Uses

This formulation of propranolol is used for infants and children to treat a certain benign tumor (proliferating infantile hemangioma). It helps to shrink the tumor. Propranolol belongs to a class of drugs known as beta blockers.

How To Use

Read the Medication Guide and Instructions for Use Leaflet provided by your pharmacist before you start giving propranolol to your child and each time you get a refill. If you have any questions, ask the doctor or pharmacist.

Give this medication to your child by mouth as directed by the doctor, usually 2 times daily (at least 9 hours apart). This medication should be given during or right after a meal/feeding. Skip the dose of the medication if your child is not eating or is vomiting.

Do not shake the bottle before use. Carefully measure the dose using a special measuring device/oral syringe. Do not use a household spoon because you may not get the correct dose. You may give this medication directly into the child's mouth with the oral syringe or the medication can be mixed in a small amount of milk or fruit juice and then given to the child. If you are unsure if your child swallowed the full dose of the medication or if your child spits up the dose, do not give another dose, but wait for the next scheduled dose.

The dosage is based on your child's medical condition, weight, and response to treatment. To reduce the risk of side effects, the doctor may direct your child to start this medication at a low dose and gradually increase the dose. The dosage may be increased by the doctor as your child gains weight. Follow the doctor's instructions carefully. The blood pressure and heart rate should be monitored for 2 hours when the medication is first started and after each dose increase.

Use this medication regularly to get the most benefit from it. To help you remember, give it at the same times each day.

Tell the doctor if your child's condition does not improve or if it worsens.

Side Effects

Dizziness, lightheadedness, or tiredness may occur as the body adjusts to the medication. Diarrhea, stomach/abdominal pain, decreased appetite, vomiting, trouble sleeping, and unusual dreams may also occur. If any of these effects last or get worse, tell the doctor or pharmacist promptly.

This drug may reduce blood flow to the hands and feet, causing them to feel cold. Tell the doctor if this occurs. Dress your child warmly.

Remember that this medication has been prescribed because the doctor has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell the doctor right away if your child has any serious side effects, including:

• fainting
• pale/blue/purple skin
• new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)
• very slow heartbeat
• irregular heartbeat
• signs of infection (such as sore throat that doesn't go away, fever, cough)
• mental/mood changes (such as agitation)

This product may cause low blood sugar (hypoglycemia), especially if your child is sick, not eating regularly, or is vomiting. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, seizures, or weakness. This product may prevent some of the symptoms of hypoglycemia (such as fast/pounding heartbeat). Other symptoms of low blood sugar, such as dizziness and sweating, are not affected by this drug. If your child has symptoms of hypoglycemia, tell the doctor right away.

This medication may increase the risk of stroke in certain children with a large hemangioma on their face or head. Get medical help right away if your child has symptoms of a stroke, including:

• trouble speaking
• weakness on one side of the body
• sudden vision changes
• confusion

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

See also Side Effects section.

Before using propranolol, tell the doctor or pharmacist if your child is allergic to it; or if your child has had a serious reaction to other beta blockers (such as metoprolol); 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 the doctor or pharmacist your child's medical history, especially of:

• breathing problems (such as asthma)
• certain heart problems (such as heart failure, slow heart rate, second- or third-degree atrioventricular block)
• severe allergic reactions
• a certain type of tumor (pheochromocytoma)
• very low blood pressure

Before having surgery, tell the doctor or dentist about all the products your child uses (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make your child dizzy. Do not let your child do any activity that requires alertness until you are sure your child can perform such activities safely.

This formulation of propranolol is not usually used by adults. It is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this medication.

Drug Interactions

Drug interactions may change how medications work or increase the risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products your child uses (including prescription/nonprescription drugs and herbal products) and share it with the doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without the doctor's approval.

Some products that may interact with this drug include:

• bile acid-binding resins (such as cholestyramine)
• epinephrine
• fezolinetant
• thioridazine

If you are breast-feeding your child, ask the doctor if any medications that you are using may pass into the breast milk and interact with this medication.

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. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include: very slow heartbeat, severe dizziness, fainting, mental/mood changes (such as restlessness), seizure.

Notes

Do not share this medication with others.

Have your child's blood pressure and pulse (heart rate) checked regularly while taking this medication, especially when this medication is first started or after a dose increase. If directed by the doctor, learn how to monitor your child's blood pressure and pulse at home, and share the results with the doctor.

Missed Dose

If you miss a dose, give it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Give the next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets. Discard the medication 2 months after the bottle is opened.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).