Streptokinase Karma

Streptokinase Karma Dosage/Direction for Use

streptokinase

Manufacturer:

Karma Pharmatech

Distributor:

Idaman Pharma
Full Prescribing Info
Dosage/Direction for Use
Note: When thrombolytic therapy is necessary or a high antibody concentration against streptokinase is present, or recent streptokinase therapy has been given (more than 5 days and less than one year previously), homologous fibrinolytics should be used (see also Precautions).
Acute transmural myocardial infarction with persistent ST-segment elevation or recent left bundle-branch block: Systemic administration: In short-term lysis for the treatment of acute myocardial infarction 1.5 Mio IU Streptokinase are given within 60 min.
Local administration: In acute myocardial infarction patients are given an intracoronary bolus of 20 000 IU Streptokinase on average and a maintenance dose of 2000 IU to 4000 IU per min over 30 to 90 min.
Acute, subacute and chronic thromboses / embolisms of peripheral venous and arterial vessels and chronic occlusive arterial diseases: Systemic administration: In short-term thrombolysis adults with peripheral venous and arterial vessel occlusions/embolisms receive an initial dose of 250 000 IU Streptokinase within 30 min, followed by a maintenance dose of 1.5 Mio IU per hour over a maximum of six hours. The six-hour Streptokinase infusion can be repeated on the following day, depending on the therapeutic success of lysis. However, repetition of treatment must on no account be conducted later than 5 days after the first course.
As an alternative to short-term lysis, a long-term lysis for the treatment of peripheral occlusions may be considered. An initial dose of 250 000 IU Streptokinase is given within 30 min, followed by a maintenance dose of 100 000 IU per hour. The duration of therapy depends on the extension and localisation of the vessel occlusion. In peripheral vessel occlusion the maximum duration is 5 days.
Local administration: Patients with acute, subacute and chronic peripheral thromboses and embolisms receive 1000 IU to 2000 IU Streptokinase in intervals of 3 to 5 min. The duration of administration depends on the length and localisation of the vessel occlusion and amounts up to 3 hours at a total dose of max. 120 000 IU Streptokinase.
A percutaneous transluminal angioplasty (mechanical vessel dilatation) can be performed simultaneously, if necessary.
Occlusions of central retinal artery or vein: Systemic administration: In case of thromboses of the central retinal vessels, lysis of arterial occlusions should be limited to max. 24 hours, in venous occlusions to max. 72 hours. If continuation of thrombolysis is indicated due to extensive thrombotic occlusions, therapy should be interrupted for one day, followed by administration of a homologous fibrinolytic.
Dosage for neonates, infants and children: Sufficient experience with Streptokinase 1 500 000 IU therapy in children is not yet available. The benefit of treatment has to be evaluated against the potential risks which may aggravate an acute life-threatening situation.
Control of therapy: Systemic administration: In case of short-term lysis over six hours heparin should be administered during or following Streptokinase infusion when the thrombin time (TT) or partial thromboplastin time (aPTT) have reached less than twice or 1.5 times the normal control value, respectively. The TT and aPTT should be prolonged to 2 to 4 fold and 1.5 to 2.5 fold the normal value, respectively, in order to ensure sufficient protection against rethrombosis (reocclusion of the vessel).
If the Streptokinase infusion is not repeated the heparin therapy is instituted simultaneously with the administration of oral anticoagulants (see Follow-up treatment as follows).
The long-term lysis is controlled with the thrombin time (TT). A 2 to 4 fold prolongation of the TT which is considered as a sufficient anticoagulant protection has to be aimed at. Therefore, a simultaneous administration of heparin may become necessary from the 16th hour of treatment. If the TT after the 16th hour is still prolonged to more than 4 fold the normal control value, the maintenance dose of Streptokinase has to be doubled for several hours until the TT recedes.
Local administration: As is usual with angiographies (x-ray of the vessels with the help of contrast media), heparin is administered - if necessary - prior to the angiography as a safeguard against catheter-induced thromboses. The success of therapy can be determined by the angiography. With a sufficient blood flow of more than 15 minutes the therapy can be considered successful and then terminated.
Follow-up treatment: After every course of streptokinase therapy, a follow-up treatment with anticoagulants or platelet aggregation inhibitors (drugs which inhibit platelet induced clot formation), can be instituted as a prevention of rethromboses. With heparin therapy, in particular, an increased risk of haemorrhage must be considered. The heparin therapy is controlled individually with the TT or aPTT. A 2 to 4 fold prolongation of the TT and 1.5 to 2.5 fold prolongation of the aPTT is aimed at. For long term prophylaxis oral anticoagulants, as - for example - coumarin derivatives platelet aggregation inhibitors can be applied.
Administration: Streptokinase 1500000 IU is administered intravenously and intracoronary. The duration of therapy depends on the nature and extension of the vessel occlusion and differs according to the indication.
Streptokinase 1 500 000 IU is presented as a white to slight yellow lyophilisate. Upon reconstitution with Water for Injection or 0.9% NaCl, clear to slight opalescent, colourless slightly yellow solution obtained.
Route of Administration: Intravenous and Intracoronary.
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