended Release - Oral may interact with certain medications such as medicines used to treat high blood pressure or other pulmonary hypertension medications. It is important to inform your doctor about all the medications you are taking to avoid potential drug interactions.

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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.