LITHIUM CARBONATE- lithium carbonate capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Camber Pharmaceuticals, Inc.

Designación común internacional (DCI):

LITHIUM CARBONATE

Composición:

LITHIUM CARBONATE 150 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 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

Resumen del producto:

Lithium Carbonate Capsules, USP Lithium Carbonate Capsules USP, 150 mg are white/white size  '4'  hard gelatin capsules, imprinted with '97'  on body and  'H'  on cap, containing white to off-white powder. They are supplied in Bottles of 30 Capsules (NDC 31722-544-30) Bottles of 100 Capsules (NDC 31722-544-01) Bottles of 500 Capsules (NDC 31722-544-05) Bottles of 1000 Capsules (NDC 31722-544-10) 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 30 Capsules (NDC 31722-545-30) Bottles of 100 Capsules (NDC 31722-545-01) Bottles of 500 Capsules (NDC 31722-545-05) Bottles of 1000 Capsules (NDC 31722-545-10) Bottles of 5000 Capsules (NDC 31752- 545-50) Blister Pack of 3x10' s (NDC 31722-545-03) Lithium Carbonate Capsules USP, 600 mg are pink/white size  '0EL'  hard gelatin capsules, imprinted with  '141'  on body and  'H'  on cap, containing white to off-white powder. They are supplied in Bottles of 30 Capsules (NDC 31722-546-30) Bottles of 100 Capsules (NDC 31722-546-01) Bottles of 500 Capsules (NDC 31722-546-05) Bottles of 1000 Capsules (NDC 31722-546-10) Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, child-resistant container as defined in the USP/NF. PROTECT FROM MOISTURE. 

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

Camber Pharmaceuticals, Inc.
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MEDICATION GUIDE
Lithium Carbonate (lith′ ee um kar′ bo nate)
Capsules, USP
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 lightheadedness o confusion
o bloating o mood changes
o slurred speech o breathing problems
o seizure o coma
What is lithium carbonate?
Lithium carbonate is prescription medicine called mood-stabilizing
agent 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 is 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 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?
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

Ficha técnica

LITHIUM CARBONATE - LITHIUM CARBONATE CAPSULE
CAMBER 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:
• 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):
• Capsules: 300 mg, 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 than those for
patients with normal renal function, titrate slowly with frequent
monitoring ( 2.5).
• Severe Renal Impairment (CLer<30mL/min): Avoid use