CAMCOLIT-400 TABLET 400 MG [SIN01305P]

Product Info

CAMCOLIT-400 TABLET 400 MG

[SIN01305P]

Uses – Treatment and prophylaxis of mania, manic-depressive illness and recurrent depression.

DOSAGE AND ADMINISTRATION – Tablets for oral administration. Camcolit-400 may be given in a single daily dose, whereas Camcolit-250 should be given in divided dosage.

Acute mania: Treatment of mania should be initiated in hospital where regular monitoring of serum lithium levels and be conducted.

The dosage of Camcolit should be adjusted to produce a serum lithium level between 0.6 and 1.2 mmol/12 hours after the last dose. The required serum lithium level may be achieved in one of two ways but whichever is adopted, regular estimations must be carried out to ensure maintenance of levels within the therapeutic range. For consistent results, it is essential that the bloods samples for serum lithium estimations are taken 12 hours after the last dose of lithium

1. 1,500–2,000 mg of lithium carbonate are administered daily for the first five or seven days. A blood sample for serum lithium estimation is taken 12 hours after the last dose on the fifth or seventh day, and the dosage of Camcolit is adjusted to keep the serum lithium level within the therapeutic range.

   Subsequently, regular serum lithium estimations must be carried out and, where necessary, the dosage of Camcolit adjusted accordingly.

   The precise initial dose of lithium should be decided in the light of the age and weight of the patient; young patients often require a dose higher than the average and older patients a lower dose.

2. A lithium clearance test is carried out and the initial dosage calculated from the results. Even when the initial dosage is calculated in this way, it is still desirable that the serum lithium levels should be determined at weekly intervals during the first three weeks of treatment, and any necessary adjustments to dosage made as a results of the levels actually obtained.

   Most of the above applies in the treatment of hypomania as well as mania, but the patient (if not too ill) can be started on treatment as an outpatient provided that facilities for periodic serum lithium monitoring are available.

Prophylaxis of recurrent affective disorders (including unipolar mania, unipolar depressions and bipolar manic-depressive illness): A dosage of 500–1,200 mg of lithium carbonate can be administered daily for the first seven days. A blood sample for serum lithium estimation is then taken 12 hours after the last dose, and the dosage of Camcolit is adjusted to keep the level of plasma lithium level within the effective range. Clinical improvement is usually associated with serum concentrations of 0.5mmol/1 or above. Toxic symptoms are usually associated with concentrations exceeding 1.5mmol/1

Use in elderly: Start treatment with a low dose. Usually 500–1,000 mg/day.

Toxic symptoms are likely with serum concentrations above 1.0mmol/1

Use in children: Not recommended.

Measurement of serum lithium concentrations: The dose required for treatment must be titrated and adjusted on the basis of regular monitoring of the serum concentration (See Monitoring of blood lithium levels – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Lithium therapy should not be initiated unless adequate facilities for routine monitoring of serum concentrations are available. On initiation of therapy serum concentrations should be measured weekly until stabilization is achieved, then weekly for one month and at monthly intervals thereafter. Additional measurements should be made if signs of lithium toxicity occur (see below), on dosage alteration, development of significant intercurrent disease, signs of manic or depressive relapse and if significant change in sodium of fluid intake occurs. More frequent monitoring is required if patients are receiving any drug treatment that affects renal clearance of lithium, e.g. diuretics and NSAIDs (See Drug Interaction – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

As bioavailability may vary between formulations, should a change of preparation be made, blood levels should be monitored weekly until restabilisation is achieved.

Withdrawal: If lithium is to be discontinued for other reasons, particularly in cases of high doses, the dose should be reduced gradually over a suitable period of time, e.g. 2 weeks, to prevent the risk of relapse.

Contra-indications:

• A history of hypersensitivity to lithium or any of the excipients.

• Untreated or untreatable hypothyroidism.

• Cardiac disease associated with rhythm disorder.

• Brugada syndrome or family history of Brugada syndrome

• Low body sodium levels for example dehydrated patients, those on low sodium diets, or those with Addison’s disease.

• Breast feeding.

• Severe Impaired Renal Function