Medicinal Products

DEPAKINE 400 mg / 4 mL

Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Lyophilisate: sodium valproate
laboratory: Sanofi-Aventis France

Injection preparation for IV route
Box of 4 bottles of lyophilisate + 4 ml solvent ampoules
All forms

Indication

Temporary treatment of epilepsies of the adult and the child, in relay of the oral form when this one is temporarily unusable.

Dosage DEPAKINE 400 mg / 4 mL Injection preparation for IV route Box of 4 vials of lyophilisate + 4 ml solvent ampoules

In a simple relay situation (for example in anticipation of a surgical procedure): between 4 and 6 hours after the last oral dose, intravenous administration of sodium valproate in 9% sodium chloride for injection,

· In 24-hour continuous infusion,

· Fractionally in 4 infusions of one hour per day, at the previous dose (usual usual dose of 20 to 30 mg / kg / day).

In a situation that requires rapid reaching and maintaining an effective plasma concentration: intravenous injection within 5 minutes of a bolus of 15 mg / kg; then perform a relay by continuous infusion, with a flow rate of 1 mg / kg / hour to be gradually adjusted to reach a blood valproic acid level around 75 mg / l. Adjust the flow rate according to the evolution of the clinical situation.

As soon as the infusion is stopped, the resumption of treatment with the oral form will ensure immediate compensation of the quantities eliminated. It will be done either at the previous dosage or after dosage adjustment.

Against indications

· History of hypersensitivity to valproate, divalproate, valpromide or any of the components of the drug.

· Acute hepatitis.

· Chronic hepatitis.

· Personal or family history of severe hepatitis, especially medication.

· Porphyria liver.

· Combination with mefloquine, St. John's wort (see section 4.5 ).

Adverse effects Depakine

Congenital, familial and genetic disorders

· Teratogenic risk (see section on Pregnancy and lactation ).

Blood and lymphatic system disorders

· Cases of dose-dependent thrombocytopenia, usually of systematic discovery and without clinical repercussions, have been described.

· In cases of asymptomatic thrombocytopenia, if the platelet count and the disease control allow, the only decrease in the dosage of this drug allows the regression of this thrombocytopenia.

· Cases of fibrinogen decrease, or prolongation of bleeding time, usually without clinical repercussions, have been reported mainly at high doses. Valproate has an inhibitory effect for the 2nd phase of platelet aggregation. More rarely have been reported cases of anemia, macrocytosis and leukopenia and exceptionally cases of pancytopenia.

· Global medullary aplasia or pure aplasia of the red line.

· Agranulocytosis

Nervous system disorders

· Transient and / or dose-related adverse events have been reported: fine attitude tremor and sedation.

· Infrequent cases of ataxia have been reported.

· Extrapyramidal disorders, sometimes irreversible, may include reversible parkinsonian syndromes.

· Very rare cases of insidious and progressive cognitive impairment (which may produce a complete picture of dementia syndrome), reversible a few weeks to a few months after stopping treatment, have been described.

· Confusional or convulsive states: a few cases of stuporous states or lethargy sometimes leading to a transient coma (encephalopathy) isolated or associated with a paradoxical recrudescence of seizures in valproate, have been observed, regressing at discontinuation of treatment or at decreased doses. These conditions occur most often during combination therapies (phenobarbital or topiramate in particular) or sudden increase in doses of valproate.

· Isolated and moderate hyperammonemia without modification of hepatic bioassays is frequently observed, especially in combination therapy, and should not interrupt treatment.

· However, cases of hyperammonemia with neurologic symptoms (up to coma) have also been reported, requiring further investigation (see Warnings and Precautions ).

· Headaches have also been reported.

Affections of the ear and labyrinth

· Exceptionally, reversible or non-reversible hearing loss has been reported.

Gastrointestinal disorders

· Some subjects may have, at the beginning of treatment, digestive disorders (nausea, vomiting, gastralgia, diarrhea) which generally give up after a few days without interruption of the treatment.

· Very rare cases of pancreatitis have been reported requiring early discontinuation of treatment. Their evolution is sometimes fatal (see section Warnings and precautions for use ).

Renal and urinary disorders

· Exceptionally, cases of renal damage have been reported.

· Very rare cases of enuresis and urinary incontinence have been reported.

Skin and subcutaneous tissue disorders

· Passive and / or dose-dependent hair loss has been reported.

· Skin reactions such as exanthematous rash have been observed. Exceptional cases of Lyell syndrome, Stevens-Johnson syndrome, and erythema multiforme have also been reported.

Metabolism and nutrition disorders

· Very rare cases of hyponatremia.

· Inappropriate secretion syndrome of the anti-diuretic hormone (S IADH).

General disorders and administration site conditions

· Weight gain has been observed. As these are a risk factor for the occurrence of polycystic ovary syndrome, the weight of the patients should be carefully monitored (see Warnings and precautions for use ).

· Very rare cases of non-severe peripheral edema have been reported.

· In the minutes following the injection, nausea or dizziness may appear, yielding spontaneously in a few minutes.

· Risk of local tissue necrosis in case of repeated injections.

Immune system disorders

· Angioedema, DRESS syndrome (Drug Rash with Eosinophilia and Systemic Symptoms) or drug hypersensitivity syndrome.

Hepatobiliary disorders

· Hepatopathies (see section Warnings and precautions for use )

Disorders of reproductive organs and breast

· Amenorrhea and menstrual irregularities.

· An impact on spermatogenesis is evoked (decreased sperm motility in particular (see section on Pregnancy and breastfeeding ).

Musculoskeletal and systemic disorders

· Cases of decreased bone mineral density, osteopenia, osteoporosis and fractures have been reported in long-term DEPAKINE patients. The mode of action of DEPAKINE on bone metabolism is not known.

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