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Hemokapron Ampoules

Generic Name and Formulations:Tranexamic acid 100mg/Ml  10% soln for IV inj.

Therapeutic Use: Bleeding disorders

Tranexamic Acid Safe for Wide Spectrum of Trauma Patients

Indications for HEMOKAPRON:

Short-term use in hemophilia to reduce   or prevent hemorrhage, and reduce the need for replacement therapy during and following tooth extraction.

Bleeding tendencies in which systemic hyperfibrinolysis is considered to be involved. (Leukemia, aplastic anemia, purpura, etc., abnormal bleeding during or after operation.)

Abnormal bleeding in which local hyperfibrinolysis is considered to be involved (pulmonary hemorrhage, epistaxis, vaginal hemorrhage, renal bleeding, abnormal bleeding during or after prostate surgery).

Symptoms, such as erythema, swelling or pruritus in the following diseases:

Eczema or similar conditions, urticaria, drug eruptions or toxicoderma

Symptoms, such as pharyngalgia, redness, hyperemia or swelling in the following diseases:

Tonsillitis, pharyngolaryngitis.

Pain in the oral cavity or mucosal aphtha in cases of stomatitis.

DOSAGE AND ADMINISTRATION

The usual daily adult dosage for intravenous injection or intramuscular injection is 250 to 500 mg of tranexamic acid in one or two divided doses During or after surgery, 500 to 1,000 mg intravenously or 500 to 2,500 mg by intravenous drip infusion are administered each time as required.

Hemokapron Ampoule Injection 10%:

The usual daily adult dosage for intravenous or intramuscular injection is 2.5 to 5 mL of tranexamic acid in one or two divided doses. During or after surgery, 5 to 10 mL intravenously or 5 to 25 mL by intravenous drip infusion are administered each time as required. The dosage should be adjusted to individuals according to the patient’s age and conditions.

PRECAUTIONS

1. Careful Administration (Hemokapron Ampoule should be administered with care in the following patients.)

with care in the following patients.)

(1) Patients with thrombosis (e.g., cerebral thrombosis, myocardial infarction, or thrombophlebitis, etc.) and

patients at risk of thrombosis [Hemokapron Ampoule may stabilize thrombosis.]

 (2) Patients with consumption coagulopathy (Use concomitantly with heparin, etc.) [Hemokapron Ampoule may stabilize thrombosis.]

3) Postoperative, recumbent ridden patients and patients undergoing astriction  [Venous thrombosis is likely to occur in these patients, and Hemokapron Ampoule may stabilize thrombosis. Pulmonary embolism has been reported in association with resolution of recumbency or removal of astriction]

 (4) Patients with renal failure [Blood concentration may increase.]

2. Drug Interactions

1) Contraindications for coadministration (Hemokapron Ampoule should not be coadministered with the following drugs.) Thrombin- Hemocoagulase- Batroxobin- Coagulation factor agents  (eptacog-alfa, etc.)

3. Adverse Reactions

Summary of the incidence of adverse reactions The most frequently observed adverse reactions reported in

a total of 2,972 patients were nausea 0.07% (2 events), vomiting 0.17% (5 events), anorexia 0.03% (1 event), diarrhea 0.07% (2 events), and drowsiness 0.03% (1 event) (based on data obtained from the literature [outside the

scope of reexamination]).

(1) Clinically significant adverse reactions (frequency unknown Note))

1) Shock Since shock may occur, patients should be carefully monitored, and appropriate measures, such as discontinuing treatment, should taken if any abnormality is observed.

(2) Other adverse reactions

The following adverse reactions may occur. Patients should be carefully monitored, and appropriate measures,

such as discontinuing treatment, should be taken if any abnormality is observed. Hypersensitivity (Itching, rash, etc.

Gastrointestinal (Nausea, vomiting Anorexia, diarrhea)- Ocular (Transient defective color vision)- Drowsiness and headache

N.B. The incidence of adverse reactions on the basis spontaneous reports or overseas resources is unknown.

4. Use in the Elderly

Since elderly patients often have reduced physiological function, careful supervision and measures such as reducing the dose are recommended.

5. Precautions concerning Use

(1) Precautions for intravenous administration: With regard to intravenous administration, inject the drug

slowly. (Symptoms such as nausea, chest discomfort, palpitations, and a fall in blood pressure may rarely occur)

 (2) Precautions for intramuscular administration: With regard to intramuscular injection, pay careful attention

to the following points to avoid injuring tissues, nerves, etc.

1) Inject the drug carefully to avoid contact with nerves

2) If repeated injection is required, change the injection site (e.g.,

 alternate between the right and left arms).

Special care should be observed when the drug is administered to premature infants,

newborns, suckling infants, and children.

3) If insertion of the injection needle induces intense pain or if blood flows back into the syringe, withdraw

the needle immediately and perform injection at a different site.

 (3) Precautions when opening the ampoule: To avoid contamination with foreign matter, wipe them off with

an alcohol swab before opening the ampule.

6. Other Precautions

Retinal degeneration has been reported with tranexamic acid in dogs after long-term, high-dose administration.

Pharmacological Class:

Plasminogen activation inhibitor.

Contraindications:

Acquired defective color vision. Subarachnoid hemorrhage. Active intravascular clotting.

PACKAGING

Cartoon box contains 5 amp.each amp.contains 5 ml ( 100mg\ml)

STORAGE AND HANDLING

A “one-point-cut ampoule” is used for this product. Hold the ampule with the mark on the neck upwards and break it open by pressure