Lithobid (lithium carbonate) is indicated in the treatment of bipolar disorder. This slowly dissolving film-coated tablet is designed to give lower serum lithium peak concentrations than obtained with conventional oral lithium dosage forms.
Desirable serum lithium concentrations are 0.6 to 1.2 mEq/L which can usually be achieved with 900-1200 mg/day. Dosage will vary from one individual to another, but generally the following dosages will maintain this concentration:
1Can be administered on TID recommended dosing interval up to 1200 mg/day.
|LITHOBID®||2 tabs||2 tabs|
|Extended-Release Tablets1||(600 mg)||(600 mg)|
Serum lithium concentrations in uncomplicated cases receiving maintenance therapy during remission should be monitored at least every two months. Patients abnormally sensitive to lithium may exhibit toxic signs at serum concentrations of 1.0 to 1.5 mEq/L. Geriatric patients often respond to reduced dosage, and may exhibit signs of toxicity at serum concentrations ordinarily tolerated by other 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 drug therapy.
- Blood samples for serum lithium determinations should be drawn immediately prior to the next dose when lithium concentrations are relatively stable (ie, 8-12 hours after previous dose). Total reliance must not be placed on serum concentrations alone. Accurate patient evaluation requires both clinical and laboratory analysis.
- LITHOBID® Extended-Release Tablets must be swallowed whole and never chewed or crushed.
The toxic concentrations for lithium (1.5 mEq/ L) are close to the therapeutic concentrations (0.6-1.2 mEq/L). It is therefore important that patients and their families be cautioned to watch for early toxic symptoms and to discontinue the drug and inform the physician should they occur. (Toxic symptoms are listed in detail under ADVERSE REACTIONS.)
No specific antidote for lithium poisoning is known. Treatment is supportive. Early symptoms of lithium toxicity can usually be treated by reduction or cessation of dosage of the drug and resumption of the treatment at a lower dose after 24 to 48 hours. In severe cases of lithium poisoning, the first and foremost goal of treatment consists of elimination of this ion from the patient.
Treatment is essentially the same as that used in barbiturate poisoning: 1) gastric lavage, 2) correction of fluid and electrolyte imbalance and, 3) regulation of kidney functioning. Urea, mannitol, and aminophylline all produce significant increases in lithium excretion. Hemodialysis is an effective and rapid means of removing the ion from the severely toxic patient. However, patient recovery may be slow.
Infection prophylaxis, regular chest X-rays, and preservation of adequate respiration are essential.
LITHOBID® (Lithium Carbonate, USP)
Extended-Release Tablets, 300 mg, peach-colored imprinted “LITHOBID 300”
(Bottle of 100)
Store between 59°-86°F (15°-30°C). Protect from moisture. Dispense in tight, child-resistant container (USP).
(Lithium Carbonate, USP)
Extended-Release Tablets, 300 mg
ANI Pharmaceuticals, Inc.
Baltimore, Maryland 21244
Noven Therapeutics, LLC
Miami, FL 33186
Print Date: 05/2009
© 2009 Noven Therapeutics, LLC
TABLET, FILM COATED, EXTENDED RELEASE
NOVEN THERAPEUTICS, LLC
| LITHOBID |
lithium carbonate tablet, film coated, extended release
|Labeler — NOVEN THERAPEUTICS, LLC (166888268)|
|ANI Pharmaceuticals, Inc.||148515737||MANUFACTURE, ANALYSIS|
Revised: 01/2010 NOVEN THERAPEUTICS, LLC