DEPAKENE Oral solution (2022)
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Περιεχόμενα
Name of the medicinal product
DEPAKENE Valproic acid 250 mg/5 mL.
Indications and clinical use
DEPAKENE (valproic acid) is indicated for: use as sole or adjunctive therapy in the treatment of simple or complex absence seizures, including petit mal, and is useful in primary generalized seizures with ...
Contraindications
DEPAKENE (valproic acid) is contraindicated in: Patients with known hypersensitivity to the drug, any ingredient in the formulation or component of the container. For a complete listing of ingredients ...
Warnings and precautions
Pregnancy Prevention Program Valproate has a high teratogenic potential and children exposed in utero to valproate have a high risk for major congenital malformations and neurodevelopmental disorders (see ...
Adverse reactions
8.1 Adverse Reaction Overview The most commonly reported adverse reactions are nausea, vomiting and indigestion. Since DEPAKENE (valproic acid) has usually been used with other antiepileptics, it is not ...
Drug interactions
9.1 Serious Drug Interactions Serious Drug Interactions Rare cases of coma have been reported in patients receiving DEPAKENE alone or in conjunction with phenobarbital (see 9.4 Drug-Drug Interactions, ...
Dosage and administration
4.1 Dosing Considerations Patients receiving combined antiepileptic therapy require careful monitoring when another agent is started, stopped or when the dose is altered (see 9 DRUG INTERACTIONS). As the ...
Overdosage
Overdosage with DEPAKENE (valproic acid) may result in somnolence, muscular hypotonia, hyporeflexia, miosis, impaired respiratory function, hypotension, metabolic acidosis, heart block, deep coma and circulatory ...
Storage and stability
Store DEPAKENE (valproic acid) oral solution between 15 and 30°C.
Special handling instructions
No Special Handling Instructions are required for this drug product.
Dosage forms, composition and packaging
<b>Table 2. Dosage Forms, Strengths, Composition and Packaging:</b> <b>Route of Administration</b> <b>Dosage Form/Strength/Composition</b> <b>Non-medicinal Ingredients</b> Oral Oral solution / 250 ...
Pharmaceutical information
Drug Substance Proper name: valproic acid Chemical name: 2-propylpentanoic acid or dipropylacetic acid Molecular formula and molecular mass: C<sub>8</sub>H<sub>16</sub>O<sub>2</sub> 144.21 Structural formula: ...
Detailed pharmacology
<b>Pharmacotherapeutic group:</b> Anticonvulsant and mood-stabilizing drug <b>ATC Code:</b> N03AG01 10.1 Mechanism of Action DEPAKENE (valproic acid) has anticonvulsant properties. Although its mechanism ...
Clinical trials
The clinical trial data on which the original indication was authorized is not available.
Microbiology
No microbiological information is required for this drug product.
Toxicology
16 Non-clinical toxicology Safety Pharmacology Valproic acid has been shown to be effective against several types of chemically and electrically induced convulsions in a variety of animal species. These ...
Marketing authorization holder
BGP Pharma ULC, 85 Advance Road, Etobicoke, Ontario, M8Z 2S6
Submission control number
261210
Date of approval
Dec 22, 2014
Date of revision
July 7, 2022
Serious warnings and precautions box
Hepatotoxicity Hepatic failure resulting in fatalities has occurred in patients receiving DEPAKENE (valproic acid). These incidences usually occurred during the first 6 months of treatment with DEPAKENE. ...
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