Primaxin IV Side Effects

Generic Name: imipenem-cilastatin

Please note - some side effects for Primaxin IV 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 IV - for the Consumer

Primaxin IV

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 IV:

Mild diarrhea; nausea; vomiting.

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

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; pain, swelling, or redness at the injection site; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe stomach cramps or pain; shortness of breath; swelling of the hands or feet; 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 IV Side Effects - for the Professional

Primaxin IV

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%), 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; 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 (%)
* One patient had both vomiting and diarrhea and is counted in each category.
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)

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 %	19/129 (14.7)
		6 mos. – 12 yrs.:	<11.5 gm %
Hematocrit	Age	<5 mos.:	<30 vol %	23/129 (17.8)
		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* (%)
* The denominator used for percentages was the number of patients for whom the test was performed during or post-treatment and, therefore, varies by test.
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%)

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

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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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