TRANEXAMIC ACID 100MG/ML 10X10ML VIALS
Generic: Tranexamic Acid
TRANEXAMIC ACID 100MG/ML 10X10ML VIALS
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Identification
Tranexamic Acid
Tranexamic Acid
Armas Pharmaceuticals Inc.
HUMAN PRESCRIPTION DRUG
Administration
INJECTION
INTRAVENOUS
ANDA212360
Active Ingredients
| Ingredient | Strength |
|---|---|
| TRANEXAMIC ACID | 100 mg/mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
Indications & Usage
1 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 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
2 DOSAGE & ADMINISTRATION • Before Extraction: Administer 10 mg/kg actual body weight of Tranexamic acid injection intravenously with replacement therapy. ( 2.1 ) • After Extraction: Administer 10 mg/kg actual body weight 3 to 4 times daily for 2 to 8 days. Infuse no more than 1 mL/minute to avoid hypotension. ( 2.1 ). • Reduce the dosage for patients with renal impairment. ( 2.2 , 8.6 ) 2.1 Recommended Dosage The recommended dose of Tranexamic acid is 10 mg/kg actual body weight intravenously administered as a single dose, immediately before tooth extractions. Infuse no more than 1 mL/minute to avoid hypotension [see Warnings and Precautions (5.1)] . Following tooth extraction, Tranexamic acid may be administered for 2 to 8 days at a dose of 10 mg/kg actual body weight 3 to 4 times daily, intravenously. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. For intravenous infusion, Tranexamic acid Injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, and Dextran solutions. Heparin may be added to Tranexamic acid Injection. Tranexamic acid Injection should NOT be mixed with blood. The drug is a synthetic amino acid and should NOT be mixed with solutions containing penicillin. Discard any unused portion. The diluted mixture may be stored for up to 4 hours at room temperature prior to patient administration. 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 to 2.83 (120 to 250 micromol/L) 10 mg/kg twice daily 2.83 to 5.66 (250 to 500 micromol/L) 10 mg/kg daily >5.66 (>500 micromol/L) 10 mg/kg every 48 hours or 5 mg/kg every 24 hours * Dose reduction is recommended for all doses, both before and after tooth extraction.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Thromboembolic Risk [see Warnings and Precautions (5.1)] • 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 Caplin Steriles Limited at 1-866-978-6111 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, cromatopsia, and visual impairment have also been reported. Anaphylaxis or anaphylactoid reactions have been reported that are suggestive of a causal relationship.
Information for Patients
17 PATIENT COUNSELING INFORMATION Thromboembolic Risk Inform patients that Tranexamic acid may increase the risk of venous and arterial thrombosis or thromboembolism and to contact their healthcare provider for any signs or symptoms suggestive of thromboembolism. Advise patients using hormonal contraception that combined use with Tranexamic acid may increase the risk for thromboembolic adverse reactions and to use effective alternative (nonhormonal) contraception during therapy with Tranexamic acid [see Warnings and Precautions (5.1), Drug Interactions (7.1), Use in Specific Populations (8.3)] . Seizures Inform patients that Tranexamic acid may cause seizures and to contact their healthcare provider for any signs or symptoms suggestive of seizures [see Warnings and Precautions (5.3)] . Hypersensitivity Reactions Inform patients that Tranexamic acid may cause hypersensitivity reactions and to contact their healthcare provider for any signs or symptoms of hypersensitivity reactions [see Warnings and Precautions (5.4)] . Visual Disturbances Inform patients that Tranexamic acid can cause visual disturbance and that they should report any eye symptoms or change in their vision to their healthcare provider and to follow-up with an ophthalmologist for a complete ophthalmologic evaluation, including dilated retinal examination of the retina [see Warnings and Precautions (5.5)] . Risk of Driving and Operating Machinery Inform patients that Tranexamic acid may cause dizziness, and that the patient should be cautioned about driving, operating machinery, or performing hazardous tasks while taking Tranexamic acid [see Warnings and Precautions (5.6)]. Distributed by: Armas Pharmaceuticals, Inc., Freehold, NJ 07728 (USA) Manufactured by: Caplin Steriles Limited, Gummidipoondi - 601 201, India. Code: TN/Drugs/TN00003457 January, 2024 22200764
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.