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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:
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:
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.
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 (%)|
|Irritation, I.V. site||2 (1.1)|
|Urine discoloration||2 (1.1)|
|*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
|Adverse Experience||No. of Patients (%)|
|Oral Candidiasis||2 (1.5%)|
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 (%)|
< 5 mos.: < 10 gm %
6 mos.-12 yrs.: < 11.5 gm %
< 5 mos.: < 30 vol %
6 mos.-12 yrs.: < 34.5 vol %
|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%)|
|Platelet Count↑||5 (4.0%)|
|Platelet Count↓||2 (2.0%)|
|Serum Creatinine↑||5 (5.0%)|
|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 Primaxin I.V. (imipenem and cilastatin for injection) Side Effects Center for a complete guide to possible side effects
Generalized seizures have been reported in patients who received ganciclovir and PRIMAXIN. These drugs should not be used concomitantly unless the potential benefits outweigh the risks.
Since concomitant administration of PRIMAXIN and probenecid results in only minimal increases in plasma levels of imipenem and plasma half-life, it is not recommended that probenecid be given with PRIMAXIN.
PRIMAXIN should not be mixed with or physically added to other antibiotics. However, PRIMAXIN may be administered concomitantly with other antibiotics, such as aminoglycosides.
Case reports in the literature have shown that co-administration of carbapenems, including imipenem, 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, Seizure Potential).
Read the Primaxin I.V. Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 12/30/2014
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