Patient Medication Information: uses, side effects, how to take - Piperacillin and Tazobactam for Injection (Mylan Pharmaceuticals)
ABOUT THIS MEDICATION
What the medication is used for:
Piperacillin and Tazobactam for Injection is used by doctors to treat bacterial infections in different parts of the body.
What it does:
Piperacillin and Tazobactam for Injection 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:
Piperacillin and Tazobactam for Injection 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:
Piperacillin sodium and tazobactam sodium.
What the nonmedicinal ingredients are:
There are no nonmedicinal ingredients.
What dosage forms it comes in:
Piperacillin and Tazobactam for Injection is available as 2.25 g, 3.375 g, and 4.5 g of powder in glass vials. The powder is mixed with sterile liquid to give a solution for injection by your doctor.
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 Piperacillin and Tazobactam for Injection stop taking the drug and seek immediate medical attention.
BEFORE you use Piperacillin and Tazobactam for Injection, talk to your doctor if are:
- allergic to Piperacillin and Tazobactam for Injection, 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
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with Piperacillin and Tazobactam for Injection include:
- Aminoglycosides (a type of antibiotic; e.g. tobramycin)
- Probenecid (a drug used to treat gout)
- Drugs used to thin blood (i.e., heparin)
- Vecuronium (a muscle relaxant), and
- Methotrexate (a drug used to treat cancer)
| PROPER USE OF THIS MEDICINE |
Piperacillin and Tazobactam for Injection administered by your doctor.
THIS MEDICATION
Usual dose:
The usual total daily dose of Piperacillin and Tazobactam for Injection adults is 12g/1.5g, given as 3g/0.375g intravenously every six hours, as
Overdose:
There have been post-marketing reports of overdose with Piperacillin and Tazobactam for Injection. 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:
Piperacillin and Tazobactam for Injection is often administered by a doctor. If you suspect a missed dose talk to your physician.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
DE EFFECTS AND WHAT TO DO ABOU
Like all medicines Piperacillin and Tazobactam for Injection 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 Piperacillin and Tazobactam for Injection (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 Piperacillin and Tazobactam for Injection and contact your doctor immediately.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency medical attention | ||
| Only if severe | In all cases | |||
| Common | Chest pain Diarrhea | ✓ | ✓ | |
| Uncommon | Confusion Convulsion Hallucinations Janudice (yellowing of skin or eyes) | ✓ ✓ ✓ ✓ | ||
| Rare | Allergic reactions such as: Chest tightness, dizziness, faintness, hives, itching, shortness of breath, skin rash, swollen face, lips, mouth or tongue, troubled breathing, wheezing | ✓ | ||
This is not a complete list of side effects. For any unexpected effects while taking Piperacillin and Tazobactam for Injection, contact your doctor or pharmacist.
HOW TO STORE IT
Piperacillin and Tazobactam for Injection vials should be stored at controlled room temperature between 15°C and 30°C.
Reporting 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 (http://hc-sc.gc.ca/dhp-
mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
By completing a Consumer 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 0701E
Ottawa, ON
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc- sc.gc.ca/dhp-mps/medeff/index-eng.php).
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.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379
Prepared on: February 18, 2015
Mylan Pharmaceuticals ULC
Etobicoke, ON M8Z 2S6
1-800-575-1379
www.mylan.ca