LITHIUM CARBONATE LITHIUM CARBONATE- lithium carbonate capsule

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Preferred Pharmaceuticals, Inc.

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 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 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, dec

Prehľad produktov:

300 mg opaque light pink/opaque light pink colored capsules (size 2) (Identified A102) 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.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

Preferred 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. Lithi

Súhrn charakteristických

LITHIUM CARBONATE LITHIUM CARBONATE- LITHIUM CARBONATE CAPSULE
PREFERRED 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)
•
•
DOSAGE AND ADMINISTRATION
•
o Capsules: 300 mg, three times daily (2)
•
o Capsules: 300 mg, twice daily (2)
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Known hypersensitivity to any inactive ingredient in the drug product.
(4) (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)
Recommended starting dosage for adults and pediatric patients over 30
kg (2.2):
Recommended starting dosage for pediatric patients 20 to 30 kg (2.2):
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