Litiam ER 400mg

Tablet
Lithium Carbonate
ACI Pharmaceuticals

Other Strength:

Alternative:
- Lithin SR 400mg



Litiam ER
Description
Litiam®ERis apreparation of Lithium carbonatewhichprovides a source of lithium ions that may act by competing withsodium ions at various sites in the body. Therapeutic concentrations of lithium havealmost no discernible psychotropic effects in normal volunteers but considerable effectin patients suffering from affective disorders. The mechanism of action is unknown.

Indications
Litiam®ERisindicated for the-

Treatment and prophylaxis ofmania, manic depressive illness and recurrent depression
Treatment of aggressive or self mutilating behaviour

Dosage and administration
Adults:
Litiam®ERtablets are usually administered according to a twice daily regimen. When Lithium levels have stabilized, a once daily regimen may be preferred.

For Acute Mania:Initial treatment dose is 1-1.5g daily for the first five days. Prophylaxisof recurrent affective disorders(Including unipolar mania & unipolar depressions and bipolar manic-depressive illness) : A low dose of 300-400 mg of lithium carbonate can be administered daily for the first seven days.DoseofLitiamis adjusted to keep the plasma lithium level within the range of 0.4-0.8 mmol/l. For Aggressive and self-mutilating behavior:Dosageis at the lower end of the range for the treatment of manic depressive illness.

Elderly:
Elderly patients often require lower lithium dosage to achieve therapeutic serum levels. As forprophylaxis, Lithium levels should be kept in the range of 0.4-0.7 mmol/l.

Children:Not recommended.

Use in pregnancy and lactation
Avoid if possible in the first trimester due to have the risk of teratogenicity, including cardiac abnormalities; dose may beincreased during the second and third trimesters but on deliveryreturn abruptly to normaldose. Close monitoring of serum-lithium concentration is advised to avoid the risk of toxicity in neonate. Nursing Mothers: Lithium is secreted in breast milk, therefore bottlefeeding isrecommended.

Side Effects
The most frequentadverse effects are the initial post-absorptive symptoms, believed to be associated witha rapid rise in serum lithium levels. They include gastrointestinal discomfort with mildnausea and diarrhea, vertigo, muscle weakness and a dazed feeling and frequentlydisappear after stabilization of therapy.The more common and persistent adverse reactions are fine tremor of the hands,fatigue, thirst and polyuria. At higher concentrations, ataxia, tinnitus, blurred vision, giddiness andincreasing polyuria are seen.Long term administration of lithium carbonate may precipitate goiterrequiring treatmentwith thyroxine, but this regresses when treatment is discontinued.

Precautions
Pretreatment physical examination and laboratory testing are required prior tocommencement of therapy and should be repeated at frequent intervals. The patientshould maintain a normal diet with adequate salt and fluid intake during therapy.Lithium toxicity is closely related to serum lithium concentrations and can occur atdosesclose to therapeutic concentrations.Diuretics should not be used during lithium therapy without appropriate dosage adjustment.Serum lithium concentrationshould be measuredregularly (every 3 months on stabilized regimens). Renal function and thyroid function should also be measured every 6 months intervals.

Contraindications
Itis contraindicated in patients with known hypersensitivity to active ingredient or any component of the product, in patients with significant cardiovascular disease or renal impairment, untreated hypothyroidism, conditions associated with hyponatremia(Addison's disease,dehydrated or severely debilitated patients, patients on low sodium diets).

Drug interaction
Lithium dosage should either be adjusted or stoppedduringconcomitant treatment as these increase or decrease the concentration of Lithium. Lithium concentration may be increased when SSRIs, Metronidazole, Tetracyclines,Topiramate, Non-steroidal anti-inflammatory drugs (NSAID),ACE inhibitors,Thiazide diuretics (maycause a paradoxical antidiuretic effect resulting inpossible water retention and lithium intoxication), Spironolactone,Frusemide,Angiotensin-II receptor antagonists, steroidsare taken concomitantly. Lithium concentration may be decreased when Xanthines (theophylline, caffeine),Sodium bicarbonate and Sodium Chloride containing products, Psyllium or Ispaghula husk, Urea,Mannitol, Acetazolamideare taken.It may cause neurotoxicity when taken with Neuroleptics (risperidone, clozapine, phenothiazines, and particularly haloperidol), SSRIs, Sumitriptan and Tricyclic Antidepressants, Calcium channel blockers, Carbamazepine or phenytoin,Methyldopa.

Overdose
Over dosage usually with serumlithium concentration of over 1.5mmol/litre may be fatal and toxic effects include tremor, ataxia, dysarthria, nystagmus, renal impairment and convulsions. If these potentially hazardous signs occur, treatment should be stopped, serumlithium concentrations redetermined and steps taken to reverse lithium toxicity. In mild cases withdrawal of Lithium and administration of sodium salts and fluid will reverse the toxicity. A serumlithium concentration in excess of 2mmol/litre requires urgent treatment.(BNF). Haemodialysis is the treatment of choice for severe poisoning and should be considered in all patients with marked neurological features.There is no known antidote to lithium poisoning and activated charcoal does not adsorb lithium.Sodium-depleting diuretics should not be used in any circumstances.All patients should be observed for a minimum of 24 hours. ECG should be monitored in symptomatic patients. Steps should be taken to correct hypotension.

Pharmaceutical precautions
Store in a cool, dry place. Protect from light.Keep out reach of children

Presentation
Litiam®ER tablet: Each extended releasetablet contains Lithium carbonateUSP400mg.

Package quantities
Litiam®ER tablet: Carton of 40tablets per pack.

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