Sabril Solution may cause permanent vision loss in a high percentage of patients. This effect may occur within weeks or sooner after starting treatment. It may also occur after months or years. The risk may increase with higher doses and prolonged use, but it may occur with any dose or length of use. Vision loss may continue to worsen after stopping Sabril Solution.
Vision loss may not be detected until it is severe. Parents or caregivers may not be able to recognize the symptoms of vision loss. Eye exams will be performed at the start of treatment and at least every 3 months during treatment. They will also be performed for 3 to 6 months after treatment stops. Some patients may develop severe vision loss even with monitoring.
Tell the doctor if the patient has or is at risk for developing another type of permanent vision loss. Tell the doctor if the patient uses other medicines that may cause serious vision problems (eg, retinopathy, glaucoma). Sabril Solution should not be used in these patients unless the benefit outweighs the risks.
Use the lowest dose of Sabril Solution for the shortest time needed. Sabril Solution should not be used for longer than 2 to 4 weeks if no improvement is seen in the patient's condition.
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 Solution is an antiepileptic. Exactly how it works is not known, but it may work by blocking certain enzymes in the brain.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Sabril Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Sabril Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Sabril Solution 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.
Use Sabril Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Sabril Solution.
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.Seek medical attention right away if any of these SEVERE side effects occur:
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.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), 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.Proper storage of Sabril Solution:
Store Sabril Solution 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 Solution out of the reach of children and away from pets
This information is a summary only. It does not contain all information about Sabril Solution. 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.