tran-ex-AM-ikAS -id

Therapeutic Classification: hemostatic agents

Pharmacologic Classification: antifibrinolytics, plasminogen inactivators

• IV: Prevention or reduction of hemorrhage during and following dental surgery in hemophiliacs.
• PO: Cyclic heavy menstrual bleeding.

• Inhibits activation of plasminogen, thereby preventing the conversion of plasminogen to plasmin.

• Decreased bleeding following dental surgery in hemophiliacs.
• Reduced need for replacement therapy.
• Reduced menstrual blood loss.

Absorption: IV administration results in complete bioavailability; 45% absorbed following oral administration.

Distribution: Penetrates readily into joint fluid and synovial membranes.

Metabolism/Excretion: 95% excreted unchanged in urine.

Half-life: IV: 2 hr (↑ in renal impairment); Oral: 11 hr.

(plasma concentrations)

Contraindicated in:

• Hypersensitivity
• Thromboembolic disorders (current, history of, or at risk for)
• Acquired defective color vision (IV)
• Subarachnoid hemorrhage
• Concurrent use of combination hormonal contraception (PO).

Use Cautiously in:

• Renal impairment (↑ dosing interval)
• Hematuria originating in the upper urinary tract
• Conditions associated with ↑ thrombus formation
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant.

CV: hypotension, thromboembolism.

EENT: visual abnormalities.

GI: diarrhea, nausea, vomiting.

MS: pain.

Neuro: headache, dizziness, SEIZURES.

Misc: PO: ANAPHYLAXIS .

Drug-Drug:

• Concurrent use of hormonal contraceptives with oral tranexamic acid may ↑ risk of thrombosis; concurrent use contraindicated.
• Concurrent use of clotting factor complexes may ↑ the risk of thrombotic complications (give tranexamic acid 8 hr following clotting factor replacement therapy).
• May ↑ the procoagulant effects of all-trans retinoic acid.
• ↓effectiveness with thrombolytic agents.

• IV (Adults and Children): 10 mg/kg just prior to surgery with appropriate replacement therapy; then 10 mg/kg 3–4 times daily for 2–8 days.

(Generic available)

• Premixed infusion: 1 g/100 mL 0.7% NaCl;
• Solution for injection: 100 mg/mL;
• Tablets: 500 mg; 650 mg;

• Prevention of postsurgical hemorrhage: Observe site of surgery for excessive bleeding.
• Heavy menstrual bleeding: Monitor menstrual flow prior to and during therapy.
• Patients taking tranexamic acid for more than several days should have ophthalmologic examinations to detect visual abnormalities prior to and at regular intervals during and after therapy. Discontinue therapy if visual changes occur.

• High Alert:Serious adverse reactions, including seizures and arrhythmias, have occurred when administering tranexamic acid incorrectly via the intrathecal route instead of through the IV route. Confirm the correct route of administration for tranexamic acid, and avoid confusion with other injectable solutions that might be administered at the same time.
• PO: Administer 3 times daily without regard to food. Swallow tablets whole; do not crush, break, or chew.

IV Administration:

• Intermittent Infusion:
  Diluent: May be diluted with most solutions, such as electrolyte, carbohydrate, amino acid, and dextran solutions. Prepare mixture on day of infusion.
• Rate: Infuse at a rate not to exceed 100 mg (1 mL)/min. More rapid administration has resulted in hypotension.
• Y-Site Compatibility:
  • clevidipine
  • defibrotide
  • heparin
• Y-Site Incompatibility:
  • ampicillin
  • ampicillin/sulbactam
  • blinatumomab
  • penicillin G
  • piperacillin/tazobactam
.

• Instruct patient to take medication as directed; do not take more than 6 tablets/day, for longer that 5 days in any menstrual cycle, or when not menstruating. Take missed doses as soon as remembered; then take next dose as least 6 hr later; do not double doses. Advise patient to read Patient Information before starting and with each Rx refill in case of changes.
• Advise patient to stop medication and inform health care professional of any changes in vision. Inform patients on prolonged therapy of the importance of regular ophthalmologic follow-up.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications. Caution patient to avoid taking hormonal contraceptives and products containing aspirin or NSAIDs without consulting health care professional.
• Instruct patient to notify health care professional if signs and symptoms of thrombosis (severe, sudden headache; pains in chest, groin, or legs, especially calves; sudden loss of coordination; sudden and unexplained shortness of breath; slurred speech; visual changes; weakness or numbness in arm or leg) or anaphylaxis (shortness of breath, throat tightness, rash) occur.
• Instruct patient to notify health care professional if heavy menstrual bleeding persists or worsens or if bleeding does not lessen after 2 cycles or tranexamic acid seems to stop working.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

• Prevention of hemorrhage during and following dental surgery in hemophiliacs.
• Reduced menstrual blood loss.

Cyklokapron, Lysteda

NDC Code^*

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-1114- Cyklokapron
    • 0013-1114-10- 10 CARTON in 1 BOX (0013-1114-10) > 1 AMPULE in 1 CARTON > 10 mL in 1 AMPULE (0013-1114-01)

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-1114- Cyklokapron
    • 0013-1114-15- 1 AMPULE in 1 CARTON (0013-1114-15) > 10 mL in 1 AMPULE (0013-1114-01)

• 0013- Pharmacia and Upjohn Company LLC
  • 0013-1114- Cyklokapron
    • 0013-1114-21- 10 VIAL in 1 BOX (0013-1114-21) > 10 mL in 1 VIAL (0013-1114-20)

• 0517- American Regent, Inc.
  • 0517-0960- Tranexamic Acid
    • 0517-0960-01- 1 VIAL, GLASS in 1 CARTON (0517-0960-01) > 10 mL in 1 VIAL, GLASS

• 0517- American Regent, Inc.
  • 0517-0960- Tranexamic Acid
    • 0517-0960-10- 10 VIAL, GLASS in 1 CARTON (0517-0960-10) > 10 mL in 1 VIAL, GLASS

• 0591- Actavis Pharma, Inc.
  • 0591-3720- Tranexamic Acid
    • 0591-3720-10- 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3720-10)

• 0591- Actavis Pharma, Inc.
  • 0591-3720- Tranexamic Acid
    • 0591-3720-30- 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3720-30)

• 17478- Akorn, Inc.
  • 17478-017- Tranexamic Acid
    • 17478-017-10- 5 AMPULE in 1 CARTON (17478-017-10) > 10 mL in 1 AMPULE

• 17478- Akorn, Inc.
  • 17478-018- Tranexamic Acid
    • 17478-018-10- 10 VIAL, SINGLE-DOSE in 1 CARTON (17478-018-10) > 10 mL in 1 VIAL, SINGLE-DOSE

• 17478- Akorn, Inc.
  • 17478-217- TRANEXAMIC ACID
    • 17478-217-10- 10 AMPULE in 1 CARTON (17478-217-10) > 10 mL in 1 AMPULE

• 23155- Heritage Pharmaceuticals Inc.
  • 23155-166- Tranexamic Acid
    • 23155-166-41- 10 VIAL, GLASS in 1 CARTON (23155-166-41) > 10 mL in 1 VIAL, GLASS (23155-166-31)

• 23155- Heritage Pharmaceuticals Inc.
  • 23155-524- Tranexamic Acid
    • 23155-524-41- 10 VIAL, GLASS in 1 CARTON (23155-524-41) > 10 mL in 1 VIAL, GLASS (23155-524-31)

• 39822- X-GEN Pharmaceuticals, Inc.
  • 39822-1000- Tranexamic Acid
    • 39822-1000-1- 10 VIAL in 1 CARTON (39822-1000-1) > 10 mL in 1 VIAL

• 39822- X-GEN Pharmaceuticals, Inc.
  • 39822-1001- Tranexamic Acid
    • 39822-1001-7- 10 VIAL in 1 CARTON (39822-1001-7) > 10 mL in 1 VIAL (39822-1001-6)

• 42192- Acella Pharmaceuticals
  • 42192-605- Tranexamic Acid
    • 42192-605-10- 10 VIAL, SINGLE-USE in 1 CARTON (42192-605-10) > 10 mL in 1 VIAL, SINGLE-USE (42192-605-01)

• 42571- Micro Labs Limited
  • 42571-189- Tranexamic Acid
    • 42571-189-57- 10 CARTON in 1 CARTON (42571-189-57) > 1 AMPULE in 1 CARTON (42571-189-56) > 10 mL in 1 AMPULE

• 42571- Micro Labs Limited
  • 42571-314- TRANEXAMIC ACID
    • 42571-314-89- 10 CARTON in 1 CARTON (42571-314-89) > 1 VIAL, GLASS in 1 CARTON (42571-314-88) > 10 mL in 1 VIAL, GLASS

• 47781- Alvogen Inc.
  • 47781-601- Tranexamic Acid
    • 47781-601-91- 10 VIAL, SINGLE-DOSE in 1 CARTON (47781-601-91) > 10 mL in 1 VIAL, SINGLE-DOSE (47781-601-22)

• 50090- A-S Medication Solutions
  • 50090-4530- Tranexamic Acid
    • 50090-4530-0- 10 mL in 1 VIAL (50090-4530-0)

• 51754- Exela Pharma Sciences, LLC
  • 51754-0108- TRANEXAMIC ACID IN SODIUM CHLORIDE
    • 51754-0108-1- 100 mL in 1 BAG (51754-0108-1)

• 51754- Exela Pharma Sciences, LLC
  • 51754-0108- TRANEXAMIC ACID IN SODIUM CHLORIDE
    • 51754-0108-3- 1000 mL in 1 CASE (51754-0108-3)

• 55150- AuroMedics Pharma LLC
  • 55150-188- Tranexamic Acid
    • 55150-188-10- 10 VIAL, SINGLE-USE in 1 CARTON (55150-188-10) > 10 mL in 1 VIAL, SINGLE-USE

• 55566- Ferring Pharmaceuticals Inc.
  • 55566-2110- Lysteda
    • 55566-2110-2- 30 TABLET in 1 BOTTLE (55566-2110-2)

• 60505- Apotex Corp.
  • 60505-3638- Tranexamic Acid
    • 60505-3638-1- 100 TABLET in 1 BOTTLE (60505-3638-1)

• 60505- Apotex Corp.
  • 60505-3638- Tranexamic Acid
    • 60505-3638-3- 30 TABLET in 1 BOTTLE (60505-3638-3)

• 61990- Apollo Pharmaceuticals Inc.
  • 61990-0611- tranexamic acid
    • 61990-0611-2- 10 VIAL, SINGLE-DOSE in 1 CARTON (61990-0611-2) > 10 mL in 1 VIAL, SINGLE-DOSE (61990-0611-0)

• 63323- Fresenius Kabi USA, LLC
  • 63323-563- Tranexamic Acid
    • 63323-563-10- 10 VIAL in 1 TRAY (63323-563-10) > 10 mL in 1 VIAL (63323-563-01)

• 65145- Caplin Steriles Limited
  • 65145-106- Tranexamic Acid
    • 65145-106-10- 10 CARTON in 1 BOX (65145-106-10) > 1 VIAL in 1 CARTON > 10 mL in 1 VIAL (65145-106-01)

• 66993- Prasco Laboratories
  • 66993-121- Tranexamic Acid
    • 66993-121-30- 30 TABLET in 1 BOTTLE (66993-121-30)

• 67457- Mylan Institutional LLC
  • 67457-197- Tranexamic Acid
    • 67457-197-10- 10 VIAL, SINGLE-DOSE in 1 PACKAGE (67457-197-10) > 10 mL in 1 VIAL, SINGLE-DOSE (67457-197-00)

• 67850- Methapharm, Inc.
  • 67850-041- Tranexamic Acid
    • 67850-041-10- 10 VIAL, SINGLE-USE in 1 CARTON (67850-041-10) > 10 mL in 1 VIAL, SINGLE-USE (67850-041-00)

• 67850- Methapharm, Inc.
  • 67850-042- Tranexamic Acid
    • 67850-042-10- 10 AMPULE in 1 CARTON (67850-042-10) > 10 mL in 1 AMPULE (67850-042-00)

• 68083- Gland Pharma Limited
  • 68083-160- Tranexamic acid
    • 68083-160-10- 10 VIAL in 1 CARTON (68083-160-10) > 10 mL in 1 VIAL

• 68084- American Health Packaging
  • 68084-929- Tranexamic Acid
    • 68084-929-32- 20 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-929-32) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-929-33)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-891- Tranexamic Acid
    • 68382-891-07- 10 VIAL in 1 CARTON (68382-891-07) > 10 mL in 1 VIAL

• 69543- Virtus Pharmaceuticals, LLC
  • 69543-376- Tranexamic Acid
    • 69543-376-22- 1 AMPULE in 1 CARTON (69543-376-22) > 10 mL in 1 AMPULE

• 69543- Virtus Pharmaceuticals, LLC
  • 69543-376- Tranexamic Acid
    • 69543-376-23- 10 AMPULE in 1 CELLO PACK (69543-376-23) > 10 mL in 1 AMPULE

• 69918- Amring Pharmaceuticals, Inc.
  • 69918-301- Tranexamic Acid
    • 69918-301-30- 30 TABLET in 1 BOTTLE (69918-301-30)

• 70121- Amneal Biosciences LLC
  • 70121-1398- Tranexamic Acid
    • 70121-1398-7- 10 CARTON in 1 PACKAGE (70121-1398-7) > 1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1398-1) > 10 mL in 1 VIAL, SINGLE-DOSE

• 70771- Cadila Healthcare Limited
  • 70771-1085- Tranexamic Acid
    • 70771-1085-6- 10 VIAL in 1 CARTON (70771-1085-6) > 10 mL in 1 VIAL

• 70860- Athenex Pharmaceutical Division, LLC.
  • 70860-400- Tranexamic Acid
    • 70860-400-10- 10 VIAL in 1 CARTON (70860-400-10) > 10 mL in 1 VIAL (70860-400-41)

• 71974- Reviresco Co., Ltd.
  • 71974-030- SKINMD LABORATORIES PURE WHITENOL SERUM
    • 71974-030-02- 1 BOTTLE, PUMP in 1 CARTON (71974-030-02) > 50 mL in 1 BOTTLE, PUMP (71974-030-01)