CAMCOLIT

Camcolit 400 mg tablets are usually administered according to a twice daily regimen. When lithium levels have stabilised, a once daily regimen may be preferred. Lithium carbonate has a narrow therapeutic window. 4). Lithium therapy should not be initiated unless adequate facilities for routine monitoring of plasma concentrations are available.

On initiation of treatment, plasma therapy concentrations should be measured weekly until stabilisation is achieved, then weekly for one month and at monthly intervals thereafter. Additional measurements should be made if signs of lithium toxicity occur, on dosage alteration, development of significant intercurrent disease, signs of manic depressions or depressive relapse and if significant change in sodium or fluid intake occurs.

g. 5). As bioavailability may vary between formulations, should a change of preparations be made, blood levels should be monitored weekly until restabilisation is achieved. 5mmol/l should be avoided. In the event of toxicity, lithium should be withdrawn immediately.

g. 2 weeks, to prevent the risk of relapse.

Posology Acute mania:

Adults: Treatment should be initiated in hospital where regular monitoring of plasma lithium levels can be conducted. 0 mmol/l 12 hours after the last dose. The required plasma 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 blood samples for plasma lithium estimations are taken 12 hours after the last dose of lithium. 1. 1,000-1,500 mg of lithium carbonate are administered daily for the first five days. A blood sample for plasma lithium estimation is taken 12 hours after the last dose on the fifth day, and the dosage of Camcolit is adjusted to keep the plasma lithium level within the therapeutic range.

Subsequently, regular plasma 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 average and older patients a lower dose.

2. Even when the initial dosage is calculated in this way, it is still desirable that plasma lithium levels should be determined at weekly intervals during the first three weeks of treatment, and any necessary adjustments to dosage made as a result 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 regular plasma lithium monitoring are available, and assays are initiated within one week.

Prophylaxis of recurrent affective disorders:

Adults: (Including unipolar mania & unipolar depressions and bipolar manicdepressive illness): A low dose of 300-400 mg of lithium carbonate can be administered daily for the first seven days. 8 mmol/l.

Aggressive and self-mutilating behaviour:

Adults: Dosage is at the lower end of the range for the treatment for manic depressive illness. Special Populations Elderly Start treatment with a low dose. Elderly patients often require lower lithium dosage to achieve therapeutic serum levels.

0 mmol/l. Toxic symptoms are more likely at lower concentrations than in the general population. Paediatric population Camcolit should not be used in children. Method of administration For oral administration.

0 mmol/l. Initial Therapy: fine tremor of the hands, polyuria and thirst may occur. Blood and lymphatic system disorders: leucocytosis. Immune system disorders: increase in antinuclear antibodies. Endocrine disorders: disturbances of thyroid function including (euthyroid) goitre, hypothyroidism and hyperthyroidism.

Very Frequent:

Hypercalcaemia. Frequency not known: hyperparathyroidism, parathyroid adenoma, parathyroid hyperplasia. Metabolism and nutrition disorders: hypercalcaemia, hypermagnesaemia, hyperglycaemia, anorexia, weight gain.

Psychiatric disorders:

Delirium Nervous system disorders: coma, benign intracranial hypertension, syndrome of irreversible lithium effectuated neurotoxicity (SILENT), encephalopathy, stupor, seizures, neuroleptic malignant syndrome, myasthenia gravis, serotonin syndrome, parkinsonism, extrapyramidal symptoms, ataxia, dizziness, memory impairment, mild cognitive impairment may occur during long term use, giddiness, nystagmus, slurred speech, vertigo, hyperactive deep tendon reflexes, dazed feeling, fine hand tremors.

Eye Disorders: scotomata and blurred vision. Cardiac disorders: cardiac arrest, ventricular fibrillation, ventricular tachycardia, ventricular arrhythmias, Torsade de pointes, QT interval prolongation, cardiomyopathy, arrhythmia, bradycardia, sinus node dysfunction, ECG changes.

Frequency not known:

Brugada syndrome (Unmasking/aggravation) Vascular disorders: peripheral circulatory collapse, hypotension. Gastrointestinal disorders: gastritis, nausea, diarrhoea, vomiting, dry mouth, excessive salivation. Lithium salts have been implicated in dysgeusia.

Skin and subcutaneous tissue disorders:

Allergic rash, exacerbation of psoriasis, acneiform eruptions, alopecia, acne, papular skin disorder, folliculitis, pruritus, rash.

Frequency not known: lichenoid drug reaction Frequency not known:

Drug reaction with eosinophilia and systemic symptoms (DRESS) Musculoskeletal and connective tissue disorders: muscle weakness, rhabdomyolysis. Renal and urinary disorders: symptoms of nephrogenic diabetes insipidus, impairment of renal function, permanent changes in the kidney, nephrotic syndrome, histological renal changes with interstitial fibrosis after long term treatment, polyuria, polydipsia.

4). Reproductive system and breast disorders: sexual dysfunction. General disorders and administration site conditions: sudden unexplained death, oedema, asthenia, lethargy, thirst, fatigue, and malaise can occur due to lithium toxicity.

Some adverse events will be seen when Lithium levels are raised – for symptoms see section

Lithium carbonate has a narrow therapeutic window. The dose required for treatment must be titrated and adjusted on the basis of regular monitoring of serum concentration of lithium. Lithium therapy should not be initiated unless adequate facilities for routine monitoring of plasma concentrations are available.

Elderly patients are particularly liable to lithium toxicity. Use with care as lithium excretion may also be reduced. 2). 4) - Thyroid function should be evaluated. Patients should be euthyroid before initiation of lithium therapy. -Cardiac function should be assessed especially in patients with cardiovascular disease.

Renal, cardiac and thyroid functions should be re-assessed periodically. 8). 8). Patients should be warned to report persistent headache and/or visual disturbances. 8). Caution should be exercised in patients with risk factors for QT interval prolongation (which include cardiac disease, bradycardia, thyroid disease, hypokalaemia, hypomagnesaemia, hypocalcaemia, female sex and advanced age.

Brugada syndrome Lithium may unmask or aggravate Brugada syndrome, a hereditary disease of the cardiac sodium channel with characteristic ECG changes (right bundle branch block and ST segment elevation in right precordial leads), which may lead to cardiac arrest or sudden death.

3). Caution is advised in patients with a family history of cardiac arrest or sudden death. Concomitant administration of antipsychotics Concomitant administration of antipsychotics should be avoided. Bariatric surgery In patients who have undergone bariatric surgery, a lower maintenance dose of lithium may be required.

Lithium levels should be closely monitored due to the risk of lithium toxicity until weight has stabilized. e. at trough level 12 hours following the last dose). 5 mmol/litre, although they can appear at lower concentrations. They call for immediate withdrawal of treatment and should always be considered very seriously Serum concentration of lithium should be measured every 5 to 7 days from initiation until stabilisation is achieved and at regular intervals for the duration of treatment.

Serum lithium concentrations should be monitored more frequently (revert to weekly monitoring) in the following circumstances: - Dosage alteration or change of lithium formulation (bioavailability may differ) - Significant intercurrent disease - Intercurrent infection - Significant change in sodium intake - Significant change in fluid intake - Treatment with drugs altering renal clearance of lithium - Treatment with drugs likely to upset electrolyte balance.

Patients should also be warned to report if polyuria or polydipsia develops. Episodes of nausea and vomiting or other conditions leading to salt/water depletion (including severe dieting) should also be reported. Patients should be advised to maintain their usual salt and fluid intake.

Lithium should be stopped 24 hours before major surgery, but the normal dose can be continued for minor surgery if fluids and electrolytes are carefully monitored Renal impairment Lithium excretion is reduced in the presence of renal impairment.

This increases the risk of toxicity. 3). If patients with mild or moderate renal impairment are being treated with lithium, serum levels should be closely monitored. Renal function should be monitored in patients with renal impairment, and in patients with polyuria and polydipsia.

9 for symptoms of intoxication) and advice given for the need for urgency in seeking medical assistance if these symptoms appear. 8). Excipients This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1. • Severely impaired renal function • Untreated or untreatable hypothyroidism. • Cardiac disease associated with rhythm disorder. 4) • Low body sodium levels for example dehydrated patients, those on low sodium diets, or those with Addison’s disease.

• Breast-feeding.