LITHIUM CARBONATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66)

Available from:

Glenmark Pharmaceuticals Inc., USA

INN (International Name):

LITHIUM CARBONATE

Composition:

LITHIUM CARBONATE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: Lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium carbonate capsule [see Adverse Reactions (6)]. Risk Summary: Lithium may cause harm when administered to a pregnant woman. Early voluntary reports to international birth registries suggested an increase in cardiovascular malformations, especially for Ebstein’s anomaly, with first trimester use of lithium. Subsequent case-control and cohort studies indicate that the increased risk for cardiac malformations is likely to be small; however, the data are insufficient to establish a drug-associated risk. There are concerns for maternal and/or neonatal lithium toxicity during late pregnancy and the postpartum period [see Clinical Considerations]. Published animal developmental and toxicity studies in mice and rats report an increased incidence of fetal mortality, decreased fetal weight, increased fetal skele

Product summary:

Lithium Carbonate Capsules, USP 150 mg supplied as light gray hard gelatin capsules imprinted with ‘150’ on the body and ‘G220’ on the cap, filled with white to off-white granules. NDC 68462-220-11: Unit-dose box of 100 capsules (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 ‘300’ on the body and ‘G221’ on the cap, filled with white to off-white granules. NDC 68462-221-11: Unit-dose box of 100 capsules (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 with ‘G222’ and light gray body imprinted with ‘600’, filled with white to off-white granules. NDC 68462-222-11: Unit-dose box of 100 capsules (10 blister cards each containing 10 capsules). NDC 68462-222-01: Bottles of 100 capsules. Storage and Dispense Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, child-resistant container as defined in the USP/NF.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Glenmark Pharmaceuticals Inc., USA
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MEDICATION GUIDE
Lithium (LITH-ee-əm) Carbonate capsules, USP
What is the most important information I should know about lithium
carbonate capsules?
Lithium carbonate capsules can cause serious side effects, including:
•
too much lithium in your blood (lithium toxicity). Lithium toxicity
that can cause death may happen
even if the lithium level in your blood is close to the right level
for you. Your healthcare provider will
need to monitor your blood levels of lithium to find the best dose for
you. Take your lithium carbonate
capsules exactly as your healthcare provider tells you to take it.
Stop taking lithium carbonate capsules
and call your healthcare provider right away if you have any symptoms
of lithium toxicity including:
Other symptoms may include:
What are lithium carbonate capsules?
Lithium carbonate capsules are prescription medicines called
mood-stabilizing agents used alone
(monotherapy) for:
•
the acute (short-term) treatment of people 7 years of age and older
with manic and mixed episodes that
happen with bipolar I disorder.
•
maintenance treatment of bipolar I disorder in people 7 years of age
and older.
It is not known if lithium carbonate capsules are safe and effective
in children under 7 years of age with
bipolar I disorder.
Who should not take lithium carbonate capsules?
Do not take lithium carbonate capsules if you are allergic to lithium
or any of the ingredients in lithium
carbonate capsules. See the end of this Medication Guide for a
complete list of ingredients in lithium
carbonate capsules.
What should I tell my healthcare provider before taking lithium
carbonate capsules?
Before taking lithium carbonate capsules, tell your healthcare
provider if you:
•
have kidney problems
•
have heart problems
•
have breathing problems
•
have thyroid problems
•
are pregnant or plan to become pregnant. Lithium carbonate may harm
your unborn baby.
•
are breastfeeding or plan to breastfeed. Lithium carbonate can pass
into your breastmilk an

Summary of Product characteristics

LITHIUM CARBONATE- LITHIUM CARBONATE CAPSULE
GLENMARK PHARMACEUTICALS INC., USA
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LITHIUM CARBONATE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LITHIUM CARBONATE
CAPSULES.
LITHIUM CARBONATE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1970
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
(2.3, 5.1).
INDICATIONS AND USAGE
Lithium is a mood-stabilizing agent indicated as monotherapy for the
treatment of bipolar I disorder:
DOSAGE AND ADMINISTRATION
Recommended starting dosage for adults and pediatric patients over 30
kg (2.2):
•
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Known hypersensitivity to any inactive ingredient in the drug product.
(4)
WARNINGS AND PRECAUTIONS
•
•
•
• Treatment of acute manic and mixed episodes in patients 7 years
and older (1)
• Maintenance treatment in patients 7 years and older (1)
• Capsules: 300 mg, three times daily
Recommended starting dosage for pediatric patients 20 to 30 kg (2.2):
• Capsules: 300 mg twice daily
Obtain serum lithium concentration assay after 3 days, drawn 12 hours
after the last oral dose and
regularly until patient is stabilized.
Acute Manic or Mixed Episodes (patients 7 years and older): Titrate to
serum lithium concentrations
0.8 to 1.2 mEq/L (2.2).
Maintenance Treatment for Bipolar I Disorder (patients 7 years and
older): Titrate to serum lithium
concentrations 0.8 to 1 mEq/L (2.2).
Pre-treatment Screening: Evaluate renal function, vital signs,
electrolytes, thyroid function, concurrent
medications, and pregnancy status (2.1).
Mild to Moderate Renal Impairment (CLer 30 to 89 mL/min): Start with
dosages l