Hemsamic injection is used to control or prevent excessive or heavy bleeding during dental procedures in patients with hemophilia. Hemsamic is for short-term use only, usually 2 to 8 days.
Hemsamic injection is an antifibrinolytic agent. It works by blocking the breakdown of blood clots. It may also be used for other conditions as determined by your doctor.
Hemsamic is available only with your doctor's prescription.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
For short-term use (2-8 days) in haemophilia patients to reduce or prevent haemorrhage and to reduce the need for replacement therapy during and following tooth extraction.
For many haemostatic purposes including prevention of bleeding after surgery of trauma (eg, tonsillectomy and adenoidectomy, prostatic surgery, ocular trauma and cervical conisation), and to prevent rebleeding of subarachnoid haemorrhage, spontaneous bleeding in haemophilia and spontaneous or postoperative corneal oedema.
To treat primary or intrauterine device (IUD)-induced menorrhagia, gastric and intestinal haemorrhage, recurrent epistaxis and hereditary angioneurotic oedema. Hemsamic also inhibits induced hyperfibrinolysis during thrombolytic treatment with plasminogen activators.
How should I use Hemsamic?
Use Hemsamic as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Hemsamic is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Hemsamic at home, a health care provider will teach you how to use it. Be sure you understand how to use Hemsamic. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use Hemsamic if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
Continue to use Hemsamic for the full course of treatment even if you feel well. Do not miss any doses.
If you miss a dose of Hemsamic, contact your doctor immediately.
Ask your health care provider any questions you may have about how to use Hemsamic.
Uses of Hemsamic in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Menstrual bleeding, heavy (oral): Treatment of cyclic heavy menstrual bleeding.
Tooth extraction in patients with hemostatic defects (injection, oral [Hemsamic; Canadian product]): Short-term use in hemophilia patients to reduce or prevent hemorrhage and reduce need for replacement therapy during and following tooth extraction.
Off Label Uses
Dental procedures in patients on oral anticoagulant therapy
Based on the American College of Chest Physicians guidelines for perioperative management of antithrombotic therapy, Hemsamic is recommended to use, when needed, in combination with the continuation of oral anticoagulant therapy for the perioperative management of patients who require minor procedures.
Hemoptysis (nonmassive), treatment
Data from a small, single-center, prospective, randomized, double-blind, placebo-controlled trial suggest that nebulized Hemsamic may be beneficial for the control of nonmassive hemoptysis by reducing the duration and volume of bleeding, with a low risk for side effects.
Each capsule also contains sodium bisulfite, sodium lauryl sulfate and Yellow No.5 (Sunset Yellow FCF) as inactive ingredients. Each 5% w/v ampoule contains Tranexamic Acid 250 mg/5 mL, has a pH of 7-8 and an osmotic pressure ratio (with respect to physiological saline) of about 1.
Each 10% w/v ampoule contains Tranexamic Acid 250 mg/2.5 mL, has a pH of 7-8 and an osmotic pressure ratio (with respect to physiological saline) of about 2.
Hemsamic is trans-4-aminomethylcyclohexanecarboxylic acid. It has a molecular formula of C8H15NO2, molecular weight of 157.21 and melting point of 386-390°C (decomposition). It occurs as white crystals or powder, odorless and has bitter taste. It is freely soluble in water or glacial acetic acid; very slightly soluble in ethanol; practically insoluble in ether; soluble in sodium hydroxide TS.
Capsule Size: No.2, total length of 17.6 mm and weight of about 350 mg.
Generic name: Hemsamic 100mg in 1mL
Dosage form: injection, solution
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Immediately before tooth extraction in patients with hemophilia, administer 10 mg per kg body weight of Hemsamic intravenously together with replacement therapy. Following tooth extraction, intravenous therapy, at a dose of 10 mg per kg body weight three to four times daily, may be used for 2 to 8 days.
Note: For patients with moderate to severe impaired renal function, the following dosages are recommended:
Serum Creatinine (µmol/L)
120 to 250 (1.36 to 2.83 mg/dL)
10 mg/kg twice daily
250 to 500 (2.83 to 5.66 mg/dL)
10 mg/kg daily
>500 (>5.66 mg/dL)
10 mg/kg every 48 hours
5 mg/kg every 24 hours
For intravenous infusion, Hemsamic 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 Hemsamic Injection. Hemsamic Injection should NOT be mixed with blood. The drug is a synthetic amino acid, and should NOT be mixed with solutions containing penicillin.
Single-dose vials and ampules
Discard Hemsamic vial or ampule and any remaining portion in the vial/ampule after single use.
The diluted mixture may be stored for up to 4 hours at room temperature prior to patient administration.
Contraindications for Co-Administration: Hemsamic should not be co-adminstered with thrombin. Co-administration may cause a thrombosis tendency. It increases the tendency towards thrombosis due to the thrombogenic property of Hemsamic.
Precautions for Co-Administration: Hemsamic should be administered with care when co-administered with the following drugs.
Hemocoagulase: Co-administration at high doses may cause a thrombosis tendency. Due to the antiplasmin action of Hemsamic, fibrin clots formed by hemocoagulase may persist in the blood stream for a relatively long period of time, which may result in a prolonged thrombotic state.
Batroxobin: Co-administration may cause thromboembolism. Hemsamic inhibits the decomposition of desA fibrin polymer produced by batroxobin.
Coagulation Factor Agents (Eptacog-α): Coagulation may be further activated at sites with enhanced local fibrinolysis eg, the oral cavity. Coagulation factors exert hemostatic actions by activating the coagulation system, where as Hemsamic exerts hemostatic actions by inhibiting the fibrinolytic system.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of Hemsamic Tablets in the treatment of heavy menstrual bleeding (HMB) was studied in two randomized, double-blind, placebo-controlled studies. One study compared the effects of two doses of Hemsamic Tablets (1950 mg and 3900 mg given daily for up to 5 days during each menstrual period) versus placebo over a 3-cycle treatment duration. A total of 304 women were randomized to this study, with 115 receiving at least one dose of 3900 mg/day of Hemsamic Tablets. A second study compared the effects of Hemsamic Tablets (3900 mg/day) versus placebo over a 6-cycle treatment duration. A total of 196 women were randomized to this study, with 117 receiving at least one dose of Hemsamic Tablets. In both studies, subjects were generally healthy women who had menstrual blood loss of ≥ 80 mL.
In these studies, subjects were 18 to 49 years of age with a mean age of approximately 40 years, had cyclic menses every 21-35 days, and a BMI of approximately 32 kg/m2. On average, subjects had a history of HMB for approximately 10 years and 40% had fibroids as determined by transvaginal ultrasound. Approximately 70% were Caucasian, 25% were Black, and 5% were Asian, Native American, Pacific Islander, or Other. Seven percent (7%) of all subjects were of Hispanic origin. Women using hormonal contraception were excluded from the trials.
The rates of discontinuation due to adverse events during the two clinical trials were comparable between Hemsamic Tablets and placebo. In the 3-cycle study, the rate in the 3900 mg Hemsamic Tablets dose group was 0.8% as compared to 1.4% in the placebo group. In the 6-cycle study, the rate in the Hemsamic Tablets group was 2.4% as compared to 4.1% in the placebo group. Across the studies, the combined exposure to 3900 mg/day Hemsamic Tablets was 947 cycles and the average duration of use was 3.4 days per cycle.
A list of adverse events occurring in ≥ 5% of subjects and more frequently in Hemsamic Tablets treated subjects receiving 3900 mg/day compared to placebo is provided in Table 2.
Long-term safety of Hemsamic Tablets was studied in two open-label studies. In one study, subjects with physician-diagnosed heavy menstrual bleeding (not using the alkaline hematin methodology) were treated with 3900 mg/day for up to 5 days during each menstrual period for up to 27 menstrual cycles. A total of 781 subjects were enrolled and 239 completed the study through 27 menstrual cycles. A total of 12.4% of the subjects withdrew due to adverse events. Women using hormonal contraception were excluded from the study. The total exposure in this study to 3900 mg/day Hemsamic Tablets was 10,213 cycles. The average duration of Hemsamic Tablets use was 2.9 days per cycle.
A long-term open-label extension study of subjects from the two short-term efficacy studies was also conducted in which subjects were treated with 3900 mg/day for up to 5 days during each menstrual period of up to 9 menstrual cycles. A total of 288 subjects were enrolled and 19% subjects completed the study through 9 menstrual cycles. A total of 2.1% of the subjects withdrew due to adverse events. The total exposure to 3900 mg/day Hemsamic Tablets in this study was 1,956 cycles. The average duration of Hemsamic Tablets use was 3.5 days per cycle.
The types and severity of adverse events in these two long-term open-label trials were similar to those observed in the double-blind, placebo-controlled studies although the percentage of subjects reporting them was greater in the 27-month study, most likely because of the longer study duration.
A case of severe allergic reaction to Hemsamic Tablets was reported in the extension trial, involving a subject on her fourth cycle of treatment, who experienced dyspnea, tightening of her throat, and facial flushing that required emergency medical treatment.
The following adverse reactions have been identified from postmarketing experience with Hemsamic. 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.
Based on US and worldwide postmarketing reports, the following have been reported in patients receiving Hemsamic for various
Nausea, vomiting, and diarrhea
Allergic skin reactions
Anaphylactic shock and anaphylactoid reactions
Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery and vein obstruction); cases have been associated with concomitant use of combination hormonal contraceptives
Impaired color vision and other visual disturbances
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