药品信息:
英文药名: Depakote ER (Divalproex Extended Release Tablets)
中文药名: 双丙戊酸钠缓释片
美国FDA昨天批准了缓释片剂Depakote（双丙戊酸钠divalproex sodium）的通用名药，该药已获准用于治疗癫痫、双向情感障碍和偏头痛。
有FDA官员就此表示，对通用名类药物的审批程序及其严格、科学，以保证药物在质量、安全性和疗效等各方面达到其专利药的水平。此次Depakote通用名的获准给患者又增加了一种可选的治疗药。
通用名双丙戊酸钠的用药安全提示将与Depakote相同，其中包括一个特别的警示信息，即使用该药后有可能导致肝脏损害（肝中毒）和胰腺炎，甚至有致命危险。而且，使用这种药物治疗还会增加胎儿出现缺陷的几率，其中包括神经管畸形。
获准产销双丙戊酸钠的企业包括：印度太阳制药公司、加拿大Genpharm、加拿大Nu-Pharm、美国Upsher-Smith、美国TEVA、美国Sandoz、印度Dr. Reddy和印度Lupin。
Depakote Delayed-Release Tablets is used for:
Controlling certain types of seizures in the treatment of epilepsy. It is also used to treat the manic phase of bipolar disorders (manic-depressive illness), and to prevent migraine headaches.
Depakote Delayed-Release Tablets is an anticonvulsant. It works by reducing or preventing the number of seizures by controlling the abnormal activity of nerve impulses in the brain and central nervous system.
Do NOT use Depakote Delayed-Release Tablets if:
you are allergic to any ingredient in Depakote Delayed-Release Tablets
you have a history of liver conditions, low levels of the enzyme ornithine carbamoyltransferase, or a urea cycle disorder
Contact your doctor or health care provider right away if any of these apply to you.
Before using Depakote Delayed-Release Tablets:
Some medical conditions may interact with Depakote Delayed-Release Tablets. 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 Depakote Delayed-Release Tablets. 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 Depakote Delayed-Release Tablets, including changes in 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 antiinflammatory drugs (NSAIDs) (eg, ibuprofen), or rifampin because they may decrease Depakote Delayed-Release Tablets'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 Depakote Delayed-Release Tablets
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 Depakote Delayed-Release Tablets 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 Depakote Delayed-Release Tablets:
Use Depakote Delayed-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Depakote Delayed-Release Tablets. Talk to your pharmacist if you have questions about this information.
Take Depakote Delayed-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Swallow Depakote Delayed-Release Tablets whole. Do not break, crush, or chew before swallowing.
Taking Depakote Delayed-Release Tablets at the same time each day will help you remember to take it.
Continue to use Depakote Delayed-Release Tablets even if you feel well. Do not miss any doses. Depakote Delayed-Release Tablets works best when there is a constant level of it in your body.
If you miss a dose of Depakote Delayed-Release Tablets, 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 Depakote Delayed-Release Tablets.
Important safety information:
Depakote Delayed-Release Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Depakote Delayed-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Depakote Delayed-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Do not stop taking Depakote Delayed-Release Tablets suddenly. This may cause seizures.
Inflammation of the pancreas is a potentially life-threatening illness associated with Depakote Delayed-Release Tablets. Symptoms include stomach pain, vomiting, or appetite loss. Contact your doctor at once if any of these symptoms occur.
Tell your doctor or dentist that you take Depakote Delayed-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
Diabetes patients - Depakote Delayed-Release Tablets may cause the results of some tests for urine ketones to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
Lab tests, including blood cell counts and liver function tests, may be performed while you use Depakote Delayed-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Depakote Delayed-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially sleepiness.
Depakote Delayed-Release Tablets should be used with extreme caution in CHILDREN younger than 10 years old; safety and effectiveness in these children have not been confirmed. CHILDREN younger than 2 years of age may be at increased risk of serious liver problems.
PREGNANCY and BREAST-FEEDING: Depakote Delayed-Release Tablets has been shown to 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 Depakote Delayed-Release Tablets while you are pregnant. Depakote Delayed-Release Tablets is found in breast milk. Do not breast-feed while you are taking Depakote Delayed-Release Tablets.
Possible side effects of Depakote Delayed-Release Tablets:
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.
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); 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 about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at .
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ,or emergency room immediately. Symptoms may include deep sleep; drowsiness; irregular heartbeat; loss of consciousness.
Proper storage of Depakote Delayed-Release Tablets:
Store Depakote Delayed-Release Tablets at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Depakote Delayed-Release Tablets out of the reach of children and away from pets. |
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