📌 COMPOSITION

• Each 5 ml of Depatop syrup contains: Sodium valproate 200 mg.
• Each 1 ml of Depatop oral drops contains: Sodium valproate 200 mg.

📌 DESCRIPTION

Depatop (Sodium valproate) is an antiepileptic agent used as monotherapy or as combined therapy for the treatment of different types of generalised and partial seizures. The main mechanism of sodium valproate is blocking high‑frequency firing (excitation) of neurons through increasing levels of gamma‑aminobutyric acid (GABA), which is the main inhibitory neurotransmitter in the brain whose principal role is reducing neuronal excitability throughout the nervous system. This effect is achieved by inhibiting GABA aminotransferase (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 antiepileptic medicine used in:

• Adults and children: Either as single agent therapy or in combination with another antiepileptic treatment:
  • Treatment of generalised epilepsy, clonic, tonic, tonic‑clonic, absence, myoclonic and atonic seizures, and Lennox‑Gastaut syndrome.
  • Treatment of partial epilepsy and partial seizures, with or without secondary generalisation.
• Children:
  • Prevent recurrence of febrile convulsions in cases where prophylaxis with non‑continuous benzodiazepine use has failed.

📌 DOSAGE & ADMINISTRATION

• The daily dose should preferably be administered during meals. Depatop oral drops should be taken after dilution with a small amount of any non‑carbonated drink.
• 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: 15 mg/kg/day, which is gradually increased by 5-10 mg/kg/week until reaching 30 mg/kg/day.
• Usual dose:
  • Infants and children: 30 mg/kg.
  • Adults: 20 to 30 mg/kg.

Note: The dose of Depatop oral drops 200 mg/ml should be prescribed in milligrams (mg) not millilitres (ml), because the syringe used to withdraw the medicine is graduated in milligrams.

Combination therapies with other antiepileptics should be administered gradually.

📌 RESTRICTIONS ON USE

Contraindications

• 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 pancreatitis: liver function tests should be measured before therapy and then monitored during the first six months of therapy.
• The concomitant use with aspirin in children under the age of 3 should be avoided due to the risk of hepatotoxicity.
• If convulsions are aggravated or repeated 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 emerges.
• Renal insufficiency patients must adjust the dosage according to clinical monitoring.
• Haematological tests including blood cell count, platelet count, bleeding time and coagulation tests are recommended prior to initiation of therapy and when the dose is increased, and every two months thereafter.
• This drug may lead to weight gain, so the patient is advised to adopt an appropriate diet.
• Depatop must not be suddenly stopped; it must be gradually decreased.

Use in Pregnancy and Lactation

Sodium valproate (pregnancy category D) is contraindicated in pregnancy unless there is no suitable alternative treatment. Lactation should be stopped during use of Depatop.

Effects on ability to drive and use machines

Patients should be warned of the risk of transient drowsiness, especially in cases of anticonvulsant polytherapy or association with benzodiazepines.

📌 DRUG INTERACTIONS

• Antiepileptics with enzyme‑inducing effects (including phenytoin, phenobarbital, carbamazepine), as well as carbapenem antibiotics, decrease 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 increased blood levels of rufinamide and propofol, as well as increased plasma concentration of zidovudine and primidone.
• The mean clearance of felbamate may decrease by up to 16% by sodium valproate.
• Concomitant use with topiramate and zonisamide increases hyperammonaemia with increased risk of encephalopathy.
• Rifampicin increases the 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, diarrhoea, abdominal pain, asthenia (which may occur at the start of treatment but usually disappear after a few days without discontinuing treatment), tremor, drowsiness, headache, extrapyramidal disorders, weight gain, temporary blood test abnormalities (anaemia, hyponatraemia, thrombocytopenia, decrease in fibrinogen levels, prolonged bleeding time, bone marrow aplasia).

📌 OVERDOSAGE

Symptoms: Nausea, vomiting and dizziness. At high plasma concentrations, signs of acute massive overdose include CNS depression or coma with muscular hypotonia, hyporeflexia, miosis, impaired respiratory function, metabolic acidosis, hypotension and circulatory shock. However, these symptoms may be variable, and seizures have been reported with very high plasma concentrations. Cases of cerebral oedema and increased intracranial pressure have been reported.

Hospital management of overdose: Symptomatic treatment including cardiorespiratory monitoring. Gastric lavage may be useful within 10-12 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.

📌 PHARMACEUTICAL FORMS

• Depatop oral drops: pack of 30 ml.
• Depatop syrup: pack of 100 ml.