LITHIUM CARBONATE- lithium carbonate capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

INN (International Name):

LITHIUM CARBONATE

Composition:

LITHIUM CARBONATE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lithium is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks. Lithium should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, and to patients receiving diuretics, since the risk of lithium toxicity is very high in such patients. If the psychiatri

Product summary:

Lithium Carbonate Capsules USP, 150 mg are supplied as No. 4 White/White Opaque Hard Gelatin Capsules Printed "West-ward 3188" in Black Ink and are available in: Bottles of 100 capsules            NDC 0904-6205-60 Lithium Carbonate Capsules USP, 300 mg are supplied as No. 1 Grey/Yellow Opaque Hard Gelatin Capsules Printed “West-ward 3189” in Black Ink and are available in: Bottles of 100 capsules            NDC 0904-6136-60 Bottles of 1000 capsules          NDC 0904-6136-80 Unit dose box of 100 capsules     NDC 0904-6136-61 Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured By: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Distributed by: Major Pharmaceuticals Livonia, MI 48150 USA Revised August 2010

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LITHIUM CARBONATE- LITHIUM CARBONATE CAPSULE
MAJOR PHARMACEUTICALS
----------
LITHIUM CARBONATE
CAPSULES, USP
Rev. 08/10
RX ONLY
WARNING
Lithium toxicity is closely related to serum lithium levels, and can
occur at doses close to
therapeutic levels. Facilities for prompt and accurate serum lithium
determinations should be
available before initiating therapy. (see DOSAGE AND ADMINISTRATION).
DESCRIPTION
Each capsule for oral administration contains 150 mg or 300 mg of
lithium carbonate. In addition, each
capsule contains the following inactive ingredient:
150 mg: Talc.
300 mg: Talc.
Capsule shell for the 150 mg potency contains: Gelatin and Titanium
Dioxide.
Capsule shell for the 300 mg potency contains: D&C Yellow #10, FD&C
Green #3, FD&C Red #40,
FD&C Yellow #6, Gelatin and Titanium Dioxide.
The printing ink contains: D&C Yellow #10, FD&C Blue #1, FD&C Blue #2,
FD&C Red #40, n-Butyl
Alcohol, Pharmaceutical Glaze, Propylene Glycol, SDA-3A Alcohol, and
Synthetic Black Iron Oxide.
Lithium is an element of the alkali-metal group with atomic number 3,
atomic weight 6.94 and an
emission line at 671 nm on the flame photometer.
Lithium Carbonate is a white, light, alkaline powder with molecular
formula Li
CO and molecular
weight 73.89.
CLINICAL PHARMACOLOGY
Preclinical studies have shown that lithium alters sodium transport in
nerve and muscle cells and effects
a shift toward intraneuronal metabolism of catecholamines, but the
specific biochemical mechanism of
lithium action in mania is unknown.
INDICATIONS AND USAGE
Lithium is indicated in the treatment of manic episodes of Bipolar
Disorder. Bipolar Disorder, Manic
(DSM-III) is equivalent to Manic Depressive illness, Manic, in the
older DSM-II terminology.
Lithium is also indicated as a maintenance treatment for individuals
with a diagnosis of Bipolar
Disorder.
Maintenance therapy reduces the frequency of manic episodes and
diminishes the intensity of those
episodes which may occur.
2
3
Typical symptoms of mania include pressure of speech, motor
hyperactivity, reduced