Lithium Carbonate description, usages, side effects, indications, overdosage, supplying and lots more!

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Lithium Carbonate

Hetero Drugs Limited
Hetero Labs Limited


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

WARNING


DOSAGE AND ADMINISTRATION

LITHIUM CARBONATE DESCRIPTION




Inactive Ingredients








CLINICAL PHARMACOLOGY


INDICATIONS & USAGE






LITHIUM CARBONATE CONTRAINDICATIONS


WARNINGS


DOSAGE AND ADMINISTRATION

Unmasking of Brugada Syndrome


Pregnancy


Lithium Induced Renal Effects






PRECAUTIONS

General


DOSAGE AND ADMINISTRATION





Information for Patients






Drug Interactions


Combined Use Of Haloperidol and Lithium.








Non-Steroidal Anti-Inflammatory Drugs (NSAIDS):

Pregnancy, Teratogenic Effects




WARNINGS

Nursing Mothers


Usage in Children

Since information regarding the safety and effectiveness of lithium in children under 12 years of age is not available, its use in such patients is not recommended at this time. There has been a report of a transient syndrome of acute dystonia and hyperreflexia occurring in a 15 kg child who ingested 300 mg of lithium carbonate.

LITHIUM CARBONATE ADVERSE REACTIONS


Lithium Toxicity










Neuromuscular:


Central Nervous System:


Cardiovascular:
WARNINGS: Unmasking of Brugada Syndromeand PRECAUTIONS: Information for the Patients

Neurological:


Gastrointestinal:


Genitourinary:


Dermatologic:


Autonomic Nervous System:


Thyroid Abnormalities:
PRECAUTIONS

EEG Changes:


EKG Changes:


Miscellaneous:


Miscellaneous Reactions Unrelated to Dosage are:


OVERDOSAGE


ADVERSE REACTIONS

Treatment


DOSAGE & ADMINISTRATION


Acute Mania


Long-Term Control




N.B.

HOW SUPPLIED


Lithium Carbonate Capsules USP

150 mg White/White hard gelatin capsules (size 4)






300 mg Pink/Pink hard gelatin capsules (size 1)








600 mg Pink/White hard gelatin capsules (size ‘0EL’)






Store and Dispense:


Lithium Carbonate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL



Lithium Carbonate


Lithium Carbonate


Lithium Carbonate

Lithium Carbonate

Lithium Carbonate

Lithium Carbonate

Lithium Carbonate CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65977-5044
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LITHIUM CARBONATE LITHIUM CATION 150 mg

Inactive Ingredients

Ingredient Name Strength
talc
GELATIN
titanium dioxide
SODIUM LAURYL SULFATE
FD&C RED NO. 40
SHELLAC
ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
propylene glycol
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE

Product Characteristics

Color Size Imprint Code Shape
WHITE (white) 14 mm 97;H CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65977-5044-0 30 in 1 BOTTLE
2 NDC:65977-5044-1 100 in 1 BOTTLE
3 NDC:65977-5044-2 500 in 1 BOTTLE
4 NDC:65977-5044-3 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090702 2009-09-25


Lithium Carbonate

Lithium Carbonate CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65977-5045
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LITHIUM CARBONATE LITHIUM CATION 300 mg

Inactive Ingredients

Ingredient Name Strength
talc
GELATIN
titanium dioxide
SODIUM LAURYL SULFATE
FD&C RED NO. 40
SHELLAC
ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
propylene glycol
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE

Product Characteristics

Color Size Imprint Code Shape
PINK (pink) 19 mm 98;H CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65977-5045-0 30 in 1 BOTTLE
2 NDC:65977-5045-1 100 in 1 BOTTLE
3 NDC:65977-5045-2 500 in 1 BOTTLE
4 NDC:65977-5045-3 1000 in 1 BOTTLE
5 NDC:65977-5045-4 5000 in 1 BOTTLE
6 10 in 1 BLISTER PACK
7 NDC:65977-5045-5 3 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090702 2009-09-25


Lithium Carbonate

Lithium Carbonate CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65977-5046
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LITHIUM CARBONATE LITHIUM CATION 600 mg

Inactive Ingredients

Ingredient Name Strength
talc
GELATIN
titanium dioxide
SODIUM LAURYL SULFATE
FD&C RED NO. 40
SHELLAC
ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
propylene glycol
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE

Product Characteristics

Color Size Imprint Code Shape
PINK (white) 23 mm 141;H CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65977-5046-0 30 in 1 BOTTLE
2 NDC:65977-5046-1 100 in 1 BOTTLE
3 NDC:65977-5046-2 500 in 1 BOTTLE
4 NDC:65977-5046-3 1000 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090702 2009-09-25


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Be sure to consult your doctor before taking any medication!
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