Depakene Syrup

Depakene Syrup is used for:

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Controlling certain types of seizures in the treatment of epilepsy. It may also be used for other conditions as determined by your doctor.

Depakene Syrup is an anticonvulsant. It works by increasing a certain chemical in the brain.

Do NOT use Depakene Syrup if:

• you are allergic to any ingredient in Depakene Syrup
• you have liver problems, ornithine transcarbamylase deficiency, or urea cycle disorder

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

Before using Depakene Syrup:

Some medical conditions may interact with Depakene Syrup. 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 a history of metabolic disease, blood disease, HIV, high blood levels of ammonia or glutamine, low levels of albumin, brain problems (eg, organic brain disease), mental retardation, inflammation of the pancreas, kidney problems, or low levels of white blood cells, or if you are scheduled for surgery
• if you have a history of ornithine transcarbamylase deficiency or unexplained coma
• if you have a family history of urea cycle disorders or unexplained infant deaths
• if you have a history of mental or mood problems, or suicidal thoughts or actions

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

• Benzodiazepines (eg, diazepam), carbamazepine, erythromycin, felbamate, fluoxetine, guanfacine, isoniazid, ketoconazole, risperidone, or salicylates (eg, aspirin) because the risk of serious side effects of Depakene Syrup, including blurred vision or other vision problems, clumsiness or unsteadiness, drowsiness, nausea, or vomiting, may be increased
• Acyclovir, cancer medicines, cholestyramine, hydantoins (eg, phenytoin), mefloquine, meropenem, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or rifampin because they may decrease Depakene Syrup's effectiveness
• Anticoagulants (eg, warfarin), barbiturates (eg, phenobarbital), ethosuximide, lamotrigine, methylphenidate, primidone, tolbutamide, or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by Depakene Syrup
• Clonazepam because the risk of seizures may be increased
• Topiramate because the risk of high ammonium levels and brain problems may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Depakene Syrup 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 Depakene Syrup:

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

• An additional patient leaflet is available with Depakene Syrup. Talk to your pharmacist if you have questions about this information.
• Depakene Syrup may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Depakene Syrup works best if it is taken at the same time each day.
• Continue to use Depakene Syrup even if you feel well. Do not miss any doses.
• If you miss a dose of Depakene Syrup, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Depakene Syrup may cause dizziness, drowsiness, or changes in vision. Use caution while driving or performing other tasks requiring alertness, coordination, or physical dexterity. Using Depakene Syrup alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Depakene Syrup. Depakene Syrup will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Depakene Syrup.
• Diabetes patients - Depakene Syrup may cause incorrect test results with urine tests for ketones. Check with your doctor before you adjust the dose of your diabetes medicine or change your diet.
• Lab tests, including blood cell counts and liver function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Depakene Syrup with caution in the ELDERLY because they may be more sensitive to its effects, especially sleepiness.
• Use Depakene Syrup with extreme caution in CHILDREN younger than 10 years of age. Safety and effectiveness in this age group have not been confirmed. CHILDREN younger than 2 years of age may be at increased risk of serious liver problems.
• PREGNANCY and BREAST-FEEDING: Depakene Syrup has been shown to cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Depakene Syrup during pregnancy. Depakene Syrup is excreted into breast milk. Do not breast-feed while you are taking Depakene Syrup.

Possible side effects of Depakene Syrup:

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:

Change in appetite; constipation; diarrhea; dizziness; drowsiness; hair loss; headache; indigestion; nausea; stomach pain; trouble sleeping; vomiting; weight changes.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal cramps; abnormal thinking; change in menstrual period; changes in behavior; chest pain; confusion; dark urine; difficulty speaking; difficulty urinating or other urination problems; extreme tiredness; fast or irregular heartbeat; fever; general body discomfort; hallucinations; hearing loss; involuntary movements of the arms and legs; involuntary movements or chewing movements of face, jaw, mouth, or tongue; joint pain; lack of energy; loss of appetite; loss of coordination; loss of seizure control; memory loss; mental or mood changes; nosebleed; pounding in the chest; severe or persistent nausea, vomiting, or stomach pain; sore throat; suicidal thoughts or actions; swelling of the arms or legs; tremor; unusual bleeding or bruising; unusual weakness; vision changes; yellowing of skin or eyes.

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 the 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/findyour.htm), or emergency room immediately. Symptoms may include deep sleep; irregular heartbeat; loss of consciousness.

Store Depakene Syrup at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Depakene Syrup out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Depakene Syrup. 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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