TRANEXAMIC ACID tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

ANI Pharmaceuticals, Inc.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In a rat embryo-fetal developmental toxicity study, tranexamic acid had no adverse effects on embryo-fetal development when administered during the period of organogenesis (from gestation days 6 through 17) at twice daily doses of 0, 150, 375, and 750 mg/kg (1, 2 and 4 times the recommended human oral dosage of 3900 mg/day based on body surface area (mg/m2 )). In a perinatal-postnatal developmental toxicity study in rats administered tranexamic acid from gestation day 6 through postnatal day 20 at twice daily doses of 0, 150, 375, and 750 mg/kg, no significant adverse effects on maternal behavior or body weight were observed, and no significant effects on pup viability, body weight, developmental milestones or adult fertility were observed. It was concluded that the no-observed-effect-level (NOEL) for this study was 1500 mg/kg/day in both F0 and F1 generations, which is equivalent to 4 times the recommended human oral dose of 3900 mg/day based on body surface area (mg/m2 ). Risk Summary Tranexamic acid is present in the mother’s milk at a concentration of about one hundredth of the corresponding serum concentration (see Data) . The amount of tranexamic acid a nursing infant would absorb is unknown. There are no adequate data on the effects of tranexamic acid on the breastfed infant or the effects of tranexamic acid on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tranexamic acid tablets and any potential adverse effects on the breast-fed child from tranexamic acid tablets or from the underlying maternal condition. Data Human Data One hour after the last dose following a 2-day treatment course in lactating women, the milk concentration of the tranexamic acid was 1% of the peak serum concentration. The safety and effectiveness of tranexamic acid tablets have been established in females of reproductive potential. Efficacy is expected to be the same for post-menarchal females under the age of 17 as for those 17 years and older. Tranexamic acid tablets are not indicated before menarche. Tranexamic acid tablets are indicated for females of reproductive potential and are not intended for use by postmenopausal women. The effect of renal impairment on the pharmacokinetics of tranexamic acid has not been studied. Because tranexamic acid is primarily eliminated via the kidneys by glomerular filtration with more than 95% excreted as unchanged in urine, the recommended dosage in patient with renal impairment is lower than the recommended dosage in patients with normal renal function [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)] . The effect of hepatic impairment on the pharmacokinetics of tranexamic acid has not been studied. Because only a small fraction of the drug is metabolized, the recommended dosage in patients with hepatic impairment is the same as in patients with normal hepatic function [see Clinical Pharmacology (12.3)] .

Produkto santrauka:

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 and are supplied in bottles of 30 (NDC 62559-265-30). 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].

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

TRANEXAMIC ACID- TRANEXAMIC ACID TABLET
ANI PHARMACEUTICALS, INC.
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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
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•
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.