Imipenem, Cilastatin, and Relebactam Injection

gram-negative bacteria: A category of bacteria identified by a lab staining test; they have a particular outer membrane structure that makes them harder to kill and more prone to antibiotic resistance.

beta-lactamase inhibitor: A drug that blocks the enzyme some bacteria use to destroy beta-lactam antibiotics, restoring the antibiotic's ability to work.

beta-lactam antibiotic: A large family of antibiotics — including penicillins, cephalosporins, and carbapenems — that kill bacteria by targeting their cell walls.

carbapenem: A powerful class of beta-lactam antibiotics often used as a last resort for serious or resistant bacterial infections.

intravenous (IV): Delivered directly into a vein, allowing medication to enter the bloodstream immediately.

infusion: A slow, controlled delivery of liquid medication into a vein over a set period of time.

HABP: Hospital-acquired bacterial pneumonia — a lung infection that develops at least 48 hours after a patient is admitted to the hospital.

VABP: Ventilator-associated bacterial pneumonia — a lung infection that develops in patients who are on a mechanical breathing machine.

cUTI: Complicated urinary tract infection — a UTI involving the kidneys, an abnormal urinary tract, or occurring in a patient with other complicating medical factors.

pyelonephritis: A kidney infection, usually caused by bacteria traveling up from the bladder.

cIAI: Complicated intra-abdominal infection — a serious infection inside the abdominal cavity, often involving multiple organs or requiring surgery.

anaphylaxis: A severe, life-threatening allergic reaction that can cause breathing difficulty, a sudden drop in blood pressure, and shock.

Clostridioides difficile (C. diff): A type of bacteria that can overgrow in the gut after antibiotic use, causing severe diarrhea and potentially dangerous colon inflammation.

colitis: Inflammation of the colon (large intestine), which can cause severe diarrhea, cramping, and in serious cases, life-threatening complications.

valproic acid: An anti-seizure medication (also used for bipolar disorder) sold under brand names like Depakote; its levels can be dangerously lowered by carbapenem antibiotics.

divalproex sodium: Another form of valproic acid used to treat seizures and bipolar disorder; also affected by carbapenem antibiotics.

breakthrough seizure: A seizure that occurs in someone whose epilepsy was previously controlled, often because their anti-seizure medication level has dropped too low.

ganciclovir: An antiviral medication used to treat cytomegalovirus (CMV) infections; combining it with imipenem raises seizure risk.

hemodialysis: A medical procedure that filters waste and excess fluid from the blood using a machine, typically used for patients with severe kidney failure.

creatinine clearance (CLcr): A measure of how well the kidneys are filtering the blood, calculated from a blood test; used to adjust doses of drugs cleared by the kidneys.

eGFR: Estimated glomerular filtration rate — a calculation that estimates how well the kidneys are filtering blood, used especially in children to adjust drug doses.

renal impairment: Reduced kidney function, which affects how the body processes and clears certain medications.

half-life: The time it takes for the concentration of a drug in the bloodstream to fall by half; helps determine how often a drug needs to be given.

pharmacokinetics: The study of how the body absorbs, distributes, metabolizes, and eliminates a drug over time.

dehydropeptidase: An enzyme found in the kidneys that breaks down imipenem; cilastatin works by blocking this enzyme to keep imipenem active.

plasma protein binding: The degree to which a drug attaches to proteins in the blood; drugs that are highly bound may behave differently in the body than those that are not.

pulmonary epithelial lining fluid: The thin layer of fluid coating the inside of the lungs; antibiotic levels in this fluid indicate how well a drug can reach a lung infection.

volume of distribution: A measure of how widely a drug spreads throughout the body's tissues compared to its concentration in the blood.

MIC (minimum inhibitory concentration): The lowest concentration of an antibiotic needed to stop a specific bacterium from growing; used to gauge whether a drug dose will be effective.

QTc interval: A measurement on a heart tracing (ECG) that reflects how long it takes the heart to reset between beats; some drugs can prolong it and raise the risk of irregular heart rhythms.

myoclonic activity: Sudden, brief, involuntary muscle jerks or twitches; a type of seizure-related movement.

antibiotic resistance: When bacteria evolve to survive antibiotic treatment, making infections harder or impossible to treat with standard drugs.

susceptible bacteria: Bacteria that are killed or stopped by a particular antibiotic at standard treatment doses.

post-menstrual age: The age of an infant calculated by adding gestational age at birth to postnatal age; used to determine maturity-based dosing in newborns.

anemia: A condition where there are too few healthy red blood cells to carry enough oxygen around the body, often causing tiredness and weakness.

hypokalemia: Abnormally low potassium levels in the blood, which can affect heart and muscle function.

hyponatremia: Abnormally low sodium levels in the blood, which can cause symptoms ranging from nausea to confusion and seizures.

alanine aminotransferase (ALT): A liver enzyme measured in blood tests; elevated levels can signal liver stress or injury.

aspartate aminotransferase (AST): Another liver enzyme checked in blood tests; elevated levels may indicate liver or muscle damage.

phlebitis: Inflammation of a vein, often at or near an IV infusion site, causing redness, warmth, or pain.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clostridioides difficile: A type of gut germ that can overgrow and cause severe, watery diarrhea, often after antibiotic use.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

gestational age: How far along a pregnancy is, usually counted in weeks from the mother's last menstrual period.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.