LITHIUM CARBONATE capsule gelatin coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

REMEDYREPACK INC.

DCI (Dénomination commune internationale):

LITHIUM CARBONATE

Composition:

LITHIUM CARBONATE 150 mg

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

LITHIUM CARBONATE- LITHIUM CARBONATE CAPSULE, GELATIN COATED
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LITHIUM AND LITHIUM CARBONATE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LITHIUM AND
LITHIUM CARBONATE.
LITHIUM ORAL SOLUTION, FOR ORAL USE
LITHIUM CARBONATE TABLETS, FOR ORAL USE
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):
Tablets or Capsules: 300 mg, three times daily or
Oral Solution: 5 mL (8mEq lithium) 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):
Tablets or Capsules: 600 mg, two to three times daily or
Oral Solution: 10 mL (16 mEq lithium), 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):
Tablets or Capsules: 300 mg to 600 mg, two to three times daily or
Oral Solution: 5 mL to 10 mL (8-16 mEq lithium), 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 (CLer