Minds On Meds

Mental Health Medications

Mood Stabilizers and Anticonvulsants

Lithobid, Page 2

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.

Long-Term Control

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:

Long-Term Control

1Can be administered on TID recommended dosing interval up to 1200 mg/day.

Morning Afternoon Nighttime
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.

Important Considerations

  • 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.

OVERDOSAGE

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.)

Treatment

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.

HOW SUPPLIED

LITHOBID® (Lithium Carbonate, USP)

Extended-Release Tablets, 300 mg, peach-colored imprinted “LITHOBID 300”

NDC 68968-4492-1

(Bottle of 100)

Storage Conditions

Store between 59°-86°F (15°-30°C). Protect from moisture. Dispense in tight, child-resistant container (USP).

LITHOBID®
(Lithium Carbonate, USP)
Extended-Release Tablets, 300 mg

Manufactured By:
ANI Pharmaceuticals, Inc.
Baltimore, Maryland 21244

For:
Noven Therapeutics, LLC
Miami, FL 33186
Print Date: 05/2009
© 2009 Noven Therapeutics, LLC

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 300 MG LABEL

NDC 68968-4492-1

100 TABLETS

LITHOBID®

(lithium carbonate)

TABLET, FILM COATED, EXTENDED RELEASE

300 mg

Rx ONLY

NOVEN THERAPEUTICS, LLC

PRINCIPAL DISPLAY PANEL – 300 MG LABEL
(click image for full-size original)
LITHOBID
lithium carbonate tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68968-4492
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
lithium carbonate (Lithium cation) lithium carbonate 300 mg
Inactive Ingredients
Ingredient Name Strength
calcium stearate
carnauba wax
Hypromellose 2910 (50 CPS)
FD&C Blue No. 2
FD&C Red No. 40
FD&C Yellow No. 6
povidone
propylene glycol
sodium chloride
sodium lauryl sulfate
sodium starch glycolate type a potato
sorbitol
titanium dioxide
Product Characteristics
Color pink (PINK) Score no score
Shape ROUND (ROUND) Size 10mm
Flavor Imprint Code LITHOBID;300
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68968-4492-1 100 TABLET, FILM COATED, EXTENDED RELEASE (100 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018027 04/27/1979
Labeler — NOVEN THERAPEUTICS, LLC (166888268)
Establishment
Name Address ID/FEI Operations
ANI Pharmaceuticals, Inc. 148515737 MANUFACTURE, ANALYSIS

Revised: 01/2010 NOVEN THERAPEUTICS, LLC