Sulbactam-Durlobactam

Sulbactam-Durlobactam is a prescription medication used for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (ABC).

• Sulbactam-Durlobactam is available under the following different brand names: Xacduro

Common side effects of Sulbactam-Durlobactam include:

• headache
• nausea
• injection-site phlebitis

Serious side effects of Sulbactam-Durlobactam include:

• not available

Rare side effects of Sulbactam-Durlobactam 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, coordination loss, 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, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because 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 dosage

Injection, powder for reconstitution

• Copackaged kit containing each component in separate vials
• Sulbactam: 1 g/vial (1 clear, single-dose vial/kit), PLUS
• Durlobactam: 0.5 g/vial (2 amber, single-dose vials/kit)

Acinetobacter baumannii-calcoaceticus infection

Adult dosage

• 2 g (1 g Sulbactam and 1 g Durlobactam) IV every 6 hours infused over 3 hours
• Recommended duration of treatment is 7–14 days; adjust the duration of therapy to the patient’s clinical status

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, healthcare provider, or pharmacist first.

• Sulbactam-Durlobactam has severe interactions with no other drugs
• Sulbactam-Durlobactam has serious interactions with at least 25 other drugs
• Sulbactam-Durlobactam has moderate interactions with no other drugs
• Sulbactam-Durlobactam has minor interactions with no 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 the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of known severe hypersensitivity to Sulbactam and Durlobactam, or other beta-lactam antibacterial drugs

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Sulbactam-Durlobactam?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Sulbactam-Durlobactam?”

Cautions

• Hypersensitivity
  • Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions were reported in patients receiving beta-lactam antibacterial drugs
  • These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity and/or a history of sensitivity to multiple allergens
• Clostridioides difficile-associated diarrhea (CDAD)
  • CDAD is reported with the use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis
  • Treatment with antibacterial agents alters the normal flora of the colon, leading to C difficile overgrowth that produces toxins A and B, which contribute to CDAD development
  • Hypertoxin-producing C difficile strains cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy
  • Consider CDAD if diarrhea occurs following antibacterial drug use
  • Careful medical history is necessary since CDAD has been reported to occur over 2 months after antibacterial administration; if severe watery or bloody diarrhea develops, the patient should contact their healthcare provider
  • If CDAD is suspected or confirmed, assess the risk/benefit of continuing treatment
  • Institute appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C difficile, and surgical evaluation, as clinically indicated
• Drug-resistant bacteria
  • Prescribing antibiotics in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit and increases the risk of developing drug-resistant bacteria
• Drug interaction overview
  • Organic anion transporter 1 (OAT1) substrate
    • OAT1 inhibitors
    • Avoid coadministration
    • OAT1 inhibitors may increase plasma concentrations of Sulbactam-Durlobactam

Pregnancy and Lactation

• There is no available data on using sulbactam plus Durlobactam in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Sulbactam: Available published data from case reports and case series with sulbactam use in combination with ampicillin during pregnancy over many decades have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Durlobactam: No human data is available
• Lactation
  • There is no data on the presence of Durlobactam in human or animal milk
  • Sulbactam is present in human milk in low concentrations