LITHIUM CARBONATE LITHIUM CARBONATE- lithium carbonate capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Alembic Pharmaceuticals Inc.

INN (International Name):

LITHIUM CARBONATE

Sammensetning:

LITHIUM CARBONATE 150 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 or capsule or lithium citrate products [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 pre

Produkt oppsummering:

Lithium Carbonate Capsules, USP   150 mg opaque buff/opaque buff colored capsules (size 4) (Identified A101) NDC 62332-013-30    Bottle of 30 capsules NDC 62332-013-31    Bottle of 100 capsules NDC 62332-013-71    Bottle of 500 capsules NDC 62332-013-91    Bottle of 1000 capsules 300 mg opaque light pink/opaque light pink colored capsules (size 2) (Identified A102) NDC 62332-014-30    Bottle of 30 capsules NDC 62332-014-31    Bottle of 100 capsules NDC 62332-014-71    Bottle of 500 capsules NDC 62332-014-91    Bottle of 1000 capsules   600 mg opaque pink/opaque buff colored capsules (size 0) (Identified A103) NDC 62332-015-30    Bottle of 30 capsules NDC 62332-015-31    Bottle of 100 capsules NDC 62332-015-71    Bottle of 500 capsules Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, child-resistant container as defined in the USP/NF. PROTECT FROM MOISTURE.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Alembic Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Lithium (LITH-ee-əm)
Carbonate Capsules
What is the most important information I should know about Lithium
Carbonate?
Lithium
Carbonate
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 exactly as your healthcare provider
tells you to take it. Stop
taking Lithium Carbonate and call your healthcare provider right away
if you have any
symptoms
of
lithium
toxicity
including:
o abnormal
heartbeat
o vomiting
o diarrhea
o drowsiness
o weak muscles
o blurred vision
o clumsiness
o ringing in your ears
o muscle
twitching
Other
symptoms
may
include:
o light
headedness
o confusion
o bloating
o mood
changes
o slurred
speech
o breathing
problems
o seizure
o coma
What
is
Lithium
Carbonate?
Lithium Carbonate 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 are safe and effective in
children under 7 years of age with
bipolar I disorder.
Who
should
not
take
Lithium
Carbonate?
Do not take Lithium Carbonate if you are allergic to 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?
Before
taking
Lithium
Carbonate,
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

Preparatomtale

LITHIUM CARBONATE LITHIUM CARBONATE- LITHIUM CARBONATE CAPSULE
ALEMBIC PHARMACEUTICALS INC.
----------
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: (1)
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):
o Capsules: 300 mg, three times daily (2)
Recommended starting dosage for pediatric patients 20 to 30 kg (2.2):
o Capsules: 300 mg, twice daily (2)
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
dosage less than those for
patients with normal renal function, titrate slowly with frequent
monitoring (2.5).
Severe Renal Impairment (CLer < 30 mL/min): Avoid use of lithium
(2.5).
DOS