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Primaxin I.V.

Last reviewed on RxList: 12/30/2014
Primaxin IV Side Effects Center

Last reviewed on RxList 12/22/2016

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. Common side effects of Primaxin I.V. include:

  • injection site reactions (swelling, redness, pain, or soreness),
  • upset stomach,
  • stomach pain,
  • nausea,
  • vomiting,
  • heartburn,
  • diarrhea,
  • sore throat,
  • vaginal itching or discharge,
  • skin rash or itching,
  • dizziness,
  • tired feeling,
  • numbness or tingling, or
  • ringing in your ears.

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

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

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.

Primaxin IV Consumer Information

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

Call your doctor at once if you have a serious side effect such as:

  • fast or pounding heartbeats;
  • diarrhea that is watery or bloody;
  • confusion, tremors, hallucinations, seizure (convulsions);
  • feeling light-headed, fainting;
  • fever, chills, body aches, flu symptoms;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • pain, swelling, or redness where the medicine was injected;
  • mild nausea, vomiting, heartburn, or stomach pain;
  • sore throat;
  • vaginal itching or discharge;
  • mild skin rash or itching;
  • dizziness or tired feeling;
  • numbness or tingling; or
  • ringing in your ears.

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 Primaxin IV (Imipenem and Cilastatin for Injection)

Primaxin IV Professional Information

SIDE EFFECTS

Adults

PRIMAXIN I.V. is generally well tolerated. Many of the 1,723 patients treated in clinical trials were severely ill and had multiple background diseases and physiological impairments, making it difficult to determine causal relationship of adverse experiences to therapy with PRIMAXIN I.V.

Local Adverse Reactions

Adverse local clinical reactions that were reported as possibly, probably, or definitely related to therapy with PRIMAXIN I.V. were:

Phlebitis/thrombophlebitis - 3.1%
Pain at the injection site - 0.7%
Erythema at the injection site - 0.4%
Vein induration - 0.2%
Infused vein infection - 0.1%

Systemic Adverse Reactions

The most frequently reported systemic adverse clinical reactions that were reported as possibly, probably, or definitely related to PRIMAXIN I.V. were nausea (2.0%), diarrhea (1.8%), vomiting (1.5%), rash (0.9%), fever (0.5%), hypotension (0.4%), seizures (0.4%) (see PRECAUTIONS), dizziness (0.3%), pruritus (0.3%), urticaria (0.2%), somnolence (0.2%).

Additional adverse systemic clinical reactions reported as possibly, probably, or definitely drug related occurring 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: Gastrointestinal - pseudomembranous colitis (the onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment, see WARNINGS), hemorrhagic colitis, hepatitis (including fulminant hepatitis), hepatic failure, jaundice, gastroenteritis, abdominal pain, glossitis, tongue papillar hypertrophy, staining of the teeth and/or tongue, heartburn, pharyngeal pain, increased salivation; Hematologic - pancytopenia, bone marrow depression, thrombocytopenia, neutropenia, leukopenia, hemolytic anemia; CNS - encephalopathy, tremor, confusion, myoclonus, paresthesia, vertigo, headache, psychic disturbances including hallucinations, dyskinesia, agitation; Special Senses - hearing loss, tinnitus, taste perversion; Respiratory - chest discomfort, dyspnea, hyperventilation, thoracic spine pain; Cardiovascular - palpitations, tachycardia; Skin - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, angioneurotic edema, flushing, cyanosis, hyperhidrosis, skin texture changes, candidiasis, pruritus vulvae; Body as a whole - polyarthralgia, asthenia/weakness, drug fever; Renal - acute renal failure, oliguria/anuria, polyuria, urine discoloration. The role of PRIMAXIN I.V. in changes in renal function is difficult to assess, since factors predisposing to pre-renal azotemia or to impaired renal function usually have been present.

Adverse Laboratory Changes

Adverse laboratory changes without regard to drug relationship that were reported during clinical trials or reported since the drug was marketed were:

Hepatic: Increased ALT (SGPT), AST (SGOT), alkaline phosphatase, bilirubin, and LDH

Hemic: Increased eosinophils, positive Coombs test, increased WBC, increased platelets, decreased hemoglobin and hematocrit, agranulocytosis, 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

In studies of 178 pediatric patients ≥ 3 months of age, the following adverse events were noted:

The Most Common Clinical Adverse Experiences Without Regard to Drug Relationship (Patient Incidence > 1%)

Adverse Experience No. of Patients (%)
Digestive System
  Diarrhea 7* (3.9)
  Gastroenteritis 2 (1.1)
  Vomiting 2* (1.1)
Skin
  Rash 4 (2.2)
  Irritation, I.V. site 2 (1.1)
Urogenital System
  Urine discoloration 2 (1.1)
Cardiovascular System
  Phlebitis 4 (2.2)
*One patient had both vomiting and diarrhea and is counted in each category.

In studies of 135 patients (newborn to 3 months of age), the following adverse events were noted:

The Most Common Clinical Adverse Experiences Without Regard to Drug Relationship (Patient Incidence > 1%)

Adverse Experience No. of Patients (%)
Digestive System
  Diarrhea 4 (3.0%)
  Oral Candidiasis 2 (1.5%)
Skin
  Rash 2 (1.5%)
Urogenital System
  Oliguria/anuria 3 (2.2%)
Cardiovascular System
  Tachycardia 2 (1.5%)
Nervous System
  Convulsions 8 (5.9%)

Patients ( ≥ 3 Months of Age) With Normal Pretherapy but Abnormal During Therapy Laboratory Values

Laboratory Parameter Abnormality No. of Patients With Abnormalities/ No. of Patients With Lab Done (%)
Hemoglobin Age
< 5 mos.: < 10 gm %
6 mos.-12 yrs.: < 11.5 gm %
19/129 (14.7)
Hematocrit Age
< 5 mos.: < 30 vol %
6 mos.-12 yrs.: < 34.5 vol %
23/129 (17.8)
Neutrophils ≤ 1000/mm³ (absolute) 4/123 (3.3)
Eosinophils ≥ 7% 15/117 (12.8)
Platelet Count ≥ 500 ths/mm³ 16/119 (13.4)
Urine Protein ≥ 1 8/97 (8.2)
Serum Creatinine > 1.2 mg/dL 0/105 (0)
BUN > 22 mg/dL 0/108 (0)
AST (SGOT) > 36 IU/L 14/78 (17.9)
ALT (SGPT) > 30 IU/L 10/93 (10.8)

Patients ( < 3 Months of Age) With Normal Pretherapy but Abnormal During Therapy Laboratory Values

Laboratory Parameter No. of Patients With Abnormalities* (%)
Eosinophil Count↑ 11 (9.0%)
Hematocrit↓ 3 (2.0%)
Hematocrit↑ 1 (1.0%)
Platelet Count↑ 5 (4.0%)
Platelet Count↓ 2 (2.0%)
Serum Creatinine↑ 5 (5.0%)
Bilirubin↑ 3 (3.0%)
Bilirubin↓ 1 (1.0%)
AST (SGOT)↑ 5 (6.0%)
ALT (SGPT)↑ 3 (3.0%)
Serum Alkaline Phosphate↑ 2 (3.0%)
*The denominator used for percentages was the number of patients for whom the test was performed during or posttreatment and, therefore, varies by test.

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

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

Related Resources for Primaxin IV

Read the Primaxin IV User Reviews »

© 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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