avycaz
Pharmaranks rates Avycaz 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Avycaz is a combination medicine containing Avibactam Sodium and Ceftazidime.
Avibactam Sodium and Ceftazidime · by Abbvie
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
What is Avycaz?
From the FDA label:AVYCAZ is an antibacterial combination product consisting of the semisynthetic cephalosporin ceftazidime pentahydrate and the beta-lactamase inhibitor avibactam sodium for intravenous administration. Ceftazidime Ceftazidime is a semisynthetic, beta-lactam antibacterial drug. It is the pentahydrate of (6 R ,7 R , Z )-7-(2-(2-aminothiazol-4-yl)-2-(2-carboxypropan-2-yloxyimino)acetamido)-8-oxo-3-(pyridinium-1-ylmethyl)-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylate. Its molecular weight is 636.6. The empirical formula is C 22 H 32 N 6 O 12 S 2 . Figure 1. Chemical structure of ceftazidime pentahydrate Avibactam Avibactam sodium chemical name is sodium [(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl] sulfate. Its molecular weight is 287.23. The empirical formula is C 7 H 10 N 3 O 6 SNa. Figure 2. Chemical structure of avibactam sodium AVYCAZ 2.5 grams (ceftazidime and avibactam) for injection is a white to yellow sterile powder for constitution consisting of ceftazidime pentahydrate and avibactam sodium packaged in glass vials. The formulation also contains sodium carbonate. Each AVYCAZ 2.5 grams single-dose vial contains ceftazidime 2 grams (equivalent to 2.601 grams sterile ceftazidime pentahydrate/sodium carbonate) and avibactam 0.5 grams (equivalent to 0.544 grams sterile avibactam sodium). The sodium carbonate content of the mixture is 236.5 mg/vial. The…
How to use
Dosage of AVYCAZ in Adult Patients with Creatinine Clearance ( CrCl ) greater than 50 mL/min ( 2.1 ) Infection Dose Frequency Infusion Time cIAI * , cUTI including Pyelonephritis, and HABP/VABP AVYCAZ 2.5 grams (ceftazidime 2 grams and avibactam 0.5 grams) Every 8 hours 2 hours * Used in conjunction with metronidazole 0.5 g intravenously every 8 hours in adult cIAI patients Dosage of AVYCAZ in Pediatric Patients aged 2 years to less than 18 years with Estimated Glomerular Filtration Rate (eGFR) greater than 50 mL/min/1.73 m 2 and in Pediatric Patients less than 2 years of age without Renal Impairment ( 2.2 ) Infection Age Range Dose Infusion Time/ Frequency cIAI * , cUTI including Pyelonephritis, HABP/VABP 2 years to less than 18 years AVYCAZ 62.5 mg/kg to a maximum of 2.5 grams (ceftazidime 50 mg/kg and avibactam 12.5 mg/kg to a maximum dose of ceftazidime 2 grams and avibactam 0.5 grams) 2 hours/ Every 8 hours 6 months to less than 2 years AVYCAZ 62.5 mg/kg (ceftazidime 50 mg/kg and avibactam 12.5 mg/kg) 3 months to less than 6 months AVYCAZ 50 mg/kg (ceftazidime 40 mg/kg and avibactam 10 mg/kg) Greater than 28 days a to less than 3 months AVYCAZ 37.5 mg/kg (ceftazidime 30 mg/kg and avibactam 7.5 mg/kg) Less than or equal to 28 days b with GA 31 weeks and older AVYCAZ 25 mg/kg (ceftazidime 20 mg/kg and avibactam 5 mg/kg) * Used in conjunction with metronidazole 10 mg/kg…
Side effects
The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [ see Warnings and Precautions ( 5.2 ) ] Clostridi oid e s difficile -Associated Diarrhea [ see Warnings and Precautions ( 5.3 ) ] Central Nervous System Reactions [ see Warnings and Precautions ( 5.4 ) ] Adult Patients : The most common adverse reactions in cIAI (≥ 5%, when used with metronidazole) patients are diarrhea, nausea and vomiting. The most common adverse reactions (3%) in cUTI patients are diarrhea and nausea. The most common adverse reactions (≥ 5%) in HABP/VABP patients were diarrhea and vomiting. ( 6.1 ) Pediatric Patients (aged 3 months to less than 18 years) : The most common adverse reactions (≥ 3%) in pediatric patients aged 3 months and older were vomiting, diarrhea, rash, and infusion site phlebitis. ( 6.1 ) Pediatric Patients (less than 3 months of age) : The most common adverse reactions (>3 %) in pediatric patients less than 3 months of age were vomiting and increased transaminases. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial s Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the…
Warnings
Important safety information
Decreased Clinical Response in A dult cIAI P atients with B aseline CrC l of 30 to L ess T han or E qual to 50 mL/ min : Monitor CrCl at least daily in adult and pediatric patients with changing renal function and adjust the dosage of AVYCAZ accordingly. ( 5.1 ) Hypersensitivity R eactions : Includes anaphylaxis and serious skin reactions. Cross sensitivity may occur in patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue AVYCAZ. ( 5.2 ) Clostrid io i des difficile -associated D iarrhea (CDAD) : CDAD has been reported with nearly all systemic antibacterial agents, including AVYCAZ. Evaluate if diarrhea occurs. ( 5.3 ) C entral Nervous System Reactions : Seizures and other neurologic events may occur, especially in patients with renal impairment. Adjust dose in patients with renal impairment. ( 5.4 ) 5.1 Decreased Clinical Response in Adult cIAI Patients with Baseline Creatinine Clearance of 30 to Less Than or Equal to 50 mL/min In a Phase 3 cIAI trial in adult patients, clinical cure rates were lower in a subgroup of patients with baseline CrCl of 30 to less than or equal to 50 mL/min compared to those with CrCl greater than 50 mL/min (Table 10). The reduction in clinical cure rates was more marked in patients treated with AVYCAZ plus metronidazole compared to meropenem-treated patients. Within this subgroup, patients treated with AVYCAZ received a 33% lower daily dose than is currently recommended for patients with CrCl 30 to less than or equal to 50 mL/min. The decreased clinical response was not observed for patients with moderate renal impairment at baseline (CrCl of 30 to less than or equal to 50 mL/min) in the Phase 3 cUTI trials or the Phase 3 HABP/VABP trial. Monitor CrCl at least daily in adult and pediatric patients with changing renal function and adjust the dosage of AVYCAZ accordingly [ see Dosage and Administration ( 2.2 , 2.3 ) , and Adverse Reactions ( 6.1 ) ] . Table 10. Clinical Cure Rate at Test of Cure in a Phase 3 cIAI Trial, by Baseline Renal Function – mMITT Population a AVYCAZ + Metronidazole % (n/N) Meropenem % (n/N) Normal function / mild impairment (CrCl greater than 50 mL/min) 85% (322/379) 86% (321/373) Moderate impairment (CrCl 30 to less than or equal to 50 mL/min) 45% (14/31) 74% (26/35) a Microbiological modified intent-to-treat (mMITT) population included patients who had at least one bacterial pathogen at baseline and received at least one dose of study drug. 5. 2 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with AVYCAZ is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be made. Exercise caution if this product is to be given to a penicillin or other beta-lactam-allergic patient because cross sensitivity among beta-lactam antibacterial drugs has been established. Discontinue the drug if an allergic reaction to AVYCAZ occurs. 5. 3 Clostridi oides difficile- associated Diarrhea Clostridi oides difficile -associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial drugs, including AVYCAZ, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial drugs 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. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. 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 drugs. If CDAD is suspected or confirmed, antibacterial drugs not directed against C. difficile may need to be discontinued. Manage fluid and electrolyte levels as appropriate, supplement protein intake, monitor antibacterial treatment of C. difficile , and institute surgical evaluation as clinically indicated. 5. 4 Central Nervous System Reactions Seizures, nonconvulsive status epilepticus (NCSE), encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported in patients treated with ceftazidime, particularly in the setting of renal impairment. Adjust dosing based on creatinine clearance [ see Dosage and Administration ( 2.2 ) ] . 5. 5 Development of Drug-Resistant Bacteria Prescribing AVYCAZ in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria [see Indications and Usage ( 1.4 )] .
Who should not take Avycaz
AVYCAZ is contraindicated in patients with known serious hypersensitivity to the components of AVYCAZ (ceftazidime and avibactam), avibactam containing products, or other members of the cephalosporin class [see Warnings and Precautions ( 5.2 )] . AVYCAZ is contraindicated in patients with known serious hypersensitivity to the components of AVYCAZ (ceftazidime and avibactam), avibactam-containing products or other members of the cephalosporin class. ( 4 )
Overdose — what happens if you take too much
In the event of overdose, discontinue AVYCAZ and institute general supportive treatment. Ceftazidime and avibactam can be removed by hemodialysis. In subjects with end-stage renal disease (ESRD) administered 1 gram ceftazidime, the mean total recovery in dialysate following a 4-hour hemodialysis session was 55% of the administered dose. In subjects with ESRD administered 100 mg avibactam, the mean total recovery in dialysate following a 4-hour hemodialysis session started 1 hour after dosing was approximately 55% of the dose. No clinical information is available on the use of hemodialysis to treat AVYCAZ overdosage [ see Clinical Pharmacology ( 12.3 ) ].
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
7.1 Probenecid In vitro , avibactam is a substrate of OAT1 and OAT3 transporters which might contribute to the active uptake from the blood compartment, and thereby its excretion. As a potent OAT inhibitor, probenecid inhibits OAT uptake of avibactam by 56% to 70% in vitro and, therefore, has the potential to decrease the elimination of avibactam when co-administered. Because a clinical interaction study of AVYCAZ or avibactam alone with probenecid has not been conducted, co-administration of AVYCAZ with probenecid is not recommended [ see Clinical Pharmacology ( 12.3 ) ] . 7.2 Drug/Laboratory Test Interactions The administration of ceftazidime may result in a false-positive reaction for glucose in the urine with certain methods. It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.
Dosage forms
Powder
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- How is Avycaz rated?
- pharmaranks gives Avycaz a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Avycaz?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Avycaz. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Avycaz?
- Avycaz is marketed by Abbvie. You can see Abbvie's full profile, rating, and other products on pharmaranks.
- Is Avycaz a brand-name or generic drug?
- Avycaz is a brand-name product with the active ingredient Avibactam Sodium and Ceftazidime.
- Is Avycaz available over the counter?
- No. Avycaz is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Avycaz come in?
- Avycaz is currently marketed as powder, per the FDA's National Drug Code Directory.
- Is Avycaz FDA-registered?
- Avycaz is on record with the U.S. FDA under application number NDA206494. You can verify this on its official FDA label.
- Has Avycaz been recalled by the FDA?
- Avycaz has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Avycaz safe?
- There's no single safe-or-not verdict. pharmaranks gives Avycaz a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Avycaz?
- Avycaz's side effects are taken directly from its FDA label. From the label: The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [ see Warnings and Precautions ( 5.2 ) ] Clostridi oid e s difficile -Associated Diarrhea [ see Warnings and Precautions ( 5.3 ) ] Central Nervous System Reactions [ se… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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avycaz
72/100