PIPERACILLIN TAZOBACTAM FOR INJECTION USP (PIPRANEM)

PIPRANEM®
(piperacillin and tazobactam) for Injection

To reduce the development of drug-resistant bacteria and maintain the effectiveness of PIPRANEM and other antibacterial drugs, PIPRANEM should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DESCRIPTION

PIPRANEM (piperacillin and tazobactam) for Injection and PIPRANEM (piperacillin and tazobactam) Injection are injectable antibacterial combination products consisting of the semisynthetic antibacterial piperacillin sodium and the β-lactamase inhibitor tazobactam sodium for intravenous administration.

Each PIPRANEM 2.25 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. The product also contains 0.5 mg of EDTA per vial.

Each PIPRANEM 3.375 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. The product also contains 0.75 mg of EDTA per vial.

Each PIPRANEM 4.5 g single dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. The product also contains 1 mg of EDTA per vial.

Each PIPRANEM 40.5 g pharmacy bulk vial contains piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 g of tazobactam sufficient for delivery of multiple doses.

PIPRANEM Injection in the VIAL Container is a frozen iso-osmotic sterile non-pyrogenic premixed solution. The components and dosage formulations are given in the table below:

Table 5: PIPRANEM In VIAL Containers Premixed Frozen Solution

Component* Function Dosage Formulations
2.25 g/50 mL 3.375 g/50 mL 4.5 g/100 mL
Piperacillin active ingredient 2 g 3 g 4 g
Tazobactam β-lactamase inhibitor 250 mg 375 mg 500 mg
Dextrose Hydrous osmolality adjusting agent 1 g 350 mg 2 g
Sodium Citrate Dihydrate buffering agent 100 mg 150 mg 200 mg
Edetate Disodium Dihydrate metal chelator 0.5 mg 0.75 mg 1 mg
Water for Injection solvent q.s. 50 mL q.s. 50 mL q.s. 100 mL
*Piperacillin and tazobactam are present in the formulation as sodium salts. Dextrose hydrous, sodium citrate dihydrate, and edetate disodium dihydrate amounts are approximate.

PIPRANEM contains a total of 2.84 mEq (65 mg) of sodium (Na+) per gram of piperacillin in the combination product.

For Consumers

What is piperacillin and tazobactam (PIPRANEM)?

Piperacillin is a penicillin antibiotic that fights bacteria in the body.

Tazobactam is an antibiotic similar to a penicillin that fights bacteria in the body.

The combination of piperacillin and tazobactam is used to treat many different infections caused by bacteria, such as urinary tract infections, bone and joint infections, severe vaginal infections, stomach infections, skin infections, and pneumonia.

This medication is sometimes given together with other antibiotics.

Piperacillin and tazobactam may also be used for purposes not listed in this medication guide.

What are the possible side effects of piperacillin and tazobactam (PIPRANEM)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • diarrhea that is watery or bloody;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • dry mouth, increased thirst, confusion, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, fainting;
  • fever, chills, body aches, flu symptoms;
  • white patches or sores inside your mouth or on your lips; or
  • seizure (convulsions).

Less serious side effects may include:

  • nausea, vomiting, stomach pain or upset;
  • constipation, mild diarrhea;
  • headache, dizziness, agitation;
  • runny nose;
  • anxiety, sleep problems (insomnia);
  • skin rash or itching;
  • pain, swelling, or other irritation where the injection was given; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What is the most important information I should know about piperacillin and tazobactam (PIPRANEM)?

You should not use this medication if you are allergic to piperacillin and tazobactam or to any other penicillin antibiotic, such as amoxicillin (Amoxil, Augmentin, Dispermox, Moxatag), ampicillin (Principen, Unasyn), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), ticarcillin (Timentin), or penicillin (Bicillin L-A, PC Pen VK, Pfizerpen), and others.

Before using piperacillin and tazobactam tell your doctor if you have kidney disease, a bleeding or blood clotting disorder, low levels of potassium in your blood, cystic fibrosis, a history of allergies, if you are on a low-salt diet, or if you are allergic to a cephalosporin antibiotic such as cefdinir (Omnicef), cefprozil (Cefzil), cefuroxime (Ceftin), cephalexin (Keflex), and others.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Piperacillin and tazobactam will not treat a viral infection such as the common cold or flu.

Piperacillin and tazobactam may cause bleeding, especially in people with kidney disease or using certain medicines. Tell your doctor if you are using any medication to prevent blood clots such as alteplase (Activase), bivalirudin (Angiomax), clopidogrel (Plavix), dabigatran (Pradaxa), dipyridamole (Persantine, Aggrenox), enoxaparin (Lovenox), fondaparinux (Arixtra), heparin, tenecteplase (TNKase), ticlopidine (Ticlid), tinzaparin (Innohep), warfarin (Coumadin, Jantoven), and others.

What should I discuss with my healthcare provider before using piperacillin and tazobactam (PIPRANEM)?

You should not use this medication if you are allergic to piperacillin and tazobactam or to any other penicillin antibiotic, such as:

  • amoxicillin (Amoxil, Augmentin, Dispermox, Moxatag);
  • ampicillin (Principen, Unasyn);
  • dicloxacillin (Dycill, Dynapen);
  • oxacillin (Bactocill);
  • ticarcillin (Timentin); or
  • penicillin (Bicillin L-A, PC Pen VK, Pfizerpen), and others.

To make sure you can safely use piperacillin and tazobactam, tell your doctor if you have any of these other conditions:

  • kidney disease (or if you are on dialysis);
  • a bleeding or blood clotting disorder;
  • an electrolyte imbalance such as low levels of potassium in your blood;
  • cystic fibrosis;
  • a history of any type of allergy;
  • if you are on a low-salt diet; or
  • if you are allergic to a cephalosporin antibiotic such as cefdinir (Omnicef), cefprozil (Cefzil), cefuroxime (Ceftin), cephalexin (Keflex), and others.

FDA pregnancy category B. Piperacillin and tazobactam is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Piperacillin and tazobactam may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use piperacillin and tazobactam (PIPRANEM)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Piperacillin and tazobactam is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Piperacillin and tazobactam must be given slowly, and the IV infusion can take at least 30 minutes to complete.

Piperacillin and tazobactam must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Prepare your dose in a syringe, IV bag, or infusion pump only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Piperacillin and tazobactam is usually given for 7 to 10 days, depending on the infection being treated. Follow your doctor’s instructions.

If you use this medication long-term, your blood will need to be tested often. Visit your doctor regularly.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Piperacillin and tazobactam will not treat a viral infection such as the common cold or flu.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using piperacillin and tazobactam.

Store unmixed medicine and the liquid diluent at cool room temperature.

Medicine mixed in an IV bag must be used within 24 hours if you keep it at room temperature.

Mixed medicine in an infusion pump must be used within 12 hours if you keep it at room temperature.

Mixed medication in an IV bag can also be stored in the refrigerator for up to 7 days. Do not freeze. Throw away any unused mixture that has not been used within that time.

What happens if I miss a dose (PIPRANEM)?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (PIPRANEM)?

Seek emergency medical attention

Overdose symptoms may include severe anxiety, agitation, feeling restless or nervous, or seizure (convulsions).

What should I avoid while using piperacillin and tazobactam (PIPRANEM)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

What other drugs will affect piperacillin and tazobactam (PIPRANEM)?

Piperacillin and tazobactam may cause bleeding, especially in people with kidney disease or using certain medicines. Tell your doctor if you are using any medication to prevent blood clots, such as:

  • abciximab (ReoPro);
  • alteplase (Activase);
  • anagrelide (Agrylin);
  • argatroban (Acova);
  • bivalirudin (Angiomax);
  • cilostazol (Pletal);
  • clopidogrel (Plavix);
  • dipyridamole (Persantine);
  • dabigatran (Pradaxa);
  • dalteparin (Fragmin);
  • dipyridamole (Persantine, Aggrenox);
  • enoxaparin (Lovenox);
  • eptifibatide (Integrelin);
  • fondaparinux (Arixtra);
  • heparin;
  • lepirudin (Refludan);
  • prasugrel (Effient);
  • tenecteplase (TNKase);
  • ticlopidine (Ticlid);
  • tinzaparin (Innohep);
  • tirofiban (Aggrastat);
  • urokinase (Abbokinase); or
  • warfarin (Coumadin, Jantoven).

Tell your doctor about all other medicines you use, especially:

  • probenecid (Benemid); or
  • another antibiotic such as kanamycin (Kantrex), neomycin (Mycifradin, Neo Fradin, Neo Tab), paromomycin (Humatin, Paromycin), streptomycin, tobramycin (Nebcin, Tobi).

This list is not complete and other drugs may interact with piperacillin and tazobactam. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about piperacillin and tazobactam.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Uses

Piperacillin/tazobactam is used to treat a wide variety of bacterial infections. It is a penicillin antibiotic. It works by stopping the growth of bacteria.

How to use Piperacillin-Tazobactam Vial

This medication is given by injection into a vein as directed by your doctor, usually every 6 hours. It should be injected slowly over at least 30 minutes. The dosage is based on your medical condition and response to treatment. For children, the dosage is also based on age and weight.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

If you are using the frozen pre-mixed solution, thaw the container at room temperature or in the refrigerator. If the bag is thawed in the refrigerator, let it sit at room temperature for at least 1 hour before using. Do not thaw by putting in warm/hot water or microwaving. After thawing, shake well and squeeze the container to check for leaks. Discard if the container leaks. Do not re-freeze the solution after thawing.

For the best effect, use this antibiotic at evenly spaced times. To help you remember, use this medication at the same time(s) every day.

Continue to use this medication for the full time prescribed, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition lasts or gets worse.

Why is this medication prescribed?

Piperacillin and tazobactam injection is used to treat pneumonia and skin, gynecological, and abdominal (stomach area) infections caused by bacteria. Piperacillin is in a class of medications called penicillin antibiotics. It works by killing bacteria that cause infection. Tazobactam is in a class called beta-lactamase inhibitor. It works by preventing bacteria from destroying piperacillin.

Antibiotics such as piperacillin and tazobactam injection will not work for colds, flu, or other viral infections. Taking or using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

How should this medicine be used?

Piperacillin and tazobactam injection comes as a powder to be mixed with liquid and injected intravenously (into a vein). It is usually given every 6 hours, but children 9 months of age and older may receive it every 8 hours. The length of treatment depends on your general health, the type of infection you have, and how well you respond to the medication. Your doctor will tell you how long to use piperacillin and tazobactam injection. After your condition improves, your doctor may switch you to another antibiotic that you can take by mouth to complete your treatment.

You may receive piperacillin and tazobactam injection in a hospital, or you may administer the medication at home. If you will be receiving piperacillin and tazobactam injection at home, your healthcare provider will show you how to use the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions.

You should begin to feel better during the first few days of treatment with piperacillin and tazobactam injection. If your symptoms do not improve or if they get worse, call your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before using piperacillin and tazobactam injection,

  • tell your doctor and pharmacist if you are allergic to piperacillin, tazobactam, cephalosporin antibiotics such as cefaclor, cefadroxil, cefuroxime (Ceftin, Zinacef), and cephalexin (Keflex); beta-lactam antibiotics such as penicillin or amoxicillin (Amoxil, Larotid, Moxatag); any other medications, or any of the ingredients in piperacillin and tazobactam injection. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aminoglycoside antibiotics such as amikacin, gentamicin, or tobramycin; anticoagulants (‘blood thinners’) such as heparin or warfarin (Coumadin, Jantoven); methotrexate (Otrexup, Rasuvo, Trexall), probenecid (Probalan, in Col-Probenecid); or vancomycin (Vancocin). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had cystic fibrosis (an inborn disease that causes problems with breathing, digestion, and reproduction) or kidney disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving piperacillin and tazobactam injection, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving piperacillin and tazobactam injection.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What side effects can this medication cause?

Piperacillin and tazobactam injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • diarrhea
  • constipation
  • nausea
  • vomiting
  • heartburn
  • stomach pain
  • fever
  • headache
  • mouth sores
  • difficulty falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

  • rash
  • itching
  • hives
  • difficulty breathing or swallowing
  • wheezing
  • severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)

Piperacillin and tazobactam injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA)

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body’s response to piperacillin and tazobactam injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving piperacillin and tazobactam injection. If you have diabetes, piperacillin and tazobactam injection can cause false results with certain urine glucose tests. Talk to your doctor about using other glucose tests while using piperacillin and tazobactam injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Related Products

Taj Generics (Taj Pharma) provides a wide range of products to the Indian market, including an extensive range of generics and specialty products; Our products cover a vast array of therapeutic categories, and we offer an extensive range of dosage forms and delivery systems including oral solids, controlled-release, steriles, injectables, topicals, liquids, transdermals, semi-solids and high-potency products. Our Generics portfolio offers over 1500 products in the major therapeutic areas of gastro-intestinal, cardiovascular, pain management, oncology, anti-infectives, paediatrics and dermatology.