VPI-Piperacillin and Tazobactam for Injection: Uses, Side Effects and Dosage

What is Piperacillin and Tazobactam for Injection used for?

Piperacillin and Tazobactam for Injection is used by doctors to treat bacterial infections:

• of the appendix and lining of the abdomen (peritoneum)
• of the skin
• of the female reproductive system
• of the lungs and lower airways that are community- or hospital-acquired

Antibacterial drugs like Piperacillin and Tazobactam for Injection treat only bacterial infections. They do not treat viral infections. Although you may feel better early in treatment, Piperacillin and Tazobactam for Injection should be used exactly as directed. Misuse or overuse of Piperacillin and Tazobactam for Injection could lead to the growth of bacteria that will not be killed by Piperacillin and Tazobactam for Injection (resistance). This means that Piperacillin and Tazobactam for Injection may not work for you in the future.

How does Piperacillin and Tazobactam for Injection works?

This product is an injectable antibiotic that contains piperacillin sodium and tazobactam sodium. Both ingredients work together to kill the bacteria and reduce the infection.

What are the ingredients in Piperacillin and Tazobactam for Injection? Medicinal ingredients: Piperacillin Sodium and Tazobactam Sodium.

Non-medicinal ingredients: None

Serious Warnings and Precautions

Notify your doctor if you are allergic to penicillin, cephalosporins or other allergens. If you have an allergic reaction during therapy with Piperacillin and Tazobactam for Injection stop taking the drug and seek immediate medical attention.

Piperacillin and Tazobactam for Injection comes in the following dosage forms:

Lyophilized powder for injection available as:

• 2.25 g (2 g piperacillin sodium / 0.25 g tazobactam sodium)
• 3.375 g (3 g piperacillin sodium / 0.375 g tazobactam sodium)
• 4.5 g (4 g piperacillin sodium / 0. 5 g tazobactam sodium)
• 13.5 g (12 g piperacillin sodium / 1.5 g tazobactam sodium)
• 40.5 g (36 g piperacillin sodium / 4.5 g tazobactam sodium)

Do not use Piperacillin and Tazobactam for Injection if:

• you are allergic to any ingredient in the drug
• you are allergic to any of the penicillins, cephalosporins or beta-lactamase inhibitors

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Piperacillin and Tazobactam for Injection. Talk about any health conditions or problems you may have, including if you:

• are allergic to Piperacillin and Tazobactam for Injection, penicillin, cephalosporins or beta-lactamase inhibitors
• have cystic fibrosis
• have a history of diarrhea or bowel problems due to an antibiotic
• have kidney, liver or gallbladder problems
• have bleeding problems

• are pregnant, planning to become pregnant or are breastfeeding. Piperacillin is excreted at low levels in human milk

• are over 65 years and have kidney, liver or heart problems
• are on a low sodium diet. This product contains sodium
• have low blood potassium levels
• are receiving cytotoxic therapy or methotrexate (for the treatment of cancer)
• are taking diuretics (drugs that increase urine production)
• are taking blood thinners (e.g. heparin) or any medicines that may affect blood clot formation
• are being treated for gonorrhea

Other Warnings:

Stop taking this product and contact your doctor right away if the following occurs:

• severe or lasting diarrhea (watery or bloody) with or without fever, stomach pain, or tenderness.

You may have Clostridium difficile colitis (bowel inflammation)

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Piperacillin and Tazobactam for Injection:

• 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)

How to take Piperacillin and Tazobactam for Injection:

Piperacillin and Tazobactam for Injection will be given to you intravenously by your doctor.

Usual dose:

Your doctor will give you the most appropriate dose based on the severity and type of your bacterial infection. If you have kidney problems or are taking medications that may interact with Piperacillin and Tazobactam for Injection, your doctor will adjust the dose.

The usual dose of Piperacillin and Tazobactam for Injection for adults is 3 g / 0.375 g, given every six hours, for a total dose of 12 g / 1.5 g per day.

For intra-abdominal infections, the dose of Piperacillin and Tazobactam for Injection for adults is 4 g / 0.5 g, given every eight hours, for a total dose of 12 g / 1.5 g per day.

For hospital-acquired pneumonia, the dose of Piperacillin and Tazobactam for Injection for adults is 4 g / 0.5 g, plus an aminoglycoside (type of antibiotic) every six hours, for a total dose of 16 g / 2 g per day.

Overdose:

Symptoms of overdose include:

• nausea, vomiting, diarrhea
• neuromuscular excitability (increased sensitivity of muscles and nerves)
• convulsions (involuntary contractions of the muscles)

Missed Dose:

Talk to your doctor if you suspect a missed dose.

What are possible side effects from using Piperacillin and Tazobactam for Injection?

These are not all the possible side effects you may feel when taking Piperacillin and Tazobactam for Injection. If you experience any side effects not listed here, contact your healthcare professional.

If you think you have taken too much Piperacillin and Tazobactam for Injection, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Side effects may include:

• 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 Piperacillin and Tazobactam for

  Injection (superinfection)

• difficulty sleeping
• headache, dizziness or lightheadedness
• anxiety, sweating, agitation
• shortness of breath
• chest pain
• abdominal pain or swelling
• fever
• pain

These are not all the possible side effects you may feel when taking Piperacillin and Tazobactam for Injection. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Storage:

Piperacillin and Tazobactam for Injection as a lyophilized powder in vials can be stored at controlled room temperature conditions (15°C to 30°C). Protect from light. Keep out of sight and reach of children.

Piperacillin and Tazobactam for Injection is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when reconstituted with acceptable diluents.

Piperacillin and Tazobactam for Injection in glass vials following reconstitution may be stored for up to 24 hours at room temperature and up to 48 hours at refrigerated temperatures. Discard unused portions after storage for 24 hours at room temperature or 48 hours when refrigerated.

If you want more information about Piperacillin and Tazobactam for Injection:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; or by contacting the sponsor, VPI Pharmaceuticals Inc., at:

  1-855-782-0731

Reporting suspected side effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

• Online at MedEffect™;
• By calling 1-866-234-2345 (toll-free);

• By completing a Patient Side Effect Reporting Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 1908C Ottawa, Ontario K1A 0K9

    Postage paid labels and the Patient Side Effect Reporting Form are available at MedEffect™.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

or by written request at:

16667 Boul. Hymus Kirkland, (QC), Canada H9H 4R9

or by e-mail at:

info@vpipharmainc.com

Last revised: May 22, 2018