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Thrombolytic / STEMI Pregnancy: Streptokinase Karma is contraindicated in pregnancy. There is no evidence of the drug's safety in pregnancy, nor is there evidence from animal work that it is free from hazard. Bleeding and anaphylactic reactions might cause abortion and foetal death, especially when streptokinase is given within the first 18 weeks of pregnancy. Use only when there is no safer alternative. It is unknown whether streptokinase is excreted in human milk. Breast milk should be discarded during the first 24 hours following thrombolytic therapy. (SPC 4.6)

Streptokinase (STEMI Thrombolysis)

Brand names: Streptase

Streptokinase is a bacterial-derived fibrinolytic agent historically used for thrombolysis in ST-elevation myocardial infarction where primary percutaneous coronary intervention is unavailable.

Adult dose

Dose: Acute myocardial infarction within 12 hours of onset with persistent ST-segment elevation or recent left bundle-branch block: systemic administration - a single dose of 1.5 million IU streptokinase infused intravenously over one hour (Streptokinase Karma 1 500 000 = one vial of powder for solution containing 1.5 million IU)
Route: Intravenous infusion over one hour (systemic administration)
Frequency: Single dose, infused over one hour
Product: UK SPC via MHRA Products - STREPTOKINASE KARMA 1 500 000 (PL494270007), Karma Pharmatech GmbH. SPC 4.1 verbatim: 'Streptokinase Karma is indicated in adults. Acute myocardial infarction: within 12 hours of onset with persistent ST-segment elevation or recent left bundle-branch block. Note: No statement on therapy outcome can be made for administration beyond the time window indicated above.' SPC 2: 'vials containing 1.5 million International Units (IU) of purified streptokinase'. SPC 4.2 verbatim: 'The administration of streptokinase may be intravenous or intracoronary.' 'Systemic administration: A single dose of 1.5 million IU streptokinase should be infused intravenously over one hour.' The SPC prints no maximum dose. SECOND ROUTE COVERED BY THE SPC (not this page's route, recorded for completeness): 'Local intracoronary administration: A bolus of 20,000 IU streptokinase should be followed by a maintenance infusion of 2,000 IU to 4,000 IU per minute over 30 to 90 minutes depending on the achievement of coronary artery patency.' ADJUVANT (4.2): 'Treatment with aspirin (150 mg daily) for at least 4 weeks is recommended for prophylaxis after streptokinase therapy for acute myocardial infarction. The first dose should be given as soon as possible after the myocardial infarction.' REPEAT USE (4.2): 'When thrombolytic therapy is necessary and a high antibody concentration against streptokinase is present or when recent streptokinase therapy has been given (more than 5 days and less than one year previously), homologous fibrinolytics should be used.' 4.4: 'Repeat treatment with streptokinase administered more than 5 days and less than 12 months after initial treatment may not be effective.' PRE-TREATMENT (4.4): 'If the patient is under active heparinization, it should be neutralised by administering protamine sulphate before the start of the thrombolytic therapy. The thrombin time should not be more than twice the normal control value before thrombolytic therapy is started. In patients previously treated with coumarin derivatives, the INR (International Normalized Ratio) must be less than 1.3 before starting the streptokinase infusion.' INFUSION RATE (4.4): 'At the beginning of therapy, a fall in blood pressure, tachycardia or bradycardia (in individual cases going as far a shock) are commonly observed. Therefore, at the beginning of therapy the infusion should be performed slowly. Corticosteroids can be administered prophylactically to reduce the likelihood of infusion-related allergic reactions.' Reconstitution is with physiological saline (see SPC 6.6, not retrieved). TRUNCATION: the 4.8 text ends at the source-fetch limit; nothing beyond it was retrieved.

Dose adjustments

Renal

No dose adjustment is printed in the SPC. 'Severe liver or kidney damage' is listed among the contraindications (SPC 4.3).

Hepatic

No dose adjustment is printed in the SPC. 'Severe liver or kidney damage' is listed among the contraindications (SPC 4.3).

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients (SPC 4.3)
  • Existing or recent internal haemorrhage
  • All forms of reduced blood coagulability, in particular spontaneous fibrinolysis and extensive clotting disorders
  • Recent cerebrovascular accident, intracranial or intraspinal surgery
  • Intracranial neoplasm; recent head trauma; arteriovenous malformation or aneurysm
  • Known neoplasm with risk of haemorrhage
  • Acute pancreatitis
  • Uncontrollable hypertension with systolic values over 200 mm Hg and/or diastolic values over 100 mm Hg, or hypertensive retinal changes Grades III/IV
  • Recent implantation of a vessel prosthesis
  • Simultaneous or recent treatment with oral anticoagulants (INR >1.3)
  • Severe liver or kidney damage
  • Endocarditis or pericarditis (pericarditis misdiagnosed as acute myocardial infarction and treated with streptokinase has resulted in pericardial effusions including tamponade)
  • Known haemorrhagic diathesis
  • Recent major operations (6th to 10th post-operative day, depending on the extent of the procedure)
  • Invasive operations, e.g. recent organ biopsy, long-term (traumatic) closed chest cardiac massage
  • Pregnancy - the SPC 4.6 states the product 'is contraindicated in pregnancy'
  • Conditions that would normally be contraindications but where benefit may outweigh risk in certain situations (SPC 4.4): recent severe gastrointestinal bleeding e.g. active peptic ulcer; risk of severe local haemorrhage; recent trauma and cardiopulmonary resuscitation; recent intubation; puncture of non-compressible vessels, intramuscular injections, large arteries; recent abortion or delivery; urogenital tract disease with bleeding sources (implanted bladder catheter); known septic thrombotic disease; severe arteriosclerotic vessel degeneration, cerebrovascular diseases; cavernous pulmonary disease; mitral valve defects or atrial fibrillation; aortic dissection; diabetic retinopathy

Side effects

  • Very common: development of antistreptokinase antibodies (SPC 4.8)
  • Common: haemorrhage at the injection site, ecchymoses, gastrointestinal bleeding, genitourinary bleeding, epistaxis
  • Uncommon: cerebral haemorrhages with complications and possible fatal outcome, retinal haemorrhages, severe haemorrhages (also fatal), liver haemorrhages, retroperitoneal bleeding, bleeding into joints, splenic rupture; blood transfusions rarely required
  • Very rare: haemorrhage into the pericardium including myocardial rupture during thrombolytic treatment of acute myocardial infarction
  • In serious haemorrhagic complications streptokinase therapy should be discontinued and a proteinase inhibitor (e.g. aprotinin) given; combination with synthetic antifibrinolytics is recommended and clotting factors can be substituted if necessary (SPC 4.8)
  • Common: allergic anaphylactic reactions, e.g. rash, flushing, itching, urticaria, angioneurotic oedema, dyspnoea, bronchospasm, hypotension
  • Very rare: delayed allergic reactions (serum sickness, arthritis, vasculitis, nephritis, neuroallergic symptoms incl. Guillain-Barre syndrome), severe allergic reactions up to shock including respiratory arrest; allergic reactions can largely be avoided by giving the infusion slowly
  • If a severe allergic reaction occurs the infusion should be discontinued immediately and lysis therapy continued with homologous fibrinolytics such as urokinase or tPA (SPC 4.8)
  • Common (at start of therapy): hypotension, tachycardia, bradycardia
  • Rare: neurologic symptoms (dizziness, confusion, paralysis, hemiparesis, agitation, convulsion) in the context of cerebral haemorrhage or cerebral hypoperfusion
  • Very rare: iritis/uveitis/iridocyclitis; crystal cholesterol embolism

Interactions

  • Increased risk of haemorrhage with anticoagulants (e.g. heparin) and with drugs that inhibit platelet formation or function (e.g. platelet aggregation inhibitors, dextrans) - in patients receiving or recently treated (SPC 4.5)
  • Active heparinisation: neutralise with protamine sulphate before starting thrombolytic therapy; thrombin time must not be more than twice the normal control value (SPC 4.4)
  • Coumarin derivatives: INR must be less than 1.3 before starting the streptokinase infusion (SPC 4.4)
  • Adjuvant acetylsalicylic acid improves response in acute myocardial infarction (SPC 4.4); see 4.2 for the adjuvant aspirin regimen

Monitoring

  • Thrombin time before starting (must be no more than twice the normal control value) (SPC 4.4)
  • INR before starting in patients previously on coumarin derivatives (must be less than 1.3) (SPC 4.4)
  • Blood pressure and heart rate at the start of the infusion - hypotension, tachycardia or bradycardia are commonly observed, so start the infusion slowly (SPC 4.4)
  • Signs of haemorrhage (SPC 4.8)
  • Signs of allergic reaction (SPC 4.8)

Clinical monograph

How it works

It forms a complex with circulating plasminogen that converts further plasminogen to plasmin, dissolving fibrin within the occluding coronary thrombus to restore perfusion.

Prescribing in practice

  • Major bleeding, including intracranial haemorrhage, is the principal hazard, so screen carefully for absolute contraindications such as recent haemorrhagic stroke, active internal bleeding, recent major surgery or trauma, and uncontrolled severe hypertension.
  • Being antigenic, it can cause allergic reactions and hypotension during infusion, and prior streptococcal exposure or previous streptokinase reduces efficacy through neutralising antibodies — so it should generally not be re-administered.
  • Primary percutaneous coronary intervention is the preferred reperfusion strategy where it can be delivered promptly.

Monitoring

Monitor closely during and after the infusion for blood pressure, allergic reactions, reperfusion arrhythmias and signs of bleeding, alongside resolution of ECG changes.

Counselling the patient

  • This is an emergency clot-dissolving treatment and carries a risk of serious bleeding.
  • Report any new severe headache, weakness or signs of bleeding immediately.
  • Inform future clinicians that you have received streptokinase, as it is generally not repeated.

Evidence & guidelines

The GISSI and ISIS-2 trials established that streptokinase reduces mortality in acute myocardial infarction, with ISIS-2 showing additional benefit when combined with aspirin.

Reference: GUSTO-1 Trial (NEJM 1993); ISIS-2 Trial (Lancet 1988); ESC STEMI 2023; SPC Streptase; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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