INDICATION: INDERAL® XL is a beta adrenergic blocker indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.
LIMITATION OF USE: INDERAL® XL is not indicated for the treatment of hypertensive emergencies.
Important Safety Information About INDERAL® XL
What is INDERAL® XL?
INDERAL® XL is a prescription medicine that belongs to a group of medicines called “beta blockers” used to treat high blood pressure. INDERAL® XL lowers blood pressure, which can reduce the risk of strokes and heart attack. INDERAL® XL is not to be used to treat high blood pressure emergencies.
What is the most important information I should know about INDERAL® XL (propranolol)?
WARNING: Do not stop taking INDERAL® XL suddenly, as heart attacks and worsening of chest pain have occurred. If your doctor decides you should stop taking INDERAL® XL, you may be instructed to slowly reduce your dose over a period of time before stopping it completely.
Do not use INDERAL® XL if you have:
- Abnormal heart rhythms caused by a malfunction of the heart’s primary pacemaker, unless a permanent pacemaker is in place
- Sudden and severe drop in blood pressure and blood flow through the body because the heart is not pumping normally
- Uncontrolled heart failure
- Any allergies to INDERAL® XL ingredients. The active ingredient is propranolol.
What should I tell my healthcare provider before taking INDERAL® XL?
Before starting INDERAL® XL, tell your healthcare provider about all of your medical conditions, including if you:
- Have heart failure
- Are scheduled for surgery and will be given anesthetic agents
- Have diabetes and take medicine to control blood sugar
- Have thyroid problems
- Have irregular heartbeats
- Have liver or kidney problems
- Have had allergic reactions to medications or have allergies
- Have asthma or other lung problems (such as bronchitis or emphysema)
- Are pregnant or trying to become pregnant. It is not known if INDERAL® XL is safe for your unborn baby. Talk with your doctor about the best way to treat your high blood pressure during pregnancy.
- Are breastfeeding. You should not breastfeed while using INDERAL® XL because the drug is passed to the infant through the mother’s milk.
Tell your healthcare provider about all of the prescription or over-the-counter medications, vitamins, or herbal supplements you are taking including:
- Other beta blockers and alpha blockers such as: clonidine (Catapres, Kapvay, Nexiclon), prazosin (Minipress, Vasoflex, Lentopres and Hypovase)
- The heart failure drug dobutamine
- Non-steroidal anti-inflammatory drugs (NSAIDS) for pain relief, fever reduction, and reducing inflammation including over-the-counter ibuprofen (e.g. Advil, Motrin)
This list is not complete and not all possible interactions are listed. Other drugs may interact with INDERAL® XL, including prescription and over-the-counter medicines, vitamins, and herbal products.
What are the possible side effects of INDERAL® XL?
The most common side effects people taking INDERAL® XL report are tiredness, dizziness (if you feel dizzy, sit or lie down and tell your doctor right away), and constipation.
Other possible side effects include difficulty breathing, tightness in the chest, heart failure, hiding symptoms of low blood sugar and overactive thyroid, especially a fast heartbeat, and certain abnormal heart rhythms.
This is not a complete list of side effects and others may occur. Click here to see the Full Prescribing Information for more detailed information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other information do I need to know about taking INDERAL® XL?
- INDERAL® XL should be taken orally.
- INDERAL® XL should be taken consistently with or without food.
- Do not stop taking INDERAL® XL suddenly. You could have chest pain or a heart attack. If your doctor decides that you should stop taking INDERAL® XL, he or she will lower your dose slowly and over time.
- Take INDERAL® XL every day at bed time or exactly as your doctor tells you. Your doctor will tell you how much INDERAL® XL to take and how often. Your doctor may start with a low dose and raise it over time.
- Do not stop taking INDERAL® XL or change your dose without talking with your doctor.
- Do not drive or use machinery until you are sure you can perform activities safely.
- If you have heart failure, consult your physician if you experience weight gain or increasing shortness of breath.
- If you have diabetes, consult your physician if you experience changes in your blood sugar levels.
- People taking INDERAL® XL may be less responsive to epinephrine used to treat a severe anaphylactic reaction.
- If you take too much INDERAL® XL call your doctor or poison control center right away.
Please also see full Prescribing Information for more information.
INDERAL® XL is a registered trademark of ANI Pharmaceuticals, Inc. Marketed and distributed by: ANI Pharmaceuticals, Inc.
INDERAL® XL, a DIFFUCAPS® drug delivery product manufactured by Adare Pharmaceuticals, Inc., Vandalia, OH 45377
©2017 ANI Pharmaceuticals, Inc.
Developed April, 2017