Lithium Carbonate (Lithium Carbonate)

Trade Name : Lithium Carbonate

Glenmark Pharmaceuticals Inc., USA

CAPSULE

Strength 150 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 Glenmark Pharmaceuticals Inc., USA. It is available in strength of 150 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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No data

Lithium toxicity is closely related to serum lithium concentrations, and can occur at doses close to therapeutic concentrations. Facilities for prompt and accurate serum lithium determinations should be available before initiating treatment n
WARNING: LITHIUM TOXICITY
See full prescribing information for complete boxed warning.
Lithium toxicity is closely related to serum lithium concentrations, and can occur at doses close to therapeutic concentrations. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy (, ).

Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder:
Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder:

Recommended starting dosage for adults and pediatric patients over 30 kg ():

Each 150 mg capsule for oral administration contains: lithium carbonate USP 150 mg and is a two piece light gray hard gelatin capsules (size u20184u2019) imprinted with u2018150u2019 on the body & u2018G220u2019 on the cap.
Each 300 mg capsule for oral administration contains: lithium carbonate USP 300 mg and is a two piece pink hard gelatin capsules (size u20182u2019) imprinted with u2018300u2019 on the body and u2018G221u2019 on the cap.
Each 600 mg capsule for oral administration contains: lithium carbonate USP 600 mg and is a two piece hard gelatin capsules (size u20180u2019 elongated) pink colored cap and light gray colored body imprinted with u2018600u2019 on the body and u2018G222u2019 on the cap.

u2022
3

Lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium carbonate capsule n
Known hypersensitivity to any inactive ingredient in the drug product. ()

No data

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.
Pediatric Patients (7 to 17 years):
Bipolar I Disorder
Common Adverse Reactions (incidence u2265 5% and at least twice the rate of placebo)
A:
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
Adult Patients:
The following adverse reactions have been identified following use of lithium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Central Nervous System
EEG Changes:
Cardiovascula
ECG Changes
Gastrointestinal
:
Genitourinary
Dermatologic
Autonomic Nervous System:
Miscellaneous
Common Adverse Reactions:
To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1(888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Table 4: Clinically Important Drug Interactions with Lithium

2.3n- 7.1
5.6n- 7.1
5.5n- 7.1

No data

2.5n- 6

The toxic concentrations for lithium (u2265 1.5 mEq/L) are close to the therapeutic concentrations At lithium concentrations greater than 3 mEq/L, patients may progress to seizures, coma, and irreversible brain damage.
Treatment:
For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or .
No specific antidote for lithium poisoning is known. Mild symptoms of lithium toxicity can usually be treated by reduction in dose or cessation of the drug.
In severe cases of lithium poisoning, the goal of treatment is elimination of this ion from the patient. Administration of gastric lavage should be performed, but use of activated charcoal is not recommended as it does not significantly absorb lithium ions. Hemodialysis is the treatment of choice as it is an effective and rapid means of removing lithium in patients with severe toxicity. As an alternative option, urea, mannitol and aminophylline can induce a significant increase in lithium excretion. Appropriate supportive care for the patient should be undertaken. Patients with impaired consciousness should have their airway protected and it is critical to correct any volume depletion or electrolyte imbalance. Patients should be monitored to prevent hypernatremia while receiving normal saline and careful regulation of kidney function is of utmost importance.
Serum lithium concentrations should be closely monitored as there may be a rebound in serum lithium concentrations as a result of delayed diffusion from the body tissues. Likewise, during the late recovery phase, lithium should be re-administered with caution taking into account the possible release of significant lithium stores in body tissues.

Each capsule for oral administration contains lithium carbonate USP, 150 mg, 300 mg or 600 mg and the following inactive ingredients: colloidal silicon dioxide, gelatin, sodium lauryl sulfate, talc, titanium dioxide, FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and the imprinting ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide.
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 USP is a white, crystalline powder with molecular formula LiCO and molecular weight 73.89 g/mol.

No data

Carcinogenesis:
There have been no long-term studies performed in animals to evaluate the carcinogenic potential of lithium.
Mutagenesis:
There have been no adequate studies conducted to evaluate the mutagenic and genotoxic potential of lithium.
Impairment of Fertility:
There have been no adequate studies performed in animals at current standards to evaluate the effect of lithium treatment on fertility. However, published studies in male mice and rats administered repeated daily dosing of lithium carbonate report adverse effects on male reproductive organs, decreased spermatogenesis and decreased testosterone levels.

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 u226418 years) was demonstrated in an 8-week, randomized, placebo-controlled, parallel group study
(NCT01166425). 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. Patients weighing more than 30 kg started lithium at 300 mg three times daily (900 mg/day) and could increase their dose by 300 mg every 3 days. Patients weighing 20 to 30 kg started lithium at 300 mg twice daily (600 mg/day) and could increase their dose by 300 mg weekly. No patients weighing less than 20 kg were enrolled. Lithium (mean serum level 0.98 u00b1 0.47 mEq/L) was statistically significantly superior to placebo in decreasing acute mania or mixed states as measured by the YMRS (see Table 5).
In a 28-week randomized withdrawal analysis, 31 pediatric patients stabilized on lithium were assigned to either continue lithium or switch to placebo. The group receiving lithium demonstrated superiority to those receiving placebo in all-cause discontinuation (see Table 5).
Table 5: Primary Efficacy Results
SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: confidence interval.

Lithium Carbonate Capsules USP
150 mg supplied as light gray hard gelatin capsules imprinted with u2018150u2019on the body & u2018G220u2019 on the cap, filled with white to off-white granules.
NDC 68462-220-11: Unit-dose box of 100 (10 blister cards each containing 10 capsules).
NDC 68462-220-01: Bottles of 100 capsules.
300 mg supplied as pink hard gelatin capsules imprinted with u2018300u2019on the body & u2018G221u2019 on the cap, filled with white to off-white granules.
NDC 68462-221-11: Unit-dose box of 100 (10 blister cards each containing 10 capsules).
NDC 68462-221-01: Bottles of 100 capsules.
NDC 68462-221-10: Bottles of 1000 capsules.
600 mg supplied as hard gelatin capsules, pink cap imprinted withu2018G222u2019 and light gray body imprinted withu2018600u2019, filled with white to off-white granules.
NDC 68462-222-11: Unit-dose box of 100 (10 blister cards each containing 10 capsules).
NDC 68462-222-01: Bottles of 100 capsules
Storage and Dispense
Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, child-resistant container as defined in the USP/NF.

Advise the patient to read FDA-approved patient labeling (Medication Guide).
Dosage and Administration:
Advise patients that lithium is a mood stabilizer, and should only be taken as directed. Emphasize the importance of compliance with the prescribed treatment and to not adjust the dose of lithium without first consulting their healthcare provider. Inform patients that they will need to have regular blood draws to determine if their dose of lithium is appropriate.
Instruct patients not to double the dose if a dose is missed, due to the complexity of individualized dosing and potential for lithium toxicity n
Lithium Toxicity:
Inform patients on adverse reactions related to lithium toxicity that require medical attention. Advise patients to discontinue lithium treatment and contact their healthcare provider if clinical signs of lithium toxicity such as diarrhea, vomiting, tremor, lack of muscle coordination, drowsiness, abnormal heart rhythm or muscular weakness occur .
Lithium-Induced Polyuria:
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 .
Hyponatremia:
Counsel patients on the adverse reactions of hyponatremia, when to seek medical attention, the importance of maintaining a normal diet including adequate salt intake and staying hydrated . Salt supplements and additional fluids may be required if excessive losses occur.
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. Johnu2019s 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) .
Drug Interactions:
Advise patients that many drugs can interact with lithium and to inform their doctor and pharmacist if they are taking any over the counter medication, including herbal medication, or are started on a new prescription .
Somnolence:
Tell patients that lithium may cause somnolence particularly when initiating treatment and to be cautious about operating vehicles or hazardous machinery, until they are reasonably certain that lithium treatment does not affect them adversely .
Pregnancy:
Advise pregnant women of the potential risk to a fetus and/or neonate n
Lactation:
Advise women that breastfeeding is not recommended during treatment with lithium n
Manufactured by:
Glenmark Pharmaceuticals Limited
Colvale-Bardez, Goa 403 513, India
Manufactured for:
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430
Questions? 1 (888) 721-7115
www.glenmarkpharma-us.com
March 2020

This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Glenmark Pharmaceuticals Limited
Colvale-Bardez, Goa 403 513, India
Manufactured for:
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430
Questions? 1 (888) 721-7115
www.glenmarkpharma-us.com
March 2020

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No data

No data

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Lithium Carbonate (Lithium Carbonate)

Trade Name : Lithium Carbonate

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Lithium Carbonate (Lithium Carbonate)

Trade Name : Lithium Carbonate

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

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NZ Drugs

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