WARFARIN SODIUM tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI)

Disponível em:

Golden State Medical Supply, Inc.

DCI (Denominação Comum Internacional):

WARFARIN SODIUM

Composição:

WARFARIN SODIUM 1 mg

Tipo de prescrição:

PRESCRIPTION DRUG

Status de autorização:

Abbreviated New Drug Application

Características técnicas

WARFARIN SODIUM- WARFARIN SODIUM TABLET
GOLDEN STATE MEDICAL SUPPLY, INC.
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WARFARIN SODIUM
TABLETS, USP
CRYS TALLINE
BLEEDING WARNING: Warfarin sodium can cause major or fatal bleeding.
Bleeding is more
likely to occur during the starting period and with a higher dose
(resulting in a higher INR). Risk
factors for bleeding include high intensity of anticoagulation (INR
>4.0), age ≥65, highly
variable INRs, history of gastrointestinal bleeding, hypertension,
cerebrovascular disease,
serious heart disease, anemia, malignancy, trauma, renal
insufficiency, concomitant drugs (see
PRECAUTIONS), and long duration of warfarin therapy. Regular
monitoring of INR should be
performed on all treated patients. Those at high risk of bleeding may
benefit from more frequent
INR monitoring, careful dose adjustment to desired INR, and a shorter
duration of therapy.
Patients should be instructed about prevention measures to minimize
risk of bleeding and to report
immediately to physicians signs and symptoms of bleeding (see
PRECAUTIONS: INFORMATION
FOR PATIENTS).
DESCRIPTION
Crystalline warfarin sodium is an anticoagulant which acts by
inhibiting vitamin K-dependent
coagulation factors. Chemically, it is
3-(α-acetonylbenzyl)-4-hydroxycoumarin sodium salt and is a
racemic mixture of the_R_- and_S_-enantiomers. Crystalline warfarin
sodium is an isopropanol clathrate.
The crystallization of warfarin sodium virtually eliminates trace
impurities present in amorphous
warfarin. Its empirical formula is C
H NaO , and its structural formula may be represented by the
following:
Crystalline warfarin sodium occurs as a white, odorless, crystalline
powder, is discolored by light and
is very soluble in water; freely soluble in alcohol; very slightly
soluble in chloroform and in ether.
Warfarin Sodium Tablets, USP for oral use also contain:
All strengths:
Anhydrous lactose, corn starch and magnesium stearate
1 mg:
D&C red #6 Barium Lake.
2 mg:
FD&C blue #2 Aluminum Lake, FD&C red #40 Aluminum Lake.
2.5 mg:
FD&C blue #2 Aluminum Lake, D