TRANEXAMIC ACID- tranexamic acid tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Tranexamic Acid (UNII: 6T84R30KC1) (Tranexamic Acid - UNII:6T84R30KC1)
Available from:
Prasco Laboratories
INN (International Name):
Tranexamic Acid
Composition:
Tranexamic Acid 650 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Tranexamic Acid Tablets are indicated for the treatment of cyclic heavy menstrual bleeding [see Clinical Studies (14) ]. Prior to prescribing Tranexamic Acid Tablets, exclude endometrial pathology that can be associated with heavy menstrual bleeding. Do not prescribe Tranexamic Acid Tablets to women who are - using combination hormonal contraception - known to have any of the following conditions: Active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, or cerebral thrombosis) A history of thrombosis or thromboembolism, including retinal vein or artery occlusion An intrinsic risk of thrombosis or thromboembolism (e.g., thrombogenic valvular disease, thrombogenic cardiac rhythm disease, or hypercoagulopathy) - Active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, or cerebral thrombosis) - A history of thrombosis or thromboembolism, including retinal vein or artery occlusion - An intrinsic risk of thrombosis or thromboembolism (e.g.,
Product summary:
Tranexamic Acid Tablets are provided as white oval-shaped tablets. Each tablet is debossed with the marking "FP650"and are supplied as: Storage Store at room temperature 25° C (77° F); excursions permitted to 15-30° C (59-86° F). [See USP Controlled Room Temperature].
Authorization status:
New Drug Application Authorized Generic
Authorization number:
66993-121-30

TRANEXAMIC ACID- tranexamic acid tablet

Prasco Laboratories

----------

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

Initial U.S. Approval: 1986

RECENT MAJOR CHANGES

Contraindications (4.1)

10/2013

Warnings and Precautions (5.1)

10/2013

INDICATIONS AND USAGE

Tranexamic Acid Tablets is an antifibrinolytic indicated for the treatment of cyclic heavy menstrual bleeding. (1)

DOSAGE AND ADMINISTRATION

1,300 mg (two 650 mg tablets) three times a day (3,900 mg/day) for a maximum of 5 days during monthly menstruation

(2.1)

Renal impairment: Dosage adjustment is needed if serum creatinine concentration (Cr) is higher than 1.4 mg/dL (2.2)

Cr above 1.4 mg/dL and ≤ 2.8 mg/dL: 1,300 mg (two 650 mg tablets) two times a day (2,600 mg/day) for a maximum

of 5 days during menstruation

Cr above 2.8 mg/dL and ≤ 5.7 mg/dL: 1,300 mg (two 650 mg tablets) once a day (1,300 mg/day) for a maximum of 5

days during menstruation

Cr above 5.7 mg/dL: 650 mg (one 650 mg tablet) once a day (650 mg/day) for a maximum of 5 days during

me nstruation

DOSAGE FORMS AND STRENGTHS

Tablets: 650 mg (3)

CONTRAINDICATIONS

Women who are using combination hormonal contraception (4.1)

Women with 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)

WARNINGS AND PRECAUTIONS

Concomitant use of tranexamic acid tablets with Factor IX complex concentrates, anti-inhibitor coagulant concentrates

or all-trans retinoic acid (oral tretinoin) may increase the risk of thrombosis. (5.1)

Visual or ocular adverse effects may occur with tranexamic acid tablets. Immediately discontinue use if visual or ocular

symptoms occur. (5.1)

In case of severe allergic reaction, discontinue tranexamic acid tablets and seek immediate medical attention. (5.2)

Cerebral edema and cerebral infarction may be caused by use of tranexamic acid tablets in women with subarachnoid

hemorrhage. (5.3)

Ligneous conjunctivitis has been reported in patients taking tranexamic acid. (5.4)

ADVERSE REACTIONS

Most common adverse reactions in clinical trials (≥ 5%, and more frequent in tranexamic acid tablets subjects compared to

placebo 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 Ferring Pharmaceuticals Inc. at 1-888-FERRING (1-

888-337-7464) 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 tablets and

tissue plasminogen activators. (7.2)

USE IN SPECIFIC POPULATIONS

Geriatric Use: Tranexamic Acid Acid Tablets is not indicated for use in postmenopausal women (8.5)

Renal impairment: Dosage adjustment is needed. (2.2, 8.6)

Hepatic impairment: No dosage adjustment is needed. (8.7)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 10/2013

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

2.2 Renal Impairment

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 Thromboembolic Risk

4.2 Hypersensitivity to Tranexamic Acid

5 WARNINGS AND PRECAUTIONS

5.1 Thromboembolic Risk

5.2 Severe Allergic Reaction

5.3 Subarachnoid Hemorrhage

5.4 Ligneous Conjunctivitis

6 ADVERSE REACTIONS

6.1 Clinical Trial Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Hormonal Contraceptives

7.2 Tissue Plasminogen Activators

7.3 Factor IX Complex Concentrates or Anti-Inhibitor Coagulant Concentrates

7.4 All-Trans Retinoic Acid (Oral Tretinoin)

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Three-Cycle Treatment Study

14.2 Six-Cycle Treatment Study

14.3 MBL Results over Time

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Tranexamic Acid Tablets are indicated for the treatment of cyclic heavy menstrual bleeding [see

Clinical Studies (14)].

Prior to prescribing Tranexamic Acid Tablets, exclude endometrial pathology that can be associated

with heavy menstrual bleeding.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dose of Tranexamic Acid Tablets for women with normal renal function is two 650

mg tablets taken three times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation.

Tranexamic Acid Tablets may be administered without regard to meals. Tablets should be swallowed

whole and not chewed or broken apart.

2.2 Renal Impairment

In patients with renal impairment, the plasma concentration of tranexamic acid increased as serum

creatinine concentration increased [see Clinical Pharmacology (12.3)]. Dosage adjustment is needed in

patients with serum creatinine concentration higher than 1.4 mg/dL (Table 1).

Table 1. Dosage of TRANEXAMIC ACID TABLETS in Patients with

Renal Impairment

Tranexamic Acid Tablets

Serum Creatinine

(mg/dL)

Adjusted Dose

Total Daily

Dos e

Cr above 1.4 and ≤ 2.8

1300 mg (two 650 mg tablets) two

times a day for a maximum of 5 days

during menstruation

2600 mg

Cr above 2.8 and ≤ 5.7

1300 mg (two 650 mg tablets) once a

day for a maximum of 5 days during

menstruation

1300 mg

Cr above 5.7

650 mg (one 650 mg tablet) once a day

for a maximum of 5 days during

menstruation

650 mg

3 DOSAGE FORMS AND STRENGTHS

650 mg tablets

4 CONTRAINDICATIONS

4.1 Thromboembolic Risk

Sections or subsections omitted from the full prescribing information are not listed.

Do not prescribe Tranexamic Acid Tablets to women who are

using combination hormonal contraception

known to have any of the following conditions:

Active thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, or cerebral

thrombosis)

A history of thrombosis or thromboembolism, including retinal vein or artery occlusion

An intrinsic risk of thrombosis or thromboembolism (e.g., thrombogenic valvular disease,

thrombogenic cardiac rhythm disease, or hypercoagulopathy)

Venous and arterial thrombosis or thromboembolism, as well as cases of retinal artery and retinal vein

occlusions, have been reported with tranexamic acid.

4.2 Hypersensitivity to Tranexamic Acid

Do not prescribe Tranexamic Acid Tablets to women with known hypersensitivity to tranexamic acid

[see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Thromboembolic Risk

Concomitant Use of Hormonal Contraceptives

Combination hormonal contraceptives are known to increase the risk of venous thromboembolism, as

well as arterial thromboses such as stroke and myocardial infarction. Because tranexamic acid tablets

are antifibrinolytic, the risk of venous thromboembolism, as well as arterial thromboses such as stroke,

may increase further when hormonal contraceptives are administered with tranexamic acid tablets. This

is of particular concern in women who are obese or smoke cigarettes, especially smokers over 35

years of age.

Women using hormonal contraception were excluded from the clinical trials supporting the safety and

efficacy of tranexamic acid tablets, and there are no clinical trial data on the risk of thrombotic events

with the concomitant use of tranexamic acid tablets with hormonal contraceptives. However, there have

been US postmarketing reports of venous and arterial thrombotic events in women who have used

tranexamic acid tablets concomitantly with combination hormonal contraceptives. For this reason,

concomitant use of tranexamic acid with combination hormonal contraceptives is contraindicated. [see

Contraindications (4.1) and Drug Interactions (7.1)].

Factor IX Complex Concentrates or Anti-Inhibitor Coagulant Concentrates

Tranexamic acid tablets are not recommended for women taking either Factor IX complex concentrates

or anti-inhibitor coagulant concentrates because the risk of thrombosis may be increased [see Drug

Interactions (7.3) and Clinical Pharmacology (12.3)].

All-Trans Retinoic Acid (Oral Tretinoin)

Exercise caution when prescribing tranexamic acid tablets to women with acute promyelocytic leukemia

taking all-trans retinoic acid for remission induction because of possible exacerbation of the

procoagulant effect of all-trans retinoic acid [see Drug Interactions (7.4) and Clinical Pharmacology

(12.3)].

Ocular Effects

Retinal venous and arterial occlusion has been reported in patients using tranexamic acid. Patients

should be instructed to report visual and ocular symptoms promptly. In the event of such symptoms,

patients should be instructed to discontinue tranexamic acid tablets immediately and should be referred

to an ophthalmologist for a complete ophthalmic evaluation, including dilated retinal examination, to

exclude the possibility of retinal venous or arterial occlusion.

5.2 Severe Allergic Reaction

A case of severe allergic reaction to tranexamic acid tablets was reported in the clinical trials,

involving a subject who experienced dyspnea, tightening of her throat, and facial flushing that required

emergency medical treatment. A case of anaphylactic shock has also been reported in the literature,

involving a patient who received an intravenous bolus of tranexamic acid.

5.3 Subarachnoid Hemorrhage

Cerebral edema and cerebral infarction may be caused by use of tranexamic acid tablets in women with

subarachnoid hemorrhage.

5.4 Ligneous Conjunctivitis

Ligneous conjunctivitis has been reported in patients taking tranexamic acid. The conjunctivitis resolved

following cessation of the drug.

6 ADVERSE REACTIONS

6.1 Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed

in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another

drug and may not reflect the rates observed in clinical practice.

Short-term Studies

The safety of tranexamic acid tablets in the treatment of heavy menstrual bleeding (HMB) was studied in

two randomized, double-blind, placebo-controlled studies [see Clinical Studies (14)]. One study

compared the effects of two doses of tranexamic acid tablets (1950 mg and 3900 mg given daily for up

to 5 days during each menstrual period) versus placebo over a 3-cycle treatment duration. A total of 304

women were randomized to this study, with 115 receiving at least one dose of 3900 mg/day of

tranexamic acid tablets. A second study compared the effects of tranexamic acid tablets (3900 mg/day)

versus placebo over a 6-cycle treatment duration. A total of 196 women were randomized to this study,

with 117 receiving at least one dose of tranexamic acid tablets. In both studies, subjects were generally

healthy women who had menstrual blood loss of ≥ 80 mL.

In these studies, subjects were 18 to 49 years of age with a mean age of approximately 40 years, had

cyclic menses every 21-35 days, and a BMI of approximately 32 kg/m . On average, subjects had a

history of HMB for approximately 10 years and 40% had fibroids as determined by transvaginal

ultrasound. Approximately 70% were Caucasian, 25% were Black, and 5% were Asian, Native

American, Pacific Islander, or Other. Seven percent (7%) of all subjects were of Hispanic origin.

Women using hormonal contraception were excluded from the trials.

The rates of discontinuation due to adverse events during the two clinical trials were comparable

between tranexamic acid tablets and placebo. In the 3-cycle study, the rate in the 3900 mg tranexamic

acid tablets dose group was 0.8% as compared to 1.4% in the placebo group. In the 6-cycle study, the

rate in the tranexamic acid tablets group was 2.4% as compared to 4.1% in the placebo group. Across

the studies, the combined exposure to 3900 mg/day tranexamic acid tablets was 947 cycles and the

average duration of use was 3.4 days per cycle.

A list of adverse events occurring in ≥ 5% of subjects and more frequently in tranexamic acid tablets

treated subjects receiving 3900 mg/day compared to placebo is provided in Table 2.

Table 2. Adverse Events Reported by ≥ 5% of Subjects Treated with Tranexamic Acid Tablets

and More Frequently in Tranexamic Acid Tablets-treated Subjects

Tranexamic

Tranexamic

Acid

3900 mg/day

n (%)

(N=232)

Placebo

n (%)

(N=139)

Total Number of Adverse Events

1500

Number of Subjects with at Least One Adverse Event

208 (89.7%)

122 (87.8%)

HEADACHE

117 (50.4%)

65 (46.8%)

NASAL & SINUS SYMPTOMS

59 (25.4%)

24 (17.3%)

BACK PAIN

48 (20.7%)

21 (15.1%)

ABDOMINAL PAIN

46 (19.8%)

25 (18.0%)

MUSCULOSKELETAL PAIN

26 (11.2%)

4 (2.9%)

ARTHRALGIA

16 (6.9%)

7 (5.0%)

MUSCLE CRAMPS & SPASMS

15 (6.5%)

8 (5.8%)

MIGRAINE

14 (6.0%)

8 (5.8%)

ANEMIA

13 (5.6%)

5 (3.6%)

FATIGUE

12 (5.2%)

6 (4.3%)

Long-term Studies

Long-term safety of tranexamic acid tablets was studied in two open-label studies. In one study, subjects

with physician-diagnosed heavy menstrual bleeding (not using the alkaline hematin methodology) were

treated with 3900 mg/day for up to 5 days during each menstrual period for up to 27 menstrual cycles. A

total of 781 subjects were enrolled and 239 completed the study through 27 menstrual cycles. A total of

12.4% of the subjects withdrew due to adverse events. Women using hormonal contraception were

excluded from the study. The total exposure in this study to 3900 mg/day tranexamic acid tablets was

10,213 cycles. The average duration of tranexamic acid tablets use was 2.9 days per cycle.

A long-term open-label extension study of subjects from the two short-term efficacy studies was also

conducted in which subjects were treated with 3900 mg/day for up to 5 days during each menstrual

period for up to 9 menstrual cycles. A total of 288 subjects were enrolled and 196 subjects completed

the study through 9 menstrual cycles. A total of 2.1% of the subjects withdrew due to adverse events.

The total exposure to 3900 mg/day tranexamic acid tablets in this study was 1,956 cycles. The average

duration of tranexamic acid tablets use was 3.5 days per cycle.

The types and severity of adverse events in these two long-term open-label trials were similar to those

observed in the double-blind, placebo-controlled studies although the percentage of subjects reporting

them was greater in the 27-month study, most likely because of the longer study duration.

A case of severe allergic reaction to tranexamic acid tablets was reported in the extension trial,

involving a subject on her fourth cycle of treatment, who experienced dyspnea, tightening of her throat,

and facial flushing that required emergency medical treatment.

6.2 Postmarketing Experience

The following adverse reactions have been identified from postmarketing experience with tranexamic

acid. Because these reactions are reported voluntarily from a population of uncertain size, it is not

always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Includes headache and tension headache

Nasal and sinus symptoms include nasal, respiratory tract and sinus congestion, sinusitis, acute sinusitis, sinus

headache, allergic sinusitis and sinus pain, and multiple allergies and seasonal allergies

Abdominal pain includes abdominal tenderness and discomfort

Musculoskeletal pain includes musculoskeletal discomfort and myalgia

Arthralgia includes joint stiffness and swelling

Based on US and worldwide postmarketing reports, the following have been reported in patients

receiving tranexamic acid for various indications:

Nausea, vomiting, and diarrhea

Allergic skin reactions

Anaphylactic shock and anaphylactoid reactions

Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis,

acute renal cortical necrosis, and central retinal artery and vein obstruction); cases have been

associated with concomitant use of combination hormonal contraceptives

Impaired color vision and other visual disturbances

Dizziness

7 DRUG INTERACTIONS

No drug-drug interaction studies were conducted with tranexamic acid tablets.

7.1 Hormonal Contraceptives

Because tranexamic acid tablets are antifibrinolytic, concomitant use of hormonal contraception and

tranexamic acid tablets may further exacerbate the increased thrombotic risk associated with

combination hormonal contraceptives. For this reason, concomitant use of Tranexamic Acid Acid

Tablets with combination hormonal contraceptives is contraindicated [see Contraindications (4) and

Warnings and Precautions (5.1)].

7.2 Tissue Plasminogen Activators

Concomitant therapy with tissue plasminogen activators may decrease the efficacy of both tranexamic

acid tablets and tissue plasminogen activators. Therefore, exercise caution if a woman taking tranexamic

acid tablets therapy requires tissue plasminogen activators.

7.3 Factor IX Complex Concentrates or Anti-Inhibitor Coagulant Concentrates

Tranexamic acid tablets are not recommended for women taking either Factor IX complex concentrates

or anti-inhibitor coagulant concentrates because the risk of thrombosis may be increased [see Warnings

and Precautions (5.1) and Clinical Pharmacology (12.3)].

7.4 All-Trans Retinoic Acid (Oral Tretinoin)

Exercise caution when prescribing tranexamic acid tablets to women with acute promyelocytic leukemia

taking all-trans retinoic acid for remission induction because of possible exacerbation of the

procoagulant effect of all-trans retinoic acid [see Warnings and Precautions (5.1) and Clinical

Pharmacology (12.3)].

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Tranexamic acid tablets are not indicated for use in pregnant women. Reproduction studies have been

performed in mice, rats and rabbits and have revealed no evidence of impaired fertility or harm to the

fetus due to tranexamic acid. However, tranexamic acid is known to cross the placenta and appears in

cord blood at concentrations approximately equal to the maternal concentration. There are no adequate

and well-controlled studies in pregnant women [see Nonclinical Toxicology (13.1)].

An embryo-fetal developmental toxicity study in rats and a perinatal developmental toxicity study in rats

were conducted using tranexamic acid. No adverse effects were observed in either study at doses up to

4 times the recommended human oral dose of 3900 mg/day based on mg/m (actual animal dose 1500

mg/kg/day).

8.3 Nursing Mothers

Tranexamic acid is present in the mother's milk at a concentration of about one hundredth of the

corresponding serum concentration. Tranexamic acid tablets should be used during lactation only if

clearly needed.

8.4 Pediatric Use

Tranexamic acid tablets are indicated for women of reproductive age and is not intended for use in

premenarcheal girls.

Based on a pharmacokinetic study in 20 adolescent females, 12 to 16 years of age, no dose adjustment is

needed in the adolescent population [see Clinical Pharmacology (12.3)].

8.5 Geriatric Use

Tranexamic acid tablets are indicated for women of reproductive age and is not intended for use by

postmenopausal women.

8.6 Renal Impairment

The effect of renal impairment on the pharmacokinetics of tranexamic acid tablets 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, dosage adjustment in patient with renal impairment is needed [see

Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].

8.7 Hepatic Impairment

The effect of hepatic impairment on the pharmacokinetics of tranexamic acid tablets has not been

studied. Because only a small fraction of the drug is metabolized, dosage adjustment in patients with

hepatic impairment is not needed [see Clinical Pharmacology (12.3)].

10 OVERDOSAGE

There are no known cases of intentional overdose with tranexamic acid tablets and no subjects in the

clinical program took more than 2 times the prescribed amount of tranexamic acid tablets in a 24-hour

period (>7800 mg/day). However, cases of overdose of tranexamic acid have been reported. Based on

these reports, symptoms of overdose may include gastrointestinal (nausea, vomiting, diarrhea);

hypotensive (e.g., orthostatic symptoms); thromboembolic (arterial, venous, embolic); visual impairment;

mental status changes; myoclonus; or rash. No specific information is available on the treatment of

overdose with tranexamic acid tablets. In the event of overdose, employ the usual supportive measures

(e.g., clinical monitoring and supportive therapy) as dictated by the patient's clinical status.

11 DESCRIPTION

Tranexamic Acid Tablets is an antifibrinolytic drug. The chemical name is trans-4-aminomethyl-

cyclohexanecarboxylic acid. The structural formula is:

Tranexamic acid is a white crystalline powder. It is freely soluble in water and in glacial acetic acid and

is very slightly soluble in ethanol and practically insoluble in ether. The molecular formula is

C H N0 and the molecular weight is 157.2.

Tranexamic acid tablets are provided as white oval-shaped tablets and are not scored. Each tablet is

debossed with the marking "FP650." The active ingredient in each tablet is 650 mg tranexamic acid. The

inactive ingredients contained in each tablet are: microcrystalline cellulose, colloidal silicon dioxide,

pregelatinized corn starch, povidone, hypromellose, stearic acid, and magnesium stearate.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Tranexamic acid is a synthetic lysine amino acid derivative, which diminishes the dissolution of

hemostatic fibrin by plasmin. In the presence of tranexamic acid, the lysine receptor binding sites of

plasmin for fibrin are occupied, preventing binding to fibrin monomers, thus preserving and stabilizing

fibrin's matrix structure.

The antifibrinolytic effects of tranexamic acid are mediated by reversible interactions at multiple

binding sites within plasminogen. Native human plasminogen contains 4 to 5 lysine binding sites with

low affinity for tranexamic acid (K = 750 µmol/L) and 1 with high affinity (K = 1.1 µmol/L). The high

affinity lysine site of plasminogen is involved in its binding to fibrin. Saturation of the high affinity

binding site with tranexamic acid displaces plasminogen from the surface of fibrin. Although plasmin

may be formed by conformational changes in plasminogen, binding to and dissolution of the fibrin matrix

is inhibited.

12.2 Pharmacodynamics

Tranexamic acid, at in vitro concentrations of 25 - 100 μM, reduces by 20 - 60% the maximal rate of

plasmin lysis of fibrin catalyzed by tissue plasminogen activator (tPA).

Elevated concentrations of endometrial, uterine, and menstrual blood tPA are observed in women with

heavy menstrual bleeding (HMB) compared to women with normal menstrual blood loss. The effect of

tranexamic acid on lowering endometrial tPA activity and menstrual fluid fibrinolysis is observed in

women with HMB receiving tranexamic acid total oral doses of 2-3 g/day for 5 days.

In healthy subjects, tranexamic acid at blood concentrations less than 10 mg/mL has no effect on the

platelet count, the coagulation time or various coagulation factors in whole blood or citrated blood.

Tranexamic acid, however, at blood concentrations of 1 and 10 mg/mL prolongs the thrombin time.

Cardiac Electrophysiology

The effect of tranexamic acid tablets on QT interval was evaluated in a randomized, single-dose, 4-way

crossover study in 48 healthy females aged 18 to 49 years. Subjects received (1) tranexamic acid

tablets 1300 mg (two 650 mg tablets), (2) tranexamic acid tablets 3900 mg (six 650 mg tablets; three

times the recommended single dose), (3) moxifloxacin 400 mg, and (4) placebo. There was no

significant increase in the corrected QT interval at any time up to 24 hours after the administration of

either dose of tranexamic acid tablets. Moxifloxacin, the active control, was associated with a maximum

14.11 msec mean increase in corrected QT interval (moxifloxacin – placebo) at 3 hours after

administration.

12.3 Pharmacokinetics

Absorption

After a single oral administration of two 650 mg tablets of tranexamic acid, the peak plasma

concentration (C

) occurred at approximately 3 hours (T

). The absolute bioavailability of

tranexamic acid tablets in women aged 18-49 is approximately 45%. Following multiple oral doses (two

650 mg tablets three times daily) administration of tranexamic acid tablets for 5 days, the mean C

increased by approximately 19% and the mean area under the plasma concentration-time curve (AUC)

remained unchanged, compared to a single oral dose administration (two 650 mg tablets). Plasma

concentrations reached steady state at the 5

dose of tranexamic acid tablets on Day 2.

The mean plasma pharmacokinetic parameters of tranexamic acid determined in 19 healthy women

following a single (two 650 mg tablets) and multiple (two 650 mg tablets three times daily for 5 days)

oral dose of tranexamic acid tablets are shown in Table 3.

Table 3. Mean (CV%) Pharmacokinetic Parameters Following a Single

(two 650 mg tablets) and Multiple Oral Dose (two 650 mg tablets three

time daily for 5 days) Administration of Tranexamic Acid Tablets in 19

Healthy Women under Fasting Conditions

Parameter

Arithmetic Mean (CV%)

Single dose

Multiple dose

= maximum concentration

= area under the drug concentration curve from time 0 to time of last

determinable concentration

= area under the drug concentration curve from time 0 to infinity

= time to maximum concentration

= terminal elimination half-life

(mcg/mL)

13.83 (32.14)

16.41 (26.19)

(mcg·h/mL)

77.96 (31.14)

77.67

(29.39)

(mcg·h/mL)

80.19 (30.43)

2.5 (1 – 5)

2.5 (2 – 3.5)

11.08 (16.94)

Effect of food: Tranexamic acid tablets may be administered without regard to meals. A single dose

administration (two 650 mg tablets) of tranexamic acid tablets with food increased both C

and AUC

by 7% and 16%, respectively.

Distribution

Tranexamic acid is 3% bound to plasma proteins with no apparent binding to albumin. Tranexamic acid is

distributed with an initial volume of distribution of 0.18 L/kg and steady-state apparent volume of

distribution of 0.39 L/kg.

Tranexamic acid crosses the placenta. The concentration in cord blood after an intravenous injection of

10 mg/kg to pregnant women is about 30 mg/L, as high as in the maternal blood.

Tranexamic acid concentration in cerebrospinal fluid is about one tenth of the plasma concentration.

The drug passes into the aqueous humor of the eye achieving a concentration of approximately one

tenth of plasma concentrations.

Metabolism

A small fraction of the tranexamic acid is metabolized.

Excretion

Tranexamic acid is eliminated by urinary excretion primarily via glomerular filtration with more than

95% of the dose excreted unchanged. Excretion of tranexamic acid is about 90% at 24 hours after

intravenous administration of 10 mg/kg. Most elimination post intravenous administration occurred

tldc

(mcg·h/mL) = area under the drug concentration curve from time 0 to 8

hours

0 -tau

Data presented as median (range)

tldc

during the first 10 hours, giving an apparent elimination half-life of approximately 2 hours. The mean

terminal half-life of tranexamic acid tablets is approximately 11 hours. Plasma clearance of tranexamic

acid is 110-116 mL/min.

Specific Populations

Pregnancy (Category B)

Tranexamic acid tablets are not indicated for use in pregnant women. Tranexamic acid is known to cross

the placenta and appears in cord blood at concentrations approximately equal to maternal concentration.

There are no adequate and well-controlled studies in pregnant women [see Use in Specific Populations

(8.1)].

Nursing Mothers

Tranexamic acid is present in the mother's milk at a concentration of about one hundredth of the

corresponding serum concentrations. Tranexamic acid tablets should be used during lactation only if

clearly needed [see Use in Specific Populations (8.3)].

Pediatric Use

Tranexamic acid tablets are indicated for women of reproductive age and are not intended for use in

premenarcheal girls.

In a randomized, single dose, two-way crossover study of two dose levels (650 mg and 1,300 mg [two

650 mg tablets]), pharmacokinetics of tranexamic acid was evaluated in 20 female adolescents (12 to 16

years of age) with heavy menstrual bleeding. The C

and AUC values after a single oral dose of 650

mg in the adolescent females were 32 – 36% less than those after a single oral dose of 1,300 mg in the

adolescent females. The C

and AUC values after a single oral dose of 1300 mg in the adolescent

females were 20 – 25% less than those in the adult females given the same dose in a separate study. [See

Use in Specific Populations (8.4)]

Geriatric Use

Tranexamic acid tablets are indicated for women of reproductive age and are not intended for use by

postmenopausal women.

Renal Impairment

The effect of renal impairment on the disposition of tranexamic acid tablets has not been evaluated.

Urinary excretion following a single intravenous injection of tranexamic acid declines as renal function

decreases. Following a single 10 mg/kg intravenous injection of tranexamic acid in 28 patients, the 24-

hour urinary fractions of tranexamic acid with serum creatinine concentrations 1.4 – 2.8, 2.8 – 5.7, and

greater than 5.7 mg/dL were 51, 39, and 19%, respectively. The 24-hour tranexamic acid plasma

concentrations for these patients demonstrated a direct relationship to the degree of renal impairment.

Therefore, dose adjustment is needed in patients with renal impairment [see Dosage and Administration

(2.2)].

Hepatic Impairment

The effect of hepatic impairment on the disposition of tranexamic acid tablets has not been evaluated.

One percent and 0.5 percent of an oral dose are excreted as a dicarboxylic acid and acetylated

metabolite, respectively. Because only a small fraction of the drug is metabolized, no dose adjustment is

needed in patients with hepatic impairment.

Drug Interactions

No drug-drug interaction studies were conducted with tranexamic acid tablets.

Hormonal Contraceptives

Because tranexamic acid tablets are antifibrinolytic, concomitant use of hormonal contraception and

tranexamic acid tablets may further exacerbate the increased thrombotic risk associated with

combination hormonal contraceptives. . For this reason, concomitant use of Tranexamic Acid Acid

Tablets with combination hormonal contraceptives is contraindicated [see Contraindications (4),

Warnings and Precautions (5.1) and Drug Interactions (7.1)]

Factor IX Complex Concentrates or Anti-inhibitor Coagulant Concentrates

Tranexamic acid tablets are not recommended in patients taking either Factor IX complex concentrates

or anti-inhibitor coagulant concentrates because the risk of thrombosis may be increased [see Warnings

and Precautions (5.1) and Drug Interactions (7.3)].

Tissue Plasminogen Activators

Concomitant therapy with tissue plasminogen activators may decrease the efficacy of both tranexamic

acid tablets and tissue plasminogen activators. Therefore, exercise caution if a patient taking tranexamic

acid tablets therapy requires tissue plasminogen activators [see Drug Interactions (7.2)].

All-Trans Retinoic Acid (Oral Tretinoin)

In a study involving 28 patients with acute promyelocytic leukemia who were given either orally

administered all-trans retinoic acid plus intravenously administered tranexamic acid, all-trans retinoic

acid plus chemotherapy, or all-trans retinoic acid plus tranexamic acid plus chemotherapy, all 4 patients

who were given all-trans retinoic acid plus tranexamic acid died, with 3 of the 4 deaths due to

thrombotic complications. It appears that the procoagulant effect of all-trans retinoic acid may be

exacerbated by concomitant use of tranexamic acid. Therefore, exercise caution when prescribing

tranexamic acid tablets to patients with acute promyelocytic leukemia taking all-trans retinoic acid [see

Warnings and Precautions (5.1) and Drug Interactions (7.4)].

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Carcinogenicity studies with tranexamic acid in male mice at doses as high as 6 times the recommended

human dose of 3900 mg/day showed an increased incidence of leukemia which may have been related to

treatment. Female mice were not included in this experiment.

The dose multiple referenced above is based on body surface area (mg/m ). Actual daily dose in mice

was up to 5000 mg/kg/day in food.

Hyperplasia of the biliary tract and cholangioma and adenocarcinoma of the intrahepatic biliary system

have been reported in one strain of rats after dietary administration of doses exceeding the maximum

tolerated dose for 22 months. Hyperplastic, but not neoplastic, lesions were reported at lower doses.

Subsequent long-term dietary administration studies in a different strain of rat, each with an exposure

level equal to the maximum level employed in the earlier experiment, have failed to show such

hyperplastic/neoplastic changes in the liver.

Mutagenesis

Tranexamic acid was neither mutagenic nor clastogenic in the in vitro Bacterial Reverse Mutation Assay

(Ames test), in vitro chromosome aberration test in Chinese hamster cells, and in in vivo chromosome

aberration tests in mice and rats.

Impairment of Fertility

Reproductive studies performed in mice, rats and rabbits have not revealed any evidence of impaired

fertility or adverse effects on the fetus due to tranexamic acid.

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 doses 1, 2 and 4 times the recommended human oral dose of 3900 mg/day. In a perinatal-

postnatal study in rats, tranexamic acid had no adverse effects on pup viability, growth or development

when administered from gestation day 6 through postnatal day 20 at doses 1, 2 and 4 times the

recommended human oral dose of 3900 mg/day.

The dose multiples referenced above are based on body surface area (mg/m ). Actual daily doses in rats

were 300, 750 or 1500 mg/kg/day.

13.2 Animal Toxicology and/or Pharmacology

Ocular Effects

In a 9-month toxicology study, dogs were administered tranexamic acid in food at doses of 0, 200, 600,

or 1200 mg/kg/day. These doses are approximately 2, 5, and 6 times, respectively, the recommended

human oral dose of 3900 mg/day based on AUC. At 6 times the human dose, some dogs developed

reversible reddening and gelatinous discharge from the eyes. Ophthalmologic examination revealed

reversible changes in the nictitating membrane/conjunctiva. In some female dogs, the presence of

inflammatory exudate over the bulbar conjunctival mucosa was observed. Histopathological

examinations did not reveal any retinal alteration. No adverse effects were observed at 5 times the

human dose.

In other studies, focal areas of retinal degeneration were observed in cats, dogs and rats following oral

or intravenous tranexamic acid doses at 6-40 times the recommended usual human dose based on mg/m

(actual animal doses between 250-1600 mg/kg/day).

14 CLINICAL STUDIES

The efficacy and safety of tranexamic acid tablets in the treatment of heavy menstrual bleeding (HMB)

was demonstrated in one 3-cycle treatment and one 6-cycle treatment, randomized, double-blind,

placebo-controlled study [see Adverse Reactions (6.1)]. In these studies, HMB was defined as an average

menstrual blood loss of ≥ 80 mL as assessed by alkaline hematin analysis of collected sanitary products

over two baseline menstrual cycles. Subjects were 18 to 49 years of age with a mean age of

approximately 40 years, had cyclic menses every 21-35 days, and a BMI of approximately 32 kg/m . On

average, subjects had an HMB history of approximately 10 years and 40% had fibroids as determined

by transvaginal ultrasound. Approximately 70% were Caucasian, 25% were Black, and 5% were Asian,

Native American, Pacific Islander, or Other. Seven percent (7%) of all subjects were of Hispanic

origin.

In these studies, the primary outcome measure was menstrual blood loss (MBL), measured using the

alkaline hematin method. The endpoint was change from baseline in MBL, calculated by subtracting the

mean MBL during treatment from the mean pretreatment MBL.

The key secondary outcome measures were based on specific questions concerning limitations in social

or leisure activities (LSLA) and limitations in physical activities (LPA). Large stains (soiling beyond

the undergarment) were also included as a key secondary outcome measure.

14.1 Three-Cycle Treatment Study

This study compared the effects of two doses of tranexamic acid tablets (1950 mg and 3900 mg given

daily for up to 5 days during each menstrual period) versus placebo on MBL over a 3-cycle treatment

duration. Of the 294 evaluable subjects, 115 tranexamic acid tablets 1950 mg/day subjects, 112

tranexamic acid tablets 3900 mg/day subjects and 67 placebo subjects took at least one dose of study

drug and had post-treatment data available.

Results are shown in Table 4. MBL was statistically significantly reduced in patients treated with 3900

mg/day tranexamic acid tablets compared to placebo. Study success also required achieving a reduction

in MBL that was determined to be clinically meaningful to the subjects. The 1950 mg/day tranexamic

acid tablets dose did not meet the criteria for success.

Table 4. Mean Reduction from Baseline in MBL

Treatment Arm

N

Bas eline

Mean MBL

(mL)

Least Squares Mean

Reduction in MBL

(mL)

Percent Reduction in

MBL

Tranexamic acid 3900

mg/day

Tranexamic acid 1950

mg/day

Placebo

Tranexamic acid tablets also statistically significantly reduced limitations on social, leisure, and

physical activities in the 3900 mg/day dose group compared to placebo (see Table 5). No statistically

significant treatment difference was observed in response rates on the number of large stains.

Table 5: Secondary Outcomes in 3-Cycle Study

Outcome Measure

N

Bas eline

Mean

Least Squares Mean

Reduction

Social and Leisure Activities

3900 mg/day tranexamic acid

3.00

0.98

Placebo

2.85

0.39

Physical Activities

3900 mg/day tranexamic acid

3.07

0.94

Placebo

2.96

0.34

N

Responders

Reduction in Large Stains

3900 mg/day tranexamic acid

Placebo

14.2 Six-Cycle Treatment Study

This study compared the effects of tranexamic acid tablets 3900 mg/day given daily for up to 5 days

during each menstrual period versus placebo on MBL over a 6-cycle treatment duration. Of the 187

evaluable subjects, 115 tranexamic acid tablets subjects and 72 placebo subjects took at least one dose

of study drug and had post-treatment data available.

Results are shown in Table 6. MBL was statistically significantly reduced in patients treated with 3900

mg/day tranexamic acid tablets compared to placebo. Study success also required achieving a reduction

in MBL that was determined to be clinically meaningful to the subjects.

Table 6. Mean Reduction from Baseline in MBL

Bas eline

Least Squares Mean

Percent Reduction in

p<0.001 versus placebo

Response categories: 1=not at all limited; 2=slightly limited; 3=moderately limited;

4 =quite a bit limited; 5=extremely limited

Positive means reflect an improvement from baseline.

p-value <0.05 versus placebo

Responders are defined as subjects who experienced a reduction from baseline in

frequency of large stains.

Non-significant difference versus placebo

*

§

Treatment Arm

N

Mean MBL

(mL)

Reduction in MBL

(mL)

Percent Reduction in

MBL

Tranexamic acid 3900

mg/day

Placebo

Limitations on social, leisure, and physical activities were also statistically significantly reduced in the

tranexamic acid tablets group compared to placebo (see Table 7). No statistically significant treatment

difference was observed in response rates on the number of large stains.

Table 7. Secondary Outcomes in 6-Cycle Study

Outcome Measure

N

Bas eline

Mean

Least Squares Mean

Reduction

Social and Leisure Activities

3900 mg/day tranexamic acid

2.92

0.85

Placebo

2.74

0.44

Physical Activities

3900 mg/day tranexamic acid

3.05

0.87

Placebo

2.90

0.40

N

Responders

Reduction in Large Stains

3900 mg/day tranexamic acid

Placebo

14.3 MBL Results over Time

The efficacy of tranexamic acid tablets 3900 mg/day over 3 menstrual cycles and over 6 menstrual

cycles was demonstrated versus placebo in the double-blind, placebo-controlled efficacy studies (see

Figure 1). The change in MBL from baseline was similar across all post-baseline treatment cycles.

Figure 1: MBL Levels over Duration of Therapy

p<0.001 versus placebo

Response categories: 1=not at all limited; 2=slightly limited; 3=moderately limited;

4 =quite a bit limited; 5=extremely limited

Positive means reflect an improvement from baseline

p-value <0.05 versus placebo

Responders are defined as subjects who experienced a reduction from baseline in

frequency of large stains

Non-significant difference versus placebo

*

§

16 HOW SUPPLIED/STORAGE AND HANDLING

Tranexamic Acid Tablets are provided as white oval-shaped tablets. Each tablet is debossed with the

marking "FP650"and are supplied as:

Quantity

Package Type

NDC Number

30 tablets

HDPE bottle

66993-121-30

Storage

Store at room temperature 25° C (77° F); excursions permitted to 15-30° C (59-86° F). [See USP

Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information)

Instruct patients that the usual schedule is to take two tablets with liquids, three times a day during

menstruation. Patients should be instructed not to exceed 3 doses (6 tablets) in a 24-hour period or to

take for more than 5 days in any menstrual cycle.

Inform patients that they should immediately stop Tranexamic Acid Tablets if they notice any eye

symptoms or change in their vision. Instruct them to report any such problems promptly to their

physician and to follow-up with an ophthalmologist for a complete ophthalmic evaluation, including

dilated retinal examination of the retina.

Inform patients that they should stop Tranexamic Acid Tablets and seek immediate medical attention if

they notice symptoms of a severe allergic reaction (e.g., shortness of breath or throat tightening).

Instruct patients that common side effects of Tranexamic Acid Tablets include headache, sinus and nasal

symptoms, back pain, abdominal pain, musculoskeletal pain, joint pain, muscle cramps, migraine, anemia

and fatigue.

Advise patients to contact their healthcare provider if their heavy menstrual bleeding symptoms persist

or worsen.

Remind patients to read the Patient Labeling carefully.

PATIENT INFORMATION

TRANEXAMIC ACID TABLETS

Read the Patient Information that comes with Tranexamic Acid Tablets before you start using the drug

and each time you get a refill. There may be new information. This leaflet does not take the place of

talking with your healthcare provider about your medical condition or your treatment.

What is Tranexamic Acid Tablets?

Tranexamic Acid Tablets is a prescription medicine used to treat your heavy monthly period

(menstruation) when your bleeding gets in the way of social, leisure and physical activities. Tranexamic

Acid Tablets does not contain any hormones. On average, Tranexamic Acid Tablets has been shown to

lower the amount of blood lost during your monthly period by about one-third, but it is not meant to stop

your period.

Tranexamic Acid Tablets is taken only during your period and is not meant to treat pre-menstrual

symptoms (symptoms that occur before your bleeding starts). Tranexamic Acid Tablets does not affect

your fertility and cannot be used as birth control. Tranexamic Acid Tablets does not protect you against

diseases that you may get if you have unprotected sex.

Tranexamic Acid Tablets has not been studied in adolescents younger than 18 years of age.

Tranexamic Acid is not for women who have already gone through menopause (post-menopausal).

Who should not take Tranexamic Acid Tablets?

Do not take Tranexamic Acid Tablets if you:

Are using a form of birth control that contains estrogen and a progestin (like a birth control pill,

patch, or vaginal ring). Ask your healthcare provider before taking Tranexamic Acid Acid Tablets if

you are not sure if your birth control method contains estrogen and a progestin.

Currently have a blood clot

Have ever had a blood clot

Have been told that you are at risk of having a blood clot

Are allergic to tranexamic acid

What should I tell my healthcare provider before taking Tranexamic Acid Tablets?

Before taking Tranexamic Acid Tablets, tell your healthcare provider about all of your medical

conditions, including whether:

You have ever had a blood clot or been told that you are at risk of having a blood clot

You are using a form of birth control that contains estrogen and a progestin (like a birth

control pill, patch, or vaginal ring). . Using hormonal birth control along with Tranexamic Acid

Tablets may increase your chance of having a serious blood clot, stroke, or heart attack. For this

reason, do not use Tranexamic Acid Tablets if you use a form of birth control that contains estrogen

and a progestin.

You are pregnant or think you may be pregnant

You are breastfeeding or plan to breast-feed. Tranexamic Acid Tablets can pass into your milk. Talk

to your healthcare provider about the best way to feed your baby if you take Tranexamic Acid

T ablets.

The time between the start of your periods is less than 21 days or more than 35 days

You have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-

counter medicines, vitamins, and herbal supplements. Tranexamic Acid Tablets and other medicines can

counter medicines, vitamins, and herbal supplements. Tranexamic Acid Tablets and other medicines can

affect each other, causing side effects. Tranexamic Acid Tablets can affect the way other medicines

work and other medicines can affect how Tranexamic Acid Tablets works.

Especially tell your healthcare provider if you take:

Birth control pills or other hormonal birth control

Medicines used to help your blood form clots

Medicines used to break up blood clots

Any medicines to treat leukemia

Ask your healthcare provider if you are not sure if your medicine is one that is described above.

How should I take Tranexamic Acid Tablets?

Take Tranexamic Acid Tablets exactly as your healthcare provider tells you.

Do not take Tranexamic Acid Tablets until your period has started.

Do not take Tranexamic Acid Tablets for more than 5 days in a row.

Do not take Tranexamic Acid Tablets when you do not have your period.

Once your period has started, take 2 tablets of Tranexamic Acid Tablets three times per day (e.g., in

the morning, afternoon, and evening).

Tranexamic Acid Tablets should be swallowed whole and not chewed or broken apart.

Tranexamic Acid Tablets may be taken with or without food.

Do not take more than 6 tablets of Tranexamic Acid Tablets in a day. If you take more than 6 tablets,

call your healthcare provider.

If you miss a dose, take it when you remember, and then take your next dose at least six hours later.

Do not take more than two tablets at a time to make up for missed doses.

If Tranexamic Acid Tablets does not help to lessen bleeding with your periods after 2 cycles or

seems to stop working, talk to your healthcare provider.

What are the possible side effects of Tranexamic Acid Tablets?

Tranexamic Acid Tablets can cause serious side effects, including:

Blood clots. You may have a higher risk of having serious blood clots if you take Tranexamic Acid

Tablets with:

medicines used to help your blood form clots

some medicines used to treat leukemia

Eye changes. Stop taking Tranexamic Acid Tablets and promptly report any eye problems you have

while taking Tranexamic Acid Tablets. Your doctor will refer you to an eye doctor who will

examine your eyes.

Allergic reaction. If you have severe shortness of breath and your throat feels tight, stop taking

Tranexamic Acid Tablets and get medical care right away.

The most common side effects of Tranexamic Acid Tablets include:

Headaches

Sinus and nasal problems

Back pain

Pain in your abdomen

Pain in your muscles or joints

Anemia

Fatigue

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects of Tranexamic Acid Tablets. For more information, ask

your healthcare provider or pharmacist.

If you notice a change in your usual bleeding pattern that worries you, or your heavy bleeding

If you notice a change in your usual bleeding pattern that worries you, or your heavy bleeding

continues, contact your healthcare provider right away. This may be a sign of a more serious

condition.

Call your healthcare provider for medical advice about side effects. You may report side effects to the

FDA at 1-800-FDA-1088. You may also report side effects to Ferring Pharmaceuticals Inc. at 1-888-

FERRING (1-888-337-7464).

How should I store Tranexamic Acid Tablets?

Store Tranexamic Acid Tablets at room temperature between 59°F to 86°F (15°C to 30°C).

Keep Tranexamic Acid Tablets and all medicines out of the reach of children.

General information about Tranexamic Acid Tablets

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information

Leaflets. Do not use Tranexamic Acid Tablets for a condition for which it was not prescribed. Do not

give Tranexamic Acid Tablets to other people, even if they have the same symptoms that you have. It

may harm them.

This patient information leaflet summarizes the most important information about Tranexamic Acid

Tablets. If you would like more information about Tranexamic Acid Tablets, talk with your healthcare

provider. You can ask your healthcare provider or pharmacist for information about Tranexamic Acid

Tablets that is written for healthcare professionals. For more information, call 1-888-FERRING (1-

888-337-7464).

What are the ingredients of Tranexamic Acid Tablets?

Active ingredient: tranexamic acid

Inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, pregelatinized corn starch,

povidone, hypromellose, stearic acid, and magnesium stearate.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Prasco Laboratories

Mason, OH 45040 USA

By: Mikart, Inc.

Atlanta, GA 30318

Iss. 10/2013 6710-03

PRINCIPAL DISPLAY PANEL - 650 mg Tablet Bottle Label

NDC 66993-121-30

30 Tablets

PRASCO

Tranexamic Acid Tablets

Rx Only

650 mg

TRANEXAMIC ACID

tranexamic acid tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 6 9 9 3-121

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tra nexa mic Acid (UNII: 6 T8 4R30 KC1) (Tranexamic Acid - UNII:6 T8 4R30 KC1)

Tranexamic Acid

6 50 mg

Inactive Ingredients

Ingredient Name

Stre ng th

Cellulo se, Micro crysta lline (UNII: OP1R32D6 1U)

Silico n Dio xide (UNII: ETJ7Z6 XBU4)

Sta rch, Co rn (UNII: O8 232NY3SJ)

Po vido nes (UNII: FZ9 8 9 GH9 4E)

Hypro mello ses (UNII: 3NXW29 V3WO)

Stea ric Acid (UNII: 4ELV7Z6 5AP)

Ma g nesium Stea ra te (UNII: 70 0 9 7M6 I30 )

Product Characteristics

Color

WHITE

S core

sco re with uneven pieces

S hap e

OVAL

S iz e

17mm

Flavor

Imprint Code

FP6 50

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

Prasco Laboratories

1

NDC:6 6 9 9 3-121-30

30 in 1 BOTTLE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA autho rized generic

NDA0 22430

0 5/17/20 10

Labeler -

Prasco Laboratories (065969375)

Registrant -

Ferring Pharmaceuticals Inc. (103722955)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Mikart, Inc.

0 30 0 348 47

MANUFACTURE(6 6 9 9 3-121) , PACK(6 6 9 9 3-121)

Revised: 10/2013

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