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:

Proficient Rx LP

INN (International Name):

LITHIUM CARBONATE

Composition:

LITHIUM CARBONATE 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lithium Carbonate Capsule USP 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 Carbonate Capsule USP 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 v

Product summary:

Lithium Carbonate Capsules USP 300 mg Pink/Pink hard gelatin capsules (size 1) Lithium Carbonate 300 mg Capsules 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 63187-304-30) Bottles of 60 Capsules (NDC 63187-304-60) Bottles of 90 Capsules (NDC 63187-304-90) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container as defined in the USP/NF. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Drugs Limited Jeedimetla, Hyderabad – 500 055, India.                                                        2008352-00 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LITHIUM CARBONATE- LITHIUM CARBONATE CAPSULE
PROFICIENT RX LP
----------
LITHIUM CARBONATE CAPSULES USP
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, 300 mg or 600 mg
of Lithium Carbonate USP.
INACTIVE INGREDIENTS
The capsules contain talc. The hard gelatin shell consists of gelatin,
titanium dioxide, sodium lauryl
sulphate and FD & C Red 40.
The printing ink contains shellac, dehydrated alcohol, isopropyl
alcohol, butyl alcohol, propylene
glycol, strong ammonia solution, black iron oxide E172 dye, potassium
hydroxide.
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.
The empirical formula for Lithium Citrate is C H Li
O ; molecular weight 209.92. Lithium acts as an
antimanic.
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 Carbonate Capsule USP 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 Carbonate Capsule USP 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