Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66)
Camber Pharmaceuticals, Inc.
LITHIUM CARBONATE
LITHIUM CARBONATE 150 mg
ORAL
PRESCRIPTION DRUG
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 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
Lithium Carbonate Capsules, USP Lithium Carbonate Capsules USP, 150 mg are white/white size '4' hard gelatin capsules, imprinted with '97' on body and 'H' on cap, containing white to off-white powder. They are supplied in Bottles of 30 Capsules (NDC 31722-544-30) Bottles of 100 Capsules (NDC 31722-544-01) Bottles of 500 Capsules (NDC 31722-544-05) Bottles of 1000 Capsules (NDC 31722-544-10) Lithium Carbonate Capsules USP, 300 mg are pink/pink size '1' hard gelatin capsules, imprinted with '98' on body and 'H' on cap, containing white to off-white powder. They are supplied in Bottles of 30 Capsules (NDC 31722-545-30) Bottles of 100 Capsules (NDC 31722-545-01) Bottles of 500 Capsules (NDC 31722-545-05) Bottles of 1000 Capsules (NDC 31722-545-10) Bottles of 5000 Capsules (NDC 31752- 545-50) Blister Pack of 3x10' s (NDC 31722-545-03) Lithium Carbonate Capsules USP, 600 mg are pink/white size '0EL' hard gelatin capsules, imprinted with '141' on body and 'H' on cap, containing white to off-white powder. They are supplied in Bottles of 30 Capsules (NDC 31722-546-30) Bottles of 100 Capsules (NDC 31722-546-01) Bottles of 500 Capsules (NDC 31722-546-05) Bottles of 1000 Capsules (NDC 31722-546-10) Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, child-resistant container as defined in the USP/NF. PROTECT FROM MOISTURE.
Abbreviated New Drug Application
Camber Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Lithium Carbonate (lith′ ee um kar′ bo nate) Capsules, USP What is the most important information I should know about lithium carbonate? 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 carbonate exactly as your healthcare provider tells you to take it. Stop taking 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 carbonate? Lithium carbonate is prescription medicine called mood-stabilizing agent 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 is safe and effective in children under 7 years of age with bipolar I disorder. Who should not take lithium carbonate? Do not take lithium carbonate 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? Before taking lithium carbonate, tell your healthcare provider if you: • have kidney problems • have heart problems • have breathing problems • have thyroid problems • are pregnant or plan Prečítajte si celý dokument
LITHIUM CARBONATE - LITHIUM CARBONATE CAPSULE CAMBER PHARMACEUTICALS, INC. ---------- 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<30mL/min): Avoid use Prečítajte si celý dokument