Orenitram

Orenitram is a prescription medication used to treat pulmonary arterial hypertension (PAH). Orenitram belongs to a group of drugs called vasodilators, which help to relax the blood vessels within and around the lungs. This helps increase your ability to breathe, especially during exercise. It also acts as a blood thinner, which decreases the chance of a blood clot.

Orenitram is also available as extended release tablets. It is usually taken 2 or 3 times a day with food. Swallow tablets whole, do not crush, divided or chew tablets.

Common side effects of Orenitram include headache, nausea, and diarrhea. 

Orenitram is a prescription medication used to treat pulmonary arterial hypertension. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• United Therapeutics Corporation

Serious side effects have been reported with Orenitram.

Common side effects of Orenitram tablets include the following:

• headache
• nausea
• diarrhea
• flushing
• jaw pain
• pain in extremities
• low levels of potassium in the blood
• stomach discomfort

This is not a complete list of Orenitram side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• diuretics such as
  • acetazolamide (Diamox)
  • amiloride (Midamor)
  • bumetanide (Bumex)
  • chlorothiazide (Diuril)
  • chlorthalidone (Thalitone)
  • ethacrynic acid (Edecrin)
  • furosemide (Lasix)
  • hydrochlorothiazide (Microzide, HCTZ)
  • metolazone (Zaroxolyn)
  • torsemide (Demadex)
  • triamterene (Dyrenium, Dyazide, Maxzide)
• angiotensin-converting enzyme (ACE) blockers such as
  • benazepril (Lotensin, Lotensin HCT)
  • captopril (Capoten, Capozide)
  • enalapril (Vasotec, Vaseretic)
  • fosinopril (Monopril, Monopril HCT)
  • lisinopril (Prinivil, Prinzide, Zestril, Zestoretic)
  • moexipril (Univasc, Uniretic)
  • quinapril (Accupril, Accuretic, Quinaretic)
  • ramipril (Altace)
  • trandolapril (Mavik, Tarka)
• angiotensin receptor II blockers such as
  • azilsartan (Edarbi)
  • candesartan (Atacand)
  • irbesartan (Avapro)
  • losartan (Cozaar)
  • olmesartan (Benicar)
  • telmisartan (Micardis, Twynsta)
  • valsartan (Diovan)
• beta blockers such as
  • metoprolol (Toprol XL, Lopressor)
  • carvedilol (Coreg)
  • bisoprolol (Zebeta)
  • betaxolol (Kerlone)
  • nebivolol (Bystolic)
  • propranolol (Inderal)
• calcium channel blockers such as
• nifedipine (Adalat, Nifedical, Procardia)
• amlodipine (Norvasc)
• verapamil (Calan, Isoptin, Covera, Verelan)
• diltiazem (Cardizem)
• vasodilators such as
  • doxazosin (Cardura)
  • prazosin (Minipress)
  • terazosin (Hytrin)
  • clonidine (Catapres)
  • hydralazine (Bidil, Hydra-Zide)
  • minoxidil

• medications that affect your platelets such as clopidogrel (Plavix), aspirin, prasugrel (Effient), ticagrelor (Brilinta), ticlopidine (Ticlid), abciximab (ReoPro), eptifibatide (Integrilin), tirofiban (Aggrastat), and cilostazol (Pletal)
• anticoagulant (blood thinner) medications such as warfarin (Coumadin, Jantoven), heparin, enoxaparin (Lovenox), fondaparinux (Arixtra), rivaroxaban (Xarelto), and apixaban (Eliquis) 
• alcohol

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with this medication, and certain precautions should be followed:

• There is an Increased risk of bleeding, particularly in you are taking blood thinners.
• Do not take this medication if you have severe liver impairment (specifically Child Pugh Class C)
• Do not take Orenitram with alcohol.
• In patients with diverticulosis Orenitram tablets can become lodged in a diverticulum.
• Do not stop taking this medication all of a sudden. Stopping this medication suddenly may cause worsening of your PAH symptoms.

Do not take this medication if you are allergic to it or to any of the inactive ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Orenitram, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Orenitram or to any of the inactive ingredients
• have liver problems
• have kidney problems
• have diverticulosis
• have low blood pressure or high blood pressure
• have had a stroke
• have stomach ulcers
• are pregnant or plan to become pregnant. It is not known if Orenitram will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Orenitram passes into your breast milk. You and your healthcare provider should decide if you will take Orenitram or breastfeed. You should not do both.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take another medicine that contains treprostinil, such as Remodulin or Tyvaso.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Take exactly as your healthcare provider tells you to take it.

• Your healthcare provider will slowly increase your dose to find the dose of that is right for you.
• Do not change your dose or suddenly stop taking this medication without first talking to your healthcare provider. Stopping this medication suddenly may cause worsening of your PAH symptoms.
• Tablets are usually taken every 12 hours, but may be taken three times daily (approximately every 8 hours). If you have side effects, your healthcare provider may tell you to change your dose or when you take this medication.
• Take with food.
• Swallow tablets whole. Do not split, chew, crush, or break your tablets. Do not take tablets that are damaged or broken. If tablets are not taken whole, they may release too much medicine at one time. This can lead to side effects.
• You may see the tablet shell in your stools (bowel movements). This is usually normal. The tablet shell is not digested. If you have diverticulosis, the tablet shell may get stuck in a blind pouch or diverticulum in your intestine.
• If you miss your dose of this medication, take the dose as soon as possible with food.
• If you miss two or more doses of this medication, call your healthcare provider to see if you need to change your dose.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

The starting recommended dose is 0.25 mg twice daily.

Your doctor may increase your dose by 0.25 mg or 0.5 mg twice daily or 0.125 mg three times daily, not more than every 3 to 4 days as tolerated.

The maximum dose is determined by tolerability.

For patients whose liver does not work as well, the dose will be adjusted. 

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Orenitram at room temperature, between 68°F to 77°F (20°C to 25°C).
• Keep this and all medications out of the reach of children.