Tranexamic acid is an antifibrinolytic agent 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. MedsAcross supplies Tranexamic acid for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
CYKLOKAPRON ® 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. CYKLOKAPRON 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.
Source: US FDA prescribing information
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 (Kd = 750 μmol/L) and 1 with high affinity (Kd = 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.
Source: US FDA prescribing information
• Before Extraction: Administer 10 mg/kg actual body weight of CYKLOKAPRON intravenously with replacement therapy as a single‑dose. • After Extraction: Administer 10 mg/kg actual body weight of CYKLOKAPRON intravenously 3 to 4 times daily for 2 to 8 days. • Infuse undiluted solution no more than 1 mL/minute to avoid hypotension. • Reduce the dosage for patients with renal impairment.
Source: US FDA prescribing information
CYKLOKAPRON Injection is contraindicated: • As a neuraxial (i.e., intrathecal, epidural) injection. • In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by CYKLOKAPRON in such patients. • In patients with active intravascular clotting. • In patients with hypersensitivity to tranexamic acid or any of the ingredients. • As a neuraxial (i.e., intrathecal, epidural) injection. • In patients with subarachnoid hemorrhage, due to risk of cerebral edema and cerebral infarction. • In patients with active intravascular clotting.
Source: US FDA prescribing information
Boxed warning (risk of medication errors due to incorrect route of administration cyklokapron): is for intravenous use only. Serious, including fatal, adverse reactions including seizures and cardiac arrythmias have occurred when CYKLOKAPRON was inadvertently administered via the neuraxial route. WARNING: RISK OF MEDICATION ERRORS DUE TO INCORRECT ROUTE OF ADMINISTRATION CYKLOKAPRON is for intravenous use only. • Risk of Thrombosis with Concomitant Use of Factor IX: Avoid concomitant use. • Seizures: Inadvertent injection into neuraxial system may result in seizures. • Hypersensitivity Reactions: In case of severe reaction, discontinue use and seek immediate medical attention. • Visual Disturbances: Visual or ocular adverse effects may occur. Discontinue use if visual or ocular symptoms occur. • Dizziness: Advise patients not to drive if dizziness occurs.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: • Risk of Medication Errors Due to Incorrect Route of Administration • Thromboembolic Risk • Seizures • Hypersensitivity Reactions • Visual Disturbances • Dizziness Most common adverse reactions are nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events.
Source: US FDA prescribing information
Prothrombotic Medical Products: Avoid concomitant use, can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid.
Source: US FDA prescribing information
Store at 20ºC to 25°C (68ºF to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
6 presentations of Tranexamic acid, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Tranexamic acid 1000 mg/10 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Tranexamic acid 650 mg tabletOralGeneric name | — | US FDA | Available on request |
| Tranexamic acid 1000 mg/100 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Cyklokapron 1000 mg/10 mL injectionIntravenous | Pfizer Laboratories | US FDA | Available on request |
| Tranexamic acid 10 mg/mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Tranexamic acid 100 mg/mL injectionIntravenousGeneric name | — | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 30 December 1986 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Tranexamic acid in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 6 presentations of Tranexamic acid and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Tranexamic acid, including Cyklokapron.
Yes. The US FDA first approved Tranexamic acid on 30 December 1986, according to Drugs@FDA.
No listed presentation of Tranexamic acid is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tranexamic acid is classified under ATC code B02AA02 (Tranexamic acid).
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