Details for: PIPERACILLIN TAZOBACTAM POWDER FOR INJECTION
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02370166 | PIPERACILLIN / TAZOBACTAM POWDER FOR INJECTION | PIPERACILLIN (PIPERACILLIN SODIUM); TAZOBACTAM (TAZOBACTAM SODIUM) | 3 G / VIAL; 0.375 G / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
| 02370174 | PIPERACILLIN / TAZOBACTAM POWDER FOR INJECTION | PIPERACILLIN (PIPERACILLIN SODIUM); TAZOBACTAM (TAZOBACTAM SODIUM) | 4 G / VIAL; 0.5 G / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
Summary Reports
Summary Safety Review - Beta-lactam antibiotics - Assessing the potential risk of severe skin side effects
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
PIPERACILLIN/TAZOBACTAM POWDER 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/TAZOBACTAM POWDER FOR INJECTION treat only bacterial infections. They do not treat viral infections. Although you may feel better early in treatment, PIPERACILLIN/TAZOBACTAM POWDER FOR INJECTION should be used exactly as directed. Misuse or overuse of PIPERACILLIN/TAZOBACTAM POWDER FOR INJECTION could lead to the growth of bacteria that will not be killed by PIPERACILLIN/TAZOBACTAM POWDER FOR INJECTION (resistance). This means that Piperacillin Sodium/Tazobactam Powder for Injection may not work for you in the future.
What it does
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.
When it should not be used
- you are allergic to any ingredient in the drug • you are allergic to any of the penicillins, cephalosporins or beta-lactamase inhibitors
What the medicinal ingredient is
Piperacillin Sodium and Tazobactam Sodium.
What the non-medicinal ingredients are
Sodium bicarbonate.
What dosage form it comes in
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)
Warnings and precautions
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/ TAZOBACTAM POWDER FOR INJECTION stop taking the drug and seek immediate medical attention.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PIPERACILLIN/TAZOBACTAM POWDER FOR INJECTION. Talk about any health conditions or problems you may have, including if you:
- are allergic to PIPERACILLIN/TAZOBACTAM POWDER 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 breast feeding. 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.
Interactions with this medication
- 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
PIPERACILLIN/TAZOBACTAM POWDER 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 Sodium/Tazobactam Sodium Powder for Injection, your doctor will adjust the dose.
The usual total daily dose of PIPERACILLIN/TAZOBACTAM POWDER FOR INJECTION for adults is 12g/1.5g, given as 3g/0.375g intravenously every six hours, as administered by the healthcare professional.
For intra-abdominal infections, the dose of PIPERACILLIN/TAZOBACTAM POWDER 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/TAZOBACTAM POWDER 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.
Side effects and what to do about them
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/TAZOBACTAM POWDER FOR INJECTION (superinfection)
- difficulty sleeping
- headache, dizziness or light-headedness
- 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 Sodium/Tazobactam Sodium Powder. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| COMMON | |||
| Chest pain | ✔ | ||
| Diarrhea | ✔ | ||
| LESS COMMON | |||
| Confusion | ✔ | ||
| Convulsions | ✔ | ||
| Hallucinations | ✔ | ||
| Jaundice (yellowing of skin or eyes) | ✔ | ||
| RARE | |||
| Allergic reactions such as: Chest tightness, dizziness, faintness, hives, itching, shortness of breath, severe skin rash, peeling or blistering skin, swollen face, lips, mouth or tongue, troubled breathing, wheezing | ✔ | ||
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.
How to store
PIPERACILLIN/TAZOBACTAM POWDER FOR INJECTION vials should be stored at controlled room temperature 15-30°C (59-86°F). Single Dose Vials. Discard unused portions.
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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
- 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 (health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.
This leaflet was prepared by Teva Canada Limited, Toronto, Ontario M1B 2K9
Last revised: March 29, 2018