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)]. Learn more about lithium (Eskalith, Lithobid), including a description, generic and brand names, drug class and mechanism, preparations, storage, reasons for prescription, dosing, drug interactions, and common side effects. Adults with manic or mixed episodes of bipolar I disorder: general discomfort when you start treatment. Concurrent medications should be assessed, and if the patient is a woman of childbearing potential, pregnancy status and potential should be considered. Your healthcare provider may change your Lithium carbonate tablet dose to make sure you are taking the dose that is right for you. Rx only 30 Tablets SUN PHARMA, fluoxetine, quetiapine, lamotrigine, Seroquel, Prozac, Abilify, olanzapine, aripiprazole, risperidone, Depakote. In severe cases with extended lesions patients may develop a locked-in syndrome (generalized motor paralysis). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. To decrease the risk of postpartum Lithium intoxication, decrease or discontinue Lithium therapy two to three days before the expected delivery date to reduce neonatal concentrations and reduce the risk of maternal Lithium intoxication due to the change in vascular volume which occurs during delivery. Sun Pharmaceutical Industries, Inc. Therefore, it is essential for patients receiving Lithium treatment to maintain a normal diet, including salt, and an adequate fluid intake (2500 to 3000 mL) at least during the initial stabilization period. Know the m e dici nes you t a ke. Table 3: Adverse Reactions Reported in 2% or More of Pediatric Patients on Lithium and That Occurred at Greater Incidence Than in the Placebo Group in the 8-Week Acute Bipolar Trial. Other reported clinical experience has not identified differences in response between the elderly and younger patients. Monitor patients for signs and symptoms of serotonin syndrome, particularly during Lithium initiation. Serum lithium should be monitored 12 hours after dose, twice weekly until serum concentration and clinical condition stabilize, and every other month thereafter Increase dose as tolerated to … Do not use Lithium carbonate tablets for a condition for which it was not prescribed. Using Lithium carbonate tablets with certain other medicines may affect each other causing possible side effects. 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). Lithium Controlled-Release and Extended-Release Tablets, Bipolar Disorder (Manic Depressive Illness or Manic Depression). It is primarily used to treat bipolar disorder and treat major depressive disorder that does not improve following the use of antidepressants. Not all possible drug interactions are listed here. Dose Adjustments During Pregnancy and the Postpartum Period: If the decision is made to continue Lithium treatment during pregnancy, serum Lithium concentrations should be monitored and the dosage adjusted during pregnancy. Indications, dose, contra-indications, side-effects, interactions, cautions, warnings and other safety information for LITHIUM CARBONATE. Cranbury, NJ 08512 Long-term Control: Manufactured by: lithium Class: Mood Stabilizer FDA Indications: Acute Mania Off-Label Use: Migraines, Bipolar Disorder Maintenance, Augmentation Of Antidepressants, Graves' … Facilities for prompt and accurate serum Lithium determinations should be available before initiating treatment, [see Dosage and Administration (2.3), Warnings and Precautions (5.1)]. Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: Before initiating treatment with Lithium, renal function, vital signs, serum electrolytes, and thyroid function should be evaluated. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Decreased tolerance to Lithium has also been reported to ensue from protracted sweating or diarrhea and, if such occur, supplemental fluid and salt should be administered under careful medical supervision and Lithium intake reduced or suspended until the condition is resolved. Do not double your dose if a dose is missed. To make sure this medicine is safe for you, tell your doctor if you have ever had: an abnormal electrocardiograph or ECG (sometimes called an EKG); Some medicines can interact with lithium and cause a serious condition called serotonin syndrome. Infants exposed to Lithium during breastfeeding may have plasma levels that are 30 to 40% of maternal plasma levels. Both lithium and amifampridine prolong the QT interval. Lithium is for use in adults and children at least 7 years old. For more information about Lithium carbonate tablets, call 1-800-818-4555. Reports of neurotoxic reactions in patients treated with both Lithium and an antipsychotic, ranging from extrapyramidal symptoms to neuroleptic malignant syndrome, as well as reports of an encephalopathic syndrome in few patients treated with concomitant therapy, risperidone, haloperidol, thioridazine, fluphenazine, chlorpromazine, perphenazine, clozapine. Table 1. -Regular release formulations: 300 mg orally 3 to 4 times a day Lithium is filtered by the glomerulus, and 80% is reabsorbed by passive diffusion in the proximal tubule. Patients abnormally sensitive to Lithium may exhibit toxic signs at serum concentrations that are within what is considered the therapeutic range. ​Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: 1. ​Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies (14)] 2. ​Maintenance treatment in patients 7 years and older [see Clinical Studies (14)] However, several indications for Too much lithium in your body can cause death. The predominant form of chronic renal disease associated with long-term Lithium treatment is a chronic tubulointerstitial nephropathy (CTIN). Early signs of toxicity include: vomiting, diarrhea, drowsiness, muscle weakness, or loss of coordination. Tell your doctor about all your current medicines. Below this threshold, clinical signs are usually present, consisting mainly of changes in mental status, such as altered personality, lethargy, and confusion. Risk Summary The biopsy findings in patients with nephrotic syndrome include minimal change disease and focal segmental glomerulosclerosis. 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. Mild hyponatremia (i.e., serum Na > 120 mEq/L) can be asymptomatic. At delivery, vascular volume rapidly decreases and the renal clearance of Lithium may decrease to pre-pregnancy concentrations. Keep the bottle tightly closed when not in use. 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. The distribution space of Lithium approximates that of total body water, and the plasma protein binding is negligible. Call your doctor for medical advice about side effects. Lithium drug interactions (in more detail). The risk is increased with concomitant use of other serotonergic drugs (including selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, triptans, tricyclic antidepressants, fentanyl, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see Drug Interactions (7.1)]. In this study, Lithium was administered at daily doses ranging from 300 to 3600 (mean dose 1483 mg ± 584) with serum levels ranging from 0 to 2.0 (mean level 0.98 mEq/L ± 0.47). It could cause harm to the unborn baby. People who take Lithium carbonate tablets may find out they also have a heart problem called Brugada Syndrome. 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. Acute Control: The toxic concentrations for Lithium (≥ 1.5 mEq/L) are close to the therapeutic concentrations [see Warnings and Precautions (5.1)]. Stop using this medicine and call your doctor right away if you have symptoms of lithium toxicity: muscle weakness, twitching, drowsiness, feeling light-headed, mood changes, blurred vision, ringing in your ears, irregular heartbeats, confusion, slurred speech, clumsiness, trouble breathing, or seizures. Lithium should not be used in severe renal insufficiency (creatinine clearance less than 30 mL/min evaluated by Cockcroft-Gault), especially if the condition requires adherence to a low-sodium diet [see Dosage and Administration (2.5)]. Specifically, it is approved to treat manic episodes (but not depressive episodes). Store and Dispense. Bottles of 100’s with Child Resistant Cap……………NDC 62756-430-88 Store at room temperature away from moisture and heat. Discontinue breastfeeding if a breastfed infant develops Lithium toxicity. Tell your doctor if you have been sweating excessively, or if you are sick with fever, vomiting, or diarrhea. What should I avoid while taking Lithium carbonate tablets? Mild symptoms of Lithium toxicity can usually be treated by reduction in dose or cessation of the drug. Hypercalcemia may not resolve upon discontinuation of Lithium, and may require surgical intervention. Respiratory manifestations include dyspnea, aspiration pneumonia, and respiratory failure. Lithium can precipitate serotonin syndrome, a potentially life-threatening condition. As an alternative option, urea, mannitol and aminophylline can induce a significant increase in Lithium excretion. More frequent serum Lithium concentration monitoring. Lithium compounds, also known as lithium salts, are primarily used as a psychiatric medication. at should I avoid while taking Lithium carbonate tablets? Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. Postmarketing cases consistent with nephrotic syndrome in patients with or without CTIN have also been reported. After equilibrium, the apparent volume of distribution is 0.7 to 1 L/kg. PHARMACIST: Please dispense with Medication Guide provided separately to each patient. Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Mutagenesis, There have been no adequate studies conducted to evaluate the mutagenic and genotoxic potential of Lithium. Talk to your healthcare provider about these activities. of D & NH), India. The discontinuation of Lithium in patients with nephrotic syndrome has resulted in remission of nephrotic syndrome. Each 5 mL of Lithium Oral Solution contains 8 mEq of Lithium ion (Li+) which is equivalent to the amount of Lithium in 300 mg of Lithium carbonate. Drink extra fluids each day to prevent dehydration. Patients rapidly treated or with serum sodium <120mEq/L are more at risk of developing osmotic demyelination syndrome (previously called central pontine myelinolysis). Follow your healthcare provider instructions about the type and amount of liquids you should drink. Long-term Lithium treatment is associated with persistent hyperparathyroidism and hypercalcemia. What should I tell my healthcare provider before taking Lithium carbonate tablets? Do not change your dose on your own. Both apparent clearance and apparent volume of distribution increase as body weight increases. Advise pregnant women of the potential risk to a fetus. In the outpatient setting, developing a therapeutic alliance with patients a… Recent high-quality studies have confirmed the central role of lithium in the treatment of bipolar disorder and have established lithium as the drug of first choice for long-term prophylaxis in this condition. Sodium affects excitation or mania. Avoid sodium restriction or diuretic administration. Looking for info on Lithium (trade name - Lithizine)? Lithium (Lithium Bromide) should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, since the risk of Lithium (Lithium Bromide) toxicity is very high in such patients. Fine hand tremor, polyuria, and thirst may occur during initial therapy for the acute manic phase and may persist throughout treatment. It is often used in bipolar disorder treatment. Accurate patient evaluation requires both clinical and laboratory analysis. You should not breast-feed while using this medicine. There have been no adequate studies performed in animals at current standards to evaluate the effect of Lithium treatment on fertility. No specific antidote for Lithium poisoning is known. Version: 6.01. Restart treatment at the preconception dose when the patient is medically stable after delivery with careful monitoring of serum Lithium concentrations [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. 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)]. Last updated on Apr 2, 2020. As a result, serum lithium levels are sensitive to physiological factors that affect renal function, including age, dehydration, sodium balance and haemodynamics 1. 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. Instruct patients not to double the dose if a dose is missed, due to the complexity of individualized dosing and potential for Lithium toxicity [see Dosage and Administration (2), Warnings and Precautions (5.1)]. A lower dose in patients < 30 kg is necessary to achieve Lithium exposures in pediatric patients similar to those observed in adults treated at recommended doses of Lithium [see Dosage and Administration (2.2)]. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Monitor all patients taking Lithium for the emergence of serotonin syndrome. In some instances, the syndrome was followed by irreversible brain damage. You may report side effects to FDA at 1-800-FDA-1088. If concomitant use of Lithium with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms. Lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the Lithium carbonate tablet [see Adverse Reactions (6)]. Generic Name: lithium (LITH ee um) Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM -II terminology. If the decision is made to continue Lithium treatment during pregnancy, monitor serum Lithium concentrations and adjust the dosage as needed in a pregnant woman because renal Lithium clearance increases during pregnancy. Inform patients that they will need to have regular blood draws to determine if their dose of Lithium is appropriate. 300 mg supplied as white to off-white, circular, biconvex, uncoated tablets debossed with “430” on one side and break line on other side. Kidney function should be assessed prior to and during Lithium treatment. More frequent monitoring of serum Lithium concentration. No specific antidote for Lithium poisoning is known [see Overdosage (10)]. When clinical manifestations of hypercalcemia are present, Lithium withdrawal and change to another mood stabilizer may be necessary. Manic symptoms include hyperactivity, rushed speech, poor judgment, reduced need for sleep, aggression, and anger. This list is not complete and many other drugs may interact with lithium. Lithium is primarily excreted in urine, proportionally to its serum concentration. Lithium toxicity is closely related to serum Lithium concentrations, and can occur at doses close to therapeutic concentrations. No patients weighing less than 20 kg were enrolled. Pediatric Use: A pharmacokinetic study of Lithium was performed in 39 subjects with bipolar I disorder. Dosage and Administration, Advise patients that Lithium is a mood stabilizer, and should only be taken as directed. 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. See the end of this Medication Guide for a complete list of ingredients in Lithium carbonate tablets. Breastfeeding is not recommended with maternal Lithium use; however, if a woman chooses to breastfeed, the infant should be closely monitored for signs of Lithium toxicity. If neurologic symptoms start to develop during treatment of hyponatremia, serum sodium correction should be suspended to mitigate the development of permanent neurologic damage. The following conditions are contraindicated with this drug. -Usual dose: 1800 mg/day Lithium (LITH-ee-əm) Carbonate Tablets USP. Who should not take Lithium carbonate tablets? m carbonate tablets may cause serious side effects, including: low levels of sodium (salt) in your blood (hyponatremia). Lithium is used as a mood stabilizer, and is used for treatment of depression and mania. We have the Indications, Actions, Therapeutic Class, Pharmacologic Class and Nursing Considerations. We comply with the HONcode standard for trustworthy health information -. are pregnant or plan to become pregnant. You can easily become dehydrated while taking lithium, which may affect your dose needs. More frequent monitoring of serum electrolyte and Lithium concentrations. 259/15, Dadra-396 191, Gastrointestinal manifestations include nausea, vomiting, diarrhea, and bloating. Sun Pharmaceutical Industries Ltd. Patients should be monitored to prevent hypernatremia while receiving normal saline and careful regulation of kidney function is of utmost importance. In some cases, drinking too much liquid can be as unsafe as not drinking enough. In case of poisoning, call your poison control center at 1-800-222-1222. Learn lithium drug with free interactive flashcards. Tell your doctor if you are pregnant or plan to become pregnant. Lithium is the most common drug cause, affecting 10% of patients treated for 15 years or more.7 Risk correlates with duration of lithium treatment. [see Dosage and Administration (2), Warnings and Precautions (5.1, [see Warnings and Precautions (5.6) and Drug Interactions (7)]. Drink extra fluids to keep from getting dehydrated while you are taking this medication. Increase Lithium dosage based on serum Lithium concentration and clinical response, acetazolamide, theophylline, sodium bicarbonate, Concomitant use may increase risk of adverse reactions of these drugs. Follow your doctor's instructions about the type and amount of liquids you should drink. Before taking Lithium carbonate tablets, tell your healthcare provider if you: Tell your healthcare provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements. You may report side effects to FDA at 1-800-FDA-1088. Cardiac manifestations involve electrocardiographic changes, such as prolonged QT interval, ST and T-wave changes and myocarditis. These adverse reactions may subside with continued treatment, concomitant administration with food, or temporary reduction or cessation of dosage. Focus on Lithium Orotate The modern boom of lithium supplements started with lithium orotate.Currently, lithium orotate is poorly-researched, and its overall safety in human users has not been determined. Risk Summary Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Monitor thyroid function before the initiation of treatment, at three months and every six to twelve months while treatment is ongoing. Monitor serum calcium concentrations regularly. e “What is the most important information I should know about Lithium carbonate tablets? Lithium is a mood stabilizer that is used to treat or control the manic episodes of bipolar disorder (manic depression). How should I store Lithium carbonate tablets? 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). al information about the safe and effective use of Lithium carbonate tablets. Concomitant use may increase serum Lithium concentrations due to reduced renal clearance. -Maintenance treatment for individuals with bipolar disorder, 12 years and older: 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)]. Impairment of Fertility. Gastrointestinal: anorexia, nausea, vomiting, diarrhea, gastritis, salivary gland swelling, abdominal pain, excessive salivation, flatulence, indigestion. [see Dosage and Administration (2.1), Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14)]. Some patients abnormally sensitive to Lithium may exhibit toxic signs at serum concentrations that are considered within the therapeutic range [see Boxed Warning, Dosage and Administration (2.3)]. ECG Changes: reversible flattening, isoelectricity or rarely inversion of T-waves, prolongation of the QTc interval. How should I take Lithium carbonate tablets? Medically reviewed by Philip Thornton, DipPharm. Avoid driving or hazardous activity until you know how lithium will affect you. Store Lithium carbonate tablets at room temperature, between 68°F to 77°F (20°C to 25°C). too much Lithium in your blood (Lithium toxicity). Lithium is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min evaluated by Cockcroft-Gault) [see Use in Specific Populations (8.6)]. Be careful if you drive or do anything that requires you to be awake and alert. Never use lithium in larger amounts, or for longer than prescribed. 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. provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Paradoxically, some cases of hyperthyroidism have been reported including Grave’s disease, toxic multinodular goiter and silent thyroiditis. Lithium a mood stabilizer that is a used to treat or control the manic episodes of bipolar disorder (manic depression ). -Regular release formulations: 600 mg orally 3 times a day, in the morning, afternoon, and nighttime Damage often is permanent. Lithium carbonate can pass into your breastmilk and may harm your baby. increased pressure in the brain and swelling in the eye (pseudotumor cerebri) that can cause vision problems or blindness. heart problems. Bottles of 30’s with Child Resistant Cap……………..NDC 62756-430-83 Changing your salt intake could change the amount of lithium in your blood. Advise women that breastfeeding is not recommended during treatment with Lithium [see Use in Specific Populations (8.2)]. There have been no long-term studies performed in animals to evaluate the carcinogenic potential of Lithium.
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