LITHIUM CARBONATE capsule, gelatin coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Aphena Pharma Solutions - Tennessee, Inc.

INN (Tên quốc tế):

LITHIUM CARBONATE

Thành phần:

LITHIUM CARBONATE 150 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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

Tóm tắt sản phẩm:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. NDC 0054-8528-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper. (For Institutional Use Only). NDC 0054-4527-25: Bottles of 100 tablets. NDC 0054-4527-31: Bottles of 1000 tablets. (Identified 54 213). NDC 0054-8526-25: Unit dose, 10 capsules per strip, 10 strips per shelf pack, 10 shelf packs per shipper. (For Institutional Use Only). NDC 0054-2526-25: Bottles of 100 capsules. (Identified 54 463). NDC 0054-8527-25: Unit dose, 10 capsules per strip, 10 strips per shelf pack, 10 shelf packs per shipper. (For Institutional Use Only). NDC 0054-2527-25: Bottles of 100 capsules. NDC 0054-2527-31: Bottles of 1000 capsules. (size 0) (Identified 54 702). NDC 0054-8531-25: Unit dose, 10 capsules per strip, 10 strips per shelf pack, 10 shelf packs per shipper. (For Institutional Use Only). NDC 0054-2531-25: Bottles of 100 capsules. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container as defined in the USP/NF. NDC 0054-8529-04: Unit dose Patient Cup™ filled to deliver 5 mL, ten 5 mL Patient Cup™ per shelf pack, ten shelf packs per shipper. (For Institutional Use Only). NDC 0054-3527-63: Bottles of 500 mL. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP/NF. 4055500/07 Revised July 2009 © RLI, 2009

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

LITHIUM CARBONATE- LITHIUM CARBONATE CAPSULE, GELATIN COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
----------
LITHIUM CARBONATE TABLETS USP, LITHIUM CARBONATE CAPSULES USP, LITHIUM
ORAL SOLUTION 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 tablet for oral administration contains:
Lithium Carbonate . . . . . . . . . . 300 mg
Each capsule for oral administration contains:
Lithium Carbonate . . . . . . . . . . 150 mg, 300 mg or 600 mg
Each 5 mL of solution for oral administration contains:
Lithium ion (Li+) . . . . . . . . . . 8 mEq
(equivalent to amount of lithium in 300 mg of lithium carbonate),
alcohol 0.3% v/v.
INACTIVE INGREDIENTS
The tablets contain calcium stearate, microcrystalline cellulose,
povidone, sodium lauryl sulfate, and
sodium starch glycolate. The capsules contain FD&C Red No. 40,
gelatin, sodium lauryl sulfate, talc,
titanium dioxide, and the imprinting ink contains FD&C Blue No. 2,
FD&C Yellow No. 6, FD&C Red
No. 40, iron oxide, polyvinly pyrrolidone, shellac. The solution
contains citric acid, raspberry blend,
sodium benzoate, sorbitol and water.
Lithium Oral Solution is a palatable oral dosage form of lithium ion.
It is prepared in solution from
lithium hydroxide and citric acid in a ratio approximately di-lithium
citrate.
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