Some commonly used brand names are:

In the U.S.—

In Canada—

Other commonly used names are: Anisoylated plasminogen-streptokinase activator complex; APSAC; tissue-type plasminogen activator (recombinant); t-PA; rt-PA.

• Thrombolytic --Alteplase, Recombinant; Anistreplase; Reteplase, Recombinant; Streptokinase; Urokinase

Thrombolytic agents are used to dissolve blood clots that have formed in certain blood vessels. These medicines are usually used when a blood clot seriously lessens the flow of blood to certain parts of the body.

Thrombolytic agents are also used to dissolve blood clots that form in tubes that are placed into the body. The tubes allow treatments (such as dialysis or injections into a vein) to be given over a long period of time.

These medicines are to be given only by or under the direct supervision of a doctor.

These medicines are available in the following dosage forms:

Parenteral
• Alteplase, Recombinant
  • Injection (U.S. and Canada)
• Anistreplase
  • Injection (U.S. and Canada)
• Reteplase, Recombinant
  • Injection (U.S.)
• Streptokinase
  • Injection (U.S. and Canada)
• Urokinase
  • Injection (U.S. and Canada)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For thrombolytic agents, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to alteplase, anistreplase, streptokinase, or urokinase. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Tell your doctor if you are pregnant or if you have recently had a baby.

There is a slight chance that use of a thrombolytic agent during the first five months of pregnancy may cause a miscarriage. However, both streptokinase and urokinase have been used in pregnant women and have not been reported to cause this problem. Also, studies in pregnant women (for streptokinase) and studies in animals (for urokinase) have not shown that these medicines cause either miscarriage or harm to the fetus (including birth defects). Studies on birth defects with alteplase and anistreplase have not been done in either pregnant women or animals.

Breast-feeding—It is not known whether thrombolytic agents pass into the breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking any of these medicines and who wish to breast-feed should discuss this with their doctor.

Children—Studies on these medicines have been done only in adult patients, and there is no specific information comparing the use of thrombolytic agents in children with use in other age groups. However, streptokinase has occasionally been used in children to dissolve blood clots in certain blood vessels. Bleeding may be more likely to occur in children, who are usually more sensitive than adults to the effects of streptokinase.

Older adults—The need for treatment with a thrombolytic agent (instead of other kinds of treatment) may be increased in elderly patients with blood clots. However, the chance of bleeding may also be increased. It is especially important that you discuss the use of this medicine with your doctor.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Before you receive a thrombolytic agent, it is especially important that your doctor know if you are taking any of the following:

• Anticoagulants (blood thinners) or
• Aspirin or
• Cefamandole (e.g., Mandol) or
• Cefoperazone (e.g., Cefobid) or
• Cefotetan (e.g., Cefotan) or
• Dipyridamole (e.g., Persantine)
• Divalproex (e.g., Depakote) or
• Enoxaparin (e.g., Lovenox) or
• Heparin or
• Indomethacin (e.g., Indocin) or
• Inflammation or pain medicine (except narcotics) or
• Phenylbutazone (e.g., Butazolidin) or
• Plicamycin (e.g., Mithracin) or
• Sulfinpyrazone (e.g., Anturane) or
• Thrombolytic agents, other or
• Ticlopidine (e.g., Ticlid) or
• Valproic acid (e.g., Depakene)—The chance of bleeding may be increased

Also, tell your doctor if you have had an injection of anistreplase or streptokinase within the past year. If you have, these medicines may not work properly if they are given to you again. Your doctor may decide to use alteplase or urokinase instead.

• Allergic reaction to streptokinase, anistreplase, or urokinase (or history of)—Increased risk of an allergic reaction
• Blood disease, bleeding problems, or a history of bleeding in any part of the body or
• Brain disease or tumor or
• Heart or blood vessel disease, including irregular heartbeat or
• High blood pressure or
• Liver disease (severe) or
• Stroke, especially with seizure (or history of)—The chance of serious bleeding may be increased

• Streptococcal (“strep”) infection (recent)
• Surgery within the last two months—Anistreplase or streptokinase may not work properly after a streptococcal infection; your doctor may decide to use a different thrombolytic agent

Also, tell your doctor if you have recently had any of the following conditions:

• Falls or blows to the body or head or any other injury or
• Injections into a blood vessel or
• Placement of any tube into the body or
• Surgery, including dental surgery—The chance of serious bleeding may be increased

If you have recently had a baby, use of these medicines may cause serious bleeding.

Dosing—

The dose of these medicines will be different for different patients. The dose you receive will depend on the medicine you receive and will be based on the condition for which you are receiving the medicine. In some cases, the dose will also depend on your body weight.

Thrombolytic agents can cause bleeding that usually is not serious. However, serious bleeding may occur in some people. To help prevent serious bleeding, carefully follow any instructions given by your health care professional. Also, move around as little as possible, and do not get out of bed on your own, unless your health care professional tells you it is all right to do so.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Tell your health care professional immediately if any of the following side effects occur:

• More common
  • Bleeding or oozing from cuts, gums, wounds, or around the place of injection;  fever;  low blood pressure 
  
  

• Less common or rare
  • Agitation;  bloating;  blue or purple toes;  blurred vision;  bruising;  changes in facial skin color ;  chest pain or discomfort;  chills;  coma;  confusion ;  darkened urine;  decreased urine output;  depression;  dizziness;  double vision;  fast or irregular breathing;  flushing or redness of skin;  gangrenous fingers or toes;  headache (mild or severe);  hostility ;  indigestion;  irritability ;  lethargy;  loss of appetite ;  muscle cramps or spasms;  muscle pain or stiffness;  muscle twitching;  nausea;  nervousness;  numbness or tingling in face, arms, legs;  pain in side or abdomen, possibly radiating to the back;  pain in toes;  pain or discomfort in arms, jaw, back or neck;  pounding in the ears;  purplish red, net-like, blotchy spots on skin;  rapid weight gain;  seizures;  shortness of breath, troubled breathing, tightness in chest, and/or wheezing ;  skin rash, hives, or itching;  slow or fast heartbeat;  stupor;  sweating;  swelling of eyes, face, lips, or tongue ;  swelling of hands or ankles;  trouble in speaking or walking;  unusual tiredness or weakness;  vomiting;  weakness in arms or legs;  yellow eyes or skin 
  
  

• Frequency not determined
  • Bluish color of fingernails, lips, skin, palms, or nail beds ;  cough;  difficulty breathing ;  drowsiness;  faintness or lightheadedness when getting up from a lying or sitting position suddenly ;  fatigue;  noisy breathing ;  welts 
  
  

• Symptoms of bleeding inside the body
  • Abdominal or stomach pain or swelling;  back pain or backaches;  blood in urine;  bloody or black, tarry stools;  constipation ;  coughing up blood;  dizziness ;  headaches (sudden, severe, or continuing);  joint pain, stiffness, or swelling;  muscle pain or stiffness (severe or continuing);  nosebleeds;  unexpected or unusually heavy bleeding from vagina;  vomiting of blood or material that looks like coffee grounds 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, alteplase may be used in certain patients with the following condition:

• Peripheral arterial occlusive disease

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.