COMPOSITION :
Each Sml of DEPATOP syrup contain : Sodium valproate 200mg.
Each Iml of DEPATOP oral drops contain : Sodium valproate 200mg .
DESCRIPTION :
DEPATOP (Sodium valproate) is an antiepileptic agent used as monotherapy or as combined therapy for the
treatment of different types of generalized and partial seizures.
The main mechanism of sodium valproate is blocking high frequency firing(excitation) of neurons through
increasing levels of Gamma amino butyric acid GABA which is the main inhibitory neurotransmitter in the
brain whose principle role is reducing neuronal excitability throughout the nervous system. This effect is
achieved by inhibiting gamma amino butyrate aminotransrerase, GABA degradative enzyme, and also by
inhibiting the reuptake of GABA by neuronal cells.
Unlike many antiepileptic drugs, DEPATOP is non-sedating when used as single therapy. In addition,
DEPATOP has a mood uplifting action which has shown to be successful with bipolar disorder and
depressive mania.
INDICATIONS :
DEPATOP is an anti-epileptic medicine used in :
¢ Adults and children: either as single agent therapy or in combination with another antiepileptic treatment:
-Treat generalized epilepsy, clonic, tonic, tonic-clonic, absence , myoclonic, and atonic seizures and
Lennox-Gastaut syndrom.
-Treatment of partial epilepsy, partial seizure , with or without secondary generalization.
e Children:
- Prevent recurrence of febrile convulsions in case of prophylaxis with non-continuous benzodiazepine use is
failed.
DOSAGE & ADMINISTRATION :
« The daily dose should preferably be administered during meals.
The dose is divided into:
- 2 doses per day in children under the age of one year.
- 3 doses per day in children and adults above the age of one year.
- Initial dose : 15mg/kg/day which is gradually increased by 5-10mg/kg/week until reaching 30mg/kg/day.
Usual dose:
- Infants and children: 30mg/kg
- Adults: 20 to 30mg/kg
Notes : The dose of Depatop oral drops 200mg/ml should be prescribed in milligrams (mg) not milliliters
because the syringe used to withdraw the medicine is graduated in milligrams.
Combination therapies with other antiepileptics should be administered gradually.
RISTRICTION ON USE :
Contraindication
- Hypersensitivity to sodium valproate or any related drug from the same family.
- Acute or chronic hepatitis.
- Personal or family history of severe hepatitis especially drug- induced.
- Hepatic porphyria.
- Combination with St.John’s Wort or Mefloquine.
Precautions
- Patients with hepatitis and pacreatitis: liver function test should be measured before therapy and then
monitored during the first six months of the therapy.
- The concomitant use with aspirin in children under the age of 3 should be avoided due to the risk of
hepatotoxicity.
- Aggravated or repeated convulsions despite proper use of the medication the patient should consult the
physician immediately.
- patients should be monitored and are advised to seek medical advice if suicidal ideation emerge.
- Renal insufficiency patients must adjust the dosage according to clinical monitoring.
- Haematological test including blood cell count, platelete count, bleeding time, and coagulation tests are
recommended prior to initiation of therapy.
- This drug leads to weight gain so the patient is advised to adopte an appropriate diet.
DEPATOP must not be suddenly stopped, it must be gradually decreased.
Using in Pregnancy &Lactation
Pregnancy and lactation : ( pregnancy category D )
Sodium valproate is contraindicated in pregnancy unless there is no suitable alternative treatment , lactation
should be stopped during using Depatop.
Effects on ability to drive and use machines
Patients should be warned of the risk of transient drowsiness, especially in cases of anti-convulsant
polytherapy or association with benzodiazepines.
DRUG INTERACTIONS :
-Antiepileptics with enzyme inducing effect (including phenytoin, phenobarbital, carbamazepines) as well as
Carbapenems antibiotics decreases valproic acid plasma concentrations.
-Sodium valproate may potentiate the effects of other psychotropics such as neuroleptics, MAO inhibitors,
antidepressants and benzodiazepines, therefore, clinical monitoring is advised and the dosage should be
adjusted when appropriate.
-Sodium valproate may lead to an increased blood levels of Rufinamid and Propofol, as well as, increased
plasma concentration of Zidovudine and Primidone.
-The mean clearance of Falbamate may decrease by up to 16% by Sodium valproate.
-Concomitant use with Topiramate and Zonisamide increase hyperammonemia with increased risk of
encephalopathy.
-Rifampicin increases hepatic metabolism of Sodium valproate.
-Sodium valproate reduces the metabolism of Lamotrigine and increases its half- life by nearly two folds
leading to increased lamotrigine toxicity.
ADVERSE EFFECTS :
Nausea , vomiting, diarrhea, abdominal pain, asthenia, which may occur at the start of the treatment but
usually disappear after few days without discontinuing the treatment, tremor, drowsiness, headache,
extrapyramidal disorders, weight gain, temporary blood test abnormalities(anemia, hyponatremia, ,
thrombocytopenia, decrease in fibrinogen levels, prolonged bleeding time, bone marrow aplasia )
OVERDOSAGE :
Signs include nausea, vomiting and dizziness:
- At plasma high conc : signs of acute massive over dose include CNS depression or coma with muscular
hypotension, hyporeflexia, miosis, impaired respiratory function, metabolic acidosis, hypotension and
ciculatory shock.
- Hospital management of overdose should be symptomatic including cardiorespiratory monitoring. Gastric
lavage may be useful in 10 to 12 hours following ingestion.
- Haemodialysis and Haemoperfusion have been successful, in addition to Naloxone in association with
activated charcoal given orally.
STORAGE INSTRUCTIONS :
Store below 30°C.
PRESENTATION :
Depatop oral drops : pack of 30 ml .
Depatop syrup : pack of 100 ml .
