Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66)
Physicians Total Care, Inc.
LITHIUM CARBONATE
LITHIUM CARBONATE 150 mg
ORAL
PRESCRIPTION DRUG
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
Lithium Carbonate Capsules USP 150 mg White/White hard gelatin capsules (size 4) Lithium Carbonate 150 mg Capsules are White/White size ‘4’ hard gelatin capsules, imprinted with ‘97’ on body and ‘H’ on cap, containing white to off-white powder. They are supplied in 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 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 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK 74146
Abbreviated New Drug Application
LITHIUM CARBONATE - LITHIUM CARBONATE CAPSULE PHYSICIANS TOTAL CARE, INC. ---------- 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 slee Belgenin tamamını okuyun