Sabril

Sabril is used for:

Treating infantile spasms in children 1 month to 2 years old. It may also be used for other conditions as determined by your doctor.

Sabril is an antiepileptic. Exactly how it works is not known, but it may work by blocking certain enzymes in the brain.

Do NOT use Sabril if:

• you are allergic to any ingredient in Sabril

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sabril :

Some medical conditions may interact with Sabril . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have vision problems, kidney problems, or certain blood problems (eg, anemia, porphyria)
• if you have a history of depression, other mental or mood problems, or suicidal thoughts or actions

Some MEDICINES MAY INTERACT with Sabril . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Hydantoins (eg, phenytoin) because their effectiveness may decreased by Sabril

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sabril may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sabril :

Use Sabril as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Sabril comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Sabril refilled.
• Take Sabril by mouth with or without food.
• Follow your doctor's instructions for how many packets to use per dose.
• Follow the instructions provided for how to mix Sabril . Do not mix Sabril with food. It can only be mixed with water. You will need to use 10 mL of water (cold or room temperature) for each packet used.
• Sabril should be taken right away after it is mixed. Do not store for use at a later time. Throw away any mixture that is left after you use a dose.
• To give Sabril , place the tip of the oral syringe into the child's mouth. Point it toward either of the child's cheeks. Push on the plunger slowly, a small amount at a time, until the entire dose is given.
• Wash the oral syringes and mixing cups in warm water. To clean the oral syringes, remove the plunger by gently pulling it straight out of the barrel. Wash the barrel and plunger by hand with soap and water, rinse, and allow to dry. The barrel and plunger may also be washed in the dishwasher utensil rack.
• Do not suddenly stop taking Sabril . There may be an increased risk of side effects (eg, seizures). If you need to stop Sabril , your doctor will gradually lower your dose.
• Talk with your doctor about what to do if your child vomits or spits up Sabril , only takes part of the dose, or misses a dose.

Ask your health care provider any questions you may have about how to use Sabril .

Important safety information:

• Sabril may cause drowsiness, dizziness, or vision problems. These effects may be worse if you take it with alcohol or certain medicines. Use Sabril with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• If symptoms do not get better within 2 to 4 weeks or if they get worse, check with your doctor.
• Sabril may cause weight gain. If you notice unusual weight gain, contact your doctor.
• Sabril may cause abnormal magnetic resonance imaging (MRI) changes in infants. It is not known if these changes may be harmful. Discuss any questions or concerns with your doctor.
• Patients who take Sabril may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Sabril closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual changes in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
• Sabril may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Sabril .
• Lab tests, including eye exams, may be performed while you use Sabril . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Sabril with caution in the ELDERLY; they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: It is not known if Sabril may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sabril while you are pregnant. Sabril is found in breast milk. Do not breast-feed while taking Sabril .

Possible side effects of Sabril :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; cough; decreased appetite; diarrhea; dizziness; drowsiness; headache; irritability; joint pain; nausea; sore throat; stomach upset; stuffy nose; tiredness; trouble sleeping; weakness; weight gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling of the hands or feet; confusion; decreased coordination; fever, chills, or persistent sore throat; increased or painful urination; memory or attention problems; mental or mood changes (eg, depression); new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; new or worsening seizures;painful menstrual period; suicidal thoughts or actions; symptoms of ear infection (eg, ear pain); tremor; trouble walking; uncontrolled eye movements; unusual swelling (eg, of the hands or feet); unusual tiredness or weakness; vision changes (eg, blurred vision, double vision); vision loss (eg, loss of the outer edges of your vision).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/DNN/), or emergency room immediately. Symptoms may include abnormal behavior; coma; confusion; mental or mood changes; new or worsening seizures; severe drowsiness; severe or persistent dizziness or headache; shortness of breath; slow heartbeat; speech problems.

Store Sabril at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in the original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sabril out of the reach of children and away from pets

General information:

• If you have any questions about Sabril , please talk with your doctor, pharmacist, or other health care provider.
• Sabril is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Sabril . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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