LITHIUM CARBONATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

LITHIUM CARBONATE

Composition:

LITHIUM CARBONATE 300 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: - Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies (14)] - Maintenance treatment in patients 7 years and older [see Clinical Studies (14)] Lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium carbonate tablet  [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 Cl

Product summary:

Lithium Carbonate Tablets, USP 300 mg supplied as white to off-white, circular, biconvex, uncoated tablets debossed with “430” on one side and break line on other side. Bottles of 30 with child-resistant cap……………..NDC 62756-430-83 Bottles of 100 with child-resistant cap……………NDC 62756-430-88 Bottles of 100.............................................………NDC 62756-430-08 Bottles of 1000............................................……..NDC 62756-430-18 Store and Dispense Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].   Dispense in a tight, child-resistant container as defined in the USP/NF. PROTECT FROM MOISTURE.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LITHIUM CARBONATE- LITHIUM CARBONATE TABLET
Sun Pharmaceutical Industries, Inc.
----------
MEDICATION GUIDE
Dispense with Medication Guide available at:
https://www.sunpharma.com/usa/products
MEDICATION GUIDE
Lithium (LITH-ee-əm) Carbonate Tablets USP
What is the most important information I should know about lithium
carbonate tablets?
Lithium carbonate tablets 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 tablets exactly as your healthcare provider tells
you to take it. Stop taking
lithium carbonate tablets and call your healthcare provider right away
if you have any symptoms
of lithium toxicity including:
•
abnormal heartbeat
•
vomiting
•
diarrhea
•
drowsiness
•
weak muscles
•
blurred vision
•
clumsiness
•
ringing in your ears
•
muscle twitching
Other symptoms may include:
•
lightheadedness
•
confusion
•
bloating
•
mood changes
•
slurred speech
•
breathing problems
•
seizure
•
coma
What are lithium carbonate tablets?
Lithium carbonate tablets are a prescription medicine 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 tablet is safe and effective in
children under 7 years of age with
bipolar I disorder.
Who should not take lithium carbonate tablets?
Do not take lithium carbonate tablets if you are allergic to lithium
or any of the ingredients in lithium
carbonate tablets. See the end of this Medication Guide for a complete
list of ingredients in lithium
carbonate tablets.
What should I tell my healthcare

Summary of Product characteristics

LITHIUM CARBONATE- LITHIUM CARBONATE TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LITHIUM CARBONATE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LITHIUM CARBONATE
TABLETS.
LITHIUM CARBONATE TABLETS, 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:
Treatment of acute manic and mixed episodes in patients 7 years and
older (1)
Maintenance treatment in patients 7 years and older (1)
DOSAGE AND ADMINISTRATION
Recommended starting dosage for adults and pediatric patients over 30
kg (2.2):
Tablets: 300 mg, three times daily
Recommended starting dosage for pediatric patients 20 to 30 kg (2.2):
Tablets: 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 (2.2).
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 less than those for
patients with normal renal function, titrate slowly with frequent
monitoring (2.5).
Severe Renal Impairment (CLer<30mL/min): Avoid use of lithium (2.5).
DOSAGE FORMS AND STRENGTHS
Table