Drug Information: Indications, Side Effects, Warnings
Category:Â Mental Disorders, Migraine, Anticonvulsants
Generic Depakote is used for controlling certain types of seizures in the treatment of epilepsy. It is also used to treat the manic phase of bipolar disorders (manic-depressive illness) and to prevent migraine headaches.
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Brand(s): Divaa / Valance / Desvaler / Depakote
Basic ingredients: sodium valproate and valproic acid
Excipients: methylhydroxypropylcellulose 4000 mPa.s (Valium) — 105.6 mg cellulose, ethyl cellulose (20 mPa.s) — 7.2 mg, sodium saccharin — 6 mg, colloidal silicon dioxide, hydrated — 32.4 mg methylhydroxypropylcellulose 6 mPa.s (Valium) — 4.8 mg, 30% polyacrylate dispersion — 16 mg macrogol 6000 — 4.8 mg talc — 4.8 mg titanium dioxide — 0.8 mg.
Anticonvulsant, muscle relaxant and has a central sedative effect. Has a antiepileptic activity in all types of epilepsy.
It is intended only for adults and children over 6 years. Tablets are taken without crushing or chewing.
The daily dose doctor selects individually.
To prevent the development of epilepsy drug should be used in the minimum effective dose.
Mean daily dose (with prolonged use):
for children 6-14 years of age (20-30 kg body weight) — 30 mg valproic acid / kg body weight (600-1200 mg);
adolescents (40-60 kg body weight) — 25 mg valproic acid / kg body weight (1000-1500 mg);
for adults and elderly patients (body weight 60 kg and above) — average 20 mg valproic acid / kg body weight (1200-2100 mg).
The daily dose may be divided into 1-2 parts preferably with meals.
Application of a full dose for one time is possible with well-controlled epilepsy.
Manic episodes in bipolar disorder:
The daily dose should be adjusted individually.
The recommended initial daily dose is 750 mg, divided into 1-2 pieces.
Mean daily dose is in the range 1000-2000 mg of sodium valproate.
Patients receiving a daily dose of 45 mg / kg / day should be under close medical supervision.
Symptoms: coma with muscular hypotonia, miosis, hyporeflexia, respiratory depression, metabolic acidosis; described cases of intracranial hypertension associated with swelling of the brain. Symptoms may vary, reported on the development of seizures in very high plasma concentrations of valproic acid.
It can be fatal if overdose is large, but usually the prognosis is favorable.
Treatment: hospital — gastric lavage, which is effective within 10-12 hours after ingestion; monitoring and correction of the functional state of the cardiovascular and respiratory systems, the maintenance of effective diuresis. In some cases, successfully is applied naloxone. In very severe cases of overdose have been pretty effective hemodialysis and hemoperfusion.
Hematopoietic system: often — thrombocytopenia; rarely — pancytopenia, anemia, leukopenia, disturbances of bone marrow hematopoiesis, including isolated cell aplasia red blood germ; agranulocytosis.
With the blood coagulation system: reported an isolated lowering fibrinogen levels and prolonged prothrombin time, usually not accompanied by clinical symptoms, especially when used in high doses (valproic acid has an inhibitory effect on the second phase of platelet aggregation).
From the nervous system: rarely — ataxia; very rarely — dementia, reversible within a few weeks or months after discontinuation of the drug, combined with atrophy of the brain, a few cases of stupor and lethargy (sometimes leading to transient coma / encephalopathy; they can be isolated or combined with an increase in seizures (although treatment), which are less likely to remove the drug or reducing the dose;
these cases are mainly observed during combination therapy, in particular with phenobarbital or topiramate, or after a sharp increase in the dose of valproic acid), extrapyramidal disorder (may be irreversible) including reversible parkinsonism, transient and / or dose-dependent light postural tremor and drowsiness, hyperammonemia, combined with neurological symptoms (in this case the patient requires additional examination).
On the part of the psyche: Infrequent — irritability, hyperactivity condition, especially at the beginning of treatment, confusion; rarely — changes in behavior, fatigue, unusual excitement, aggression, mood, depression, dysarthria, psychosis, restlessness; the frequency is unknown — hallucinations.
On the part of the organ of vision: the frequency is unknown — diplopia, nystagmus, flickering «flies» in front of his eyes.
On the part of the organ of hearing: rarely — reversible or irreversible deafness.
From the urinary system: very rarely — enuresis. There were a few isolated reports of the development of a reversible Fanconi’s syndrome, the mechanism of which is still unclear.
Skin and subcutaneous tissue disorders: common — or transient dose-dependent alopecia; very rarely — erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, rash.
From the digestive system: often — at the beginning of treatment nausea, vomiting, epigastric pain, diarrhea that with continued taking the drug usually disappear after a few days; rarely — liver damage; very rarely — pancreatitis, sometimes with fatal consequences.
On the part of the vessels: vasculitis.
From a metabolism: often — isolated and moderate hyperammonemia in the absence of changes in the parameters in liver function tests and neurological manifestations, which does not require discontinuation of the drug; very rarely — syndrome of inappropriate secretion of ADH, hyponatremia, weighobesity is a risk factor for the development of polycystic ovary syndrome, yot gain (because u should carefully monitor the patient with an increase in body weight).
Indications for use:
In adults, as monotherapy or in combination with other antiepileptic drugs:
— Treatment and prevention of bipolar affective disorder.
— Treatment of generalized seizures (clonic, tonic, tonic-clonic, myoclonic, absence seizures, atonic);
-Treatment of partial seizures (partial seizures with secondary generalization or without);
— Lennox-Gastaut syndrome;
In children, as monotherapy or in combination with other antiepileptic drugs:
— Treatment of generalized seizures (clonic, tonic, tonic-clonic, absence seizures, myoclonic, atonic);
— Lennox-Gastaut syndrome;
— Treatment of partial seizures (partial seizures with secondary generalization or without it).
— Hypersensitivity to sodium valproate, valproic acid, valproate seminatriya, valpromidu or to any of the supporting components of the drug;
— Acute hepatitis;
— Chronic hepatitis;
— Severe liver disease (especially drug-induced hepatitis) in the history of the patient and his close blood relatives;
— Severe liver fatal when using valproic acid have close blood relatives of the patient;
— Hepatic porphyria;
— Severe liver or pancreas;
— Combination with mefloquine;
— A combination of drugs with St. John’s wort;
— Severe violations of the pancreas;
— Children under 6 years of age (the risk of getting the tablet into the airway during swallowing).
— Diseases of the liver and pancreas in history;
— Congenital fermentopathy;
— Inhibition of bone marrow hematopoiesis (leukopenia, thrombocytopenia, anemia);
— Renal insufficiency (dose adjustments);
— Patients receiving multiple anticonvulsants (because of the increased risk of liver damage);
— Concomitant use of neuroleptics, MAO inhibitors, antidepressants, benzodiazepines (possibility of potentiation of their effects);
— Concomitant use of drugs that provoke seizures or reduce seizure threshold, such as tricyclic antidepressants, selective serotonin reuptake inhibitors; phenothiazine derivatives, derivatives buterofenona, chloroquine, bupropion, tramadol (risk provoking seizures);
— Simultaneous reception of phenobarbital, primidone, phenytoin, lamotrigine, zidovudine, felbamate, aspirin, carbapenems, rifampicin, anticoagulants, cimetidine, erythromycin, nimodipine (due to pharmacokinetic interactions at the level of metabolism or plasma proteins may change plasma concentrations or these drugs and / or valproic acid);
— Concomitant use with carbamazepine (risk of potentiation of toxic effects of carbamazepine and reduce plasma concentrations of valproic acid);
— Simultaneous with topiramate (risk of encephalopathy).
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