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APO-LITHIUM CARBONATE 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: APO-LITHIUM CARBONATE (Lithium Carbonate Capsules) is indicated in: • the treatment of manic episodes of manic-depressive illness. Maintenance therapy has been found to be useful in preventing or diminishing the frequency of subsequent relapses in bipolar manic-depressive patients (with a history of mania). 1.1…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Typical symptoms of mania, as an affective disorder, include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, or poor judgment, aggressiveness, and possibly hostility.
When given to a patient experiencing a manic episode, APO-LITHIUM CARBONATE may produce a normalization of symptomatology within 1 to 3 weeks. Selection of patients and approach to lithium therapy 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 Diagnosis 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, • ECG, possibly electrolytes, • TSH.
Long-term treatment should also include:
APO-LITHIUM CARBONATE (Lithium Carbonate Capsules) Page 6 of 36 • creatinine clearance, • a urine concentration test. Also, consider serum calcium level before onset of treatment, after 6 months, and yearly thereafter in long-term treatment.
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, • a check for lithium adverse reactions 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, • attention to renal and thyroid function should be maintained throughout, with tests used for baseline screening repeated as required.
1 Adverse Reaction Overview Adverse reactions may be encountered even when serum lithium levels remain below 1 mEq/L. The most frequent adverse reactions are the initial post-absorptive symptoms, believed to be associated with rapid rise in serum lithium levels.
They include nausea, abdominal pain, vomiting, diarrhea, vertigo, muscle weakness, sleepiness and a dazed feeling, and frequently disappear after stabilization of therapy. The more common and persistent adverse reactions are fine tremor of the hands which is not responsive to antiparkinson drugs, and at times, fatigue, thirst and polyuria (renal toxicity).
These adverse reactions may subside with continued treatment or a temporary reduction or cessation of dosage. If persistent, a lowering or cessation of dosage and reassessment of lithium therapy is indicated. 5 to 2 mEq/L, and moderate to severe reactions at levels above 2 mEq/L.
Permanent neurological damage has been reported after exposure to toxic levels of lithium. A number of patients may experience lithium accumulation during initial therapy, increasing to toxic levels and requiring immediate discontinuation of the drug.
Some elderly patients with lowered renal clearances for lithium may also experience different degrees of lithium toxicity, requiring reduction or temporary withdrawal of medication. However, in patients with normal renal clearance the toxic manifestations appear to occur in a fairly regular sequence related to serum lithium levels.
The usually transient gastrointestinal symptoms are the earliest adverse reactions to occur. A mild degree of fine tremor of the hands may persist throughout therapy. Thirst and polyuria may be followed by increased drowsiness, ataxia, tinnitus, and blurred vision, indicating early intoxication.
As intoxication progresses the following manifestations may be encountered: confusion, increasing disorientation, muscle twitching, hyperreflexia, nystagmus, seizures, diarrhea, vomiting and eventually coma and death. 5 Post-Market Adverse Reactions The following toxic reactions have been reported and appear to be related to serum lithium levels, including levels within the therapeutic range.
, Skin, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) 07/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ................................................................................................................... 1 Pediatrics ...................................................................................................................
2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS ......................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................. 5 4 DOSAGE AND ADMINISTRATION ...................................................................................... 1 Dosing Considerations ...............................................................................................
2 Recommended Dose and Dosage Adjustment .......................................................... 4 Administration ........................................................................................................... 5 Missed Dose ..............................................................................................................
9 5 OVERDOSAGE .................................................................................................................. 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING...................................... 1 Special Populations..................................................................................................
APO-LITHIUM CARBONATE is contraindicated in patients: • who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, COMPOSITION AND PACKAGING.
• with significant renal or cardiovascular disease; • with severe debilitation; • with severe dehydration; • with sodium depletion; • receiving diuretics; • brain damage; • conditions requiring low sodium intake. If the psychiatric indication is life-threatening, and if such a patient fails to respond to other measures, APO-LITHIUM CARBONATE may be undertaken with extreme caution, including daily serum lithium determinations and adjustments to the usually low doses ordinarily tolerated by these individuals.
In such instances, hospitalization is necessary. APO-LITHIUM CARBONATE (Lithium Carbonate Capsules) Page 5 of 36
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Lithium Carbonate in Canada.
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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 adverse reactions.
Three daily doses should be used initially, at least until the daily dosage is established. The next aim 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:
APO-LITHIUM CARBONATE (Lithium Carbonate Capsules) Page 7 of 36 • careful reconfirmation of the diagnosis of primary affective disorder; • the health status of the patient; • the adverse reactions of lithium therapy experienced by the patient, • 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 APO-LITHIUM CARBONATE. Once daily administration Clinical trials comparing once daily at bedtime dosing versus 2 to 4 times-a-day dosing have shown that urinary volume is significantly decreased with single daily dosing.
Total daily doses of APO-LITHIUM CARBONATE required to reach therapeutic levels were lower with the once-daily dosage schedule than with the divided dosage schedule. In addition, administration of a single bedtime dose of APO-LITHIUM CARBONATE may result in initial post-absorptive symptoms, which are believed to be associated with rapid rise in serum lithium levels, to occur at night while the patient is sleeping.
In one study, significantly less sclerotic glomeruli, atrophic tubules and interstitial fibrosis were observed in patients on a single daily dosage regimen, as compared to patients on a multiple daily dosage regimen. 2 Recommended Dose and Dosage Adjustment Acute Mania The therapeutic dose 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 concentrations and clinical response. 2 mEq or mmol/L (in blood samples drawn […]
Autonomic Nervous System: blurred vision, dry mouth. Cardiovascular: cardiac arrhythmia, hypotension, peripheral circulatory collapse. • EEG Changes: diffuse slowing, widening of frequency spectrum, potentiation and disorganization of background rhythm.
APO-LITHIUM CARBONATE (Lithium Carbonate Capsules) Page 15 of 36 • ECG Changes: reversible flattening, isoelectricity or inversion of T waves. CNS: blackout spells, epileptiform seizures, slurred speech, dizziness, vertigo, incontinence of urine or feces, somnolence, psychomotor retardation, restlessness, confusion, stupor, coma.
Dermatologic: drying and thinning of hair, anesthesia of skin, acne, chronic folliculitis, xerosis cutis, alopecia and exacerbation of psoriasis. • Drug Rash with Eosinophilia and Systemic Symptoms (DRESS): skin eruption, hematologic abnormalities (eosinophilia, atypical lymphocytosis), lymphadenopathy, and internal organ involvement (liver, kidney, lung).
Gastrointestinal: anorexia, nausea, vomiting, diarrhea. Genitourinary: albuminuria, oliguria, polyuria, glycosuria. Miscellaneous: fatigue, lethargy, transient scotomata, dehydration, weight loss, tendency to sleep. Miscellaneous reactions frequently unrelated to dosage: leucocytosis, headache, diffuse non-toxic goiter with or without hypothyroidism, transient hyperglycemia, generalized pruritus with or without rash, cutaneous ulcers, albuminuria, worsening of organic brain syndrome, excessive weight gain, edematous swelling of ankles or wrists, and thirst or polyuria, sometimes resembling diabetes insipidus, and metallic taste.
A single instance has been reported of the development of painful discoloration of fingers and toes and coldness of the extremities within one day of starting treatment with lithium carbonate. The mechanism through which these symptoms (resembling Raynaud's syndrome) developed is not known.
Recovery followed discontinuance. ) and hyperactive deep tendon reflexes.
Serious reactions to long-term therapy:
In addition to other possible adverse reactions, the main concern during chronic lithium therapy centres on the kidney function, the thyroid, parathyroid, the bones and skin. Thyroid Abnormalities: euthyroid goiter and/or hypothyroidism (including myxedema) accompanied by lower T3 and T4 levels and elevated TSH.
Iodine131 uptake may be elevated. On the average 5 to 15% of patients on long-term lithium therapy manifest clinical signs or have altered serum hormone levels. Rare cases of hyperthyroidism have been reported. APO-LITHIUM CARBONATE (Lithium Carbonate Capsules) Page 16 of 36
1 Pregnant Women .................................................................................................... 2 Breast-feeding .........................................................................................................
3 Pediatrics ................................................................................................................. 4 Geriatrics .................................................................................................................
1 Adverse Reaction Overview ..................................................................................... 5 Post-Market Adverse Reactions .............................................................................. 4 Drug-Drug Interactions ............................................................................................
5 Drug-Food Interactions............................................................................................ 1 Mechanism of Action ...............................................................................................
2 Pharmacodynamics ................................................................................................. 3 Pharmacokinetics ....................................................................................................
3 Comparative Bioavailability Studies......................................................................... 27 APO-LITHIUM CARBONATE (Lithium Carbonate Capsules) Page 4 of 36 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-LITHIUM CARBONATE (Lithium Carbonate Capsules) is indicated in: • the treatment of manic episodes of manic-depressive illness.
Maintenance therapy has been found to be useful in preventing or diminishing the frequency of subsequent relapses in bipolar manic-depressive patients (with a history of mania). 3 Pediatrics). 2 Geriatrics Geriatrics (> 65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric […]