Imipenem-Cilastatin-Relebactam

Imipenem-Cilastatin-Relebactam is a prescription medication used to treat complicated infections such as  Pneumonia, Urinary Tract Infections, and Intra-abdominal Infections. 

• Imipenem-Cilastatin-Relebactam is available under the following different brand names: Recarbrio

Common side effects of Imipenem-Cilastatin-Relebactam include:

• Increased blood pressure,
• Nausea,
• Diarrhea,
• Vomiting,
• Abnormal liver function tests,
• Fever,
• Headache, and
• Pain, bruising, swelling, or irritation where the medicine was injected

Serious side effects of Imipenem-Cilastatin-Relebactam include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Tremors,
• Seizure,
• Severe stomach pain, and
• Watery or bloody diarrhea (even if it occurs months after the last dose)

Rare side effects of Imipenem-Cilastatin-Relebactam 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, 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

• 500 mg/500 mg/250 mg per vial (ie, 1.25g/vial)

Bacterial Pneumonia

Adult dosage

• 1.25 g Intravenous every 6 hours for 4-14 days

Urinary Tract Infection

Adult dosage

• 1.25 g Intravenous every 6 hours for 4-14 days

Intra-abdominal Infections

Adult dosage

• 1.25 g Intravenous every 6 hours for 4-14 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.

• Imipenem-Cilastatin-Relebactam has severe interactions with no other drugs.
• Imipenem-Cilastatin-Relebactam has serious interactions with the following drugs
  • BCG intravesical life
  • cholera vaccine
  • divalproex sodium
  • ganciclovir
  • probenecid
  • valacyclovir
  • valproic acid
• Imipenem-Cilastatin-Relebactam has moderate interactions with the following drugs
  • BCG vaccine live
  • cyclosporine
  • sodium picosulfate
  • sodium picosulfate/magnesium oxide/anhydrous citric acid
  • typhoid vaccine live
• Imipenem-Cilastatin-Relebactam 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 your products. 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, or if you have health questions or concerns.

Contraindications

• History of severe hypersensitivity to imipenem, cilastatin, sulbactam, or any other component

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Imipenem-Cilastatin-Relebactam?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Imipenem-Cilastatin-Relebactam?”

Cautions

• Serious and occasionally fatal hypersensitivity (anaphylactic) reactions are reported in patients receiving therapy with beta-lactams; carefully assess allergy history for the previous hypersensitivity to carbapenems, penicillins, cephalosporins, other beta-lactams, and other allergens
• Clostridium difficile-associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents; if CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C difficile may need to be discontinued
• Prescribing antibiotics 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 drug-resistant bacteria
• CNS adverse effects
  • CNS adverse reactions (.g, seizures, confusional states, myoclonic activity) reported with imipenem/cilastatin, especially if imipenem exceeds recommended dosage
  • Most commonly reported in patients with CNS disorders (.g, brain lesions, seizures) and/or compromised renal function
  • Continue anticonvulsant therapy in patients with known seizure disorders
  • If CNS adverse reactions occur, patients should undergo a neurological evaluation to determine if the drug should be discontinued
• Drug interaction overview
  • Ganciclovir: Generalized seizures reported with coadministration of ganciclovir and imipenem/cilastatin
  • Increased seizure potential with valproic acid
  • Coadministration with valproic acid or divalproex sodium may increase the risk of breakthrough seizures
  • Avoid concomitant use or consider alternative antibacterial drugs other than carbapenems
  • In vitro animal data suggest carbapenems may inhibit the hydrolysis of valproic acid's glucuronide metabolite (VPA-g) back to valproic acid, thus decreasing the serum concentrations of valproic acid

Pregnancy and Lactation

• Data are insufficient in pregnant women to establish whether there is a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Lactation
  • There are insufficient data on the presence of imipenem/cilastatin and sulbactam in human milk, and no data on the effects on the breastfed child, or the effects on milk production
  • Relebactam is present in the milk of lactating rats