Pronunciation:

pi-per-a-SIL-in SOE-dee-um, taz-oh-BAK-tam SOE-dee-um

Brand Names:

• Zosyn

Dosage Forms:

• Powder for Solution
• Solution

Classifications:

Therapeutic—

Antibiotic

Pharmacologic—

Piperacillin

Uses of This Medicine:

Piperacillin and tazobactam combination injection is used to treat bacterial infections in many different parts of the body (eg, stomach or bowel, lungs, skin, female reproductive organs).

Piperacillin and tazobactam combination is an antibiotic that belongs to the group of medicines known as penicillins and beta-lactamase inhibitors. It works by killing the bacteria and preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of piperacillin and tazobactam combination injection in children 2 months of age and older with lung infections (eg, nosocomial pneumonia) or stomach or bowel infections (eg, appendicitis, peritonitis). However, safety and efficacy have not been established in children younger than 2 months of age with nosocomial pneumonia, appendicitis, or peritonitis and in children with other infections (eg, skin infections, endometritis, pelvic inflammatory disease, community-acquired pneumonia).

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of piperacillin and tazobactam combination injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving piperacillin and tazobactam combination.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amifampridine
• Bupropion
• Chlortetracycline
• Cholera Vaccine, Live
• Demeclocycline
• Donepezil
• Doxycycline
• Eravacycline
• Ethinyl Estradiol
• Hydroxychloroquine
• Levonorgestrel
• Lymecycline
• Meclocycline
• Methacycline
• Methotrexate
• Minocycline
• Oxytetracycline
• Rolitetracycline
• Sarecycline
• Tetracycline
• Tigecycline
• Vancomycin
• Vecuronium
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to cephalosporins, beta-lactams, or penicillins, history of—Should not be used in patients with this condition.

• Congestive heart failure or
• Diarrhea or
• Heart disease or
• Hypokalemia (low potassium in the blood) or
• Kidney failure or
• Patients who are on a low-salt diet or
• Seizures—Use with caution. May make these conditions worse.

• Cystic fibrosis (genetic disorder)—Patients with this condition may have an increased chance of fever and skin rash.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so the needle will need to stay in place for at least 30 minutes. Your doctor will decide how many treatments you will need.

Precautions While Using This Medicine:

Your doctor will check your or your child's progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects. If your or your child's symptoms do not improve or if they become worse, call your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child has itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this medicine.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with this medicine. Check with your doctor right away if you or your child has black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness while you are receiving this medicine.

This medicine may cause hemophagocytic lymphohistiocytosis, a severe inflammatory condition which can be life-threatening, which is caused by an overactive immune system. Check with your doctor right away if you have a fever, right upper abdominal or stomach pain and fullness, rash, swollen, painful, or tender lymph glands in the neck, armpit, or groin, mental status changes, shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination, or seizures.

This medicine may cause serious bleeding problems. Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, or pinpoint red spots on your skin.

Tell your doctor right away if you have seizures, muscle spasm or jerking of all extremities, sudden loss of consciousness, or loss of bladder control. These could be symptoms of a serious nervous system problem.

Check with your doctor right away if you have a bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Piperacillin and tazobactam combination may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop receiving this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Before you have any medical tests, tell the doctor in charge that you or your child are receiving this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Diarrhea

Less common

Bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

blurred vision

burning upper abdominal or stomach pain

changes in urination

chest pain

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fever or sweating

headache

lower back or side pain

nausea or vomiting

pain, tenderness, or swelling of the foot or leg

pain, warmth, or burning in the fingers, toes, and legs

problems with vision or hearing

skin rash

slow or fast heartbeat

trouble breathing

Rare

Agitation

bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

bone pain

bruising

chills

cold sweats

cough

deep or fast breathing with dizziness

depression

diarrhea, watery and severe, which may also be bloody

drowsiness

dry mouth

hives

hostility

itching of the vagina or genital area

lethargy

muscle pain, cramps, stiffness, or twitching

nightmares

numbness or tingling in the hands, feet, or lips

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

sore throat

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

stomach cramps, pain, or tenderness

swollen glands

temporary blindness

thick, white vaginal discharge with no odor or with a mild odor

total body jerking

unexplained weight loss

unusual bleeding or bruising

Incidence not known

Back or leg pain

black, tarry stools

blistering, peeling, or loosening of the skin

bloody or cloudy urine

high fever

joint or muscle pain

light-colored stools

loss of bladder control

mental status changes

muscle spasm or jerking of all extremities

pale skin

red irritated eyes

red skin lesions, often with a purple center

seizures

shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination

sudden loss of consciousness

swelling of the feet or lower legs

swollen, painful, or tender lymph glands in the neck, armpit, or groin

trouble breathing

upper right abdominal or stomach pain

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Constipation

trouble sleeping

Less common

Acid or sour stomach

cracks in the skin at the corners of the mouth

hiccup

irritation and redness of the skin

runny nose

sneezing

stuffy nose

Rare

Body aches or pain

change in taste or bad unusual or unpleasant (after) taste

feeling of constant movement of self or surroundings

sensation of spinning

severe sleepiness

voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.