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LITHANE is a brand name for Lithium Carbonate, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: LITHANE (lithium carbonate) is indicated for: the treatment of acute manic episodes in patients with manic-depressive disorders. Maintenance therapy has been found useful in preventing or diminishing the frequency of subsequent relapses in bipolar manic-depressive patients (with a strong history of mania). 1.1…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Selection of patients and approach to lithium therapy: since lithium acts without the production of "sedation", some prefer it to neuroleptics or use these to supplement lithium therapy and obtain rapid control of overt manic behaviour.
Lithium also has a useful indication in those cases that fail to respond to neuroleptics. The results of lithium therapy depend largely on the nature and course of the illness itself, rather than on the symptoms. The selection of patients for long-term treatment requires a clear-cut diagnosis of primary affective disorder, the condition for which the stabilizing effects of lithium have been found useful.
The variables that have been more consistently associated with response to lithium therapy in patients with a primary affective disorder are: the good quality of remissions with good function and no significant symptomatology during the free intervals between previous episodes of illness; low frequency of episodes, typically 1 or 2 (and not more than 3 or 4) per year; and symptomatology during the acute episodes that meet strict criteria for a primary affective disorder (DSM-III: Research Diagnostic Criteria).
Screening for lithium candidates should include at least: a medical history and physical examination with emphasis on the CNS, urinary, cardiovascular, gastrointestinal and endocrine systems and the skin. It should also include: routine 24 hour urine volume, serum creatinine, record of weight, an ECG, possibly electrolytes and TSH, and for long-term treatment, creatinine clearance and a urine concentration test.
Other examinations and tests should be used when indicated. Monitoring lithium treatment should include, for each visit: mental status, physical examination, weight, 12 hour serum lithium and a check for lithium side effects and compliance.
It should also include serum creatinine every 2 months, plasma thyroid hormone and TSH every 6 to 12 months, particularly in female patients, and attention to renal and thyroid function should be maintained throughout, with tests used for baseline screening repeated as required.
Also, consider serum calcium level before onset of treatment, after 6 months, and yearly thereafter in long-term treatment. The first objective of treatment is to establish an effective and safe daily dosage of lithium with the aid of standardized 12 hour serum lithium levels maintained within the therapeutic range, as high as necessary for efficacy, and with the patient as much as possible free of significant side effects.
and usually respond to reduction of dosage. Lithium intoxication has been preceded by the appearance or aggravation of the following symptoms: sluggishness, drowsiness, lethargy, coarse tremors or muscle twitching, loss of appetite, vomiting and diarrhea.
Occurrence of these symptoms requires immediate cessation of medication and careful clinical reassessment and management. In eight cases of lithium poisoning, the patients frequently developed muscle rigidity with hyperactive deep reflexes, generalized muscle tremors or fasciculations, attacks of hyperextension of the limbs with gasping and wide opening of the eyes, and sometimes epileptic seizures and various neurological dysfunction.
There was progressive impairment of consciousness and in some patient’s coma. Electroencephalography (EEG) changes in some patients consisted of decrease of alpha activity and increase of theta and delta activity, the latter at times paroxysmal with maximal activity frontally.
Periods of beta activity with sharp waves were also observed. The kidney function was probably impaired in several patients. Three of these patients died, all of pulmonary complications. Treatment No specific antidote for lithium poisoning is known.
The treatment of lithium poisoning is symptomatic. Early symptoms of lithium toxicity can usually be treated by reduction or cessation of dosage of the drug and resumption of treatment at a lower dose after 24 to 48 hours. In severe cases of lithium poisoning, the first and foremost goal of treatment consists of elimination of this ion from the organism.
Treatment of lithium poisoning is 1) lavage, 2) correction of fluid and electrolyte imbalance, and 3) regulation of kidney function. Sodium depletion in particular must be corrected. However, administration of large amounts of sodium in the absence of depletion of this electrolyte has not been very successful in many as a means of speeding lithium excretion.
, General). Lithium may be used concomitantly with neuroleptic drugs (See 7 WARNINGS AND PRECAUTIONS, Neurologic and 9 DRUG INTERACTIONS). Serum lithium levels in uncomplicated cases receiving maintenance therapy during remission should be monitored at least every 2 months.
4 mmol/L. Elderly patients often respond to reduced dosage and may exhibit signs of toxicity at serum levels ordinarily tolerated by other patients. Table 1. e. 8-12 hours after the previous dose). Total reliance must not be placed on serum levels alone.
Accurate patient evaluation requires both clinical and laboratory analysis. Discontinuation of Therapy The majority of patients do not experience withdrawal symptoms or rebound phenomenon upon cessation of long-term lithium therapy.
In view of the occasional reports of sudden relapses occurring with abrupt discontinuation, gradual discontinuation is recommended unless abrupt withdrawal is necessary because of toxicity. 5 Missed Dose In case of missed dose, the next dose should be taken as scheduled.
A double dose should not be taken.
Product Monograph Date:
September 2022 LITHANE Lithium Carbonate Page 8 of 30 5 OVERDOSAGE Symptoms Lithium toxicity is closely related to the concentration of lithium in the blood and is usually associated with serum levels in excess of 2 mmol/L. Early signs of toxicity which may occur at lower serum levels are described under section
LITHANE (lithium carbonate) is contraindicated in patients with: who are hypersensitive to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see 6 Dosage forms, strengths, composition and packaging.
significant cardiovascular or renal disease; evidence of severe debilitation; evidence of severe dehydration; sodium depletion; brain damage; conditions requiring low sodium intake.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Three daily doses should be used initially, at least until the daily dosage is established.
The next aim Product Monograph Date:
September 2022 LITHANE Lithium Carbonate Page 6 of 30 is to move to an optimal dose, which should be as low as possible, consistent with protection against relapse. During follow-up, an adjustment to lower dosages may be required to minimize adverse effects, and a change in the lithium preparation used and/or the frequency of dosing, either towards multiple doses or towards a single dose, may be necessary to handle absorption- related adverse effects or concern over possible renal toxicity.
Intermittent lithium treatment in carefully selected patients has been recommended by some lithium experts, but should not be undertaken without careful planning and great caution. The cooperation of patients and relatives is required throughout.
Before deciding on the institution of long-term treatment, it is essential to establish that the patient has clearly responded to a course of stabilizing lithium therapy and that the risk of such therapy is acceptable. Maintaining a patient with a lithium non-responsive condition on long-term therapy poses an unacceptable risk.
A decision with regards to long-term therapy can be made during a time-limited trial of lithium therapy with frequent reassessment of outcome. The following are among the factors to be reassessed before a decision is made: careful reconfirmation of the diagnosis of primary affective disorder; the health status of the patient; the side effects of lithium therapy experienced by the patient; and the response to treatment.
Assessment of response to treatment is based strictly on firm evidence of relapse prevention during a reasonable trial period, but can be assisted by consideration of the predictors of response outlined above. Great pains should be taken to exclude false responders and false non-responders.
It should also be borne in mind that non-responders are more susceptible to the adverse effects of lithium. 2 Recommended Dose and Dosage Adjustment Acute Mania The therapeutic dose of LITHANE (lithium carbonate) for the treatment of acute mania should be based primarily on the patient's clinical condition.
It must be individualized for each patient according to blood levels and clinical response. 5 mmol/L (in blood samples drawn before the patient has had his first lithium dose of the day; see Note below Table 1). In properly screened adult patients, the suggested daily dosage for acute mania is 1800 mg (approximately 50 mmol), divided into three doses.
In view of the large variability of renal lithium excretion between individuals, it is suggested that lithium treatment be started at a dose between 600 and 900 mg/day, reaching a level of 1200 to 1800 mg in divided doses on the second day (Table 1).
Depending on the patient's clinical condition, the initial dosage should be adjusted to produce the desired serum lithium level. The weight of the patient should also influence the choice of the initial dose. LITHANE should be used cautiously and in reduced doses in the elderly patient, usually in the range of 600 to 1200 mg/day.
5 mmol/L (Table 1). Long-Term Control After the acute […]
Lithium excretion may be facilitated by the judicious use of intravenous urea, sodium bicarbonate, acetazolamide or aminophylline. Hemodialysis is an effective and rapid means of removing the ion from the severely toxic patient or in the presence of impaired renal function.
Infection prophylaxis, regular chest X-rays and preservation of adequate respiration are essential. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2 – Dosage Forms, Strengths, Composition and Packaging Description Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Capsules 150 mg, 300 mg Gelatin (from capsules) Product Monograph Date: September 2022 LITHANE Lithium Carbonate Page 9 of 30 LITHANE (lithium carbonate) is available as capsules containing 150 and 300 mg of lithium carbonate.
LITHANE capsules contain pure lithium carbonate with no excipient. The 300 mg green and ivory #1 capsules are available in opaque plastic bottles (HDPE) of 1000 capsules. The 150 mg ivory #3 capsules are available in opaque plastic bottles of 100 and 1000 capsules.
7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General Periodic review and monitoring of kidney and cardiovascular function is advisable during therapy with lithium carbonate. Other laboratory tests should be performed as indicated by the patient's clinical condition.
The appearance of signs of toxicity or a rise in the blood level of lithium after the dosage is stabilized should alert the physician to determine the reasons for lithium accumulation. Therapy with LITHANE (lithium carbonate) requires reaching plasma levels of lithium which are relatively close to the toxic level.
Since lithium is excreted primarily by the kidney, adequate renal function and adequate salt and fluid intake (2500 to 3000 mL) are essential in order to avoid lithium accumulation and intoxication. Thus, a decision to initiate lithium therapy should be preceded by a thorough clinical examination and evaluation of each patient, including laboratory determinations, ECG, and a very careful assessment of renal function.
Means of obtaining accurate determination of serum lithium levels should be available, since frequent serum determinations are required especially during the initial period of treatment. 5 mmol/L, if serious adverse reactions and lithium intoxication are to be avoided.
This lithium level refers to a blood sample drawn before the patient has had his/her first lithium dose of the day, therefore, 9 - 12 hours after his/her last dose of drug. Serum lithium levels should usually be monitored three times weekly during the initial period of administration and periodically as required thereafter.
5 - 2 mmol/L, the drug should be discontinued and, if appropriate, administration resumed at a lower level after 24 hours. Prodromal toxic signs such as fatigue, muscular weakness, incoordination, drowsiness, coarse tremors, diarrhea and vomiting, provide a sensitive warning of lithium intoxication.
In view of the limited dosage range of lithium compared to other psychotropic agents, particular care is required for the patient to receive exactly the prescribed number of LITHANE capsules. Cardiovascular Patients with underlying cardiovascular disease should be observed carefully for signs of arrhythmias.
2 Recommended Dose and Dosage Adjustment. Endocrine and Metabolism Since the formation of non-toxic goiters has been reported during lithium therapy, the thyroid gland should be examined before treatment and appropriate thyroid function tests performed.
Non-toxic Product Monograph […]