Meropenem-vaborbactam
Generic Name: meropenem-vaborbactam
Brand Names:
Vabomere
11 DESCRIPTION VABOMERE (meropenem and vaborbactam) for injection is a combination product that contains meropenem, a synthetic penem antibacterial drug and vaborbactam, a cyclic boronic acid beta-lactamase inhibitor, for intravenous administration. Meropenem, present as a trihydrate, is a white to light yellow crystalline powder, with a molecular weight of 437.52.
Overview
11 DESCRIPTION VABOMERE (meropenem and vaborbactam) for injection is a combination product that contains meropenem, a synthetic penem antibacterial drug and vaborbactam, a cyclic boronic acid beta-lactamase inhibitor, for intravenous administration. Meropenem, present as a trihydrate, is a white to light yellow crystalline powder, with a molecular weight of 437.52.
Uses
1 INDICATIONS AND USAGE VABOMERE (meropenem and vaborbactam) is a combination of meropenem, a penem antibacterial, and vaborbactam, a beta-lactamase inhibitor, indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible bacteria. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of VABOMERE and other antibacterial drugs, VABOMERE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.2 ) 1.1.
Dosage
2 DOSAGE AND ADMINISTRATION Administer VABOMERE 4 grams (meropenem 2 grams and vaborbactam 2 grams) every 8 hours by intravenous infusion over 3 hours for up to 14 days, in patients 18 years of age and older with an estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m 2 . ( 2.1 ) Dosage adjustment is recommended in patients with renal impairment who have an eGFR less than 50 mL/min/ 1.73m 2 . ( 2.2 ) eGFR As calculated using the Modification of Diet in Renal Disease (MDRD) formula; (mL/min/ 1.73m 2 ) Recommended Dosage Regimen for VABOMERE (meropenem and vaborbactam) All doses of VABOMERE are administered intravenously over 3 hours; , Doses adjusted for renal impairment should be administered after a hemodialysis session; , The total duration of treatment is for up to 14 days.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Seizure Potential [see Warnings and Precautions (5.2) ] Rhabdomyolysis [see Warnings and Precautions (5.3) ] Clostridioides difficile -associated Diarrhea [see Warnings and Precautions (5.4) ] Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid [see Warnings and Precautions (5.5) ] Thrombocytopenia [see Warnings and Precautions (5.6) ] Potential for Neuromotor Impairment [see Warnings and Precautions (5.7) ] Development of Drug-Resistant Bacteria [see Warnings and Precautions (5.8) ] Overgrowth of Non-susceptible Organisms [see Warnings and Precautions (5.9) ] The most frequently re...
Interactions
7 DRUG INTERACTIONS Hormonal Contraceptives: Effectiveness may be reduced; use an effective alternative non-hormonal form of contraception or additional contraceptive method. ( 7.4 , 12.3 ) 7.1 Valproic Acid Case reports in the literature have shown that co-administration of carbapenems, including meropenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures.
Warnings
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions were reported with the use of VABOMERE. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterial drugs. Discontinue infusion if signs of acute hypersensitivity occur. ( 5.1 ) Seizures and other adverse Central Nervous System experiences have been reported during treatment with meropenem, a component of VABOMERE. ( 5.2 ) Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue VABOMERE and initiate appropriate therapy. ( 5.3 ) Clostridioides difficile -associated diarrhea has been reported with nearly all systemic antibacterial agents, including VABOMERE. Evaluate patients if diarrhea occurs. 4 CONTRAINDICATIONS VABOMERE is contraindicated in patients with known hypersensitivity to any components of VABOMERE (meropenem and vaborbactam), or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs [see Warnings and Precautions (5.1) ] .
Pregnancy
8.1 Pregnancy Risk Summary Fetal malformations were observed in vaborbactam-treated rabbits, therefore advise pregnant women of the potential risks to the fetus. There are insufficient human data to establish whether there is a drug-associated risk of major birth defects or miscarriages with VABOMERE, meropenem, or vaborbactam in pregnant women.
Storage
Store VABOMERE vials at 20°C to 25°C (68°F to 77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F) [see USP, Controlled Room Temperature (CRT)].
Frequently Asked Questions
What is Meropenem-vaborbactam used for?▼
1 INDICATIONS AND USAGE VABOMERE (meropenem and vaborbactam) is a combination of meropenem, a penem antibacterial, and vaborbactam, a beta-lactamase inhibitor, indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible bacteria. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of VABOMERE and other antibacterial drugs, VABOMERE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.2 ) 1.1.
What are the side effects of Meropenem-vaborbactam?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Seizure Potential [see Warnings and Precautions (5.2) ] Rhabdomyolysis [see Warnings and Precautions (5.3) ] Clostridioides difficile -associated Diarrhea [see Warnings and Precautions (5.4) ] Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid [see Warnings and Precautions (5.5) ] Thrombocytopenia [see Warnings and Precautions (5.6) ] Potential for Neuromotor Impairment [see Warnings and Precautions (5.7) ] Development of Drug-Resistant Bacteria [see Warnings and Precautions (5.8) ] Overgrowth of Non-susceptible Organisms [see Warnings and Precautions (5.9) ] The most frequently re...
Can I take Meropenem-vaborbactam during pregnancy?▼
8.1 Pregnancy Risk Summary Fetal malformations were observed in vaborbactam-treated rabbits, therefore advise pregnant women of the potential risks to the fetus. There are insufficient human data to establish whether there is a drug-associated risk of major birth defects or miscarriages with VABOMERE, meropenem, or vaborbactam in pregnant women.
What are the important warnings for Meropenem-vaborbactam?▼
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions were reported with the use of VABOMERE. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterial drugs. Discontinue infusion if signs of acute hypersensitivity occur. ( 5.1 ) Seizures and other adverse Central Nervous System experiences have been reported during treatment with meropenem, a component of VABOMERE. ( 5.2 ) Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue VABOMERE and initiate appropriate therapy. ( 5.3 ) Clostridioides difficile -associated diarrhea has been reported with nearly all systemic antibacterial agents, including VABOMERE. Evaluate patients if diarrhea occurs. 4 CONTRAINDICATIONS VABOMERE is contraindicated in patients with known hypersensitivity to any components of VABOMERE (meropenem and vaborbactam), or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs [see Warnings and Precautions (5.1) ] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.