Medicinal Products

DEPAKINE 500 mg gastro-resistant tablet box of 1 tube of 40

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

Gastroresistant tablet
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 500 mg gastro-resistant tablet box of 1 tube of 40

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.

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.

· Valproate is contraindicated in patients with known mitochondrial disorders, caused by mutations in the nuclear gene encoding the enzyme mitochondrial polymerase γ (POLG), e.g. Alpers-Huttenlocher syndrome, and in children under two years of age suspected of having a POLG-related disorder (see Warnings and Precautions ).

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

Adverse effects Depakine

Classification of expected frequencies:

Very common (≥ 10%) Frequent (≥1% - <10%); Uncommon (≥ 0.1% - <1%); Rare (≥ 0.01% - <0.1%); Very rare (<0.01%); Undetermined (can not be estimated from the available data)

Congenital, familial and genetic disorders

· Congenital malformations, neuro-developmental disorders (see sections Warnings and precautions for use and Pregnancy and breast-feeding ).

Blood and lymphatic system disorders

· Common: anemia, thrombocytopenia

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.

· Uncommon: leukopenia, pancytopenia.

· Rare: global medullary aplasia or pure aplasia of the red line, agranulocytosis, macrocytic anemia, macrocytosis.

investigations

· Frequent: weight gain *

· Rare: Decreased at least one coagulation factor, abnormal coagulation tests (such as prolongation of prothrombin time, increase in activated partial thromboplastin time, prolongation of thrombin time, increase in INR) (see sections entitled care and precautions for use and Pregnancy and lactation ), vitamin B8 (biotin) deficiency / biotinidase deficiency

Since weight gain is a risk factor for the occurrence of polycystic ovarian syndrome, the weight of patients should be carefully monitored (see section Warnings and precautions for use ).

Nervous system disorders

· Very common: tremors

· Common: extrapyramidal stupor *, sedation, convulsion *, memory problems, headache, nystagmus.

· Uncommon: coma *, encephalopathy *, lethargy *, reversible parkinsonian syndromes, ataxia, paraesthesia.

· Rare: insidious and progressive cognitive impairment (which can produce a complete picture of dementia syndrome), reversible a few weeks to a few months after stopping treatment.

* Cases of stuporous states or lethargy leading sometimes to a transient coma (encephalopathy) under valproate, have been observed, regressing at the end of treatment or the reduction of doses. These conditions occur most often during combination therapies (phenobarbital or topiramate in particular) or sudden increase in doses of valproate.

Affections of the ear and labyrinth

· Frequent: hearing loss

Respiratory, thoracic and mediastinal disorders

· Uncommon: pleural effusion

Gastrointestinal disorders

· Very common: nausea

· Common: vomiting, gum disease (mainly gingival hyperplasia), stomatitis, epigastric pain, diarrhea that may occur in some patients at the beginning of treatment, but who generally give up after a few days without interruption of treatment.

· Uncommon: Pancreatitis which can be fatal and requires early discontinuation of treatment (see Warnings and Precautions ).

Renal and urinary disorders

· Uncommon: kidney failure

· Rare: enuresis, urinary incontinence, tubulointerstitial nephritis.

Skin and subcutaneous tissue disorders

· Frequent: transient and / or dose-dependent hair loss

· Uncommon: angioedema, skin reactions, hair disorders (such as abnormal hair texture, changes in hair color, abnormal growth of hair)

· Rare: Lyell's syndrome, Stevens-Johnson syndrome, erythema multiforme, DRESS syndrome (Drug Rash with Eosinophilia and Systemic Symptoms) or drug hypersensitivity syndrome.

Endocrine disorders

· Uncommon: syndrome of inappropriate secretion of the anti-diuretic hormone (SIADH), hyperandrogenism (hirsutism, virilism, acne, androgenic alopecia, and / or increased levels of androgenic hormones)

· Rare: hypothyroidism (see section on Pregnancy and lactation )

Metabolism and nutrition disorders

· Common: hyponatremia

· Rare: hyperammonemia * (see section Warnings and precautions for use ).

* Isolated and moderate hyperammonemia without modification of liver bioassays may be 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 ).

Benign, malignant and unspecified tumors (incl cysts and polyps)

· Rare: myelodysplastic syndrome

Vascular disorders

· Frequent: bleeding (see sections Warnings and precautions for use and side effects )

General disorders and administration site conditions

· Uncommon: hypothermia, non-severe peripheral edema

Hepatobiliary disorders

· Common: hepatopathies (see Warnings and Precautions ) section.

Disorders of reproductive organs and breast

· Common: menstrual irregularities

· Uncommon: amenorrhea

· Rare: impact on spermatogenesis (decreased mobility of spermatozoa in particular) (see section Pregnancy and lactation ), polycystic ovaries.

Musculoskeletal and systemic disorders

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

· Rare: Systemic lupus erythematosus (see Warnings and precautions for use ), rhabdomyolysis (see Warnings and Precautions ) section.

Psychiatric disorders

· Common: confusional state, hallucinations, aggression *, agitation *, attention disorders *

· Rare: abnormal behavior *, psychomotor hyperactivity *, learning difficulties *

* These effects are seen primarily in the pediatric population.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals must report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of regional pharmacovigilance centers. Website: www.ansm.sante.fr

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