LITHIUM CARBONATE tablet LITHIUM CARBONATE capsule, gelatin coated LITHIUM solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Hikma Pharmaceuticals USA Inc.

INN (Nama Antarabangsa):

LITHIUM CARBONATE

Komposisi:

LITHIUM CARBONATE 300 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of 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)]. 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 an increased incidence of fetal mortality, decreas

Ringkasan produk:

Lithium Oral Solution USP, 8 mEq per 5 mL. Lithium Oral Solution, USP is supplied as a clear, colorless to slightly amber or red solution. NDC 0054-3527-63: Bottle of 500 mL 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. Lithium Carbonate Tablets, USP 300 mg supplied as white to off-white, biconvex tablet, scored on one side with product identification “54 452” debossed on the other side. NDC 0054-8528-25: 10x10 Unit-Dose (For Institutional Use Only) NDC 0054-4527-25: Bottle of 100 Tablets NDC 0054-4527-31: Bottle of 1,000 Tablets Lithium Carbonate Capsules, USP 150 mg supplied as opaque white capsules imprinted with product identification “54 213” on both caps and bodies and containing a white powder. NDC 0054-8526-25: 10x10 Unit-Dose (For Institutional Use Only). NDC 0054-2526-25: Bottle of 100 Capsules 300 mg supplied as opaque, light pink-colored capsules imprinted with product identification “54 463” on both caps and bodies and containing a white powder. NDC 0054-8527-25: 10x10 Unit-Dose (For Institutional Use Only). NDC 0054-2527-25: Bottle of 100 Capsules NDC 0054-2527-31: Bottle of 1,000 Capsules 600 mg supplied as gelatin capsules having opaque, light pink-colored caps with white bodies, imprinted with product identification “54 702” on both caps and bodies and containing a white powder. NDC 0054-8531-25: 10x10 Unit-Dose (For Institutional Use Only). NDC 0054-2531-25: Bottle of 100 Capsules Storage 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. PROTECT FROM MOISTURE.

Status kebenaran:

New Drug Application

Risalah maklumat

LITHIUM CARBONATE- LITHIUM CARBONATE CAPSULE, GELATIN COATED
LITHIUM- LITHIUM SOLUTION
Hikma Pharmaceuticals USA Inc.
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MEDICATION GUIDE
MEDICATION GUIDE
Lithium (LITH-ee-əm) oral solution
Lithium Carbonate tablets
Lithium Carbonate capsules
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
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 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:
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 and Lithium Carbonate?
Lithium and Lithium Carbonate are prescription medicines called
mood-stabilizing agents 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 and Lithium Carbonate are safe and
effective in children under 7 years of age
with bipolar I disorder.
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

Ciri produk

LITHIUM CARBONATE- LITHIUM CARBONATE TABLET
LITHIUM CARBONATE- LITHIUM CARBONATE CAPSULE, GELATIN COATED
LITHIUM- LITHIUM SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
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
(2.3, 5.1).
INDICATIONS AND USAGE
Lithium is a mood-stabilizing agent indicated as monotherapy for the
treatment of bipolar I disorder:
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
•
•
CONTRAINDICATIONS
Known hypersensitivity to any inactive ingredient in the drug product.
(4)
Treatment of acute manic and mixed episodes in patients 7 years and
older (1)
Maintenance treatment in patients 7 years and older (1)
Recommended starting dosage for adults and pediatric patients over 30
kg (2.2):
•
•
Tablets or Capsules: 300 mg, three times daily, or
Oral Solution: 8mEq lithium (5 mL) three times daily
Recommended starting dosage for pediatric patients 20 to 30 kg (2.2):
•
•
Tablets or Capsules: 300 mg twice daily, or
Oral Solution: 8mEq (5mL), 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 l