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Valproate Sodium) for Intravenous Injection with Or Without Associated Hyperammonemia

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Valproate Sodium) for Intravenous Injection with Or Without Associated Hyperammonemia HIGHLIGHTS OF PRESCRIBING INFORMATION • Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in These highlights do not include all the information needed to use Depacon mental status (5.8, 5.9) safely and effectively. See full prescribing information for Depacon. • Hypothermia; Hypothermia has been reported during valproate therapy Depacon (valproate sodium) for intravenous injection with or without associated hyperammonemia. This adverse reaction can Initial U.S. Approval: 1996 also occur in patients using concomitant topiramate (5.10) WARNING: LIFE THREATENING ADVERSE REACTIONS • Multi-organ hypersensitivity reaction; discontinue Depacon (5.11) See full prescribing information for complete boxed warning • Somnolence in the elderly can occur. Depacon dosage should be • Hepatotoxicity, including fatalities, usually during first 6 months increased slowly and with regular monitoring for fluid and nutritional of treatment. Children under the age of two years and patients intake (5.13) with mitochondrial disorders are at higher risk. Monitor patients -------ADVERSE REACTIONS------- closely, and perform serum liver testing prior to therapy and at Adverse reactions occurring in at least 5% of patients treated with Depakote in frequent intervals thereafter (5.1) Monotherapy or Adjunctive Complex Partial Seizures Trials: • Fetal Risk, particularly neural tube defects, other major • Abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, malformations, and decreased IQ (5.2, 5.3, 5.4) asthenia, ataxia, bronchitis, constipation, depression, diarrhea, diplopia, • Pancreatitis, including fatal hemorrhagic cases (5.5) dizziness, dyspepsia, dyspnea, ecchymosis, emotional lability, fever, flu syndrome, headache, infection, insomnia, nausea, nervousness, -------RECENT MAJOR CHANGES------- nystagmus, peripheral edema, pharyngitis, rhinitis, somnolence, thinking Boxed Warning, Hepatotoxicity 07/2013 abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, Boxed Warning, Fetal Risk 06/2013 weight loss (6.1) Indications and Usage, Important Limitations (1.2) 06/2013 Contraindications, Known or Suspected Mitochondrial Disorders (4) 07/2013 Warnings and Precautions, Hepatotoxicity (5.1) 07/2013 Additional Adverse Reactions not included above that occurred in > 0.5% of Warnings and Precautions, Birth Defects (5.2) 06/2013 patients treated with Depacon: Warnings and Precautions, Decreased IQ (5.3) 06/2013 • Chest pain, euphoria, hypesthesia, injection site inflammation, injection Warnings and Precautions, Use in Women of Childbearing Potential (5.4) site pain, injection site reaction, pain, sweating, taste perversion, 06/2013 vasodilation (6) -------INDICATIONS AND USAGE------- Depacon is an anti-epileptic drug and is indicated as an intravenous alternative in patients in whom oral administration of valproate products is temporarily Additional adverse reactions not included above that occurred in other clinical not feasible in the following conditions: trials with Depakote: • Monotherapy and adjunctive therapy of complex partial seizures and • Accidental injury, back pain, increased appetite, rash (6) simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1) -------DOSAGE AND ADMINISTRATION------- To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. Depacon is intended for intravenous use only. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. • Epilepsy -------DRUG INTERACTIONS------- o Complex Partial Seizures in Adults and Children 10 years of age or • Hepatic enzyme-inducing drugs (e.g., phenytoin, carbamazepine, older: Initial dose is 10 to 15 mg/kg/day, increasing at 1 week phenobarbital, primidone, rifampin) can increase valproate clearance, intervals by 5 to10 mg/kg/day to achieve optimal clinical response. while enzyme inhibitors (e.g., felbamate) can decrease valproate Maximum recommended dose is 60 mg/kg/day (2.1). clearance. Therefore increased monitoring of valproate and concomitant o Simple and Complex Absence Seizures: Initial dose is 10 to 15 drug concentrations and dosage adjustment are indicated whenever mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day to enzyme-inducing or inhibiting drugs are introduced or withdrawn (7.1) achieve optimal clinical response. Maximum recommended dose is • Aspirin, carbapenem antibiotics: Monitoring of valproate concentrations 60 mg/kg/day (2.1). is recommended (7.1) -------DOSAGE FORMS AND STRENGTHS------- • Co-administration of valproate can affect the pharmacokinetics of other Injection: 100 mg per mL in a 5 mL single dose vial (3) drugs (e.g. diazepam, ethosuximide, lamotrigine, phenytoin) by -------CONTRAINDICATIONS------- inhibiting their metabolism or protein binding displacement (7.2) • Hepatic disease or significant hepatic dysfunction (4, 5.1) • Dosage adjustment of amitryptyline/nortryptyline, warfarin, and • Known mitochondrial disorders caused by mutations in mitochondrial zidovudine may be necessary if used concomitantly with Depacon (7.2) DNA polymerase γ (POLG) (4, 5.1) • Topiramate: Hyperammonemia and encephalopathy (5.9, 7.3) • Suspected POLG-related disorder in children under two years of age (4, -------USE IN SPECIFIC POPULATIONS------- 5.1) • Pregnancy: Depacon can cause congenital malformations including • Known hypersensitivity to the drug (4, 5.11) neural tube defects and decreased IQ. (5.2, 5.3 8.1) • Urea cycle disorders (4, 5.6) • Pediatric: Children under the age of two years are at considerably higher -------WARNINGS AND PRECAUTIONS------- risk of fatal hepatotoxicity (5.1, 8.4) • Hepatotoxicity; evaluate high risk populations and monitor serum liver • Geriatric: Reduce starting dose, increase dosage more slowly; monitor tests (5.1) fluid and nutritional intake, and somnolence (5.13, 8.5) • Birth defects and decreased IQ following in utero exposure; only use to treat pregnant women with epilepsy if other medications are unacceptable; should not be administered to a woman of childbearing See 17 for PATIENT COUNSELING INFORMATION potential unless essential (5.2, 5.3, 5.4) • Pancreatitis; Depacon should ordinarily be discontinued (5.5) Revised: 07/2013 • Thrombocytopenia; monitor platelet counts and coagulation tests (5.7) FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: LIFE THREATENING ADVERSE REACTIONS 5.1 Hepatotoxicity 1 INDICATIONS AND USAGE 5.2 Birth Defects 1.1 Epilepsy 5.3 Decreased IQ Following in utero Exposure 1.2 Important Limitations 5.4 Use in Women of Childbearing Potential 2 DOSAGE AND ADMINISTRATION 5.5 Pancreatitis 2.1 Epilepsy 5.6 Urea Cycle Disorders 2.2 General Dosing Advice 5.7 Thrombocytopenia 3 DOSAGE FORMS AND STRENGTHS 5.8 Hyperammonemia 4 CONTRAINDICATIONS 5.9 Hyperammonemia and Encephalopathy associated with Concomitant 5 WARNINGS AND PRECAUTIONS Topiramate Use Reference ID: 3349699 5.10 Hypothermia 11 DESCRIPTION 5.11 Multi-Organ Hypersensitivity Reactions 12 CLINICAL PHARMACOLOGY 5.12 Interaction with Carbapenem Antibiotics 12.1 Mechanism of Action 5.13 Somnolence in the Elderly 12.2 Pharmacodynamics 5.14 Post-traumatic Seizures 12.3 Pharmacokinetics 5.15 Monitoring: Drug Plasma Concentration 13 NONCLINICAL TOXICOLOGY 5.16 Effect on Ketone and Thyroid Function Tests 13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility 5.17 Effect on HIV and CMV Viruses Replication 14 CLINICAL STUDIES 6 ADVERSE REACTIONS 14.1 Epilepsy 6.1 Epilepsy 15 REFERENCES 6.2 Mania 16 HOW SUPPLIED/STORAGE AND HANDLING 6.3 Migraine 17 PATIENT COUNSELING INFORMATION 6.4 Other Patient Populations 17.1 Hepatotoxicity 7 DRUG INTERACTIONS 17.2 Pancreatitis 7.1 Effects of Co-Administered Drugs on Valproate Clearance 17.3 Birth Defects and Decreased IQ 7.2 Effects of Valproate on Other Drugs 17.4 Hyperammonemia 7.3 Topiramate 17.5 CNS Depression 8 USE IN SPECIFIC POPULATIONS 17.6 Multi-Organ Hypersensitivity Reactions 8.1 Pregnancy * Sections or subsections omitted from the full prescribing information are not 8.3 Nursing Mothers listed 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE Reference ID: 3349699 FULL PRESCRIBING INFORMATION WARNING: LIFE THREATENING ADVERSE REACTIONS Hepatotoxicity General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitored closely for appearance of these symptoms. Serum liver tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months [see Warnings and Precautions (5.1)]. Children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those on multiple anticonvulsants, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease. When Depacon is used in this patient group, it should be used with extreme caution and as a sole agent. The benefits of therapy should be weighed against the risks. The incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups. Patients with Mitochondrial Disease: There is an increased
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