📌 COMPOSITION

Each prolonged‑release F/C tablet contains: Sodium valproate 333 mg – Valproic acid 145 mg (equivalent to 500 mg sodium valproate).

📌 DESCRIPTION

Depatop Chrono 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 by 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 (the GABA‑degrading enzyme) and also by inhibiting the reuptake of GABA by neuronal cells. Unlike many antiepileptic drugs, Depatop Chrono is non‑sedating when used as single therapy. In addition, Depatop Chrono has a mood‑uplifting action which has shown to be successful in bipolar disorder and depressive mania. Depatop Chrono has a prolonged effect, so it prevents the occurrence of seizures for a long time.

📌 INDICATIONS

• Used 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.
• In children: Prevention of recurrence of febrile convulsions when prophylaxis with non‑continuous benzodiazepine use has failed.

📌 DOSAGE & ADMINISTRATION

• The dose is determined according to the doctor’s consultation.
• 1‑2 doses/day, preferably during meals, or a single dose if the disease is well controlled by the treatment.

📌 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.
• Concomitant use of mefloquine or St. John’s Wort.

Precautions

• Patients with hepatitis or pancreatitis: liver function tests should be measured before therapy and then monitored during the first six months of therapy.
• Concomitant use of aspirin with Depatop Chrono in children under 3 years should be avoided due to the risk of hepatotoxicity.
• If seizures recur or worsen 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.
• Patients with renal insufficiency must have the dosage adjusted 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 at dose increments, and then every two months.
• This drug may lead to weight gain, so the patient is advised to adopt an appropriate diet.
• Depatop Chrono must not be stopped suddenly; it must be gradually tapered.

Use in Pregnancy and Lactation

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

Effects on ability to drive and use machines

Patients should be warned of the risk of drowsiness, especially in cases of anticonvulsant polytherapy or concomitant use 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.
• Plasma levels rise with worsening of side effects (sedation) when used with sodium valproate.
• Sodium valproate increases blood levels of rufinamide and propofol, as well as plasma concentrations of zidovudine and primidone.
• The mean clearance of felbamate may be decreased by up to 16% by sodium valproate.
• Topiramate and zonisamide increase hyperammonaemia with an 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‑fold, leading to increased lamotrigine toxicity.

📌 ADVERSE EFFECTS

Nausea, vomiting, diarrhoea, abdominal pain, asthenia (may occur at the start of treatment but usually disappear after a few days), tremor, drowsiness, headache, extrapyramidal disorders, weight gain, temporary blood test abnormalities (anaemia, hyponatraemia, thrombocytopenia, decreased fibrinogen levels, prolonged bleeding time, bone marrow aplasia).

📌 OVERDOSAGE

Symptoms: Nausea, vomiting, dizziness. In severe overdose, CNS depression or coma with muscular hypotonia, hyporeflexia, miosis, impaired respiratory function may occur. Nevertheless, 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 recorded.

Treatment: Hospital management of overdose is symptomatic, including cardiorespiratory monitoring. Gastric lavage may be useful within 10‑12 hours of ingestion. Haemodialysis and haemoperfusion have been successful, in addition to naloxone with oral activated charcoal.

📌 STORAGE INSTRUCTIONS

Store below 30°C in a dry place.

📌 PHARMACEUTICAL FORMS

• Depatop Chrono prolonged‑release tablets: Pack of 30 tablets and hospital packs of different sizes.