Medicinal Products

DEPAKINE CHRONO 500 mg

Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Sodium valproate, Valproic acid, Quantity corresponding to: Sodium valproate
laboratory: Sanofi-Aventis France

Break-off film-coated tablet
Box of 1 Box of 100
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.

Dosage DEPAKINE CHRONO 500 mg Separation-time film-coated tablet 1 box of 100

DEPAKINE CHRONO is a DEPAKINE sustained-release formulation that reduces peak plasma concentrations and provides more consistent plasma concentrations in the nycthemeron.

Given the dosage, this drug is reserved for adults and children over 17 kg.

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

The initial daily dosage is usually 10-15 mg / kg, then the doses are increased to the optimal dosage (see Getting Started).

The average dosage is 20 to 30 mg / kg per day. However, when seizure control is not achieved at this dosage, the dose may be increased and patients should be closely monitored.

In children, the usual dosage is 30 mg / kg per day.

In adults, the usual dosage is 20 to 30 mg / kg per day.

In the elderly, dosage should be determined according to seizure control.

The daily dosage should be based on age and body weight; however, the wide individual sensitivity to valproate must be taken into account.

A good correlation has not been established between daily dose, serum concentrations, and therapeutic effect: dosage should be determined primarily by clinical response.

Determination of plasma valproic acid levels may be considered in addition to clinical monitoring when seizure control is not achieved or when adverse effects are suspected. The range of therapeutic efficacy is usually between 40 and 100 mg / l (300 to 700 μmol / l).

Administration mode

Oral way.

The daily dose is to be administered in 1 or 2 doses, preferably during meals.

Administration in a single dose is possible in the case of well-balanced epilepsy.

Swallow the tablet without crushing or chewing it.

Start of treatment

· In patients for whom adequate control has been achieved with DEPAKINE immediate release forms, when DEPAKINE CHRONO is used, the daily dose should be maintained.

· In the case of a patient already on treatment and receiving other antiepileptic drugs, gradually introduce DEPAKINE CHRONO to reach the optimal dose in about two weeks, then possibly reduce the associated therapies according to the control obtained.

· In the case of a patient not receiving other antiepileptic drugs, the dosage increase is preferably carried out in successive increments every 2 to 3 days to reach the optimal dose in about 1 week. .

· If necessary, the combination of other antiepileptic medicinal products should be carried out in a progressive manner (see section Interactions with other medicinal products and other forms of interaction

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 Chrono

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 patients treated with DEPAKINE CHRONO. The mode of action of DEPAKINE CHRONO on bone metabolism is not known.

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