Ceftolozane and tazobactam

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

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

Call your doctor at once if you have:

• severe stomach pain; or

• diarrhea that is watery or bloody.

Side effects may be more likely in older adults.

Common side effects may include:

• nausea, diarrhea;

• headache; or

• fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• If you have an allergy to ceftolozane and tazobactam or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take ceftolozane and tazobactam with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Note: Zerbaxa (ceftolozane/tazobactam) is a combination product. Dosage recommendations are expressed as grams of ceftolozane/tazobactam combination.

Intra-abdominal infections (complicated): IV: 1.5 g every 8 hours for 4 to 14 days in combination with metronidazole

Urinary tract infections (complicated, includes pyelonephritis): IV: 1.5 g every 8 hours for 7 days

Refer to adult dosing.

No dosage adjustment necessary.

1% to 10%:

Cardiovascular: Hypotension (≤2%), atrial fibrillation (≤1%)

Central nervous system: Headache (3% to 6%), insomnia (complicated intra-abdominal infections: 4%; complicated UTIs: 1%), anxiety (≤2%), dizziness (≤1%)

Dermatologic: Skin rash (≤2%)

Endocrine: Hypokalemia (complicated intra-abdominal infections: 3%; complicated UTIs: <1%)

Gastrointestinal: Nausea (3% to 8%), diarrhea (complicated intra-abdominal infections: 6%; complicated UTIs: 2%), constipation (2% to 4%), vomiting (complicated intra-abdominal infections: 3%, complicated UTIs: 1%), abdominal pain (≤1%)

Hematologic & oncologic: Anemia (≤2%), thrombocythemia (≤2%)

Hepatic: Increased serum ALT (2%), increased serum AST (1% to 2%)

Miscellaneous: Fever (complicated intra-abdominal infections: 6%; complicated UTIs: 2%)

<1% (Limited to important or life-threatening): Abdominal distention, angina pectoris, candidiasis, Clostridium difficile associated diarrhea, dyspnea, dyspepsia, flatulence, fungal urinary tract infection, gastritis, hyperglycemia, hypomagnesemia, hypophosphatemia, increased gamma-glutamyl transferase, increased serum alkaline phosphatase, infusion site reaction, nonhemorrhagic stroke, oropharyngeal candidiasis, paralytic ileus, positive direct Coombs test, renal failure, renal insufficiency, tachycardia, urticaria, venous thrombosis, vulvovaginal candidiasis

CrCl 30 to 50 mL/min: 750 mg (ceftolozane 500 mg- tazobactam 250 mg) IV infusion every 8 hours
CrCl 15 to 29 mL/min: 375 mg (ceftolozane 250 mg- tazobactam 125 mg) IV infusion every 8 hours

Comment:
For patients with changing renal function, monitor CrCl at least daily and adjust dose accordingly.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.