LITHIUM CARBONATE tablet

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

REMEDYREPACK INC.

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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)] T[see Clinical Studies (14)] - Maintenance treatment in patients 7 years and older [see Clinical Studies (14)] Mai[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

Sommarju tal-prodott:

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’s with Child Resistant Cap……………..NDC 62756-430-83 Bottles of 100’s with Child Resistant Cap……………NDC 62756-430-88 Bottles of 100’s with Non Child Resistant Cap………NDC 62756-430-08 Bottles of 1000’s with Non Child Resistant Cap……..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.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

LITHIUM CARBONATE- LITHIUM CARBONATE TABLET
REMEDYREPACK INC.
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MEDICATION GUIDE
MEDICATION GUIDE
Lithium (LITH-ee-əm) Carbonate Tablets USP
Wh at is the most important infor m at i on I should kn ow ab o ut
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.
Wh o 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.
Wh at should I tell my healthcare provider before taking lithium
carbonate tablets?
Before taking lithium carbonate tablets,

Karatteristiċi tal-prodott

LITHIUM CARBONATE- LITHIUM CARBONATE TABLET
REMEDYREPACK INC.
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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).
RECENT MAJOR CHANGES
Indications and Usage ( 1) 10/2018
Dosage and Administration ( 2.2) 10/2018
Warnings and Precautions ( 5.1) 12/2018
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