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Lithium Carbonate (Lithium Carbonate)

Trade Name : Lithium Carbonate

Mylan Pharmaceuticals Inc.

TABLET, EXTENDED RELEASE

Strength 450 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 Mylan Pharmaceuticals Inc.. It is available in strength of 450 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

Packaging and Delivery

Validated Cold Chain Shipment

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
  • WARNING
  • 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 (see ).
  • Lithium carbonate extended-release tablets, USP contain lithium carbonate, USP, a white, granular, odorless 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.
  • Each white to off-white, round, scored tablet, debossed with above the score and below the score on one side of the tablet and on the other side, contains lithium carbonate 450 mg. Inactive ingredients consist of magnesium stearate, povidone, sodium alginate, and sodium starch glycolate (potato).
  • Meets USP Dissolution Test 3.
  • Lithium carbonate extended-release tablets 450 mg are designed to release a portion of the dose initially and the remainder gradually; the release pattern of the extended-release tablets reduces the variability in lithium blood levels seen with the immediate release dosage forms.
  • 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 extended-release tablets are indicated in the treatment of manic episodes of manic-depressive illness. Maintenance therapy prevents or diminishes the intensity of subsequent episodes in those manic-depressive patients with a history of mania.
  • 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 carbonate extended-release tablets may produce a normalization of symptomatology within 1 to 3 weeks.
  • No data
  • No data
  • The occurrence and severity of adverse reactions are generally directly related to serum lithium concentrations as well as to individual patient sensitivity to lithium, and generally occur more frequently and with greater severity at higher concentrations.
  • Adverse reactions may be encountered at serum lithium levels below 1.5 mEq/L. Mild to moderate adverse reactions may occur at levels from 1.5 to 2.5 mEq/L, and moderate to severe reactions may be seen at levels of 2.0 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 a temporary reduction or cessation of dosage. If persistent, 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 levels below 2.0 mEq/L. At higher levels, ataxia, giddiness, tinnitus, blurred vision, and a large output of dilute urine may be seen. Serum lithium levels above 3.0 mEq/L may produce a complex clinical picture, involving multiple organs and organ systems. Serum lithium levels should not be permitted to exceed 2.0 mEq/L during the acute treatment phase.
  • The following reactions have been reported and appear to be related to serum lithium levels, including levels within the therapeutic range:
  • Neuromuscular/Central Nervous System:
  • Cardiovascular:
  • Gastrointestinal:
  • Genitourinary:
  • Dermatologic:
  • Autonomic Nervous System:
  • Thyroid Abnormalities:
  • 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 the starting of treatment with lithium. The mechanism through which these symptoms (resembling Raynaudu2019s syndrome) developed is not known. Recovery followed discontinuance.
  • The toxic levels for lithium (u2265 1.5 mEq/L) are close to the therapeutic levels (0.6 to 1.2 mEq/L). 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. Toxic symptoms are listed in detail under .
  • No specific antidote for lithium poisoning is known. 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 function. 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.
  • Infection prophylaxis, regular chest X-rays and preservation of adequate respiration are essential.
  • Doses of extended-release tablets are usually given b.i.d. (approximately 12-hour intervals). When initiating therapy with extended-release lithium, dosage must be individualized according to serum levels and clinical response.
  • When switching a patient from immediate-release capsules to lithium carbonate extended-release tablets, give the same total daily dose when possible. Most patients on maintenance therapy are stabilized on 900 mg daily, e.g., lithium carbonate extended-release tablets 450 mg b.i.d. When the previous dosage of immediate-release lithium is not a multiple of 450 mg, e.g., 1,500 mg, initiate lithium carbonate extended-release tablets at the multiple of 450 mg nearest to, but the original daily dose, i.e., 1,350 mg. When the 2 doses are unequal, give the larger dose in the evening. In the above example, with a total daily dose of 1,350 mg, generally 450 mg of lithium carbonate extended-release tablets should be given in the morning and 900 mg of lithium carbonate extended-release tablets in the evening. If desired, the total daily dose of 1,350 mg can be given in 3 equal 450-mg doses of lithium carbonate extended-release tablets. These patients should be monitored at 1- to 2-week intervals, and dosage adjusted if necessary, until stable and satisfactory serum levels and clinical state are achieved.
  • When patients require closer titration than that available with doses of lithium carbonate extended-release tablets in increments of 450 mg, immediate-release capsules should be used.
  • Lithium Carbonate Extended-Release Tablets, USP are available containing 450 mg of lithium carbonate, USP.
  • The 450 mg tablets are white to off-white, round, scored tablets debossed with above the score and below the score on one side of the tablet and on the other side. They are available as follows:
  • NDC 0378-1450-01bottles of 100 tablets
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Protect from moisture.u00a0
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Manufactured by:n n Hyderabad u2014 500 096, India
  • 75074158
  • Revised: 1/2020MX:LITCER:R9
  • NDC 0378-1450-01
  • Lithiumn- Carbonaten- Extended-Releasen- Tablets, USP
  • 450 mg
  • Rx onlyu00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each tablet contains:Lithium carbonate, USPu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0450 mg
  • Usual Dosage:
  • WARNINGS:
  • Keep this and all medication out ofn- the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See n- USP Controlled Room Temperature.]
  • Protect from moisture.
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RMX1450A2
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89

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