"The U.S. Food and Drug Administration today approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transpla"...
(treprostinil) Extended Release Tablets
What is Orenitram?
It is not known if Orenitram is safe and effective in children under 18 years of age.
Who should not take Orenitram?
Do not take Orenitram if you have severe liver problems.
What should I tell my healthcare provider before taking Orenitram?
Before you take Orenitram, tell your healthcare provider if you:
- have liver problems
- have low blood pressure or high blood pressure
- have had a stroke
- have stomach ulcers
- have diverticulosis
- have any other medical conditions
- 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 healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Orenitram and other medicines may affect each other causing side effects. Do not start any new medicine until you check with your healthcare provider.
Especially tell your healthcare provider if you take another medicine that contains treprostinil, such as Remodulin or Tyvaso.
Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
How should I take Orenitram?
- Take Orenitram exactly as your healthcare provider tells you to take it.
- Your healthcare provider will slowly increase your dose to find the dose of Orenitram that is right for you.
- Do not change your dose or suddenly stop taking Orenitram without first talking to your healthcare provider. Stopping Orenitram suddenly may cause worsening of your PAH symptoms.
- Orenitram is 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 Orenitram.
- Take Orenitram with food.
- Swallow Orenitram tablets whole. Do not split, chew, crush, or break your Orenitram tablets. Do not take Orenitram tablets that are damaged or broken. If Orenitram 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 Orenitram, take the dose as soon as possible with food.
- If you miss two or more doses of Orenitram, call your healthcare provider to see if you need to change your dose.
- If you take too much Orenitram, call your healthcare provider or go to the nearest hospital emergency room right away.
What should I avoid while taking Orenitram?
Do not take Orenitram with alcohol.
What are the possible side effects of Orenitram?
Orenitram can cause serious side effects, including an increased risk of bleeding.
The most common side effects of Orenitram include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Orenitram. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Orenitram?
- Store Orenitram at room temperature, between 68°F to 77°F (20°C to 25°C).
Keep Orenitram and all medicines out of the reach of children.
General information about the safe and effective use of Orenitram.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
Use Orenitram only for the condition for which it was prescribed. Do not give Orenitram to other people, even if they have the same symptoms you have. It may harm them.
If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Orenitram that is written for health professionals. For more information, go to www.ORENITRAM.com or call 1-877-864-8437.
What are the ingredients in Orenitram?
Active ingredient: treprostinil
Inactive ingredients: xylitol, maltodextrin, sodium lauryl sulfate, magnesium stearate, cellulose acetate, triethyl citrate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. In addition tablets may contain colorants FD&C Blue #2, iron oxide yellow, and iron oxide red. The imprinting ink contains shellac glaze, ethanol, isopropyl alcohol, iron oxide black, nbutyl alcohol, propylene glycol, and ammonium hydroxide.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 1/24/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Orenitram Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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