TRANEXAMIC ACID tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

TRANEXAMIC ACID (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1)

Beschikbaar vanaf:

Bryant Ranch Prepack

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Tranexamic Acid Tablets are indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential [see Clinical Studies (14)]. Tranexamic acid tablets are contraindicated in females of reproductive potential who are [see Warnings and Precautions (5.1)]: Tranexamic acid tablets are contraindicated in females with reproductive potential with known hypersensitivity to tranexamic acid [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)]. Risk Summary Tranexamic acid tablets are not indicated for use in pregnant women. There are no available data on tranexamic acid use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Tranexamic acid crosses the placenta. Animal reproduction studies have not identified adverse developmental outcomes with oral administration of tranexamic acid to pregnant rats at doses up to 4 times the recommended human dose (see Data) . In the US general population, the

Product samenvatting:

Tranexamic Acid Tablets USP 650 mg are provided as white to off-white, oval, unscored tablets debossed with “AMG229” on one side with the other side blank. NDC: 71335-1981-1: 8 TABLETs in a BOTTLE NDC: 71335-1981-2: 30 TABLETs in a BOTTLE NDC: 71335-1981-3: 4 TABLETs in a BOTTLE Storage Store at 20° to 25°C (68° to 77°F); excursions permitted at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

TRANEXAMIC ACID- TRANEXAMIC ACID TABLET
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRANEXAMIC ACID
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TRANEXAMIC ACID
TABLETS.
TRANEXAMIC ACID TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1986
INDICATIONS AND USAGE
Tranexamic Acid Tablets are an antifibrinolytic indicated for the
treatment of cyclic heavy menstrual
bleeding in females of reproductive potential. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 650 mg (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions in clinical trials (≥ 5%, and more
frequent in tranexamic acid-treated
subjects compared to placebo-treated subjects) are headache, sinus and
nasal symptoms, back pain,
abdominal pain, musculoskeletal pain, joint pain, muscle cramps,
migraine, anemia and fatigue. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ANI PHARMACEUTICALS,
INC. AT 1-800-308-
6755 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Concomitant therapy with tissue plasminogen activators may decrease
the efficacy of both tranexamic
acid and tissue plasminogen activators. (7.2)
USE IN SPECIFIC POPULATIONS
•
1,300 mg three times a day (3,900 mg/day) for a maximum of 5 days
during monthly menstruation
(2.1)
Renal impairment: Lower dosage is needed (for a maximum of 5 days
during menstruation) if serum
creatinine concentration (Cr) is higher than 1.4 mg/dL (2.2)
o
o
o
Cr above 1.4 mg/dL and ≤ 2.8 mg/dL: 1,300 mg two times a day (2,600
mg/day)
Cr above 2.8 mg/dL and ≤ 5.7 mg/dL: 1,300 mg once a day (1,300
mg/day)
Cr above 5.7 mg/dL: 650 mg once a day (650 mg/day)
Concomitant use of combined hormonal contraceptives (4.1)
Active thromboembolic disease or a history or intrinsic risk of
thrombosis or thromboembolism,
including retinal vein or artery occlusion (4.1)
Hypersensitivity to tranexamic acid (4.2