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PRIADEL is a brand name for Lithium Citrate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1. In the management of acute manic or hypomanic episodes. 2. In the management of episodes of recurrent depressive disorders where treatment with other antidepressants has been unsuccessful. 3. In the prophylaxis against bipolar affective disorders. 4. Control of aggressive behaviour or intentional self-harm.
Verbatim from this product's MHRA label. Tap a section to expand.
Dosage must be individualised depending on serum lithium levels and clinical response. The dosage necessary to maintain serum lithium levels within the therapeutic range varies from patient to patient. The minimum effective dose should be sought and maintained.
As a general rule, the following dosing schedule is recommended. Please refer also to the specific recommendations for the different indications as listed below: 1. In patients of average weight (70kg) an initial daily dose of 10-30ml Priadel Liquid (equivalent to 408-1224mg lithium carbonate) should be given in divided doses, ideally twice a day.
When changing between lithium preparations serum lithium levels should first be checked, then Priadel Liquid therapy started at a daily dose as close as possible to the dose of the other form of lithium. As bioavailability varies from product to product (particularly with regard to slow release preparations) a change of product should be regarded as initiation of new treatment.
2. Four to a maximum of seven days after starting treatment, serum lithium levels should be measured. Optimal maintenance serum levels may vary from patient to patient. 3. Blood samples should be taken 12 or 24 hours after the previous dose of lithium, just before the next dose is due, to measure the serum lithium level at its trough.
The objective is to adjust the Priadel dose so as to maintain the “Target” serum lithium concentrations at 12 and 24 hours shown in the table below. 5/5ml double ended spoon to provide adjustments equivalent to 102mg and 204mg lithium carbonate respectively.
Serum lithium levels should be monitored weekly until stabilisation is achieved. 5 mmol/l. The liquid should be taken at the same time every day. A double dose to make up for a dose that has been missed should not be taken. 4. Lithium therapy should not be initiated unless adequate facilities for routine monitoring of serum concentrations are available.
Following stabilisation of serum lithium levels, the period between subsequent measurements can be increased gradually, but should not normally exceed two to three months. 9). 5. Whilst a high proportion of acutely ill patients may respond within three to seven days of the commencement of therapy with Priadel Liquid it should be continued through any recurrence of the affective disturbance.
0 mmol/l. The adverse reactions usually subside with a temporary reduction or discontinuation of lithium treatment. Mild gastrointestinal effects such as nausea, a general discomfort and vertigo, may occur initially, but frequently disappear after the first few days of lithium administration.
Fine hand tremors, polyuria and mild thirst may persist. Tabulated list of adverse reactions System Organ Class Adverse reactions Blood and lymphatic system disorders Leucocytosis. Endocrine disorders • Long-term adverse effects may include thyroid function disturbances such as euthyroid goitre and/or hypothyroidism and thyrotoxicosis.
Lithium-induced hypothyroidism may be managed successfully with concurrent thyroxine. • Hypermagnesaemia has been reported. • Very frequent: Hypercalcaemia • Frequency not known: Hyperparathyroidism, parathyroid adenoma, parathyroid hyperplasia Metabolism and nutrition disorders Weight increase, hyperglycaemia.
Psychiatric disorders Confusion, delirium Nervous system disorders • Ataxia, hyperactive deep tendon reflexes, slurred speech, dizziness, stupor, coma, myasthenia gravis, giddiness, dazed feeling, memory impairment. 4). 5), extrapyramidal disorders, encephalopathy, cerebellar syndrome (usually reversible), nystagmus.
The above symptoms may result in fall. • Peripheral neuropathy may occur on long- term treatment and is usually reversible at cessation of lithium. • Dysgeusia. • Serotonin syndrome • Neuroleptic malignant syndrome Eye disorders Blurred vision, scotoma.
5), AV block, cardiomyopathy.
Frequency not known:
Brugada syndrome (Unmasking/aggravation) Gastrointestinal disorders Abdominal discomfort, taste disorder, nausea, vomiting, diarrhoea, gastritis, salivary hypersecretion, dry mouth, anorexia. Skin and subcutaneous tissue disorder Folliculitis, pruritus, papular skin disorders, acne or acneform eruptions, aggravation or occurrence of psoriasis, allergic rashes, alopecia, cutaneous ulcers Frequency unknown: lichenoid drug reaction.
• General When considering Priadel therapy, it is necessary to ascertain whether patients are receiving lithium in any other form. If so, check serum levels before proceeding. 2). 9). They should be warned of the urgency of immediate action should these symptoms appear, and also of the need to maintain a constant and adequate salt and water intake.
At the first sign of toxicity, the patient should consult a physician and lithium levels should be checked. 9). • Monitoring recommendations Before starting treatment with lithium, renal function, cardiac function and thyroid function should be evaluated.
Patients should be euthyroid before initiation of lithium therapy. 3). Renal, cardiac and thyroid functions should be re-assessed regularly during treatment with lithium. 2. • Renal impairment Since lithium is primarily excreted via the renal route, significant accumulation of lithium may occur in patients with renal insufficiency.
2) and the dose should be adjusted accordingly. If very regular and close monitoring of serum lithium levels and plasma creatinine levels is not possible, lithium should not be prescribed in this population. 3). The possibility of hypothyroidism and renal dysfunction arising during prolonged treatment should be borne in mind and periodic assessments made.
Patients should be warned to report if polyuria or polydipsia develop. 8), renal function should be monitored in addition to the routine serum lithium assessment. 8). • Fluid/electrolyte balance If episodes of nausea, vomiting, diarrhoea, excessive sweating, and/or other conditions leading to salt/water depletion (including severe dieting) occur, lithium dosage should be closely monitored and dosage adjustments made as necessary.
Drugs likely to upset electrolyte balance such as diuretics should also be reported. Indeed, sodium depletion increases the lithium plasma concentration (due to competitive reabsorption at the renal level). In these cases, lithium dosage should be closely monitored and reduction of dosage may be necessary.
1. • Cardiac disease. • Cardiac insufficiency. • Severe renal impairment. • Untreated hypothyroidism. • Breast-feeding. • Patients with low body sodium levels, including for example dehydrated patients or those on low sodium diets. • Addison’s disease.
• Brugada syndrome or family history of Brugada syndrome.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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This is important as the full prophylactic effect may not occur for 6 to 12 months after the initiation of therapy. 6. In patients who show a positive response with Priadel Liquid, treatment is likely to be long term. Careful clinical appraisal of the patient should be exercised throughout medication (see Precautions).
7. If lithium is to be discontinued, particularly in cases of high doses, the dose should be reduced gradually. Prophylactic treatment of bipolar affective disorders and control of aggressive behaviour or intentional self-harm: It is recommended that the described treatment schedule is followed.
The dosage needed may vary from patient to patient. 5 mmol/l. Optimal maintenance serum lithium levels may vary from patient to patient.
Treatment of acute manic or hypomanic episodes and recurrent depressive disorders:
It is likely that a higher than normal Priadel Liquid intake may be necessary during an acute phase. 2 mmol/l until acute symptoms have been controlled. In all other details the described treatment schedule is recommended. The dosage needed may vary from patient to patient.
5 mmol/l. Once clinical control is achieved, dosage should be reduced to the prophylactic dose.
Elderly:
Elderly patients or those below 50kg in weight, often require lower lithium dosage to achieve therapeutic serum lithium levels. Starting doses of 204mg to 408mg are recommended taken twice daily. Dosage increments of 204 to 408mg every 3 to 5 days are usual.
0 mmol/L. 8 mmol/L is generally in the range of 612 to 1224 mg/day.
Paediatric population:
Not recommended. 4). 3). Method of administration For oral administration.
4). This is usually reversible on lithium withdrawal. • Long-term treatment with lithium may result in permanent changes in kidney histology, and impairment of renal function. • High serum concentrations of lithium including episodes of acute lithium toxicity may aggravate these changes.
• Rare cases of nephrotic syndrome have been reported. 4). Reproductive system and breast disorders Sexual dysfunction. General disorders and administration site conditions • Peripheral oedema. • Urticaria and angioedema, attributed to some excipients such as acacia powder (or Arabic gum).
If any of the above symptoms appear, treatment should be stopped immediately and arrangements made for serum lithium measurement. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Caution should be exercised to ensure that diet and fluid intake are normal in order to maintain a stable electrolyte balance. This may be of special importance in very hot weather or work environment. Infectious diseases including colds, influenza, gastro- enteritis and urinary infections may alter fluid balance and thus affect serum lithium levels.
Treatment discontinuation should be considered during any intercurrent infection. 8). 8). Patients should be warned to report persistent headache and/or visual disturbances. g. 8). • 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.
Lithium is not recommended in patients with known Brugada syndrome or a family history of Brugada syndrome. Caution is advised in patients with a family history of cardiac arrest or sudden death. • 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. • Elderly patients Elderly patients are particularly liable to lithium toxicity and may exhibit adverse reactions at serum levels ordinarily tolerated by younger patients.
2). • Paediatric population The use in children is not recommended. • Excipients This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.