Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)
NorthStar Rx LLC
DIVALPROEX SODIUM
VALPROIC ACID 250 mg
ORAL
PRESCRIPTION DRUG
Divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). The efficacy of divalproex sodium extended-release tablets is based in part on studies of divalproex sodium delayed-release tablets in this indication, and was confirmed in a 3-week trial with patients meeting DSM-IV TR criteria for bipolar I disorder, manic or mixed type, who were hospitalized for acute mania [see Clinical Stu
Divalproex Sodium Extended-Release Tablets USP, 250 mg are white to off white, oval shaped film-coated tablets, imprinted with “I 49” on one side with edible blue ink and plain on other side. Bottles of 100 NDC 16714-484-01 Bottles of 500 NDC 16714-484-02 Divalproex Sodium Extended-Release Tablets USP, 500 mg are grey colored, oval shaped film-coated tablets, imprinted with “I 50” on one side with edible blue ink and plain on other side. Bottles of 100 NDC 16714-485-01 Bottles of 500 NDC 16714-485-02 Recommended Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.
Abbreviated New Drug Application
NorthStar Rx LLC ---------- MEDICATION GUIDE Divalproex Sodium Extended-Release Tablets USP (dye val' proe ex soe' dee um) What is the most important information I should know about divalproex sodium extended-release tablets? Do not stop divalproex sodium extended-release tablets without first talking to a healthcare provider. Stopping divalproex sodium extended-release tablets suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). Divalproex sodium extended-release tablets can cause serious side effects, including: 1. Serious liver damage that can cause death, especially in children younger than 2 years old and patients with mitochondrial disorders. The risk of getting this serious liver damage is more likely to happen within the first 6 months of treatment. Call your healthcare provider right away if you get any of the following symptoms: • feeling very weak, tired, or uncomfortable (malaise) • swelling of your face • not feeling hungry • nausea or vomiting that does not go away • diarrhea • pain on the right side of your stomach (abdomen) • dark urine • yellowing of your skin or the whites of your eyes • loss of seizure control in people with epilepsy In some cases, liver damage may continue even though the medicine is stopped. Your healthcare provider will do blood tests to check your liver before and during treatment with divalproex sodium extended- release tablets. 2. Divalproex sodium extended-release tablets may harm your unborn baby. • If you take divalproex sodium extended-release tablets during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord (such as spina bifida or neural tube defects). These defects can begin in the first month, even before you know you are pregnant. Other birth defects that affect the structures of the heart, head, arms, legs, and the opening where the urine comes out (urethra) on th Baca dokumen lengkapnya
DIVALPROEX SODIUM - DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE NORTHSTAR RX LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2000 WARNING: LIFE THREATENING ADVERSE REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ HEPATOTOXICITY, INCLUDING FATALITIES, USUALLY DURING THE FIRST 6 MONTHS OF TREATMENT. CHILDREN UNDER THE AGE OF TWO YEARS AND PATIENTS WITH MITOCHONDRIAL DISORDERS ARE AT HIGHER RISK. MONITOR PATIENTS CLOSELY, AND PERFORM SERUM LIVER TESTING PRIOR TO THERAPY AND AT FREQUENT INTERVALS THEREAFTER (5.1) FETAL RISK, PARTICULARLY NEURAL TUBE DEFECTS, OTHER MAJOR MALFORMATIONS, AND DECREASED IQ (5.2, 5.3, 5.4) PANCREATITIS, INCLUDING FATAL HEMORRHAGIC CASES (5.5) INDICATIONS AND USAGE Divalproex sodium extended-release tablets are indicated for: Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features (1.1) Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2) Prophylaxis of migraine headaches (1.3) DOSAGE AND ADMINISTRATION Divalproex sodium extended-release tablets are intended for once-a-day oral administration. Divalproex sodium extended-release tablets should be swallowed whole and should not be crushed or chewed (2.1, 2.2). Mania: Initial dose is 25 mg/kg/day, increasing as rapidly as possible to achieve therapeutic response or desired plasma level (2.1). The maximum recommended dosage is 60 mg/kg/day (2.1, 2.2). Complex Partial Seizures: Start at 10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day to achieve optimal clinical response; if response is not satis Baca dokumen lengkapnya