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 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

Prehľad produktov:

Lithium Carbonate Capsules USP 300 mg supplied as pink hard gelatin capsules imprinted with ‘300’on the body & ‘G221’ on the cap, filled with white to off-white granules. NDC 68788-7164-3: Bottles of 30 capsules NDC 68788-7164-6: Bottles of 60 capsules NDC 68788-7164-9: Bottles of 90 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.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

Preferred Pharmaceuticals Inc.
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MEDICATION GUIDE
Lithium (LITH-ee-əm) carbonate capsules
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 carbonatecapsules 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 and may
harm

Súhrn charakteristických

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:
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: 300mg, 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 less t