tranexamic acid

REMS

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

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;
Use of hormonal contraceptives (PO);
OB: Safety not established.

CNS: SEIZURES, headache, dizziness

EENT: visual abnormalities

CV: hypotension, thromboembolism, thrombosis

GI: diarrhea, nausea, vomiting

MS: pain

Misc: POANAPHYLAXIS

Drug-drug:

Concurrent use of hormonal contraceptives may ↑ risk of thrombosis (PO); 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.

(Generic available)

Solution for injection: 100 mg/mL
Tablets: 650 mg

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.

Renal Impairment

IV (Adults and Children ): SCr 1.36–2.83 mg/dL—10 mg/kg twice daily; SCr 2.83–5.66 mg/dL— 10 mg/kg daily; SCr >5.66 mg/dL— 10 mg/kg every 48 hr or 5 mg/kg once daily.
PO (Adults ): 1300 mg 3 times daily for a maximum of 5 days during menstruation.

Renal Impairment

PO (Adults ): SCr 1.41–2.8 mg/dL–1300 mg twice daily for a maximum of 5 days during menstruation; SCr 2.81–5.7 mg/dL–1300 mg daily for a maximum of 5 days during menstruation; SCr >5.7 mg/dL–650 mg daily for a maximum of 5 days during menstruation;.

Cyklokapron, Lysteda

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

Therapeutic effects:

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

Therapeutic Classification: hemostatic agents

Pharmacologic Classification: antifibrinolytics, plasminogen inactivators

Absorption: 100% bioavailable with IV administration; 45% bioavailability after oral administration.

Distribution: Penetrates readily into joint fluid and synovial membranes.

Metabolism/Excretion: 95% excreted unchanged in urine.

Half-Life: 2 hr (IV) (↑ in renal impairment); 11 hr (PO).

(blood levels)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	unknown	7–8 hr
PO	unknown	2.5 hr	unknown

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 hrs 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.

tran-ex-AM-ikAS -id

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)

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Code ⬆