DEPAKOTE SPRINKLES Capsule (2020)

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AbbVie Inc.

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BOXED WARNING SECTION

WARNING: LIFE THREATENING ADVERSE REACTIONS Hepatotoxicity General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. ...

1. Indications and Usage

1.1 Epilepsy Depakote Sprinkle Capsules are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures ...

2. Dosage and Administration

2.1 Epilepsy Depakote Sprinkle Capsules are administered orally. As Depakote dosage is titrated upward, concentrations of clonazepam, diazepam, ethosuximide, lamotrigine, tolbutamide, phenobarbital, carbamazepine, ...

3. Dosage Forms and Strengths

Depakote Sprinkle Capsules are for oral administration. Depakote Sprinkle Capsules contain specially coated particles of divalproex sodium equivalent to 125 mg of valproic acid in a hard gelatin capsule. ...

4. Contraindications

Depakote Sprinkle Capsules should not be administered to patients with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions (5.1)]. Depakote Sprinkle Capsules is contraindicated ...

5. Warnings and Precautions

5.1 Hepatotoxicity General Information on Hepatotoxicity Hepatic failure resulting in fatalities has occurred in patients receiving valproate. These incidents usually have occurred during the first six ...

6. Adverse Reactions

The following serious adverse reactions are described below and elsewhere in the labeling: Hepatic failure [see Warnings and Precautions (5.1)] Birth defects [see Warnings and Precautions ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of Depakote. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 Effects of Co-Administered Drugs on Valproate Clearance Drugs that affect the level of expression of hepatic enzymes, particularly those that elevate levels of glucuronosyltransferases (such as ritonavir), ...

8. Use in Specific Populations

8.6 Effect of Disease Liver Disease Liver disease impairs the capacity to eliminate valproate [see Boxed Warning, Contraindications (4), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3)] ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including Depakote Sprinkle Capsules, during pregnancy. ...

8.2. Lactation

Risk Summary Valproate is excreted in human milk. Data in the published literature describe the presence of valproate in human milk (range: 0.4 mcg/mL to 3.9 mcg/mL), corresponding to 1% to 10% of maternal ...

8.3. Females and Males of Reproductive Potential

Contraception Women of childbearing potential should use effective contraception while taking valproate [see Boxed Warning, Warnings and Precautions (5.4), Drug Interactions (7), and Use in Specific ...

8.4. Pediatric Use

Experience has indicated that pediatric patients under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those with the aforementioned conditions ...

8.5. Geriatric Use

No patients above the age of 65 years were enrolled in double-blind prospective clinical trials of mania associated with bipolar illness. In a case review study of 583 patients, 72 patients (12%) were ...

10. Overdosage

Overdosage with valproate may result in somnolence, heart block, deep coma, and hypernatremia. Fatalities have been reported; however patients have recovered from valproate levels as high as 2,120 mcg/mL. ...

11. Description

Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent ...

12.1. Mechanism of Action

Divalproex sodium dissociates to the valproate ion in the gastrointestinal tract. The mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that ...

12.2. Pharmacodynamics

The relationship between plasma concentration and clinical response is not well documented. One contributing factor is the nonlinear, concentration dependent protein binding of valproate which affects ...

12.3. Pharmacokinetics

Absorption/Bioavailability Equivalent oral doses of Depakote (divalproex sodium) products and DEPAKENE (valproic acid) capsules deliver equivalent quantities of valproate ion systemically. Although the ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Valproate was administered orally to rats and mice at doses of 80 and 170 mg/kg/day (less than the maximum recommended human dose on a mg/m² basis) for two years. The primary findings were ...

14. Clinical Studies

14.1 Epilepsy The efficacy of valproate in reducing the incidence of complex partial seizures (CPS) that occur in isolation or in association with other seizure types was established in two controlled ...

15. References

1. Meador KJ, Baker GA, Browning N, et al. Fetal antiepileptic drug exposure and cognitive outcomes at age 6 years (NEAD study): a prospective observational study. Lancet Neurology 2013; 12 (3):244-252. ...

16.1. How Supplied

Depakote Sprinkle Capsules (divalproex sodium delayed release capsules), for oral use 125 mg, are white opaque and blue, and are supplied in bottles of 100 (NDC 0074-6114-13) and Unit Dose Packages of ...

16.2. Storage and Handling

Recommended Storage: Store capsules below 77°F (25°C).

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Hepatotoxicity Warn patients and guardians that nausea, vomiting, abdominal pain, anorexia, diarrhea, asthenia, and/or jaundice ...