Mirodep®
РастворA drug from the group of fatty acid derivatives, mainly used as an antiepileptic drug, but also to treat bipolar disorder and prevent migraines.
Important
Indications
Temporary substitution of oral dosage forms of valproic acid (whose use is not possible for various reasons):
• treatment of epilepsy (as monotherapy and in combination with other antiepileptic drugs) in adults and children from birth:
- generalised epileptic seizures (absans, atonic, atonic, clonic, myoclonic, tonic, tonic-clonic);
- epileptic encephalopathy with childhood debut (Lennox-Gasto syndrome);
- partial epileptic seizures (partial seizures with or without secondary generalisation).
• prevention of febrile seizures in children (when such prevention is necessary).
Contraindications
Do not use Mirodep® if you are:
- allergic to valproic acid (and its salts), valpromide or any of the excipients listed in section 6 of the leaflet insert;
- acute and chronic hepatitis;
- a history of severe liver disease (especially drug-induced hepatitis) (including in your close blood relatives);
- if your close blood relatives have had severe liver diseases with fatal outcome when using medicinal products containing valproic acid;
- severe liver and/or pancreatic dysfunction;
- a rare disease associated with pigment metabolism disorders (hepatic porphyria);
- established mitochondrial diseases caused by mutations in the nuclear gene encoding the mitochondrial enzyme γ-polymerase (POLG), such as Alpers-Huttenlocher syndrome, and suspected diseases due to defects in the γ-polymerase enzyme;
- established disorders of the urea cycle (urea cycle);
- established primary systemic carnitine deficiency with unadjusted hypocarnitinaemia;
- disorders of the blood coagulation system, accompanied by increased bleeding, spontaneous bleeding (haemorrhagic diathesis) and low platelet content in the blood (thrombocytopenia);
- concomitant use of mefloquine (antimalarial drug) or St John's wort preparations;
- pregnancy in epilepsy, unless there are no alternative methods of epilepsy treatment;
- pregnancy in the treatment and prophylaxis of bipolar disorders;
- preserved childbearing potential, but you are not following your doctor's instructions under the "Pregnancy Prevention Programme".
Usage
Always use the product in full compliance with the recommendations of your doctor. If in doubt, consult your doctor. Therapy with Mirodep® should only be carried out under the supervision of a physician experienced in the treatment of epilepsy. The recommended daily dose of valproic acid should be selected individually and adjusted according to age, body weight and individual sensitivity. The goal of therapy is optimal control of epileptic seizures using the lowest dose of the drug. The use of Mirodep® in monotherapy and in the lowest effective dose is preferred. No clear correlation between daily dose, serum valproic acid concentration and therapeutic effect has been established, the optimal dose should be selected mainly on the basis of clinical effect. Determination of plasma valproic acid concentrations may be considered as an adjunct to clinical monitoring (especially in cases of uncontrolled epilepsy or suspected side effects). Doses providing serum valproic acid concentrations of 40-100 mg/L (300-700 µmol/L) are usually effective.
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Drugs in the category Neurology
Has contraindications. Needs specialist overview.