LITHIUM solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Lithium Citrate (UNII: 5Z6E9K79YV) (Lithium Cation - UNII:8H8Z5UER66)

Available from:

Precision Dose Inc.

INN (International Name):

Lithium Citrate

Composition:

Lithium Cation 8 meq in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 tablet or 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 developmental and toxicity studies in mice and rats report

Product summary:

Lithium Oral Solution USP, 8 mEq per 5 mL. Lithium Oral Solution USP is supplied as a clear nearly colorless solution. NDC 68094-757-62 5 mL per unit dose cup Thirty (30) cups per shipper Store and Dispense Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Dispense in a tight, child-resistant container as defined in the USP/NF.

Authorization status:

New Drug Application

Patient Information leaflet

Precision Dose Inc.
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This Medication Guide is approved by the U.S. Food and Drug
Administration.
MEDICATION GUIDE
Lithium (LITH-ee-əm) Oral Solution USP
Lithium Carbonate Tablets USP
Lithium Carbonate Capsules USP
Rx only
What is the most important information I should know about Lithium and
Lithium Carbonate?
Lithium and 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 or Lithium Carbonate exactly as your healthcare
provider tells you to take it. Stop
taking Lithium and Lithium Carbonate and call your healthcare provider
right away if you have any
symptoms of lithium toxicity including:
•
abnormal heartbeat
•
diarrhea
•
weak muscles
•
clumsiness
•
vomiting
•
drowsiness
•
blurred vision
•
ear ringing
What is Lithium and Lithium Carbonate?
Lithium and Lithium Carbonate are prescription medicines called
mood-stabilizing agents used to treat
manic episodes and as a long term treatment of bipolar disorder.
Lithium and Lithium Carbonate are not for people with severe kidney
problems.
It is not known if Lithium and Lithium Carbonate are safe and
effective in children.
Who should not take Lithium or Lithium Carbonate?
Do not take Lithium or Lithium Carbonate if you are allergic to
Lithium or any of the ingredients in
Lithium Carbonate or Lithium Citrate. See the end of this Medication
Guide for a complete list of
ingredients in Lithium and Lithium Carbonate.
What should I tell my healthcare provider before taking Lithium or
Lithium Carbonate?
Before taking Lithium or Lithium Carbonate, tell your healthcare
provider if you:
•
have kidney problems
•
have heart problems
•
have thyroid problems
•
are pregnant or plan to become pregnant. Lithium and Lithium Carbonate
may harm your unborn
baby.
•
are bre

Summary of Product characteristics

LITHIUM- LITHIUM SOLUTION
PRECISION DOSE INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LITHIUM SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LITHIUM.
LITHIUM ORAL SOLUTION, 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 30 to 89 mL/min): Start with
low dose, titrate slowly with frequent
monitoring. (2.8)
Severe Renal Impairment (CLer<30mL/min): Avoid use of lithium.(2.8)
DOSAGE FORM