Primaxin IM Side Effects

Generic Name: imipenem-cilastatin

Please note - some side effects for Primaxin IM may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Primaxin IM - for the Consumer

Primaxin IM

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Primaxin IM:

Mild diarrhea; minor pain, swelling, or redness at the injection site; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Primaxin IM:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; breathing problems; chest pain; dark urine; decreased urination; fast or irregular heartbeat; fever, chills, or sore throat; hearing loss; joint pain or tenderness; mental or mood changes (eg, agitation, anxiety, confusion); numbness or tingling of the skin; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe stomach cramps or pain; shortness of breath; swelling of the hands or feet; swelling or redness at the injection site; tremors or abnormal muscle movements; unusual bruising or bleeding; unusual tiredness or weakness; unusual vaginal odor or discharge; vein swelling or tenderness; white patches in the mouth; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Primaxin IM Side Effects - for the Professional

Primaxin IM

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, 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.

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Side Effects by Body System - for Healthcare Professionals

General

Imipenem is generally well tolerated.

Local

Local side effects associated with IV administration have included phlebitis or thrombophlebitis at the injection site (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%), and injection site reaction.

Gastrointestinal

Gastrointestinal side effects have included nausea (2%), vomiting (1.5%), and diarrhea (1.8%). Pseudomembranous colitis, hemorrhagic colitis, gastroenteritis, abdominal pain, glossitis, tongue papillar hypertrophy, staining of the teeth or tongue, heartburn, pharyngeal pain, and increased salivation have been reported in less than 0.2% of patients. Constipation has also been reported.

Nervous system

Seizures may be dose-related and are generally reported in patients with renal insufficiency, central nervous system pathology (stroke or neoplasm), or a history of seizure disorder, head trauma, or alcoholism.

A 49-year-old woman with advanced ovarian adenocarcinoma experienced severe myoclonus of the upper extremities while receiving imipenem 500 mg every 6 hours. The myoclonus started to improve within 12 hours of imipenem discontinuation.

Neurologic side effects have included seizures (0.4%), dizziness (0.3%), and somnolence (0.2%). Encephalopathy, tremors, confusion, myoclonus, paresthesia, vertigo, headache, psychic disturbances, including hallucinations have been reported in less than 0.2% of patients. Exacerbation of myasthenia gravis has also been reported.

Dermatologic

Dermatologic side effects have included rash (0.9%), pruritus (0.3%), and urticaria (0.2%). Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, angioneurotic edema, flushing cyanosis, hyperhidrosis, skin texture changes and candidiasis have been reported in less than 0.2% of patients.

Hypersensitivity

One study demonstrated an increased incidence of allergic reactions in patients with cystic fibrosis who were given imipenem.

Hypersensitivity to imipenem is unusual. However, fever, pruritus, rash, eosinophilia, or positive direct Coombs' test may indicate the presence of hypersensitivity. Patients allergic to other beta-lactam antibiotics may be allergic to imipenem.

Cardiovascular

Cardiovascular side effects have rarely included hypotension, palpitations, and tachycardia.

Genitourinary

Genitourinary side effects have included pruritus vulvae and urine discoloration in less than 0.2% of patients. Urine protein, red and/or white blood cells, casts, bacteria, bilirubin, and urobilinogen have also been reported.

Hematologic

Hematologic side effects have included pancytopenia, bone marrow depression, neutropenia, thrombocytosis, thrombocytopenia, leukopenia, and hemolytic anemia in less than 0.2% of patients. Increased eosinophils, positive Coombs test, increased white blood cells, increased platelets, decreased hemoglobin and hematocrit, anemia, agranulocytosis, increased monocytes, abnormal prothrombin time, increased lymphocytes, and increased basophils have also been reported.

Hepatic

Hepatic side effects have included hepatitis (including fulminant hepatitis) and jaundice in less than 0.2% of patients. Transient elevations in liver function tests (ALT, AST, alkaline phosphatase, bilirubin, and LDH) and hepatic failure have also been reported.

Metabolic

Metabolic side effects have included decreased serum sodium, increased potassium, and increased chloride.

Musculoskeletal

Musculoskeletal side effects have included polyarthralgia in less than 0.2% of patients.

Renal

Renal side effects have included acute renal failure, oliguria, anuria, and polyuria in less than 0.2% of patients. Increased BUN and creatinine have also been reported.

Respiratory

Respiratory side effects have included chest discomfort, dyspnea, hyperventilation, and thoracic spine pain in less than 0.2% of patients.

Other

Up to 4% of patients treated with imipenem develop superinfection during therapy. The most common organisms are Enterococcus faecium, Stenotrophomonas maltophilia, methicillin-resistant Staphylococcus aureus, and Candida species.

Other

Other side effects have included hearing loss, tinnitus, taste perversion, drug fever, and asthenia/weakness in less than 0.2% of patients. Pain has also been reported.

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