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Lithium Carbonate (Lithium Carbonate)

Trade Name : Lithium Carbonate

West-Ward Pharmaceuticals Corp.

TABLET, EXTENDED RELEASE

Strength 300 mg/1

LITHIUM CARBONATE Mood Stabilizer [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Lithium Carbonate (Lithium Carbonate) which is also known as Lithium Carbonate and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 300 mg/1 per ml. Read more

Lithium Carbonate (Lithium Carbonate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy n
  • Lithium Carbonate Extended-release Tablets USP contain lithium carbonate USP, a white granular powder with molecular formula LiCO and molecular weight 73.89. 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.
  • Lithium Carbonate Extended-release Tablets USP are available for oral administration containing 300 mg of lithium carbonate USP. This slowly dissolving, film-coated tablet is designed to give lower serum lithium peak concentrations than obtained with conventional oral lithium dosage forms. Each tablet contains the following inactive ingredients: calcium stearate, Opadry II (Beige), povidone, sodium chloride, sodium lauryl sulfate and sorbitol. Opadry II (Beige) contains: hypromellose, polydextrose, polyethylene glycol, red iron oxide, titanium dioxide, triacetin and yellow iron oxide.
  • The tablets meet the requirements of USP Dissolution Test 5 in the USP monograph for Lithium Carbonate Extended-release Tablets USP, 300 mg.
  • Preclinical studies have shown that lithium alters sodium transport in nerve and muscle cells and effects a shift toward intraneuronal metabolism of catecholamines, but the specific biochemical mechanism of lithium action in mania is unknown.
  • Lithium carbonate is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium carbonate is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur.
  • Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.
  • No data
  • The ability to tolerate lithium is greater during the acute manic phase and decreases when manic symptoms subside .
  • The distribution space of lithium approximates that of total body water. Lithium is primarily excreted in urine with insignificant excretion in feces. Renal excretion of lithium is proportional to its plasma concentration. The elimination half-life of lithium is approximately 24 hours. Lithium decreases sodium reabsorption by the renal tubules which could lead to sodium depletion. Therefore, it is essential for the patient to maintain a normal diet, including salt, and an adequate fluid intake (2500 to 3500 mL) at least during the initial stabilization period. Decreased tolerance to lithium has 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.
  • In addition to sweating and diarrhea, concomitant infection with elevated temperatures may also necessitate a temporary reduction or cessation of medication.
  • Previously existing thyroid disorders do not necessarily constitute a contraindication to lithium treatment. Where hypothyroidism preexists, careful monitoring of thyroid function during lithium stabilization and maintenance allows for correction of changing thyroid parameters and/or adjustment of lithium doses, if any. If hypothyroidism occurs during lithium stabilization and maintenance, supplemental thyroid treatment may be used.
  • The occurrence and severity of adverse reactions are generally directly related to serum lithium concentrations and to individual patient sensitivity to lithium. They generally occur more frequently and with greater severity at higher concentrations.
  • Adverse reactions may be encountered at serum lithium concentrations below 1.5 mEq/L. Mild to moderate adverse reactions may occur at concentrations from 1.5 to 2.5 mEq/L, and moderate to severe reactions may be seen at concentrations from 2 mEq/L and above.
  • Fine hand tremor, polyuria and mild thirst may occur during initial therapy for the acute manic phase and may persist throughout treatment. Transient and mild nausea and general discomfort may also appear during the first few days of lithium administration.
  • These side effects usually subside with continued treatment or with a temporary reduction or cessation of dosage. If persistent, a cessation of lithium therapy may be required. Diarrhea, vomiting, drowsiness, muscular weakness and lack of coordination may be early signs of lithium intoxication, and can occur at lithium concentrations below 2 mEq/L. At higher concentrations, giddiness, ataxia, blurred vision, tinnitus and a large output of dilute urine may be seen. Serum lithium concentrations above 3 mEq/L may produce a complex clinical picture involving multiple organs and organ systems. Serum lithium concentrations should not be permitted to exceed 2 mEq/L during the acute treatment phase.
  • The following reactions have been reported and appear to be related to serum lithium concentrations, including concentrations within the therapeutic range:
  • Central Nervous System
  • Cardiovascularn- [See and ]
  • Gastrointestinal
  • Genitourinary
  • Dermatologic
  • Autonomic Nervous System
  • Thyroid Abnormalitiesn- (see )
  • EEG Changes
  • EKG Changes
  • Miscellaneous
  • Some reports of nephrogenic diabetes insipidus, hyperparathyroidism and hypothyroidism which persist after lithium discontinuation have been received.
  • A few reports have been received of the development of painful discoloration of fingers and toes and coldness of the extremities within one day of starting lithium treatment. The mechanism through which these symptoms (resembling Raynaudu2019s Syndrome) developed is not known. Recovery followed discontinuance.
  • No data
  • The toxic concentrations for lithium (u22651.5 mEq/L) are close to the therapeutic concentrations. It is therefore important that patients and their families be cautioned to watch for early toxic symptoms and to discontinue the drug and inform the physician should they occur n
  • No specific antidote for lithium poisoning is known. Treatment is supportive. Early symptoms of lithium toxicity can usually be treated by reduction or cessation of dosage of the drug and resumption of the 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 patient.
  • Treatment is essentially the same as that used in barbiturate poisoning: 1) gastric lavage, 2) correction of fluid and electrolyte imbalance and, 3) regulation of kidney functioning. Urea, mannitol, and aminophylline all produce significant increases in lithium excretion. Hemodialysis is an effective and rapid means of removing the ion from the severely toxic patient. However, patient recovery may be slow.
  • Infection prophylaxis, regular chest X-rays, and preservation of adequate respiration are essential.
  • A condition known as Brugada Syndrome may pre-exist and be unmasked by lithium therapy. Brugada Syndrome is a heart disorder characterized by abnormal electrocardiographic (ECG) findings and risk of sudden death. Patients should be advised to seek immediate emergency assistance if they experience fainting, lightheadedness, abnormal heart beats, or shortness of breath because they may have a potentially life-threatening heart disorder known as Brugada Syndrome.
  • Lithium Carbonate Extended-release Tablets USP
  • 300 mg tablets are supplied as beige coated, round biconvex tablets with u201c54 107u201d debossed on one side and plain on the other side.
  • NDC 0054-0021-25: Bottle of 100 Tablets
  • NDC 0054-0021-29: Bottle of 500 Tablets
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in tight, child-resistant container as defined in USP/NF.
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10002523/10
  • Revised December 2019
  • Lithium Carbonate Extended-release Tablets USP, 300 mg
  • NDC 0054-0021-25
  • Rx Only

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