Ceftolozane-Tazobactam

Ceftolozane-Tazobactam is a prescription medication used for the treatment of various bacterial infections such as Intra-abdominal infections, Urinary Tract Infections, and Bacterial Pneumonia.

• Ceftolozane-Tazobactam is available under the following different brand names: Zerbaxa

Common side effects of Ceftolozane-Tazobactam include:

• nausea,
• diarrhea,
• headache,
• fever,
• kidney problems, and
• abnormal liver function tests

Serious side effects of Ceftolozane-Tazobactam include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• severe stomach pain,
• diarrhea that is watery or bloody (even if it occurs months after the last dose),
• little or no urination,
• swelling in the feet or ankles,
• tiredness,
• shortness of breath,
• sudden numbness,
• weakness, and
• problems with vision or speech

Rare side effects of Ceftolozane-Tazobactam include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Intravenous injection, powder for reconstitution

• 1.5 g/vial (.e, 1.5 g = 1 g ceftolozane plus 0.5 g tazobactam)
• Dose based on the sum weight of each ingredient
• Complicated Intra-abdominal Infections

Adult dosage

• 1.5 g Intravenous every 8 hours into 4-14 days

Pediatric dosage

• CrCl above 50 mL/min/1.73 m2: 30 mg/kg intravenous every 8 hours into 5-14 days; not to exceed 1.5 g/dose

Complicated Urinary Tract Infections

Adult dosage

• 1.5 g Intravenous every 8 hours for 7 days

Pediatric dosage

• CrCl above 50 mL/min/1.73 m2: 30 mg/kg intravenous every 8 hours into 5-14 days; not to exceed 1.5 g/dose

Bacterial Pneumonia

Adult dosage

• 3 g Intravenous every 8 hours into 8-14 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ceftolozane-Tazobactam has no noted severe interactions with any other drugs.
• Ceftolozane-Tazobactam has no noted serious interactions with any other drugs.
• Ceftolozane-Tazobactam has no noted moderate interactions with any other drugs.
• Ceftolozane-Tazobactam has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to any of the components 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ceftolozane-Tazobactam?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ceftolozane-Tazobactam?”

Cautions

• Clinical cure rates are lower in patients with baseline CrCl of 30 to below 50 mL/min when compared with other antibiotics in clinical trials; monitor CrCl at least daily in patients with changing renal function and adjust dosage accordingly
• Serious and occasionally fatal hypersensitivity (anaphylactic) reactions reported with beta-lactam antibacterial agents; before initiating therapy make careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillin, or other beta-lactams; if this product is to be given to a patient with a cephalosporin, penicillin, or other beta-lactam allergies, exercise caution because cross-sensitivity has been established; if an anaphylactic reaction occurs, discontinue the drug and institute appropriate therapy
• Prescribing antibiotics in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria
• Clostridium difficile-associated diarrhea
  • As with all antibiotics, Clostridium difficile-associated diarrhea (CDAD) has been reported; may range in severity from mild diarrhea to fatal colitis; treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD; CDAD must be considered in all patients who present with diarrhea following antibacterial use; careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents
  • If CDAD is confirmed, discontinue antibacterial not directed against C. difficile, if possible; manage fluid and electrolyte levels as appropriate, supplement protein intake, monitor antibacterial treatment of C. difficile, and institute surgical evaluation as clinically indicated

Pregnancy and Lactation

• There are no data available on Ceftolozane-Tazobactam or its components regarding use in pregnant women to assess the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Human data: Although available studies with multiple cephalosporins cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified an association of cephalosporin use during pregnancy with major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Lactation
  • There are no data on the presence of either drug component in human milk; there are no data on the effects of either drug component on the breastfed infant or milk production
  • Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from therapy or underlying maternal conditions