Description overdue on 05/08/2014
- Latin name: Depakine Enteric 300
- ATC code: N03AG01
- Active substance: Valproic acid (Valproic acid)
- Manufacturer: Sanofi-Winthrop Industrie (France)
- Composition
- Product form
- Pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications
- Contraindications
- Side effects
- Instructions for use
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Reviews
- Price, where to buy
Composition
The active substance Depakine enteric 300 - sodium valproate. Auxiliary components of the formulation as a syrup for oral administration: methyl parahydroxybenzoate . saccharose . glycerol . concentrated hydrochloric acid . Purified water . Propyl . 70% sorbitol solution . artificial cherry flavor . caustic soda .
Lyophilized powder for solution, which is intended for internal administration contain in addition to sodium valproate water for injection.
Coated tablets, besides the active substances contain auxiliary components such as povidone K90 . talc . hydrated calcium silicate . magnesium stearate .
Product form
Enteric Depakinum 300 is available as a syrup, a lyophilized powder for injection, as well as tablets.
Pharmacological action
Anticonvulsants, helping with the epilepsy .
Pharmacodynamics and pharmacokinetics
Valproate located in a preparation, increases the content gamma aminobutyric acid, in the central nervous system, thus inhibiting the enzyme GABA trnasferazu .
The bioavailability of the drug - about 100%. Its volume of distribution is limited to the blood and extracellular fluid. Stable drug concentration in plasma after oral administration is observed after 3-4 days, in turn, with an internal administration the equilibrium concentration is reached within a few minutes. Depakine enteric has a good degree of connection to plasma proteins. The half-life of the drug - 8-20 hours (in children - in short). It is shown mainly in the urine through the beta-oxidation and glyukuronirovaniya.
Indications
Indications for use of this tool are:
- generalized epilepsy ;
- specific syndromes (e.g. Vesta or Lennox-Gastaut );
- focal epilepsy .
Contraindications
The drug is banned at:
- Acute hepatitis ;
- active hepatitis family history;
- violations of the pancreas;
- hypersensitivity to some components of the drug;
- chronic hepatitis ;
- hepatic porphyria ;
- hemorrhagic diathesis ;
- children aged under 3 years (for tablets and lyophilized powder for injection use).
Side effects
Before the drug may be some neurological disorders. For example, confusion . tremor . lethargy . ataxia . drowsiness . coma . Generally, this happens after increasing dose Depakine enteric.
In rare cases, it may be Dementia , and gastrointestinal symptoms Which themselves disappear after a few days, the preparation for it is not necessary to cancel.
In addition, when receiving drug reported cases of hair loss, reducing the level of fibrinogen thrombocytopenia , Increased bleeding time, leukopenia . anemia . pancytopenia . pancreatitis . vasculitis . It may appear isolated and reasonable ammoniemia But it does not require drug withdrawal. Also known cases of weight gain, disturbances in the regularity of the menstrual cycle, amenorrhea Reversible loss of hearing and irreversible. In some cases, there is poliformnaya erythema , Toxic epidermal necrolysis , Skin allergic reactions . Stevens-Johnson syndrome . Fanconi's anemia .
Instructions for use
Syrup Depakine enteric administered orally using a special double-sided spoon, which is available in the set. A small part of the spoon contains - 100 mg, most - 200 mg. Starting dose - 10-15 mg / kg, it increased with time until an optimum dosage - 20-30 mg / kg. For the therapeutic effect and it can be increased, but in this case requires careful control of a physician, especially if the dose above 50 mg / kg.
Lyophilized powder for injection administered at 0, 4-0, 8 g (jet) or 0, 025 g / kg (drip) for 1-2 days. If after oral administration must go to the internal administration dose envisaged 0, 5-1 mg / kg every 4-6 hours after the last oral use.
The solution for infusion is prepared immediately before use, if during the day it did not apply, the drug must be disposed of.
Depakine enteric 300 tablets administered orally during meals, without chewing. Initial dosage weighs more than 25 kg, usually - 10-15 mg / kg, then it gradually raised to 5-10 mg / kg every week. Maximum Dosage - 30 mg / kg per day, if it is necessary to increase, then the drug is held under strict medical supervision. Tablets are recommended to take 2 times during the day.
Overdose
If overdose, the following symptoms: coma Which accompanies muscle hypotonia . corestenoma . seizures . hyporeflexia . respiratory depression . There is also increased intracranial pressure due brain edema .
Treatment is carried out by means of gastric lavage (no later than 10-12 hours after administration of the drug), it is also provided hemodialysis , Activated charcoal method, control of the cardiovascular and respiratory systems.
Cooperation
In combination with Depakine enteric neuroleptics . benzodiazepines . MAO inhibitors . primidone , and antidepressants may increase the action of the latter. So in this case, we need strict medical supervision. Furthermore, this increases the concentration of drug phenobarbital and zidovudine in plasma and on the contrary, lowers the total concentration of phenytoin .
Depakine enteric also increases the toxic effect carbamazepine and zidovudine It makes it difficult biotransformation lamotrigine and increases its half-life period.
Antiepileptic drugs in combination with enteric Depakinum reduce its concentration in the blood plasma, and felbamate, cimetidine . erythromycin and drugs bind strongly to plasma proteins, on the contrary, increase it.
The combination of this drug with mefloquine leads to increased biotransformation valproic acid, because of what can be convulsions.
Terms of sale
This medication is sold strictly on prescription.
Storage conditions
Store this medication should be in a dry, well-sheltered from the world scene. The optimum temperature is 25 ° C.
Shelf life
Depakine enteric need to store no more than 3 years.
Reviews
Many of those who appointed Depakine enteric fear many side effects as described in the instructions. However, this tool is known for its efficiency.
Price, where to buy
Price Depakine enteric tablets at pharmacies on average 970 rubles.