Cefuroxime AXETIL 250 MG TABLET Side effects

How do you administer this medicine?
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What are the possible side effects of Cefuroxime AXETIL 250 MG TABLET?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

Less serious side effects may include:

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Cefuroxime AXETIL 250 MG TABLET in details

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Cefuroxime AXETIL 250 MG TABLET (Cefuroxime AXETIL 250 MG TABLET (Cefuroxime AXETIL 250 MG TABLET injection) injection) is generally well tolerated. The most common adverse effects have been local reactions following IV administration. Other adverse reactions have been encountered only rarely.

Local Reactions: Thrombophlebitis has occurred with IV administration in 1 in 60 patients.

Gastrointestinal: Gastrointestinal symptoms occurred in 1 in 150 patients and included diarrhea (1 in 220 patients) and nausea (1 in 440 patients). The onset of pseudomembranous colitis may occur during or after antibacterial treatment.

Hypersensitivity Reactions: Hypersensitivity reactions have been reported in fewer than 1% of the patients treated with Cefuroxime AXETIL 250 MG TABLET (Cefuroxime AXETIL 250 MG TABLET (Cefuroxime AXETIL 250 MG TABLET injection) injection) and include rash (1 in 125). Pruritus, urticaria, and positive Coombs' test each occurred in fewer than 1 in 250 patients, and, as with other cephalosporins, rare cases of anaphylaxis, drug fever, erythema multiforme, interstitial nephritis, toxic epidermal necrolysis, and Stevens-Johnson syndrome have occurred.

Blood: A decrease in hemoglobin and hematocrit has been observed in 1 in 10 patients and transient eosinophilia in 1 in 14 patients. Less common reactions seen were transient neutropenia (fewer than 1 in 100 patients) and leukopenia (1 in 750 patients). A similar pattern and incidence were seen with other cephalosporins used in controlled studies. As with other cephalosporins, there have been rare reports of thrombocytopenia.

Hepatic: Transient rise in SGOT and SGPT (1 in 25 patients), alkaline phosphatase (1 in 50 patients), LDH (1 in 75 patients), and bilirubin (1 in 500 patients) levels has been noted.

Kidney: Elevations in serum creatinine and/or blood urea nitrogen and a decreased creatinine clearance have been observed, but their relationship to Cefuroxime AXETIL 250 MG TABLET (Cefuroxime AXETIL 250 MG TABLET (Cefuroxime AXETIL 250 MG TABLET injection) injection) is unknown.

Postmarketing Experience with Cefuroxime AXETIL 250 MG TABLET (Cefuroxime AXETIL 250 MG TABLET (Cefuroxime AXETIL 250 MG TABLET injection) injection) : In addition to the adverse events reported during clinical trials, the following events have been observed during clinical practice in patients treated with Cefuroxime AXETIL 250 MG TABLET (Cefuroxime AXETIL 250 MG TABLET (Cefuroxime AXETIL 250 MG TABLET injection) injection) and were reported spontaneously. Data are generally insufficient to allow an estimate of incidence or to establish causation.

Neurologic: Seizure.

Non-site specific: Angioedema.

Cephalosporin-class Adverse Reactions: In addition to the adverse reactions listed above that have been observed in patients treated with Cefuroxime AXETIL 250 MG TABLET (Cefuroxime AXETIL 250 MG TABLET (Cefuroxime AXETIL 250 MG TABLET injection) injection), the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:

Adverse Reactions: Vomiting, abdominal pain, colitis, vaginitis including vaginal candidiasis, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, and hemorrhage.

Several cephalosporins, including Cefuroxime AXETIL 250 MG TABLET (Cefuroxime AXETIL 250 MG TABLET (Cefuroxime AXETIL 250 MG TABLET injection) injection), have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy should occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Altered Laboratory Tests: Prolonged prothrombin time, pancytopenia, agranulocytosis.

What is the most important information I should know about Cefuroxime AXETIL 250 MG TABLET?

Cefuroxime AXETIL 250 MG TABLET contraindications

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Cefuroxime AXETIL 250 MG TABLET (Cefuroxime AXETIL 250 MG TABLET (Cefuroxime AXETIL 250 MG TABLET injection) injection) for Injection USP and Dextrose Injection USP is contraindicated in patients with known allergy to the cephalosporin group of antibiotics. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

References

  1. European Chemicals Agency - ECHA. "Cefuroxime: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
  2. NCIt. "Cefuroxime: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
  3. KEGG. "Antiinfectives". http://www.genome.jp/kegg-bin/get_ht... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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