LITHIUM CARBONATE capsule

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:

Alembic Pharmaceuticals Limited

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

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

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