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Streptase

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Streptase

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Streptase Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Streptase (streptokinase) is used in the treatment of heart attack or lung blood clots (pulmonary embolism) as well as leg blood clots (deep venous thrombosis-DVT). It is an enzyme. The brand name drug Streptase is no longer available in the U.S. Generic versions may still be available. Common side effects include nausea, dizziness, low blood pressure or mild fever. It can also cause nerve damage.

Streptase (streptokinase) is given by injection by a health care professional. Dose is dependent upon the condition of the patient and response to treatment. Streptase may interact with blood thinners, non-steroidal anti-inflammatory drugs (NSAIDs), or aspirin. Drugs that can reverse effects of streptokinase include aminocaproic acid, aprotinin, and tranexamic acid. Tell your doctor all medications you are taking. Streptase should be given to a pregnant woman only if prescribed. It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

Our Streptase (streptokinase) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Streptase FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions have been associated with intravenous therapy and may also occur with intracoronary artery infusion:

Bleeding:   The reported incidence of bleeding (major or minor) has varied widely depending on the indication, dose, route and duration of administration, and concomitant therapy.

Minor bleeding can be anticipated mainly at invaded or disturbed sites. If such bleeding occurs, local measures should be taken to control the bleeding.

Severe internal bleeding involving gastrointestinal (including hepatic bleeding), genitourinary, retroperitoneal, or intracerebral sites has occurred and has resulted in fatalities. In the treatment of acute myocardial infarction with intravenous Streptokinase, the GISSI and ISIS-2 studies reported a rate of major bleeding (requiring transfusion) of 0.3-0.5%. However, rates as high as 16% have been reported in studies which required administration of anticoagulants and invasive procedures.

Major bleed rates are difficult to determine for other dosages and patient populations because of the different dosing and intervals of infusions. The rates reported appear to be within the ranges reported for intravenous administration in acute myocardial infarction.

Should uncontrollable bleeding occur, Streptokinase infusion should be terminated immediately, rather than slowing the rate of administration of or reducing the dose of Streptokinase. If necessary, bleeding can be reversed and blood loss effectively managed with appropriate replacement therapy. Although the use of aminocaproic acid in humans as an antidote for Streptokinase has not been documented, it may be considered in an emergency situation.

Allergic Reactions:   Fever and shivering, occurring in 1-4% of patients (1,2) , are the most commonly reported allergic reactions with intravenous use of Streptase, Streptokinase, in acute myocardial infarction. Anaphylactic and anaphylactoid reactions ranging in severity from minor breathing difficulty to bronchospasm, periorbital swelling or angioneurotic edema have been observed rarely. Other milder allergic effects such as urticaria, itching, flushing, nausea, headache and musculoskeletal pain have also been observed, as have delayed hypersensitivity reactions such as vasculitis and interstitial nephritis. Anaphylactic shock is very rare, having been reported in 0-0.1% of patients (1,2,4) .

Mild or moderate allergic reactions may be managed with concomitant antihistamine and/or corticosteroid therapy. Severe allergic reactions require immediate discontinuation of Streptase, Streptokinase, with adrenergic, antihistamine, and/or corticosteroid agents administered intravenously as required.

Respiratory:   There have been reports of respiratory depression in patients receiving Streptokinase. In some cases, it was not possible to determine whether the respiratory depression was associated with Streptokinase or was a symptom of the underlying process. If respiratory depression is associated with Streptokinase, the occurrence is believed to be rare.

Other Adverse Reactions:   Transient elevations of serum transaminases have been observed. The source of these enzyme rises and their clinical significance is not fully understood.

There have been reports in the literature of cases of back pain associated with the use of Streptokinase. In most cases the pain developed during Streptokinase intravenous infusion and ceased within minutes of discontinuation of the infusion.

Read the entire FDA prescribing information for Streptase (Streptokinase) »

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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