Brand Name
Cyklokapron
Generic Name
TRanexamic
View Brand Information FDA approval date: December 30, 1986
Classification: Antifibrinolytic Agent
Form: Injection, Tablet
What is Cyklokapron (TRanexamic)?
CYKLOKAPRON ® is indicated in patients with hemophilia for short-term use 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 to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
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Brand Information
Cyklokapron (tranexamic acid)
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
1INDICATIONS AND USAGE
CYKLOKAPRON
2DOSAGE FORMS AND STRENGTHS
Injection: 1,000 mg/10 mL (100 mg/mL) clear and colorless solution in single-dose ampules
Injection: 1,000 mg/10 mL (100 mg/mL) clear and colorless solution in single-dose vials
3CONTRAINDICATIONS
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
4ADVERSE REACTIONS
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
4.1Postmarketing 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.
5OVERDOSAGE
Cases of overdosage of CYKLOKAPRON have been reported. Based on these reports, symptoms of overdosage may be gastrointestinal, e.g., nausea, vomiting, diarrhea; hypotensive, e.g., orthostatic symptoms; thromboembolic, e.g., arterial, venous, embolic; neurologic, e.g., visual impairment, convulsions, headache, mental status changes; myoclonus; and rash.
6DESCRIPTION
Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is
Empirical Formula: C
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.
7HOW SUPPLIED/STORAGE AND HANDLING
CYKLOKAPRON Injection is a clear and colorless solution supplied in the following presentations:
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].
8PRINCIPAL DISPLAY PANEL - 10 mL Ampule Label
Pfizer
NDC 0013-1114-01
10 mL ampule
Cyklokapron
1,000 mg/10 mL
(100 mg/mL)
PAA221603
9PRINCIPAL DISPLAY PANEL - 10 mL Ampule Carton - NDC 0013-1114-01
NDC 0013-1114-01
Contains 1 Ampule 10 mL
1000 mg/10 mL
(100 mg/mL)
(100 mg/mL)
Solution for intravenous injection
Single-Dose ONLY
Rx only
Pfizer Injectables
10PRINCIPAL DISPLAY PANEL - 10 mL Ampule Carton - NDC 0013-1114-15
NDC 0013-1114-15
Contains 1 Ampule 10 mL
Cyklokapron
1,000 mg/10 mL
Intravenous Use Only
Single-Dose Ampule
Rx only
Pfizer
11PRINCIPAL DISPLAY PANEL - 10 x 10 mL Ampule Box Label
NDC 0013-1114-10
Rx only
12PRINCIPAL DISPLAY PANEL - 10 mL Vial Label
NDC 0013-1114-20
10 mL Vial
Cyklokapron
1,000 mg/10 mL
(100 mg/mL)
Intravenous Use Only
13PRINCIPAL DISPLAY PANEL - 10 mL Vial Box
NDC 0013-1114-21
10 x 10 mL Vials
Cyklokapron
1,000 mg/10 mL (100 mg/mL)
Intravenous Use Only
Single-Dose Vial
Pfizer
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