Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Tranexamic Acid Injection 1,000 mg/10 mL (100 mg/mL) is a clear, colorless solution and is available as follows. Carton of 10 mL glass ampule (10 mL fill in 10 mL glass ampule) NDC 42571-189-56 Carton of 10 x 10 mL ampules NDC 42571-189-57 Tranexamic Acid Injection 1,000 mg/10 mL (100 mg/mL) is a clear, colorless solution and is available as follows. Carton of 10 mL glass vials (10 mL fill in 10 mL glass vials) NDC 42571-314-88 Carton of 10 x 10 mL vials NDC 42571-314-89 Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 42571-189-56 Tranexamic Acid Injection 1,000 mg/10 mL (100 mg/mL) Intravenous Use Only Rx Only Single-Dose Ampule. Discard unused portion. 10 mL Ampule MICRO LABS NDC 42571-189-56 Rx Only Tranexamic Acid Injection 1,000 mg/10 mL (100 mg/mL) Intravenous Use Only Rx Only Single-Dose Ampule. Discard unused portion. Contains 1 Ampule 10 mL MICRO LABS NDC 42571-189-57 Tranexamic Acid Injection 1,000 mg/10 mL (100 mg/mL) Intravenous Use Only Rx Only Single-Dose Ampule. Discard unused portion. 10 x 10 mL Ampule MICRO LABS tranexamic-ampulelabel.jpg tranexamic-ampulelcrtn.jpg tranexamic-10ampulelcrtn.jpg
- 16 HOW SUPPLIED/STORAGE AND HANDLING Tranexamic Acid Injection 1,000 mg/10 mL (100 mg/mL) is a clear, colorless solution and is available as follows. Carton of 10 mL glass ampule (10 mL fill in 10 mL glass ampule) NDC 42571-189-56 Carton of 10 x 10 mL ampules NDC 42571-189-57 Tranexamic Acid Injection 1,000 mg/10 mL (100 mg/mL) is a clear, colorless solution and is available as follows. Carton of 10 mL glass vials (10 mL fill in 10 mL glass vials) NDC 42571-314-88 Carton of 10 x 10 mL vials NDC 42571-314-89 Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 42571-189-56 Tranexamic Acid Injection 1,000 mg/10 mL (100 mg/mL) Intravenous Use Only Rx Only Single-Dose Ampule. Discard unused portion. 10 mL Ampule MICRO LABS NDC 42571-189-56 Rx Only Tranexamic Acid Injection 1,000 mg/10 mL (100 mg/mL) Intravenous Use Only Rx Only Single-Dose Ampule. Discard unused portion. Contains 1 Ampule 10 mL MICRO LABS NDC 42571-189-57 Tranexamic Acid Injection 1,000 mg/10 mL (100 mg/mL) Intravenous Use Only Rx Only Single-Dose Ampule. Discard unused portion. 10 x 10 mL Ampule MICRO LABS tranexamic-ampulelabel.jpg tranexamic-ampulelcrtn.jpg tranexamic-10ampulelcrtn.jpg
Overview
Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is Molecular Formula: C 8 H 15 NO 2 Molecular Weight: 157.2 Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid and Water for Injection to 1 mL. The aqueous solution for injection has a pH of 6.5 to 8.0. STRUCTURE
Indications & Usage
Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. ( 1 )
Dosage & Administration
Before Extraction: Administer 10 mg/kg actual body weight of tranexamic acid injection intravenously with replacement therapy as a single-dose. ( 2.1 ) After Extraction: Administer 10 mg/kg actual body weight of tranexamic acid injection intravenously 3 to 4 times daily for 2 to 8 days. ( 2.1 ) Infuse undiluted solution no more than 1 mL/minute to avoid hypotension. ( 2.3 ) Reduce the dosage for patients with renal impairment. ( 2.2 , 8.6 ) 2.1 Recommended Dosage The recommended dose of tranexamic acid injection is 10 mg/kg actual body weight administered as a single intravenous dose immediately before tooth extractions . Following tooth extraction, tranexamic acid injection may be administered at a dose of 10 mg/kg actual body weight intravenously 3 to 4 times daily for 2 to 8 days. 2.2 Recommended Dosage for Patients with Varying Degrees of Renal Impairment For patients with moderate to severe impaired renal function, the following dosages are recommended: Table 1. Recommended Dosage in Patients with Varying Degrees of Renal Impairment* Serum Creatinine (mg/dL) Tranexamic Acid Intravenous Dosage 1.36 mg/dL to 2.83 mg/dL 10 mg/kg intravenously twice daily 2.83 mg/dL to 5.66 mg/dL 10 mg/kg intravenously daily >5.66 mg/dL 10 mg/kg intravenously every 48 hours or 5 mg/kg intravenously every 24 hours * Dose reduction is recommended for all doses, both before and after tooth extraction. 2.3 Preparation and Administration Tranexamic acidinjectionis for intravenous administration only. Tranexamic acidinjectioncan be administered undiluted or as a diluted solution. Use aseptictechniqueto prepare tranexmaic acid injection. Parenteraldrugproducts should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.Tranexmaicacid injection is a clear and colorless solution. Discard the vial if particulate matter is observed. Calculate the dose (mg) based on thepatient’sactual body weight and the total volume (mL) of tranexamic acid injection solution required. If diluting tranexamic acid injection , follow the instructions below: From the diluent infusion bag, withdraw avolumeequal to the volume of the tranexamic acid injection solution required for the patient’s dose. Withdraw the required volume oftranexamicacid injection solution from the vial and dilute with a compatible diluent (see below) to make a finalconcentrationof 10 mg/mL or 20 mg/mL. Discard any unused portion left in the vial. For intravenousinfusion, tranexamic acid injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, andDextransolutions. Heparin may be added totranexamicacid injection. Tranexamic acidinjectionshould NOT be mixed with blood. The drug is asyntheticamino acid and should NOT be mixed with solutions containing penicillin. Gently invert theinfusionbag to mix the diluted solution. DO NOT SHAKE. If not usedimmediately, store the diluted tranexamic acid injection infusion solution at room temperature 20ºC to 25°C (68ºF to 77°F) for up to 4hours. Administration Infuse undilutedsolutionno more than 1 mL/minute to avoid hypotension [see Adverse Reactions (6.2) ] . Administer theundilutedand diluted solutions intravenously according to Table 2. Table 2.AdministrationRates for Undiluted and Diluted Solutions Undiluted solution Diluted solution Final concentration 100 mg/mL 10 mg/mL 20 mg/mL Administration rate 0.5 mL/minute (no more than 1 mL/minute) 5 mL/minute 2.5 mL/minute
Warnings & Precautions
Risk of Thrombosis with Concomitant Use of Factor IX: Avoid concomitant use. ( 5.2 ) Seizures: Inadvertent injection into neuraxial system may result in seizures. ( 5.3 ) Hypersensitivity Reactions: In case of severe reaction, discontinue use and seek immediate medical attention. ( 5.4 ) Visual Disturbances: Visual or ocular adverse effects may occur. Discontinue use if visual or ocular symptoms occur. ( 5.5 ) Dizziness: Advise patients not to drive if dizziness occurs. ( 5.6 ) 5.1 Risk of Medication Errors Due to Incorrect Route of Administration Tranexamicacidinjection is for intravenous use only. Serious, including fatal, adverse reactions including seizures and cardiac arrythmias have occurred whentranexamicacid injection was inadvertently administered via the neuraxial route. Confirm thecorrectroute of administration for tranexamic acid injection and avoid confusion with other injectable solutions that might be administered at the sametimeas tranexamic acid injection. Clearly label syringes containing tranexamic acid injection with the intravenous route ofadministration. 5.2 Thromboembolic Risk Tranexamic acid injection is contraindicated in patients with active intravascular clotting. Tranexamic acid is an antifibrinolytic and may increase the risk of thromboembolic events. Venous and arterial thrombosis or thromboembolism has been reported in patients treated with tranexamic acid injection. Avoid concomitant use of tranexamic acid injection and medical products that are pro-thrombotic, as the risk of thrombosis may be increased. These medications include but are not limited to, Factor IX Complex concentrates, Anti-inhibitor Coagulant concentrates, and hormonal contraceptives [see Drug Interactions (7.1) , Use in Specific Populations (8.3) ] . 5.3 Seizures Tranexamic acid injection may cause seizures, including focal and generalized seizures. The most common setting for tranexamic acid-induced seizures has been during cardiovascular surgery (a setting in which tranexamic acid injection is not FDA-approved and which uses doses of up to 10-fold higher than the recommended human dose and in patients inadvertently given tranexamic acid via the neuraxial route). Tranexamic acid injection is contraindicated for neuraxial administration (i.e., epidural, intrathecal). Consider dose reduction during surgery and dose adjustments for patients with clinical conditions such as renal dysfunction. Closely monitor the patient during surgery. Consider electroencephalogram (EEG) monitoring for patients with history of seizures or who experience myoclonic movements, twitching, or show evidence of focal seizures. Discontinue tranexamic acid injection if seizures occur. 5.4 Hypersensitivity Reactions Cases of hypersensitivity reactions, including anaphylactic reactions, have occurred with use of intravenous tranexamic acid. Discontinue treatment with tranexamic acid injection if serious reaction occurs, provide appropriate medical management, and do not restart treatment. Tranexamic acid injection is contraindicated in patients with a history of hypersensitivity to tranexamic acid. 5.5 Visual Disturbances Although not seen in humans, focal areas of retinal degeneration have been observed in cats and dogs following oral or intravenous tranexamic acid at doses between 250 to 1600 mg/kg/day (1.6 to 22 times the recommended usual human dose based on body surface area) from 6 days to 1 year. No retinal changes have been observed in eye examinations of patients treated with tranexamic acid for up to 8 years. Patients expected to be treated for greater than 3 months may consider ophthalmic monitoring including visual acuity and optical coherence tomography at regular intervals. Discontinue tranexamic acid injection if changes in ophthalmological examination occurs. 5.6 Dizziness Tranexamic acid injection may cause dizziness. Concomitant use of other drugs that may also cause dizziness may worsen this effect. Advise patients to avoid driving or using machines until they know how tranexamic acid injection affects them.
Boxed Warning
RISK OF MEDICATION ERRORS DUE TO INCORRECT ROUTE OF ADMINISTRATION Tranexamic acidinjectionis for intravenous use only. Serious, including fatal, adverse reactions including seizures and cardiac arrythmias have occurred whentranexamicacid injection was inadvertently administered via the neuraxial route [see Warnings and Precautions (5.1) ] . WARNING: RISK OF MEDICATION ERRORS DUE TO INCORRECT ROUTE OF ADMINISTRATION See full prescribing information for complete boxed warning. Tranexamic acid injection is for intravenous use only. Serious, including fatal, adverse reactions including seizures and cardiac arrythmias have occurred when tranexamic acid injection was inadvertently administered intrathecally via the neuraxial route. ( 5.1 )
Contraindications
Tranexamic acid Injection is contraindicated: As a neuraxial (i.e., intrathecal, epidural) injection [see Warnings and Precautions (5.1) ] . In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients. In patients with active intravascular clotting [see Warnings and Precautions (5.2) ] . In patients with hypersensitivity to tranexamic acid or any of the ingredients [see Warnings and Precautions (5.4) ] . As a neuraxial (i.e., intrathecal, epidural) injection. ( 4 ) In patients with subarachnoid hemorrhage, due to risk of cerebral edema and cerebral infarction. ( 4 ) In patients with active intravascular clotting. ( 4 ) In patients with severe hypersensitivity reactions to tranexamic acid or any of the ingredients. ( 4 )
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Risk of Medication Errors Due to Incorrect Route of Administration [see Warnings and Precautions (5.1) ] Thromboembolic Risk [see Warnings and Precautions (5.2) ] Seizures [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Visual Disturbances [see Warnings and Precautions (5.5) ] Dizziness [see Warnings and Precautions (5.6) ] Most common adverse reactions are nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA, Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of 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. Gastrointestinal disturbances (nausea, vomiting, diarrhea) may occur and may resolve with dose-reduction. Allergic dermatitis and giddiness have been reported. Hypotension has been reported when intravenous injection is too rapid. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery, vein obstruction and cases associated with concomitant use of combination hormonal contraceptives) have been rarely reported in patients receiving tranexamic acid for indications other than hemorrhage prevention in patients with hemophilia. Convulsion, chromatopsia, and visual impairment have also been reported. Anaphylaxis or anaphylactoid reactions have been reported that are suggestive of a causal relationship.
Drug Interactions
Prothrombotic Medical Products: Avoid concomitant use, can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid. ( 5.2 , 7.1 , 8.3 ) 7.1 Prothrombotic Medical Products Avoid concomitant use of tranexamic acid injection with medical products that are prothrombotic because concomitant use can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid [see Warnings and Precautions (5.2) , Use in Specific Populations (8.3) ] .
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