InnoPran XL

Avoid drinking alcohol. It may increase your blood levels of propranolol.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

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© InnoPran XL Patient Information is supplied by Cerner Multum, Inc. and InnoPran XL Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Propranolol is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure may reduce the risk of stroke and heart attacks.

Propranolol is also used to treat severe chest pain (angina), migraine headaches, or hypertrophic subaortic stenosis (thickened heart muscle).

This medicine may also be used to treat irregular heartbeats, tremors, or pheochromocytoma (adrenal gland tumor). It may also be used to reduce the risk of death in patients who have heart attacks.

Propranolol oral solution is used to treat proliferating infantile hemangioma.

This medicine is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. .

Propranolol may cause heart failure in some patients. Check with your doctor right away if you or your child are having chest pain or discomfort, dilated neck veins, extreme fatigue, irregular breathing, an irregular heartbeat, shortness of breath, swelling of the face, fingers, feet, or lower legs, weight gain, or wheezing.

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you or your child have these problems or if you notice a change in the results of your blood or urine sugar tests.

Make sure any doctor or dentist who treats you knows that you are using this medicine. Do not stop taking this medicine before surgery without your doctor's approval.

This medicine may cause some people to become less alert than they are normally. If this side effect occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert while taking propranolol.

Do not interrupt or stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, or white spots in your mouth or lips, or unusual tiredness or weakness.

Propranolol will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system and may cause drowsiness. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or medicine for seizures, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may increase risk of stroke in PHACE syndrome patients with severe blood vessel problems in the brain. Talk to your child's doctor about this risk.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

• It is used to treat high blood pressure.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how InnoPran XL affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• Talk with your doctor before you drink alcohol.
• If you smoke, talk with your doctor.
• If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with InnoPran XL.
• This medicine may hide the signs of low blood sugar. Talk with the doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• This medicine may make it harder to tell if you have signs of an overactive thyroid like fast heartbeat. If you have an overactive thyroid and stop taking this medicine all of a sudden, it may get worse and could be life-threatening. Talk with your doctor.
• If you are taking InnoPran XL and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
• If you have had a very bad allergic reaction, talk with your doctor. You may have a chance of an even worse reaction if you come into contact with what caused your allergy. If you use epinephrine to treat very bad allergic reactions, talk with your doctor. Epinephrine may not work as well while you are taking this medicine.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using InnoPran XL while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
• Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
• Very bad dizziness or passing out.
• Chest pain that is new or worse.
• Feeling confused.
• Hallucinations (seeing or hearing things that are not there).
• Memory problems or loss.
• Mood changes.
• A burning, numbness, or tingling feeling that is not normal.
• Change in eyesight.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Any unexplained bruising or bleeding.
• Slow heartbeat.
• A heartbeat that does not feel normal.
• Feeling cold.
• Change in sex ability.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Hard stools (constipation).
• Loose stools (diarrhea).
• Feeling sleepy.
• Feeling tired or weak.
• Upset stomach or throwing up.
• Not able to sleep.
• Stomach cramps.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

8.1 Pregnancy

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Intrauterine growth retardation, small placentas, and congenital anomalies have been reported for neonates whose mothers received propranolol HCl during pregnancy.

Animal Data: In a series of reproductive and developmental toxicology studies, propranolol was given to rats by gavage or in the diet throughout pregnancy and lactation. At doses of 150 mg/kg/day, but not at doses of 80 mg/kg/day (equivalent to the maximum recommended human oral daily dose (MRHD) on a body surface area basis), treatment was associated with embryotoxicity (reduced litter size and increased resorption rates) as well as neonatal toxicity (deaths). Propranolol HCl was also administered (in the feed) to rabbits (throughout pregnancy and lactation) at doses as high as 150 mg/kg/day (about 5 times the MRHD). No evidence of embryo or neonatal toxicity was noted.

8.2 Labor and Delivery

Neonates whose mothers received propranolol HCl at parturition have exhibited bradycardia, hypoglycemia, and/or respiratory depression. Adequate facilities for monitoring such infants at birth should be available.

8.3 Nursing Mothers

Propranolol is excreted in human milk.

8.4 Pediatric Use

Safety and effectiveness of propranolol in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of InnoPran XL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6 Renal Impairment

The exposure to propranolol is increased in patients with renal impairment. Initiate InnoPran XL therapy in patients with impaired renal function at the lowest dose (80 mg) once daily and monitor patients for marked bradycardia and hypotension [see Clinical Pharmacology (12.6)].

8.7 Hepatic Impairment

The exposure to propranolol is increased in patients with hepatic impairment. Initiate InnoPran XL therapy in patients with impaired hepatic function at the lowest dose (80 mg) once daily and monitor patients for marked bradycardia and hypotension [see Clinical Pharmacology (12.6)].