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:

Bryant Ranch Prepack

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Lithium is a mood-stabilizing agent indicated for the treatment of manic episodes and as maintenance treatment for Bipolar I Disorder. Lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium carbonate capsule or lithium citrate products [see Adverse Reactions ( 6), Description ( 11)]. 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 devel

Prehľad produktov:

Lithium Carbonate Capsules, USP Lithium Carbonate Capsules USP, 300 mg are pink/pink size '1' hard gelatin capsules, imprinted with '98' on body and 'H' on cap, containing white to off-white powder. They are supplied in Bottles of 1000 Capsules (NDC 63629-1917-1) Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight container as defined in the USP/NF.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

LITHIUM CARBONATE - LITHIUM CARBONATE CAPSULE
Bryant Ranch Prepack
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MEDICATION GUIDE
Lithium Carbonate (LITH ee um KAR-bo-nate)
Capsules
What is the most important information I should know about lithium
carbonate capsules?
Lithium Carbonate can cause serious side effects, including too much
lithium in your blood (lithium
toxicity).
Lithium toxicity can 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:
• abnormal heartbeat • vomiting • diarrhea • drowsiness
• weak muscles • blurred vision • clumsiness • ear ringing
What is lithium carbonate capsules?
Lithium Carbonate is prescription medicines called mood-stabilizing
agents used to treat manic episodes and
as a long term treatment of bipolar disorder.
Lithium Carbonate is not for people with severe kidney problems.
It is not known if lithium carbonate is safe and effective in
children.
Who should not take lithium carbonate capsules?
Do not take lithium carbonate capsules 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 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
your baby. Talk to your healthcare provider about the best way to feed
your baby if you take lithium
car

Súhrn charakteristických

LITHIUM CARBONATE - LITHIUM CARBONATE CAPSULE
BRYANT RANCH PREPACK
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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 (
2.6, 5.1).
INDICATIONS AND USAGE
Lithium is a mood stabilizing agent indicated for the treatment of
manic episodes and as maintenance
treatment for Bipolar I Disorder ( 1)
DOSAGE AND ADMINISTRATION
• Recommended starting dosage ( 2.2):
o Capsules: 300 mg, three times daily
• Obtain serum lithium concentration assay after 4 days, drawn 12
hours after the last oral dose and
regularly until patient is stabilized.
• Manic Episode: Titrate to serum lithium concentrations 0.8 to 1.2
mEq/L, which may be achieved with (
2.3):
o Capsules: 600 mg, two to three times daily
• Maintenance Treatment for Bipolar I Disorder: Titrate to serum
lithium concentrations 0.8 to 1 mEq/L,
which may be achieved with ( 2.4):
o Capsules: 300 mg to 600 mg, two to three times daily
• Pre-treatment screening: Evaluate renal function, vital signs,
electrolytes, thyroid function, concurrent
medications, and pregnancy status ( 2.1)
• Adjust daily dosage based on serum lithium concentration and
clinical response ( 2.6)
• Mild to moderate renal impairment (CLcr 30 to 89 mL/min): Start
with low dose, titrate slowly with
frequent monitoring ( 2.8)
• Severe renal impairment (CLcr < 30 mL/min): Avoid use of lithium (
2.8)
DOSAGE FORMS AND STRENGTHS
• Capsules: 150 mg, 300 mg, 600 mg of lithium carbonate ( 3)
CONTRAINDICATIONS
Known hypersensitivity to