Tazocin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

TAZOCIN is used by doctors to treat bacterial infections in different parts of the body.

What it does:

TAZOCIN belongs to a group of injectable antibiotic combinations containing piperacillin sodium and tazobactam sodium. Piperacillin is a penicillin-type antibiotic that

interferes with bacterial cell wall formation and tazobactam reduces the action of bacteria which inactivate piperacillin.

Both work together to reduce the bacterial infection.

When it should not be used:

TAZOCIN should not be used in patients with a history of allergic reactions to any of the penicillins and/or cephalosporins, beta lactamase inhibitors or to any of the

nonmedicinal ingredients in this formulation (see What the nonmedicinal ingredients are).

What the medicinal ingredient is:

TAZOCIN contains the active ingredients Piperacillin

Sodium and Tazobactam Sodium.

What the important nonmedicinal ingredients are:

Citric acid (monohydrate) and edetate disodium (dihydrate).

What dosage forms it comes in:

TAZOCIN is available as a lyophilized powder for injection.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions Notify your doctor if you are allergic to penicillin, cephalosporins or other allergens. If an allergic reaction occurs during therapy with TAZOCIN stop taking the drug and seek immediate medical attention.

BEFORE you use TAZOCIN talk to your doctor if you:

• are allergic to TAZOCIN, penicillin, cephalosporins or beta-lactamase inhibitors
• have kidney or liver problems
• have gall bladder problems
• have low levels of potassium in blood or taking diuretics
• are on a low sodium diet as this product contains sodium

• are pregnant or could become pregnant during treatment

• are breast feeding. Piperacilin is excreted at low levels in human milk.
• have cystic fibrosis or bleeding problems
• have a history of severe diarrhea or bowel problems due to an antibiotic
• are being treated for gonorrhea

• are taking any medicines including:

  Aminoglycosides, Probenecid, blood thinners (e.g.

  Heparin), Vecuronium or Methotrexate

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with TAZOCIN include:

• Aminoglycosides (a type of antibiotic, e.g.

  tobramycin)

• Probenecid (a drug used to treat gout)
• Drugs used to thin blood (e.g. Heparin)
• Vecuronium (a muscle relaxant)
• Methotrexate (a drug used to treat cancer)

PROPER USE OF THIS MEDICATION

TAZOCIN will be administered by your doctor.

Usual dose:

The usual total daily dose of TAZOCIN for adults is

12g/1.5g, given as 3g/0.375g intravenously every six hours, as administered by the healthcare professional.

Overdose:

There have been post-marketing reports of overdose with TAZOCIN. The majority of those events experienced including nausea, vomiting, and diarrhea have also been

reported with the usual recommended dosages. You may experience neuromuscular excitability (increased sensitivity of muscles and nerves) or convulsions if higher than

recommended doses are given intravenously (particularly in the presence of kidney failure).

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

TAZOCIN is often administered by a doctor. If you suspect a missed dose talk to your physician.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines TAZOCIN may have side effects. The most common side effects are:

• Nausea or indigestion
• Vomiting
• diarrhea or constipation
• rash, itchy or red skin
• allergic reaction such as hives
• a new infection caused by bacteria that are resistant to TAZOCIN (superinfection)

• difficulty sleeping

  • headache, dizziness or light-headedness
  • anxiety, sweating, agitation
  • shortness of breath
  • chest pain
  • abdominal pain or swelling
  • fever
  • pain

Serious skin reactions have occurred in patients taking piperacillin/tazobactam combinations. If you develop symptoms such as peeling or blistering skin or severe rash, contact your doctor immediately.

If you suffer severe, persistent, watery or bloody diarrhea, with or without fever and abdominal pain, you may have Clostridium difficile colitis (bowel inflammation). If this happens, stop taking TAZOCIN and contact your doctor immediately.

This is not a complete list of side effects. For any unexpected effects while taking TAZOCIN, contact your doctor or pharmacist.

HOW TO STORE IT

TAZOCIN vials should be stored at controlled room temperature 15-30^oC.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

-------------------------------------------------------------------------- $ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701D

  Ottawa, Ontario

  K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.pfizer.ca

or by contacting the sponsor, Pfizer Canada Inc., at:

1-800-463-6001

Last revised: April 8, 2014