Aprotex
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Prices in online pharmacies:
from 710 rub.
Buy
Aprotex is a polyvalent plasma protease inhibitor with antifibrinolytic, antiproteolytic, hemostatic action.
Release form and composition
Dosage forms:
- lyophilisate for the preparation of a solution for intravenous (iv) administration: lyophilized powder of almost white or white color (in vials: in a cardboard box of 1, 5 or 10 vials; for hospitals - in a cardboard box of 30, 50, 85 or 100 vials);
- solution for infusion: transparent slightly colored or colorless liquid (in glass transparent bottles: 10 ml - in a cardboard box of 1, 5, 10 or 25 bottles; 50 ml - in a cardboard box of 1 or 5 bottles).
1 bottle contains:
- active substance: aprotinin - 10,000 antitrypsin units (ATpE) or 100,000 ATpE;
- auxiliary components: lactose, sodium hydroxide.
1 ml of solution contains:
- active substance: aprotinin - 10,000 kallikrein inactivating units (KIE);
- auxiliary components: sodium chloride, water for injection.
Indications for use
- acute pancreatitis, exacerbation of chronic pancreatitis, prevention of postoperative pancreatitis, pancreatic necrosis;
- prevention of embolism in polytrauma and after surgery;
- hyperfibrinolytic bleeding in the post-traumatic, postoperative (especially after surgery on the lungs, prostate gland) period, with polymenorrhea, before childbirth, during and after them, with amniotic fluid embolism;
- complications of thrombolytic therapy;
- coagulopathy, characterized by secondary hyperfibrinolysis;
- prevention of bleeding during open-heart surgery using a heart-lung machine;
- traumatic, endotoxic or hemolytic shock (treatment and prevention of development);
- prevention of postoperative mumps.
Contraindications
- I and III trimesters of pregnancy;
- syndrome of disseminated intravascular coagulation (DIC) (except for the phase of coagulopathy);
- breast-feeding;
- hypersensitivity to bovine protein;
- individual intolerance to the components of the drug.
It is recommended to prescribe Aprotex with caution to patients with a history of allergic reactions, cardiopulmonary bypass surgery, circulatory arrest during an operation using a heart-lung machine, deep hypothermia, prior therapy with aprotinin, in the case of taking muscle relaxants 2-3 days before drug administration, in II trimester of pregnancy (only for health reasons).
Method of administration and dosage
The lyophilisate and the solution are injected intravenously by jet (slowly, up to 5 ml per minute) or by drip and intraperitoneal injection. During the application of Aprotex, the patient should be in a horizontal position.
Lyophilisate
To prepare a solution from a lyophilisate, add 2 ml of isotonic sodium chloride solution to the contents of 1 bottle with a dosage of 10,000 ATre, with a dosage of 100,000 ATre - 20 ml.
Recommended daily dosing regimen:
- bleeding: the initial dose is 300,000 ATPE, then intravenous stream every 4 hours, 140,000 ATPE until hemostasis normalizes;
- acute pancreatitis: intravenous stream (slowly) - 200,000-300,000 ATre once, then intravenous drip - 200,000-300,000 ATre per day. Treatment continues until the normalization of laboratory parameters and the clinical condition of the patient;
- prevention of postoperative pancreatitis: intravenous stream - 200,000 ATre;
- shock states: initial dose - 200,000-300,000 ATre, then intravenous jet at 140,000 ATre every 4 hours;
- coagulopathy, determined by secondary hyperfibrinolysis: 750,000 ATpE and higher;
- prevention of fatty embolism: intravenous (slow) - 200,000 ATPE daily.
In case of pancreatic necrosis with an effusion into the abdominal cavity containing enzymes, in addition to intravenous administration, Aprotex can be administered intraperitoneally.
In addition, the lyophilisate solution is used topically in the treatment of prolonged minor bleeding. To do this, a gauze napkin soaked with a solution (75,000 ATRE) is applied to the bleeding site.
In case of violations of hemostasis in children, the drug is prescribed at the rate of 15,000 ATre per 1 kg of the child's weight per day.
Solution for infusion
Recommended dosage:
- bleeding and hemorrhage associated with hyperfibrinolysis: intravenous drip - 100,000-200,000 KIE, with intense bleeding - up to 500,000 KIE;
- exacerbation of chronic pancreatitis: once 25,000 KIU per hour, course of treatment - 3-6 days. The maximum daily dose is 50,000 KIU;
- acute pancreatitis: initial dose - 500,000-1,000,000 KIE, then gradually reduce the dose to 50,000-300,000 KIE within 2-6 days, treatment is continued until the complete disappearance of enzymatic toxemia;
- coagulopathy in combination with secondary hyperfibrinolysis: 1,000,000 CIE and above;
- prevention of bleeding during surgery (before, during and after the intervention): intravenous stream or drip - 200,000-400,000 KIE in the first day, then 100,000 KIE during the next two days;
- obstetric practice: initial dose - 1,000,000 KIE, then 200,000 KIE every hour until the bleeding stops completely. At the same time, local application is shown with the help of tampons soaked in the drug at a concentration of 100,000 KIE, they should be applied to the focus of bleeding;
- postoperative period, prevention of damage to the pancreas: initial dose - 200,000 KIU, then 100,000 KIE every 6 hours for two days after the operation;
- violation of hemostasis in children: at the rate of 20,000 KIE per 1 kg of body weight.
In acute necrosis of the pancreas with enzymatic effusion into the abdominal cavity, against the background of intravenous administration of aprotinin, patients are additionally injected with the solution intra-abdominally.
Side effects
- digestive system: against the background of rapid administration - nausea and vomiting of a transient nature;
- cardiovascular system: tachycardia, decreased blood pressure; against the background of high (6,000,000- 9,000,000 ATpE, or 8,000,000-12,000,000 CIU) doses of aprotinin - an increased risk of myocardial infarction during repeated coronary artery bypass grafting;
- allergic reactions: pruritus, urticaria, conjunctivitis, rhinitis, bronchospasm, anaphylaxis, anaphylactic shock;
- nervous system: confusion, hallucinations, psychotic reactions;
- local reactions: with prolonged therapy - thrombophlebitis at the injection site;
- others: myalgia.
special instructions
Due to the high risk of anaphylaxis, the use of Aprotex is recommended to start after the test to determine hypersensitivity. To do this, it is necessary to inject 1 ml (10,000 KIE) of aprotinin into the patient. If there are no signs of an allergic reaction within 10 minutes after the introduction of the test dose, you can proceed to the introduction of a therapeutic dose, otherwise the use of aprotinin is prohibited.
If it is necessary to prescribe the drug to patients with an increased risk of developing allergic reactions, antihistamines should be administered beforehand. When symptoms of allergy appear, the administration of aprotinin is canceled immediately. Previous (in the period from 2 to 24 weeks) drug therapy increases the risk of developing allergic reactions.
In thrombohemorrhagic syndrome, the drug can be used only after elimination of all blood clotting disorders against the background of simultaneous prophylactic administration of heparin.
Due to the risk of renal failure and death, it is necessary to use Aprotex with extreme caution when blood circulation stops during an operation using a heart-lung machine. When using extracorporeal circulation during heart surgery in patients receiving high doses of aprotinin, the activated blood clotting time should be maintained at a level above 750 seconds. Heparin levels are measured using a heparin-prothrombin titration test.
The effect of the drug on the patient's ability to drive vehicles and mechanisms has not been established.
Drug interactions
Aprotex inhibits the action of urokinase, streptokinase, alteplase and other fibrinolytic agents.
It potentiates the effect of heparin; when aprotinin is added to heparinized blood, the clotting time of whole blood increases.
Simultaneous use with dextran preparations causes mutual enhancement of the action.
Pharmaceutical compatible only with electrolyte and dextrose solutions.
Analogs
Analogs of Aprotex are: Traskolan, Gordox, Vero-narcap, Aerus, Ingiprol for injection, Ingitril, Kontrikal, Trasilol 500000.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C, the lyophilisate should be protected from light.
Shelf life: lyophilisate - 3 years; solution - 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Aprotex: prices in online pharmacies
|
Drug name Price Pharmacy |
|
Aprotex 10000 ATre lyophilisate for the preparation of a solution for intravenous administration 10 pcs. 710 RUB Buy |
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
