Primaxin IV Side Effects Center

Last updated on RxList: 8/3/2022
Primaxin IV Side Effects Center

What Is Primaxin IV?

Primaxin I.V. (imipenem and cilastatin) for Injection is a combination of an antibiotic and a drug that helps the antibiotic work more effectively by preventing the breakdown of the antibiotic in the kidneys, used to treat severe infections of the lower respiratory tract, skin, stomach, female reproductive organs, and other body systems. Primaxin I.V. is available in generic form.

What Are Side Effects of Primaxin IV?

Common side effects of Primaxin I.V. include:

Tell your doctor if you have serious side effects of Primaxin I.V. including:

Primaxin IV may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • severe stomach pain,
  • diarrhea that is watery or bloody,
  • upper stomach pain,
  • loss of appetite,
  • yellowing of the skin or eyes,
  • seizure,
  • fever, and
  • lightheadedness

Get medical help right away, if you have any of the symptoms listed above.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • 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.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Primaxin IV

The total daily dosage for Primaxin I.V. is based on the type or severity of infection, the patient's renal function, and body weight.

What Drugs, Substances, or Supplements Interact with Primaxin IV?

Primaxin I.V. may interact with valproic acid, ganciclovir, probenecid, or antibiotics. Tell your doctor all medications you use.

Primaxin IV During Pregnancy or Breastfeeding

During pregnancy, Primaxin I.V. should be used only when prescribed. This medication passes into breast milk. Though there have been no reports of harm to nursing infants, consult your doctor before breastfeeding.

Additional Information

Our Primaxin I.V. (imipenem and cilastatin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

QUESTION

Bowel regularity means a bowel movement every day. See Answer
Primaxin IV Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;
  • upper stomach pain, loss of appetite;
  • jaundice (yellowing of the skin or eyes);
  • a seizure (convulsions);
  • fever; or
  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • pain, swelling, redness, bruising, or hardening where the medicine was injected;
  • dizziness, drowsiness;
  • nausea, vomiting, diarrhea; or
  • itching, rash.

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.

SLIDESHOW

Fungal Skin Infections: Types, Symptoms, and Treatments See Slideshow
Primaxin IV Professional Information

SIDE EFFECTS

The following serious adverse reactions are described in greater detail in the Warnings and Precautions section.

  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Seizure Potential [see WARNINGS AND PRECAUTIONS]
  • Increased Seizure Potential Due to Interaction with Valproic Acid [see WARNINGS AND PRECAUTIONS]
  • Clostridioides difficile-Associated Diarrhea (CDAD) [see WARNINGS AND PRECAUTIONS]
  • Development of Drug-Resistant Bacteria [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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

Adult Patients

During clinical investigations 1,723 patients were treated with PRIMAXIN. Table 4 shows the incidence of adverse reactions reported during the clinical investigations of adult patients treated with PRIMAXIN.

Table 4: Incidence (%)* of Adverse Reactions Reported During Clinical Investigations of Adult Patients Treated with PRIMAXIN

Body System Adverse Reactions Frequency (%)
Local Administration site Phlebitis/thrombophlebitis 3.1%
Pain at the injection site 0.7%
Erythema at the injection site 0.4%
Vein in duration 0.2%
Gastrointestinal Nausea 2.0%
Diarrhea 1.8%
Vomiting 1.5%
Skin Rash 0.9%
Pruritus 0.3%
Urticaria 0.2%
Vascular Hypotension 0.4%
Body as a Whole Fever 0.5%
Nervous system Seizures 0.4%
Dizziness 0.3%
Somnolence 0.2%
*Adverse reactions with an incidence ≥0.2% of PRIMAXIN-treated adult patients.

Additional adverse reactions reported in less than 0.2% of the patients or reported since the drug was marketed are listed within each body system in order of decreasing severity [see Table 5].

Table 5: Additional Adverse Reactions Occurring in Less than 0.2% of Adult Patients Listed within Each Body System in Order of Decreasing Severity

Body System Adverse Reactions
Gastrointestinal Pseudo membranous Colitis (the onset of Pseudo membranous colitis symptoms), Hemorrhagic Colitis
Gastroenteritis
Abdominal Pain
Glossitis
Tongue Papillar
Hypertrophy
Heartburn
Pharyngeal Pain
Increased Salivation
CNS Encephalopathy
Confusion
Myoclonus
Paresthesia
Vertigo
Headache
Special Senses Hearing Loss
Tinnitus
Respiratory Chest Discomfort
Dyspnea
Hyperventilation
Thoracic Spine Pain
Cardiovascular Palpitations
Tachycardia
Skin Erythema Multiforme
Angioneurotic Edema
Flushing
Cyanosis
Hyperhidrosis
Skin Texture Changes
Candidiasis
Pruritus Vulvae
Local Administration site Infused vein infection
Body as a Whole Polyarthralgia
Asthenia/Weakness
Renal Oliguria/Anuria
Polyuria

Adverse Laboratory Changes

The following adverse laboratory changes were reported during clinical trials:

Hepatic: Increased alanine aminotransferase (ALT or SGPT), aspartate aminotransferase (AST or SGOT), alkaline phosphatase, bilirubin, and lactate dehydrogenase(LDH)

Hemic: Increased eosinophils, positive Coombs test, increased WBC, increased platelets, decreased hemoglobin and hematocrit, increased monocytes, abnormal prothrombin time, increased lymphocytes, increased basophils

Electrolytes: Decreased serum sodium, increased potassium, increased chloride

Renal: Increased BUN, creatinine

Urinalysis: Presence of urine protein, urine red blood cells, urine white blood cells, urine casts, urine bilirubin, and urine urobilinogen.

Pediatric Patients

Table 6: Incidence (%)* of Adverse Reactions Reported During Clinical Investigations of Pediatric Patients Greater Than or Equal to 3 Months of Age Treated with PRIMAXIN

Body System Adverse Reactions Frequency (%)
Local Administration Site Phlebitis 2.2%
Intravenous Site Irritation 1.1%
Gastrointestinal Diarrhea 3.9%
Gastroenteritis 1.1%
Vomiting 1.1%
Skin Rash 2.2%
Renal Urine Discoloration 1.1%
*Adverse reactions that occurred in >1% of PRIMAXIN-treated pediatric patients (greater than or equal to 3 months of age)

Table 7: Incidence (%)* of Adverse Reactions Reported During Clinical Investigations of Pediatric Patients Neonates to 3 Months of Age Treated with PRIMAXIN

Body System Adverse Reactions Frequency (%)
Gastrointestinal Diarrhea 3%
CNS Convulsions 5.9%
Cardiovascular Tachycardia 1.5%
Skin Rash 1.5%
Body as a Whole Oral Candidiasis 1.5%
Renal Oliguria/Anuria 2.2%
*Adverse reactions that occurred in >1% of PRIMAXIN-treated pediatric patients (neonates to 3 months of age)

Adverse Laboratory Changes

The following adverse laboratory changes were reported in studies of 178 pediatric patients 3 months of age: increased AST (SGOT), decreased hemoglobin/hematocrit, increased platelets, increased eosinophils, increased ALT (SGPT), increased urine protein, decreased neutrophils.

The following adverse laboratory changes were reported in studies of 135 patients (neonates to 3 months of age): increased eosinophils, increased AST (SGPT),increased serum creatinine, increased/decreased platelet count, increased/decreased bilirubin, increased ALT (SGPT), increased alkaline phosphatase, increased/decreased hematocrit.

Post marketing Experience

The following adverse reactions have been identified during post-approval use of PRIMAXIN. 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.

Table 8: Adverse Reactions Identified During Post Approval Use of PRIMAXIN

Body System Adverse Reactions
Gastrointestinal Hepatitis (including fulminant hepatitis)
Hepatic failure
Jaundice
Staining of the teeth and/or tongue
Hematologic Pancytopenia
Bone marrow depression
Thrombocytopenia
Neutropenia
Leukopenia
Hemolytic anemia
CNS Tremor
Psychic disturbances including hallucinations
Dyskinesia
Agitation
Special Senses Taste perversion
Skin Stevens-Johnson syndrome
Toxic epidermal necrolysis
Body as a whole Drug fever
Renal Acute renal failure
Urine discoloration

Adverse Laboratory Changes

Adverse laboratory changes reported since the drug was marketed were:

Hematologic: agranulocytosis.

Examination of published literature and spontaneous adverse reactions reports suggested a similar spectrum of adverse reactions in adult and pediatric patients.

DRUG INTERACTIONS

Ganciclovir

Generalized seizures have been reported in patients who received ganciclovir and PRIMAXIN. These drugs should not be used concomitantly with PRIMAXIN unless the potential benefits outweigh the risks.

Probenecid

Concomitant administration of PRIMAXIN and probenecid results in increases in the plasma level and half-life of imipenem. Therefore, it is not recommended that probenecid be given concomitantly with PRIMAXIN.

Valproic Acid

Case reports in the literature have shown that co-administration of carbapenems, including PRIMAXIN, 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. Although the mechanism of this interaction is unknown, data from in vitro and animal studies suggest that 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 [see WARNINGS AND PRECAUTIONS]. The concomitant use of PRIMAXIN and valproic acid/divalproex sodium is generally not recommended. Antibacterials other than carbapenems should be considered to treat infections in patients whose seizures are well-controlled on valproic acid or divalproex sodium.

Read the entire FDA prescribing information for Primaxin IV (Imipenem and Cilastatin for Injection)

© Primaxin IV Patient Information is supplied by Cerner Multum, Inc. and Primaxin IV Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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