Lithosun Sr 400Mg

COMPOSITION Each extended-release uncoated tablet of Lithosun SR contains Lithium Carbonate USP 400 mg. 

PHARMACOLOGICAL ACTIONS: The specific biochemical mechanisms of Lithium for the treatment of mania are not known. Lithium is known to alter sodium transport in neuronal cells thereby effecting intracellular shift of catecholamines. 

INDICATIONS: Lithium Carbonate is indicated in the treatment of manic phase of mania depressive psychosis. Continuing Lithium Carbonate treatment, prevents or decreases the intensity of manic episodes.

WARNINGS: Lithium Carbonate should not be given to those patients of M. D. P who also suffer from renal or cardiovascular disease, debilitation, dehydration or sodium deprivation with or without diuretic treatment. It should be used with caution if above conditions co-exist with M. D. P only when other treatment modalities have failed. Chronic lithium treatment may produce nephrogenic diabetes insipidus which would require careful monitoring. A renal function test is advised prior to initiating lithium therapy. All patients receiving lithium with haloperidol and other antipsychotic drugs should be monitored for neurologic toxicity. Diarrhea, vomiting, tremors, ataxia, drowsiness and weakness occur as signs of lithium toxicity. Lithium potentiates the action of neuromuscular blocking agents. They should be used with caution. Activities requiring alertness may be impaired with lithium. 

USAGE IN PREGNANCY: Lithium should not be used in first trimester of pregnancy unless potential benefits are deemed to outweigh the risk. 

USAGE IN NURSING MOTHERS: Breast feeding is not advised unless the benefits of lithium use outweigh the disadvantages. 

USE IN CHILDREN: Data on safety and effectiveness of lithium use in children are not available. 

PRECAUTIONS: Lithium should be used with caution in patients receiving diuretics, inadequate fluid intake or hyponatremia due to any cause including excessive sweating and diarrhea. In hypothyroid patients, lithium may necessitate increased dosage of thyroxine. Non-steroidal anti-inflammatory drugs may increase serum lithium levels. 

ADVERSE REACTIONS: Tremors, polyuria, polydipsia, nausea and general sense of discomfort may occur in beginning. They become less or subside with passage of time or decreasing lithium dose. Diarrhea, vomiting, drowsiness, weakness, giddiness, ataxia, blurred vision, tinnitus and diabetes insipidus generally occur at higher doses or when toxic levels of lithium are reached. Signs of pseudotumor cerebri, athetosis and hyperactive tendon reflexes, blackouts, convulsions, incontinence, stupor and coma are CNS signs of high lithium concentration. Other effects on various systems are CVS: Cardiac arrhythmia, hypotension and circulatory collapse. Gastrointestinal: anorexia, nausea, vomiting, diarrhea. Genitourinary: albuminuria, oliguria, polyuria, glycosuria. Dermatologic: dry and thin hair, folliculitis, exacerbation of psoriasis. Autonomic: blurred vision and dry mouth. Endocrine: Hyperthyroidism (very rare) and hypothyroidism. Laboratory value changes such as slowing of EEG rhythm and potentiation and disorganization of background rhythm may be recorded. ECG: reversible flattening or inversion of T waves. 

OVERDOSAGE: Signs and symptoms of overdosage are those listed in adverse reactions. Elimination of excess dose ingested by gastric lavage, maintenance of fluid and electrolyte balance, maintaining adequate renal perfusion and increasing lithium excretion by administration of mannitol and/or aminophylline are helpful. In severely toxic patients' hemodialysis may be required. In cases of pulmonary congestion, respiratory support and antibiotics may be required. 

SUN PHARMA