2010/09/21

Aprotex

Composition, structure and packing

Lyophilisates for solution for i / v administration in the form of white or almost white powder.

1 vial. aprotinin tys.ATrE 10 - - 100 tys.ATrE Excipients: lactose, sodium hydroxide.

Clinico-pharmacological group: Haemostatic drug. Inhibitor of fibrinolysis - polyvalent proteinase inhibitor plasma

Pharmacological action

Polyvalent protease inhibitors, has antiproteoliticheskoe, antifibrinoliticheskoe and haemostatic effect. Inactivates important protease (trypsin, chymotrypsin, kininogenazy, kallikrein, including activating fibrinolysis). Hinders as the total proteolytic activity and the activity of individual proteolytic enzymes. Availability of drugs with activity determines the effectiveness of aprotinin in patients with lesions of the pancreas and other conditions involving high content of kallikrein and other proteases in plasma and tissues. Lowers blood fibrinolytic activity, inhibits fibrinolysis and has haemostatic effect in coagulopathies. The blockade of the kallikrein-kinin system allows you to use it for prevention and treatment of various forms of shock.

Statement
pancreatitis (acute, exacerbation of chronic)
pancreatic necrosis.
performance of diagnostic studies and operations on the pancreas (the prevention of enzymatic autolysis of the pancreas during surgery on it and adjacent organs of the abdominal cavity).
prevention of acute nonspecific postoperative parotitis.
haemorrhage on the background giperfibrinoliza: post-traumatic, postoperative (especially during operations on the prostate, lung), before, after and during childbirth (including amniotic fluid embolism in); polimenoreya. Angioedema. Shock (toxic, traumatic, burn, hemorrhagic).
extensive and deep traumatic tissue damage.
as adjuvant therapy - coagulopathy, characterized by secondary giperfibrinolizom (in the initial phase, before the onset of effect after the use of heparin and replacement of clotting factors), massive bleeding (during thrombolytic therapy) during extracorporeal circulation.
prevention of postoperative pulmonary embolism and bleeding, fat embolism in polytrauma, especially with fractures of the lower extremities and cranial bones.

Dosage regimen

V / a (slowly) only in the "lying".

In therapeutic purposes in the initial dose of 50 tys.KIE (at a rate not exceeding 5 ml / min), then i / v drip, 50 tys.KIE / h.

When bleeding and hemorrhages associated with giperfibrinolizom, in / in drip - 100-200 tys.KIE, if necessary, up to 500 tys.KIE (depending on the intensity of bleeding).

When coagulopathies in conjunction with secondary giperfibrinolizom administered in a dose of 1 million CIE and more.

During surgical interventions for prevention before, during and after the operation - 200-400 tys.KIE in / jet (slow or drip), then for the next 2 days at 100 tys.KIE. In obstetric practice, the initial dose - 1 million CIE, then every hour for 200 tys.KIE to stop bleeding.

When violations of hemostasis in children - 20 tys.KIE / kg / day. Perhaps the local use: gauze soaked in 100 tys.KIE, apply to the site of bleeding.

In rheumatic affections of the joints appoint 200 tys.KIE in the form of intra-articular injections.

In acute pancreatitis - 0.5-1 million KIE, with a subsequent decrease for 2-6 days to 50-300 tys.KIE to complete withdrawal (after the disappearance of enzymatic toxemia).

With exacerbation of chronic pancreatitis is introduced singly for 25 tys.KIE per hour for 3-6 days; daily dose - 25-50 tys.KIE.

In the postoperative period and prevention (at the risk of injury of the pancreas), the initial dose - 200 tys.KIE, then within 2 days after surgery on 100 tys.KIE every 6 hours

Side effect

From the CCC: lowering blood pressure, tachycardia.

From the central nervous system: psychotic reactions, hallucinations, confusion.

Allergic reactions: hives, itchy skin, rhinitis, conjunctivitis, anaphylactic reactions (up to anaphylactic shock).

On the part of the digestive system: nausea, vomiting (with fast injection).

Local reactions: thrombophlebitis at the injection site (with a long introduction).

Other: bronchospasm, myalgia.

Contraindications
hypersensitivity
pronounced allergic reactions (including the protein in cattle)
DVS-syndrome (except for phase coagulopathy);
pregnancy (I and III trimester)
Lactation

Pregnancy and lactation

Acceptance of the drug is contraindicated (I and III trimesters).

Cautions

If you have any side effects during the administration should stop immediately.

When giperfibrinolize syndrome and DIC appointment aprotinin is only possible after the removal of all forms of internal combustion engines and on the background of preventive administration of heparin.

Particular caution should assign patients who in the previous 2-3 days was prescribed muscle relaxants.

To prevent allergic reactions is possible appointment of antihistamine drugs and SCS. In cases where, for whatever reason can not be done long in / infusion, you can enter sc every 2-3 hours

Drug Interactions

Pharmaceutical incompatible with other drugs (except for solutions of electrolytes and dextrose).

Inhibitory effects of streptokinase, urokinase and alteplazy; intensifies the effect of heparin (an addendum to the heparinized blood causes an increase in clotting time of whole blood).

Synergism observed with a joint appointment of aprotinin and reomakrodeksa.

Terms and Conditions of storage

Store in a dry place protected from light, at a temperature of 0-20 ° C..

Shelf life - 2 years.