País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
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 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 devel
Lithium Carbonate Capsules, USP 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 100 Capsules (NDC 63629-1916-1) Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight container as defined in the USP/NF. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Abbreviated New Drug Application
LITHIUM CARBONATE - LITHIUM CARBONATE CAPSULE Bryant Ranch Prepack ---------- MEDICATION GUIDE Lithium Carbonate (LITH ee um KAR-bo-nate) Capsules What is the most important information I should know about lithium carbonate capsules? 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 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: • abnormal heartbeat • vomiting • diarrhea • drowsiness • weak muscles • blurred vision • clumsiness • ear ringing What is lithium carbonate capsules? Lithium Carbonate is prescription medicines called mood-stabilizing agents used to treat manic episodes and as a long term treatment of bipolar disorder. Lithium Carbonate is not for people with severe kidney problems. It is not known if lithium carbonate is safe and effective in children. 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 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 your baby. Talk to your healthcare provider about the best way to feed your baby if you take lithium car Leer el documento completo
LITHIUM CARBONATE - LITHIUM CARBONATE CAPSULE BRYANT RANCH PREPACK ---------- 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 ( 2.6, 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): o Capsules: 300 mg, 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): o Capsules: 600 mg, 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): o Capsules: 300 mg to 600 mg, 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 (CLcr 30 to 89 mL/min): Start with low dose, titrate slowly with frequent monitoring ( 2.8) • Severe renal impairment (CLcr < 30 mL/min): Avoid use of lithium ( 2.8) DOSAGE FORMS AND STRENGTHS • Capsules: 150 mg, 300 mg, 600 mg of lithium carbonate ( 3) CONTRAINDICATIONS Known hypersensitivity to Leer el documento completo