Medicinal Products

DEPAKINE 200 mg

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

Gastroresistant tablet
Box of 1 Tube of 40
All forms

Indication

In adults: either as monotherapy or in combination with another antiepileptic treatment:

· Treatment of generalized epilepsies: clonic, tonic, tonic-clonic seizures, absences, myoclonic seizures, atonic, and Lennox-Gastaut syndrome.

· Treatment of partial epilepsies: partial seizures with or without secondary generalization.

In children: either as monotherapy or in combination with another antiepileptic treatment:

· Treatment of generalized epilepsies: clonic, tonic, tonic-clonic seizures, absences, myoclonic seizures, atonic, and Lennox-Gastaut syndrome.

· Treatment of partial epilepsies: partial seizures with or without secondary generalization.

In children:

· Prevention of recurrent seizures after one or more febrile seizures, with complicated fever seizure criteria, in the absence of intermittent benzodiazepine prophylaxis.

Dosage DEPAKINE 200 mg Gastroresistant tablet Box of 1 Tube of 40

This form is not suitable for children under 6 years old (risk of mis-driving).

Of the oral dosage forms, the syrup, oral solution and LP granule forms are particularly suitable for administration in children under 11 years of age.

Dosage

Average dosage per 24 hours:

· Infants and children: 30 mg per kg (syrup, oral solution or extended release granule forms are preferably used).

· Adolescents and adults: 20 to 30 mg per kg (compressed forms or chrono-tablet or extended-release granules will preferably be used).

Administration mode

Oral way.

The daily dose is to be administered in 2 or 3 doses, preferably during meals.

Start of treatment

· In the case of a patient already on treatment and receiving other antiepileptic drugs, gradually introduce sodium valproate to reach the optimum dose in approximately two weeks, then possibly reduce the associated therapies according to the control obtained;

· If the patient is not receiving other antiepileptic drugs, the dosage is preferably escalated every 2 to 3 days to reach the optimal dosage in about 1 week. .

· If necessary, the combination of other antiepileptic medicinal products should be carried out gradually (see section Interactions with other medicinal products and other forms of interaction ).

Against indications

· History of hypersensitivity to valproate, sodium 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 the case of asymptomatic thrombocytopenia, if the platelet count and the disease control permit, the only decrease in the dosage of this drug usually 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.

· Sometimes irreversible extrapyramidal disorders that may include reversible Parkinson's syndromes.

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

· Confusional or convulsive states: some 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 the end of treatment or at the reduction of 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 antidiuretic hormone (SIADH).

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.

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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