LITHIUM CARBONATE capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

REMEDYREPACK INC.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 capsule [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, decreased fetal weight, increased fetal skeletal abnormalities, and cleft palate (mouse fetuses only) with oral doses of lithium that produced serum concentrations similar to the human therapeutic range. Other published animal studies report adverse effects on embryonic implantation in rats after lithium administration. Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population(s) is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations: Dose Adjustments During Pregnancy and the Postpartum Period: If the decision is made to continue lithium treatment during pregnancy, serum lithium concentrations should be monitored and the dosage adjusted during pregnancy. Two to three days prior to delivery, lithium dosage should be decreased or discontinued to reduce the risk of maternal and/or neonatal toxicity. Lithium may be restarted in the post-partum period at preconception doses in medically stable patients as long as serum lithium levels are closely monitored [see Dosage and Administration ( 2.4), Warnings and Precautions ( 5.1)]. Fetal/Neonatal Adverse Reactions: Lithium toxicity may occur in neonates who were exposed to lithium in late pregnancy. A floppy baby syndrome including neurological, cardiac, and hepatic abnormalities that are similar to those seen with lithium toxicity in adults have been observed. Symptoms include hypotonia, respiratory distress syndrome, cyanosis, lethargy, feeding difficulties, depressed neonatal reflexes, neonatal depression, apnea, and bradycardia. Monitor neonates and provide supportive care until lithium is excreted and toxic signs disappear, which may take up to 14 days. Consider fetal echocardiography between 16 and 20 weeks gestation in a woman with first trimester lithium exposure because of the potential increased risk of cardiac malformations. Risk Summary: Limited published data reports the presence of lithium carbonate in human milk with breast milk levels measured at 0.12 to 0.7 mEq or 40 to 45% of maternal plasma levels. Infants exposed to lithium during breastfeeding may have plasma levels that are 30 to 40% of maternal plasma levels. Signs and symptoms of lithium toxicity such as hypertonia, hypothermia, cyanosis, and ECG changes have been reported in some breastfed neonates and infants. Increased prolactin levels have been measured in lactating women, but the effects on milk production are not known. Breastfeeding is not recommended with maternal lithium use; however, if a woman chooses to breastfeed, the infant should be closely monitored for signs of lithium toxicity. Discontinue breastfeeding if a breastfed infant develops lithium toxicity. Clinical Considerations: Consider regular monitoring of lithium levels and thyroid function in a breastfed infant. The safety and effectiveness of lithium for monotherapy treatment of acute manic or mixed episodes of bipolar I disorder and maintenance monotherapy of bipolar I disorder in pediatric patients ages 7 to 17 years of age have been established in an acute-phase clinical trial of 8 weeks in duration followed by a 28-week randomized withdrawal phase [see Dosage and Administration ( 2.1), Adverse Reactions ( 6.1), Clinical Pharmacology ( 12.3), Clinical Studies ( 14)] . The safety and effectiveness of lithium has not been established in pediatric patients less than 7 years of age with bipolar I disorder. Clinical studies of lithium carbonate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other treatment. Lithium is known to be substantially excreted by the kidneys, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. As lithium is eliminated primarily through the kidney, lithium renal clearance is decreased in patients with abnormal renal function, and the risk of lithium intoxication increases considerably in this setting. Lithium should not be used in severe renal insufficiency (creatinine clearance less than 30 mL/min evaluated by Cockcroft-Gault), especially if the condition requires adherence to a low-sodium diet [see Dosage and Administration ( 2.5)] . Start patients with mild to moderately impaired renal function (creatinine clearance 30 to 89 mL/min evaluated by Cockcroft-Gault) with lower doses of lithium and titrate slowly while frequently monitoring serum lithium concentrations and for signs of lithium toxicity [see Dosage and Administration ( 2.5)] .

Produktsammanfattning:

300 mg supplied as pink hard gelatin capsules imprinted with ‘300’ on the body and ‘G221’ on the cap, filled with white to off-white granules. NDC: 70518-0668-00 NDC: 70518-0668-01 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK Storage 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]. Protect from moisture. Dispense in a tight, child-resistant container as defined in the USP/NF. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

REMEDYREPACK INC.
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MEDICATION GUIDE
Lithium ( LITH-ee-əm) Carbonate capsules, USP
What is the most important information I should know about lithium
carbonate capsules?
Lithium carbonate capsules 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 carbonate capsules exactly as your healthcare provider tells
you to take it. Stop taking
lithium carbonate capsules and call your healthcare provider right
away if you have any
symptoms of lithium toxicity including:
1.
Other symptoms may include:
What are lithium carbonate capsules?
Lithium carbonate capsules 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 carbonate capsules are safe and effective
in children under 7 years of age with
bipolar I disorder.
Who should not take lithium carbonate capsules?
Do not take lithium carbonate capsules if you are allergic to lithium
or any of the ingredients in lithium
carbonate capsules. See the end of this Medication Guide for a
complete list of ingredients in lithium
carbonate capsules.
What should I tell my healthcare provider before taking lithium
carbonate capsules?
Before taking lithium carbonate capsules, tell your healthcare
provider if you:
•
have kidney problems
•
have heart problems
•
have breathing problems
•
have thyroid problems
•
are pregnant or plan to become pregnant. Lithium carbonate may harm
your unborn baby.
•
are breastfeeding or plan to breastfeed. Lithium carbonate can pass
into your breastmilk and may
harm yo

Produktens egenskaper

LITHIUM CARBONATE- LITHIUM CARBONATE CAPSULE
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LITHIUM CARBONATE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LITHIUM CARBONATE
CAPSULES.
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:
• 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):
• Capsules: 300 mg, three times daily
Recommended starting dosage for pediatric patients 20 to 30 kg ( 2.2):
• Capsules: 300 mg 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).
Severe Renal Impairment (CLer < 30 mL/min): Avoid use of lithium (
2.5).
DOSAGE FORMS AND STRE