Merrem IV

What Is Merrem IV?

Merrem IV (meropenem) is an antibiotic used to treat certain types of bacterial infections. It is administered intravenously. Merrem is used in the treatment of infections of the abdomen, such as appendicitis and peritonitis, bacterial meningitis (infection of the lining of the brain), and skin infections.

What Are Side Effects of Merrem IV?

Side effects of Merrem include:

• nausea,
• vomiting,
• diarrhea,
• constipation,
• headache, or
• soreness, redness, or swelling at the injection site.

Merrem IV During Pregnancy and Breastfeeding

Adequate and well-controlled studies of this drug in pregnant women are lacking, and this drug should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk.

Additional Information

Our Merrem IV Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Merrem IV Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;
• a seizure (convulsions);
• sores or white patches in your mouth or throat (yeast infection or "thrush");
• severe tingling or numbness; or
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects may include:

• headache;
• nausea, vomiting, diarrhea, constipation;
• rash; or
• anemia.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Merrem IV (Meropenem)

 

Merrem IV Professional Information

SIDE EFFECTS

The following are discussed in greater detail in other sections of labeling:

• Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
• Severe Cutaneous Adverse Reactions [see WARNINGS AND PRECAUTIONS]
• Seizure Potential [see WARNINGS AND PRECAUTIONS]
• Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid [see WARNINGS AND PRECAUTIONS]
• Clostridium difficile – associated Diarrhea [see WARNINGS AND PRECAUTIONS]
• Development of Drug-Resistant Bacteria [see WARNINGS AND PRECAUTIONS]
• Overgrowth of Nonsusceptible Organisms [see WARNINGS AND PRECAUTIONS]
• Thrombocytopenia [see WARNINGS AND PRECAUTIONS]
• Potential for Neuromotor Impairment [see WARNINGS AND PRECAUTIONS]

Adverse Reactions From Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adult Patients

During clinical investigations, 2904 immunocompetent adult patients were treated for non-CNS infections with MERREM IV (500 mg or 1 gram every 8 hours). Deaths in 5 patients were assessed as possibly related to meropenem; 36 (1.2%) patients had meropenem discontinued because of adverse events. Many patients in these trials were severely ill and had multiple background diseases, physiological impairments and were receiving multiple other drug therapies. In the seriously ill patient population, it was not possible to determine the relationship between observed adverse events and therapy with MERREM IV.

The following adverse reaction frequencies were derived from the clinical trials in the 2904 patients treated with MERREM IV.

Local Adverse Reactions

Local adverse events that were reported with MERREM IV were as follows:

Inflammation at the injection site	2.4%
Injection site reaction	0.9%
Phlebitis/thrombophlebitis	0.8%
Pain at the injection site	0.4%
Edema at the injection site	0.2%

Systemic Adverse Reactions

Systemic adverse events that were reported with MERREM IV occurring in greater than 1.0% of the patients were diarrhea (4.8%), nausea/vomiting (3.6%), headache (2.3%), rash (1.9%), sepsis (1.6%), constipation (1.4%), apnea (1.3%), shock (1.2%), and pruritus (1.2%).

Additional systemic adverse events that were reported with MERREM IV and occurring in less than or equal to 1.0% but greater than 0.1% of the patients are listed below within each body system in order of decreasing frequency:

Bleeding events were seen as follows: gastrointestinal hemorrhage (0.5%), melena (0.3%), epistaxis (0.2%), hemoperitoneum (0.2%).

Body as a Whole: pain, abdominal pain, chest pain, fever, back pain, abdominal enlargement, chills, pelvic pain

Cardiovascular: heart failure, heart arrest, tachycardia, hypertension, myocardial infarction, pulmonary embolus, bradycardia, hypotension, syncope

Digestive System: oral moniliasis, anorexia, cholestatic jaundice/jaundice, flatulence, ileus, hepatic failure, dyspepsia, intestinal obstruction

Hemic/Lymphatic: anemia, hypochromic anemia, hypervolemia

Metabolic/Nutritional: peripheral edema, hypoxia

Nervous System: insomnia, agitation, delirium, confusion, dizziness, seizure, nervousness, paresthesia, hallucinations, somnolence, anxiety, depression, asthenia [see WARNINGS AND PRECAUTIONS]

Respiratory: respiratory disorder, dyspnea, pleural effusion, asthma, cough increased, lung edema

Skin and Appendages: urticaria, sweating, skin ulcer

Urogenital System: dysuria, kidney failure, vaginal moniliasis, urinary incontinence

Adverse Laboratory Changes

Adverse laboratory changes that were reported and occurring in greater than 0.2% of the patients were as follows:

Hepatic: increased alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase, lactate dehydrogenase (LDH), and bilirubin

Hematologic: increased platelets, increased eosinophils, decreased platelets, decreased hemoglobin, decreased hematocrit, decreased white blood cell (WBC), shortened prothrombin time and shortened partial thromboplastin time, leukocytosis, hypokalemia

Renal: increased creatinine and increased blood urea nitrogen (BUN)

Urinalysis: presence of red blood cells

Complicated Skin and Skin Structure Infections
In a study of complicated skin and skin structure infections, the adverse reactions were similar to those listed above. The most common adverse events occurring in greater than 5% of the patients were: headache (7.8%), nausea (7.8%), constipation (7.0%), diarrhea (7.0%), anemia (5.5%), and pain (5.1%). Adverse events with an incidence of greater than 1%, and not listed above, include: pharyngitis, accidental injury, gastrointestinal disorder, hypoglycemia, peripheral vascular disorder, and pneumonia.

Patients With Renal Impairment

For patients with varying degrees of renal impairment, the incidence of heart failure, kidney failure, seizure and shock reported with MERREM IV, increased in patients with moderately severe renal impairment (creatinine clearance 10 to 26 mL/min) [see DOSAGE AND ADMINISTRATION,WARNINGS AND PRECAUTIONS, Use In Specific Populations and CLINICAL PHARMACOLOGY].

Pediatric Patients

Systemic and Local Adverse Reactions

Pediatric Patients with Serious Bacterial Infections (excluding Bacterial Meningitis):

MERREM IV was studied in 515 pediatric patients (3 months to less than 13 years of age) with serious bacterial infections (excluding meningitis, see next section) at dosages of 10 mg/kg to 20 mg/kg every 8 hours. The types of systemic and local adverse events seen in these patients are similar to the adults, with the most common adverse events reported as possibly, probably, or definitely related to MERREM IV and their rates of occurrence as follows:

Diarrhea	3.5%
Rash	1.6%
Nausea and Vomiting	0.8%

Pediatric Patients with Bacterial Meningitis

MERREM IV was studied in 321 pediatric patients (3 months to less than 17 years of age) with meningitis at a dosage of 40 mg/kg every 8 hours. The types of systemic and local adverse events seen in these patients are similar to the adults, with the most common adverse reactions reported as possibly, probably, or definitely related to MERREM IV and their rates of occurrence as follows:

Diarrhea	4.7%
Rash (mostly diaper area moniliasis)	3.1%
Oral Moniliasis	1.9%
Glossitis	1.0%

In the meningitis studies, the rates of seizure activity during therapy were comparable between patients with no CNS abnormalities who received meropenem and those who received comparator agents (either cefotaxime or ceftriaxone). In the MERREM IV treated group, 12/15 patients with seizures had late onset seizures (defined as occurring on day 3 or later) versus 7/20 in the comparator arm. The meropenem group had a statistically higher number of patients with transient elevation of liver enzymes.

Pediatric Patients (Neonates and Infants less than 3 months of Age)

MERREM IV was studied in 200 neonates and infants less than 3 months of age. The study was open-label, uncontrolled, 98% of the infants received concomitant medications, and the majority of adverse events were reported in neonates less than 32 weeks gestational age and critically ill at baseline, making it difficult to assess the relationship of the adverse events to MERREM IV.

The adverse reactions seen in these patients that were reported and their rates of occurrence are as follows:

Convulsion	5.0%
Hyperbilirubinemia (conjugated)	4.5%
Vomiting	2.5%

Adverse Laboratory Changes in Pediatric Patients

Laboratory changes seen in the pediatric studies, including the meningitis studies, were similar to those reported in the adult studies.

Post Marketing Experience

The following adverse reactions have been identified during post-approval use of MERREM IV. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Worldwide post-marketing adverse reactions not otherwise listed in the Adverse Reactions from Clinical Trials section of this prescribing information and reported as possibly, probably, or definitely drug related are listed within each body system in order of decreasing severity.

Blood And Lymphatic System Disorders: agranulocytosis, neutropenia, and leukopenia; a positive direct or indirect Coombs test, and hemolytic anemia.

Immune System Disorders: angioedema.

Skin And Subcutaneous Disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme and acute generalized exanthematous pustulosis.

Read the entire FDA prescribing information for Merrem IV (Meropenem)