PRIMAXIN I.M.

In 686 patients in multiple dose clinical trials of PRIMAXIN I.M., the following adverse reactions were reported:

Local Adverse Reactions

The most frequent adverse local clinical reaction that was reported as possibly, probably, or definitely related to therapy with PRIMAXIN I.M. was pain at the injection site (1.2%).

Systemic Adverse Reactions

The most frequently reported systemic adverse clinical reactions that were reported as possibly, probably, or definitely related to PRIMAXIN I.M. were nausea (0.6%), diarrhea (0.6%), vomiting (0.3%) and rash (0.4%).

Adverse Laboratory Changes

Adverse laboratory changes without regard to drug relationship that were reported during clinical trials were:

Hemic: decreased hemoglobin and hematocrit, eosinophilia, increased and decreased WBC, increased and decreased platelets, decreased erythrocytes, and increased prothrombin time.

Hepatic: increased AST, ALT, alkaline phosphatase, and bilirubin.

Renal: increased BUN and creatinine.

Urinalysis: presence of red blood cells, white blood cells, casts, and bacteria in the urine.

Potential ADVERSE EFFECTS

In addition, a variety of adverse effects, not observed in clinical trials with PRIMAXIN I.M., have been reported with intravenous administration of PRIMAXIN I.V. (Imipenem and Cilastatin for Injection). Those listed below are to serve as alerting information to physicians.

Systemic Adverse Reactions

The most frequently reported systemic adverse clinical reactions that were reported as possibly, probably, or definitely related to PRIMAXIN I.V. (Imipenem and Cilastatin for Injection) were fever, hypotension, seizures (see PRECAUTIONS), dizziness, pruritus, urticaria, and somnolence.

Additional adverse systemic clinical reactions reported possibly, probably, or definitely drug related 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 antibiotic 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, seizures, paresthesia, vertigo, headache, psychic disturbances including hallucinations; Special Senses: hearing loss, tinnitus, taste perversion; Respiratory: chest discomfort, dyspnea, hyperventilation, thoracic spine pain; Cardiovascular: palpitations, tachycardia; Renal: acute renal failure, oliguria/anuria, polyuria, urine discoloration; Skin: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, angioneurotic edema, flushing, cyanosis, hyperhidrosis, skin texture changes, candidiasis, pruritus vulvae; Body as a whole: polyarthralgia, asthenia/weakness, drug fever.

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 LDH; Hemic: positive Coombs test, decreased neutrophils, agranulocytosis, increased monocytes, abnormal prothrombin time, increased lymphocytes, increased basophils;

Electrolytes: decreased serum sodium, increased potassium, increased chloride; Urinalysis: presence of urine protein, urine bilirubin, and urine urobilinogen.

Lidocaine HCl — Refer to the package circular for lidocaine HCl.

Since concomitant administration of PRIMAXIN (Imipenem-Cilastatin Sodium) 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 I.M.

PRIMAXIN I.M. should not be mixed with or physically added to other antibiotics. However, PRIMAXIN I.M. may be administered concomitantly with other antibiotics, such as aminoglycosides.

Decreased serum levels of valproic acid with co-administration of carbapenem antibiotics have been reported during post-marketing and in some cases breakthrough seizures have occurred. Careful monitoring of serum levels of valproic acid should be considered if imipenem is to be co-administered with valproic acid.

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