Last updated on Apr 2, 2020. Lithium may be restarted in the post-partum period at preconception doses in medically stable patients as long as serum Lithium levels are closely monitored [see Dosage and Administration (2.4), Warnings and Precautions (5.1)]. EEG Changes: diffuse slowing, widening of frequency spectrum, potentiation and disorganization of background rhythm. [See Boxed Warning, Warnings and Precautions (5.1), Drug Interactions (7.1)]. Serum lithium concentrations should not be permitted to exceed 2 mEq/L. You may report side effects to FDA at 1-800-FDA-1088. Available for Android and iOS devices. In a 28-week randomized withdrawal analysis, 31 pediatric patients stabilized on Lithium were assigned to either continue Lithium or switch to placebo. Cranbury, NJ 08512 Lithium is used to treat and prevent episodes of mania (frenzied, abnormally excited mood) in people with bipolar disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). ECG Changes: reversible flattening, isoelectricity or rarely inversion of T-waves, prolongation of the QTc interval. Obtain serum Lithium concentration assay after 3 days, drawn 12 hours after the last oral dose and regularly until patient is stabilized. The group receiving Lithium demonstrated superiority to those receiving placebo in all-cause discontinuation (see Table 5). [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. Advise the patient to read FDA-approved patient labeling (Medication Guide). (U.T. Lithium may cause harm when administered to a pregnant woman. See Table 1 for dosage recommendations for acute and maintenance treatment of bipolar I disorder in adult and pediatric patients (7 to 17 years). -Regular release formulations: 600 mg orally 3 times a day, in the morning, afternoon, and nighttime The real job of psychopharmacology is to improve the biology of the person's brain enough to make them available for other treatments, such as psychotherapy. Neurological signs of Lithium toxicity range from mild neurological adverse reactions such as fine tremor, lightheadedness, lack of coordination, and weakness; to moderate manifestations like giddiness, apathy, drowsiness, hyperreflexia, muscle twitching, ataxia, blurred vision, tinnitus, and slurred speech; and severe manifestations such as clonus, confusion, seizure, coma, and death. Sun Pharmaceutical Industries Ltd. Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Published animal developmental and toxicity studies in mice and rats report an increased incidence of fetal mortality, decreased fetal weight, increased fetal skeletal abnormalities, and cleft palate (mouse fetuses only) with oral doses of Lithium that produced serum concentrations similar to the human therapeutic range. In this study, 81 patients with a Young Mania Rating Scale (YMRS) score of 20 or more were randomized to receive Lithium or placebo in a 2:1 ratio. Lithium is not approved for use by anyone younger than 7 years old. Each tablet for oral administration contains Lithium carbonate USP, 300 mg and the following inactive ingredients: microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate type A, colloidal silicon dioxide and calcium stearate. The background risk of major birth defects and miscarriage for the indicated population(s) is unknown. Drink extra fluids each day to prevent dehydration. -Extended release formulations: 600 mg orally in the morning and at nighttime The risk of Lithium toxicity is increased by: Monitor for signs and symptoms of Lithium toxicity. In severe cases with extended lesions patients may develop a locked-in syndrome (generalized motor paralysis). Additionally, lithium orotate supplements have not been officially approved by the FDA for any medical use or other health application. hydrochlorothiazide, chlorothiazide, furosemide. Lithium may take up to 24 hours to distribute into brain tissue, so occurrence of acute toxicity symptoms may be delayed. Chronic Lithium treatment may be associated with diminution of renal concentrating ability, occasionally presenting as nephrogenic diabetes insipidus, with polyuria and polydipsia. Take your Lithium carbonate tablets exactly as prescribed by your healthcare provider. Lithium also helps to prevent or … Concomitant use may increase the risk of neurologic adverse reactions in the form of ataxia, tremors, nausea, vomiting, diarrhea and/or tinnitus. w should I take Lithium carbonate tablets? Paradoxically, some cases of hyperthyroidism have been reported including Grave’s disease, toxic multinodular goiter and silent thyroiditis. Avoid becoming overheated or dehydrated during exercise and in hot weather. You may report side effects to FDA at 1-800-FDA-1088. Not all possible drug interactions are listed here. Indications, dose, contra-indications, side-effects, interactions, cautions, warnings and other safety information for LITHIUM CARBONATE. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. Lithium-induced cases of hyperparathyroidism are more often multiglandular compared to standard cases. You can ask your pharmacist or healthcare provider for information about Lithium carbonate tablets that is written for healthcare professionals. Patients should be monitored to prevent hypernatremia while receiving normal saline and careful regulation of kidney function is of utmost importance. Call your doctor for medical advice about side effects. lithium Class: Mood Stabilizer FDA Indications: Acute Mania Off-Label Use: Migraines, Bipolar Disorder Maintenance, Augmentation Of Antidepressants, Graves' … Two to three days prior to delivery, Lithium dosage should be decreased or discontinued to reduce the risk of maternal and/or neonatal toxicity. -Extended release formulations: 900 mg orally in the morning and at nighttime These adverse reactions may subside with continued treatment, concomitant administration with food, or temporary reduction or cessation of dosage. Consultation with a cardiologist is recommended if: (1) treatment with Lithium is under consideration for patients suspected of having Brugada Syndrome or patients who have risk factors for Brugada Syndrome, e.g., unexplained syncope, a family history of Brugada Syndrome, or a family history of sudden unexplained death before the age of 45 years, (2) patients who develop unexplained syncope or palpitations after starting Lithium treatment. Lithium is in a class of medications called antimanic agents. How should I store Lithium carbonate tablets? Inactive ingredients: microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate type A, colloidal silicon dioxide and calcium stearate. If you have severe headaches behind your eyes, ringing in the ears, blurred vision, double vision, or brief periods of blindness, talk to your health care provider right away. Signs and symptoms of Lithium toxicity such as hypertonia, hypothermia, cyanosis, and ECG changes have been reported in some breastfed neonates and infants. Cases of pseudotumor cerebri (increased intracranial pressure and papilledema) have been reported with Lithium use. Table 2. Follow your doctor's instructions about the type and amount of liquids you should drink. Lithium excretion in feces is insignificant. -Maintenance treatment for individuals with bipolar disorder. Both apparent clearance and apparent volume of distribution increase as body weight increases. Lithium may prolong the effects of neuromuscular blocking agents. Last updated on Aug 24, 2020. NSAID decrease renal blood flow, resulting in decreased renal clearance and increased serum Lithium concentrations. Lithium compounds, also known as lithium salts, are primarily used as a psychiatric medication. This condition is usually reversible when Lithium is discontinued, although for patients treated with long-term Lithium, nephrogenic diabetes insipidus may be only partly reversible upon discontinuation of Lithium. What are the ingredients in Lithium carbonate tablets? e “What is the most important information I should know about Lithium carbonate tablets? False hypercalcemia due to plasma volume depletion resulting from nephrogenic diabetes insipidus should be excluded in individuals with mildly increased serum calcium. Monitor for neurologic adverse reactions. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Lithium Controlled-Release and Extended-Release Tablets, Bipolar Disorder (Manic Depressive Illness or Manic Depression). l your healthcare provider about all the medicines you take. More frequent monitoring of serum Lithium concentration. Each 300 mg tablet for oral administration contains: Lithium carbonate USP and is white to off-white, circular, biconvex, uncoated tablet debossed with “430” on one side and break line on other side. In these disorders, it … Clinical studies of Lithium carbonate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. As a result, serum lithium levels are sensitive to physiological factors that affect renal function, including age, dehydration, sodium balance and haemodynamics 1. Concomitant use may produce hypothyroidism. Genitourinary: glycosuria, decreased creatinine clearance, albuminuria, oliguria, and symptoms of nephrogenic diabetes insipidus including polyuria, thirst, and polydipsia. -Regular release formulations: 600 mg orally 3 times a day, in the morning, afternoon, and nighttime You should not breastfeed during treatment with Lithium carbonate tablets. Lithium carbonate tablets can make you sleepy. Tell your doctor if you are pregnant or plan to become pregnant. Postmarketing cases consistent with nephrotic syndrome in patients with or without CTIN have also been reported. Blood samples for serum Lithium determination should be drawn immediately prior to the next dose when Lithium concentrations are relatively stable (i.e., 12 hours after the previous dose). We have the Indications, Actions, Therapeutic Class, Pharmacologic Class and Nursing Considerations. Other published animal studies report adverse effects on embryonic implantation in rats after Lithium administration. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use lithium only for the indication prescribed. The following adverse reactions are described in greater detail in other sections: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Do not crush, chew, or break an extended-release tablet. Emphasize the importance of compliance with the prescribed treatment and to not adjust the dose of Lithium without first consulting their healthcare provider. Adults with manic or mixed episodes of bipolar I disorder: general discomfort when you start treatment. Lithium a mood stabilizer that is a used to treat or control the manic episodes of bipolar disorder (manic depression ). Where hypothyroidism occurs during Lithium stabilization and maintenance, supplemental thyroid treatment may be used. Serotonin Syndrome, Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of Lithium with other, serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, tramadol, tryptophan, buspirone, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid) [see Warnings and Precautions (5.6) and Drug Interactions (7)]. Counsel patients on the adverse reactions related to Lithium-induced polyuria, when to seek medical attention, and the importance of maintaining normal diet with salt and staying hydrated [see Warnings and Precautions (5.2)]. The safety and effectiveness of Lithium for monotherapy treatment of acute manic or mixed episodes of bipolar I disorder and maintenance monotherapy of bipolar I disorder in pediatric patients ages 7 to 17 years of age have been established in an acute-phase clinical trial of 8 weeks in duration followed by a 28-week randomized withdrawal phase [see Dosage and Administration (2.1), Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14)]. Copyright 1996-2020 Cerner Multum, Inc. Such patients should be carefully managed to avoid dehydration with resulting Lithium retention and toxicity. Lithium drug interactions (in more detail). Start patients with mild to moderately impaired renal function (creatinine clearance 30 to 89 mL/min evaluated by Cockcroft-Gault) with dosages less than those for patients with normal renal function [see Dosage and Administration (2.2)]. More frequent monitoring of serum electrolyte and Lithium concentrations. The dose usually ranges from 600 mg to 1200 mg daily, but some people may require higher doses depending on weight or symptoms. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. Measure liquid medicine carefully. PROTECT FROM MOISTURE. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. Common Adverse Reactions (incidence ≥ 5% and at least twice the rate of placebo): nausea/vomiting, polyuria, thyroid abnormalities, tremor, thirst/polydipsia, dizziness, rash/dermatitis, ataxia/gait disturbance, decreased appetite, and blurry vision. Titrate slowly while frequently monitoring serum Lithium concentrations and monitoring for signs of Lithium toxicity. Be careful if you drive or do anything that requires you to be awake and alert. At Lithium concentrations greater than 3 mEq/L, patients may progress to seizures, coma, and irreversible brain damage. We comply with the HONcode standard for trustworthy health information -. of D & NH), India. Clinical Considerations Prescription lithium (Eskalith, Lithobid) has been used for decades to treat some mental health conditions, including bipolar disorder depression. A concentration above 3 mEq/L is considered a medical emergency; serum concentrations above 3 mEq/L may be associated with multiple organ involvement, changes in mental status, coma, and eventually death. Long-term Control: Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. In addition, concomitant infection with elevated temperatures may also necessitate a temporary reduction or cessation of medication. selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), medicines used to treat migraine headaches called triptans. Table 4: Clinically Important Drug Interactions with Lithium. The safety and efficacy of Lithium as a treatment for acute manic or mixed episodes of bipolar I disorder in pediatric patients (ages 7 to ≤18 years) was demonstrated in an 8-week, randomized, placebo-controlled, parallel group study (NCT01166425). Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM -II terminology. Monitor all patients taking Lithium for the emergence of serotonin syndrome. It is also approved as a "maintenance treatment," which is a long-term treatment to help prevent episodes of mania or depression. 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