Treatment of manic episode in bipolar disorder. Prevention of relapse of bipolar disorder. Reduction in the severity and frequency of subsequent manic episodes in patients with a history of mania. Prevention of episodes of depression in recurrent depressive disorders.
Composition:
1 tabl contains 250 mg of lithium carbonate. The preparation contains lactose.
Action:
The mechanism of action of lithium is not fully understood. It is believed that it inhibits the transport of sodium into the neuron, disrupting the release of noradrenaline and Dopamine (but not serotonin) induced by depolarisation at o.u.n. At the same time, lithium inhibits some of the uptake of these catecholamines. In healthy people, lithium does not exert psychotropic effects. Lithium carbonate is almost completely absorbed from the gastrointestinal tract. Absorption is slow and takes about 8 hours. Maximum concentrations are achieved after 2-4 h. It is not bound to proteins. It is almost entirely (about 95%) excreted in the urine; small amounts of 4-5% are excreted with sweat. T0,5 is about 19 h, however, shows large individual differences (13-33 h) and depends on the age of the patient, the condition of his kidneys and the time of treatment with lithium. In older people, renal clearance of lithium is reduced and T0,5 elongate. Sodium (and water) deficiency enhances lithium reabsorption in the proximal tubules, prolongs the elimination period, which leads to increased blood levels of the drug. The therapeutic effect occurs after 1-3 weeks of therapy.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients. Severe renal failure. Freshly infarcted myocardial infarction. Organic brain damage. Leukemia. Pregnancy (teratogenic effect in the first trimester). Breastfeeding period (Lithium is excreted in breast milk).
Precautions:
The use of the drug is not recommended (due to an increased risk of toxic symptoms) in patients with: severe renal failure, cardiovascular diseases, untreated hypothyroidism, unadjusted sodium levels due to dehydration, Adison's disease, in the case of reduced salt supply in the diet . Special care should be taken in patients with Parkinson's disease, sinus node dysfunctions and sinus-chamber conduction, epilepsy, psoriasis, congenital muscular fatigue, diabetes mellitus, and schizophrenia. In the case of diarrhea, excessive sweating (eg during infection), it may be necessary to reduce the dose or temporarily discontinue lithium therapy. Histological changes in kidneys (including tubular-parenchymal nephropathy) have been reported after prolonged lithium treatment, which may lead to renal dysfunction. It is not known whether these changes are always reversible after discontinuation of lithium. Periodic monitoring of renal function is recommended. Caution should be exercised when treating patients treated with lithium electroconvulsive therapy (ECT) due to the increased risk of neurological side effects (delirium, prolonged seizures, confusion) - use electroshock carefully and the patient should be closely monitored. Exercise caution in patients taking lithium with neuroleptics due to the possibility of symptoms of malignant neuroleptic syndrome. Elderly people may be more sensitive to lithium toxicity due to impaired renal function and excretion. Lithium therapy should be discontinued immediately if first symptoms of toxicity occur, including: cardiovascular disorders (eg QT / QTc prolongation in the ECG test), gastrointestinal disorders (eg diarrhea, vomiting and dehydration), neurological disorders (eg ataxia) , tremor, hypertonia, involuntary muscle contractions, hyperreflexia, speech disorders, confusion, drowsiness and nystagmus). Patients treated with the product should be monitored for signs of suicidal ideation and behavior (especially at the beginning of treatment and after the change of the dose); this applies especially to the so-called "young adults" and patients with behavior or suicidal thoughts in the interview.In patients who experience a worsening of the clinical condition (including new symptoms and / or suicidal thoughts or behaviors), a change in the therapeutic procedure, including the possibility of discontinuation of treatment with the preparation, should be considered. Due to the lactose content, the preparation should not be used in patients with galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.
Pregnancy and lactation:
Lithium should not be used during pregnancy, especially in the first trimester. The use of lithium during pregnancy, especially in the first trimester, is associated with an increased incidence of congenital malformations, especially in the cardiovascular system. Lithium is excreted in breast milk, due to the possibility of symptoms of poisoning in the child, during breastfeeding therapy is contraindicated.
Side effects:
The occurrence and severity of side effects depend on the patient's sensitivity and the concentration of the drug in the blood serum. In the initial period of treatment, tremors, gastrointestinal disorders, polyuria, thirst, muscle weakness, and tiredness are relatively frequent. The symptoms become less pronounced during continued treatment. Not known: leukocytosis, goitre, hypothyroidism, hyperparathyroidism, hyperglycemia, hypercalcemia, weight gain, anorexia, hallucinations, drowsiness, memory disturbances, convulsions, muscular tremors (fine and coarse), ataxia, athetic movements, nerve conduction disturbances, increased tendon reflexes, extrapyramidal symptoms, seizures, blurred speech, dizziness, nystagmus, stupor, coma, brain tumor, headache, taste disorders,myasthenia gravis, visual disturbances, blurred vision, arrhythmia, bradycardia, sinus node dysfunction, peripheral edema, ECG changes (reversible flattening and T-wave inversion), peripheral circulation failure, hypotension, Raynaud's symptom, nausea, vomiting, diarrhea, abdominal pain, salivation, dryness of oral mucous membranes, alopecia, acne, folliculitis, pruritus, worsening of psoriasis, rash, ulceration, hyperkeratosis, other signs of skin hypersensitivity, joint pain, myalgia, symptoms of renal diabetes, incontinence, after prolonged lithium treatment, histological changes (including tubular and parenchymal nephropathy) and renal dysfunction, impotence, sexual dysfunction, edema.
Dosage:
Orally. Due to the low therapeutic coefficient of lithium carbonate, the individual dose should be determined based on the measurement of serum lithium concentration and the clinical improvement achieved. The daily dose is usually 0.5 to 1.25 g in divided doses. The daily dose should be increased gradually. At the initial stage of therapy, serum lithium levels should be monitored at least once a week. It is recommended to maintain the serum lithium concentration in the range of 0.5-0.8 mmol / l (preventing relapse of affective disorders). After reaching the required concentration, the control may be carried out less frequently, every month or every two months; during remission every 2-3 months In acute (manic) conditions, a dose of 1.5-2 g per day is used - the concentration of lithium in the blood plasma should be from 0.6 to 1.2 mmol / l. After the resolution of the acute phase, the dose should be reduced immediately. The daily dose should be divided into at least 3 parts. If you miss one dose, do not double the Next one. It is recommended that the lithium be gradually withdrawn (for a period of at least 2 weeks), as this may delay the recurrence of the symptoms of the underlying disease. If the first signs of toxicity appear, treatment should be stopped immediately. The product is not recommended for children under 12 years of age.