Primaxin IV
- Generic Name: imipenem and cilastatin for injection
- Brand Name: Primaxin I.V.
Primaxin I.V.(Imipenem and Cilastatin for Injection) side effects drug center
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:
- dark urine,
- easy bruising or bleeding,
- hearing changes (e.g., decreased hearing),
- mental/mood changes (e.g., confusion, hallucinations),
- persistent sore throat,
- fever,
- swollen tongue,
- yellowing eyes or skin, or
- muscle twitching or spasms.
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.
Primaxin IV Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- severe stomach pain, diarrhea that is watery or bloody;
- upper stomach pain, loss of appetite;
- jaundice (yellowing of the skin or eyes);
- a seizure (convulsions);
- fever; or
- a light-headed feeling, like you might pass out.
Common side effects may include:
- pain, swelling, redness, bruising, or hardening where the medicine was injected;
- dizziness, drowsiness;
- nausea, vomiting, diarrhea; or
- itching, rash.
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
The following serious adverse reactions are described in greater detail in the Warnings and Precautions section.
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Seizure Potential [see WARNINGS AND PRECAUTIONS]
- Increased Seizure Potential Due to Interaction with Valproic Acid [see WARNINGS AND PRECAUTIONS]
- Clostridium difficile-Associated Diarrhea (CDAD) [see WARNINGS AND PRECAUTIONS]
- Development of Drug-Resistant Bacteria [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adult Patients
During clinical investigations 1,723 patients were treated with PRIMAXIN. Table 4 shows the incidence of adverse reactions reported during the clinical investigations of adult patients treated with PRIMAXIN.
Table 4: Incidence (%)* of Adverse Reactions Reported
During Clinical Investigations of Adult Patients Treated with PRIMAXIN
| Body System | Adverse Reactions | Frequency (%) |
| Local Administration site | Phlebitis/thrombophlebitis | 3.1% |
| Pain at the injection site | 0.7% | |
| Erythema at the injection site | 0.4% | |
| Vein induration | 0.2% | |
| Gastrointestinal | Nausea | 2.0% |
| Diarrhea | 1.8% | |
| Vomiting | 1.5% | |
| Skin | Rash | 0.9% |
| Pruritus | 0.3% | |
| Urticaria | 0.2% | |
| Vascular | Hypotension | 0.4% |
| Body as a Whole | Fever | 0.5% |
| Nervous system | Seizures | 0.4% |
| Dizziness | 0.3% | |
| Somnolence | 0.2% | |
| * Adverse reactions with an incidence ≥ 0.2% of PRIMAXIN-treated adult patients. | ||
Additional adverse reactions reported 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 (see Table 5).
Table 5: Additional Adverse Reactions Occurring in
Less than 0.2% of Adult Patients Listed within Each Body System in Order of
Decreasing Severity
| Body System | Adverse Reactions |
| Gastrointestinal | Pseudomembranous Colitis (the onset of Pseudomembranous colitis symptoms), Hemorrhagic Colitis |
| Gastroenteritis | |
| Abdominal Pain | |
| Glossitis | |
| Tongue Papillar | |
| Hypertrophy | |
| Heartburn | |
| Pharyngeal Pain | |
| Increased Salivation | |
| CNS | Encephalopathy |
| Confusion | |
| Myoclonus | |
| Paresthesia | |
| Vertigo | |
| Headache | |
| Special Senses | Hearing Loss |
| Tinnitus | |
| Respiratory | Chest Discomfort |
| Dyspnea | |
| Hyperventilation | |
| Thoracic Spine Pain | |
| Cardiovascular | Palpitations |
| Tachycardia | |
| Skin | Erythema Multiforme |
| Angioneurotic Edema | |
| Flushing | |
| Cyanosis | |
| Hyperhidrosis | |
| Skin Texture Changes | |
| Candidiasis | |
| Pruritus Vulvae | |
| Local Administration site | Infused vein infection |
| Body as a Whole | Polyarthralgia |
| Asthenia/Weakness | |
| Renal | Oliguria/Anuria |
| Polyuria |
Adverse Laboratory Changes
The following adverse laboratory changes were reported during clinical trials:
Hepatic: Increased alanine aminotransferase (ALT or SGPT), aspartate aminotransferase (AST or SGOT), alkaline phosphatase, bilirubin, and lactate dehydrogenase (LDH)
Hemic: Increased eosinophils, positive Coombs test, increased WBC, increased platelets, decreased hemoglobin and hematocrit, 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
Table 6: Incidence (%)* of Adverse Reactions Reported
During Clinical Investigations of Pediatric Patients Greater Than or Equal to 3
Months of Age Treated with PRIMAXIN
| Body System | Adverse Reactions | Frequency (%) |
| Local Administration Site | Phlebitis | 2.2% |
| Intravenous Site Irritation | 1.1% | |
| Gastrointestinal | Diarrhea | 3.9% |
| Gastroenteritis | 1.1% | |
| Vomiting | 1.1% | |
| Skin | Rash | 2.2% |
| Renal | Urine Discoloration | 1.1% |
| *Adverse reactions that occurred in >1 % of PRIMAXIN-treated pediatric patients (greater than or equal to 3 months of age) | ||
Table 7: Incidence (%)* of Adverse Reactions Reported
During Clinical Investigations of Pediatric Patients Neonates to 3 Months of
Age Treated with PRIMAXIN
| Body System | Adverse Reactions | Frequency (%) |
| Gastrointestinal | Diarrhea | 3% |
| CNS | Convulsions | 5.9% |
| Cardiovascular | Tachycardia | 1.5% |
| Skin | Rash | 1.5% |
| Body as a Whole | Oral Candidiasis | 1.5% |
| Renal | Oliguria/Anuria | 2.2% |
| *Adverse reactions that occurred in >1 % of PRIMAXIN-treated pediatric patients (neonates to 3 months of age) | ||
Adverse Laboratory Changes
The following adverse laboratory changes were reported in studies of 178 pediatric patients 3 months of age: increased AST (SGOT), decreased hemoglobin/hematocrit, increased platelets, increased eosinophils, increased ALT (SGPT), increased urine protein, decreased neutrophils.
The following adverse laboratory changes were reported in studies of 135 patients (neonates to 3 months of age): increased eosinophils, increased AST (SGPT), increased serum creatinine, increased/decreased platelet count, increased/decreased bilirubin, increased ALT (SGPT), increased alkaline phosphatase, increased/decreased hematocrit.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of PRIMAXIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Table 8: Adverse Reactions Identified During Post
Approval Use of PRIMAXIN
| Body System | Adverse Reactions |
| Gastrointestinal | Hepatitis (including fulminant hepatitis) |
| Hepatic failure | |
| Jaundice | |
| Staining of the teeth and/or tongue | |
| Hematologic | Pancytopenia |
| Bone marrow depression | |
| Thrombocytopenia | |
| Neutropenia | |
| Leukopenia | |
| Hemolytic anemia | |
| CNS | Tremor |
| Psychic disturbances including hallucinations | |
| Dyskinesia | |
| Agitation | |
| Special Senses | Taste perversion |
| Skin | Stevens-Johnson syndrome |
| Toxic epidermal necrolysis | |
| Body as a whole | Drug fever |
| Renal | Acute renal failure |
| Urine discoloration |
Adverse Laboratory Changes
Adverse laboratory changes reported since the drug was marketed were:
Hematologic: agranulocytosis.
Examination of published literature and spontaneous adverse reactions reports suggested a similar spectrum of adverse reactions in adult and pediatric patients.
Read the entire FDA prescribing information for Primaxin IV (Imipenem and Cilastatin for Injection)
&Copy; 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.