LITHIUM CARBONATE tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

PD-Rx Pharmaceuticals, Inc.

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: - Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies ( 14 )] - Maintenance treatment in patients 7 years and older [see Clinical Studies ( 14 )] 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-a

Огляд продуктів:

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 72789-174-01: Bottle of 100 Tablets 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.

Статус Авторизація:

New Drug Application

інформаційний буклет

PD-Rx Pharmaceuticals, 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:
•
abnormal
heartbeat
•
vomiting
•
diarrhea
•
drowsiness
•
weak muscles
•
blurred vision
•
clumsiness
•
ringing in your ears
•
muscle twitching
Other symptoms may include:
•
lightheadedness
•
confusion
•
bloating
•
mood changes
•
slurred speech
•
breathing problems
•
seizure
•
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 my healthcare provider before taking Lithium or
Lithium

Характеристики продукта

LITHIUM CARBONATE- LITHIUM CARBONATE TABLET
PD-RX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LITHIUM CARBONATE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LITHIUM
CARBONATE.
LITHIUM CARBONATE TABLETS, 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:
Treatment of acute manic and mixed episodes in patients 7 years and
older ( 1)
Maintenance treatment in patients 7 years and older ( 1)
DOSAGE AND ADMINISTRATION
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 lithium
concentrations 0.8 to 1 mEq/L ( 2.2).
Pre-treatment Screening: Evaluate renal function, vital signs,
electrolytes, thyroid function, concurrent
medications, and pregnancy status ( 2.1).
Mild to Moderate Renal Impairment (CLer 30 to 89 mL/min): Start with
dosages less than those for
patients with normal renal function, titrate slowly with frequent
monitoring ( 2.5)