Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66)
Alembic Pharmaceuticals Limited
ORAL
PRESCRIPTION DRUG
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
Lithium Carbonate Capsules USP 150 mg opaque buff/opaque buff colored capsules (size 4) (Identified A 101) NDC 46708-303-30: Bottles of 30 capsules. NDC 46708-303-31: Bottles of 100 capsules. NDC 46708-303-71: Bottles of 500 capsules. NDC 46708-303-91: Bottles of 1000 capsules. 300 mg opaque light pink/opaque light pink colored capsules (size 2) (Identified A 102) NDC 46708-304-30: Bottles of 30 capsules. NDC 46708-304-31: Bottles of 100 capsules. NDC 46708-304-71: Bottles of 500 capsules. NDC 46708-304-91: Bottles of 1000 capsules. 600 mg opaque pink/opaque buff colored capsules (size 0) (Identified A 103) NDC 46708-305-30: Bottles of 30 capsules. NDC 46708-305-31: Bottles of 100 capsules. NDC 46708-305-71: Bottles of 500 capsules. Store and Dispense: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container as defined in the USP/NF. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Village Panelav, P. O. Tajpura, Near Baska, Taluka-Halol, Panchmahal, Gujarat, India. Revised: 11/2011
Abbreviated New Drug Application
LITHIUM CARBONATE - LITHIUM CARBONATE CAPSULE ALEMBIC PHARMACEUTICALS LIMITED ---------- 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: Lithium Carbonate USP . . . . . . . . . . 150 mg, 300 mg or 600 mg INACTIVE INGREDIENTS: The capsules contain talc, gelatin, FD&C Red No. 40, titanium dioxide, D&C Yellow No. 10, FD&C Yellow No. 6, and the imprinting ink contains black iron oxide, & Pharmaceutical glaze. 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. 2 3 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. CONTRAINDICATIONS Lithium shoul Lestu allt skjalið