mitant use of RECARBRIO with valproic acid or divalproexsodium may reduce the serum concentration of valproic acidwhich may increase the risk of breakthrough seizures. Avoidconcomitant use or consider alternative antibacterial drugs otherthan carbapenems. (5.3, 7.2)
Clostridium difficile-Associated Diarrhea (CDAD): Has beenreported with imipenem/cilastatin plus relebactam. eva luate ifdiarrhea occurs. (5.4)
ADVERSE REACTIONS
The most frequently reported adverse reactions occurring in greaterthan or equal to 2 % of patients treated with imipenem/cilastatin plusrelebactam 250 mg were diarrhea, nausea, headache, vomiting,alanine aminotransferase increased, aspartate aminotransferaseincreased, phlebitis/infusion site reactions, pyrexia, and hypertension.(6)
To report SUSPECTED ADVERSE REACTIONS, contact MerckSharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Ganciclovir: Avoid concomitant use. (7.1)
Valproic Acid or Divalproex Sodium: Avoid concomitant use. (7.2)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 07/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Complicated Urinary Tract Infections (cUTI), includingPyelonephritis
1.2 Complicated Intra-abdominal Infections (cIAI)
1.3 Usage
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage in Adults
2.2 Dosage Adjustments in Patients with Renal Impairment
2.3 Preparation of RECARBRIO Solution for IntravenousAdministration
2.4 Preparation of RECARBRIO Solution for IntravenousAdministration in Patients with Renal Impairment
2.5 Storage of Constituted Solution
2.6 Incompatible Injectable Drug Products
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
5.2 Seizures and Other Central Nervous System (CNS)Adverse Reactions
5.3 Increased Seizure Potential Due to Interaction with ValproicAcid
5.4 Clostridium difficile-Associated Diarrhea (CDAD)
5.5 Development of Drug-Resistant Bacteria
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Ganciclovir
7.2 Valproic Acid
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing informationare not listed.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Complicated Urinary Tract Infections (cUTI), including Pyelonephritis
RECARBRIOTM is indicated in patients 18 years of age and older who have limited or no alternativetreatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis,caused by the following susceptible gram-negative microorganisms: Enterobacter cloacae, Escherichiac |
