Alembic Limited
Lithium Carbonate Capsules USP
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
Rx Only
LITHIUM CARBONATE DESCRIPTION
Inactive Ingredients: 23CLINICAL PHARMACOLOGY
LITHIUM CARBONATE INDICATIONS AND USAGE
LITHIUM CARBONATE CONTRAINDICATIONS
WARNINGS
DOSAGE AND ADMINISTRATIONPRECAUTIONS
General Precautions
DOSAGE AND ADMINISTRATIONInformation for Patients
Drug Interactions
Combined use of haloperidol and lithium.Non-steroidal anti-inflammatory drugs (NSAIDS)
Pregnancy
Teratogenic Effects
Pregnancy Category DWARNINGSNursing Mothers
Usage in Children
LITHIUM CARBONATE ADVERSE REACTIONS
Lithium toxicityNeuromuscular
Central Nervous SystemCardiovascularNeurologicalGastrointestinalGenitourinaryDermatologicAutonomic Nervous System Thyroid Abnormalities
PRECAUTIONSEEG ChangesEKG ChangesMiscellaneousMiscellaneous reactions unrelated to dosage are:OVERDOSAGE
ADVERSE REACTIONS
TreatmentLITHIUM CARBONATE DOSAGE AND ADMINISTRATION
Acute Mania
Long-term ControlPatients abnormally sensitive to lithium may exhibit toxic signs at serum levels of 1 to 1.5 mEq/L. Elderly patients often respond to reduced dosage, and may exhibit signs of toxicity at serum levels ordinarily tolerated by other patients.
N.B.HOW SUPPLIED
Lithium Carbonate Capsules USP
150 mg opaque buff/opaque buff colored capsules (size 4)
300 mg opaque light pink/opaque light pink colored capsules (size 2)
600 mg opaque pink/opaque buff colored capsules (size 0)
Store and Dispense:
Lithium Carbonate
Lithium Carbonate CAPSULE
Product Information
|
|
Product Type
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Human prescription drug label |
Item Code (Source)
|
NDC:46708-013 |
|
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
LITHIUM CARBONATE LITHIUM CATION |
|
150 mg
|
Product Characteristics
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|
Color
|
Size
|
Imprint Code
|
Shape
|
|
orange (OPAQUE BUFF) |
14 mm |
A;101 |
CAPSULE |
Packaging
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|
#
|
Item Code
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Package Description
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Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:46708-013-30 |
30 in 1 BOTTLE |
|
|
|
2 |
NDC:46708-013-31 |
100 in 1 BOTTLE |
|
|
|
3 |
NDC:46708-013-71 |
500 in 1 BOTTLE |
|
|
|
4 |
NDC:46708-013-91 |
1000 in 1 BOTTLE |
|
|
|
Lithium Carbonate
Lithium Carbonate CAPSULE
Product Information
|
|
Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:46708-014 |
|
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
LITHIUM CARBONATE LITHIUM CATION |
|
300 mg
|
Product Characteristics
|
|
Color
|
Size
|
Imprint Code
|
Shape
|
|
pink (OPAQUE LIGHT PINK) |
18 mm |
A;102 |
CAPSULE |
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:46708-014-30 |
30 in 1 BOTTLE |
|
|
|
2 |
NDC:46708-014-31 |
100 in 1 BOTTLE |
|
|
|
3 |
NDC:46708-014-71 |
500 in 1 BOTTLE |
|
|
|
4 |
NDC:46708-014-91 |
1000 in 1 BOTTLE |
|
|
|
Lithium Carbonate
Lithium Carbonate CAPSULE
Product Information
|
|
Product Type
|
Human prescription drug label |
Item Code (Source)
|
NDC:46708-015 |
|
Route of Administration
|
ORAL |
DEA Schedule
|
|
Active Ingredient/Active Moiety
|
|
Ingredient Name
|
Basis of Strength
|
Strength
|
|
LITHIUM CARBONATE LITHIUM CATION |
|
600 mg
|
Product Characteristics
|
|
Color
|
Size
|
Imprint Code
|
Shape
|
|
orange (OPAQUE BUFF) |
23 mm |
A;103 |
CAPSULE |
Packaging
|
|
#
|
Item Code
|
Package Description
|
Marketing Start Date
|
Marketing End Date
|
|
1 |
NDC:46708-015-30 |
30 in 1 BOTTLE |
|
|
|
2 |
NDC:46708-015-31 |
100 in 1 BOTTLE |
|
|
|
3 |
NDC:46708-015-71 |
500 in 1 BOTTLE |
|
|
|
