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The following serious and otherwise important adverse reaction is described in greater detail in the WARNINGS AND PRECAUTIONS section of the label:
Anaphylactic Reactions [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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Multiple-dose Dosing Regimens with 7 to 10 Days' Duration: In multiple-dose clinical trials, 912 subjects were treated with CEFTIN (125 to 500 mg twice daily). It is noted that 125 mg twice daily is not an approved dosage. Twenty (2.2%) subjects discontinued medication due to adverse reactions. Seventeen (85%) of the 20 subjects who discontinued therapy did so because of gastrointestinal disturbances, including diarrhea, nausea, vomiting, and abdominal pain. The percentage of subjects treated with CEFTIN who discontinued study drug because of adverse reactions was similar at daily doses of 1,000, 500, and 250 mg (2.3%, 2.1%, and 2.2%, respectively). However, the incidence of gastrointestinal adverse reactions increased with the higher recommended doses.
The adverse reactions in Table 5 are for subjects (n = 912) treated with CEFTIN in multiple-dose clinical trials.
Table 5: Adverse Reactions ( ≥ 1%) after
Multiple-dose Regimens with CEFTIN Tablets
(n = 912)
|Blood and lymphatic system disorders|
|Transient elevation in AST||2%|
|Transient elevation in ALT||2%|
|Transient elevation in LDH||1%|
The following adverse reactions occurred in less than 1% but greater than 0.1% of subjects (n = 912) treated with CEFTIN in multiple-dose clinical trials.
Immune System Disorders: Hives, swollen tongue.
Metabolism and Nutrition Disorders: Anorexia.
Nervous System Disorders: Headache.
Cardiac Disorders: Chest pain.
Respiratory Disorders: Shortness of breath.
Skin and Subcutaneous Tissue Disorders: Rash, itch
Renal and Urinary Disorders: Dysuria.
General Disorders and Administration Site Conditions: Chills, sleepiness, thirst.
Investigations: Positive Coombs' test.
5-Day Regimen: In clinical trials using CEFTIN 250 mg twice daily in the treatment of secondary bacterial infections of acute bronchitis, 399 subjects were treated for 5 days and 402 subjects were treated for 10 days. No difference in the occurrence of adverse reactions was found between the 2 regimens.
Early Lyme Disease with 20-Day Regimen: Two multicenter trials assessed CEFTIN 500 mg twice daily for 20 days. The most common drug-related adverse experiences were diarrhea (10.6%), Jarisch-Herxheimer reaction (5.6%), and vaginitis (5.4%). Other adverse experiences occurred with frequencies comparable to those reported with 7 to 10 days' dosing. Single-dose Regimen for Uncomplicated Gonorrhea: In clinical trials using a single 1,000mg dose of CEFTIN, 1,061 subjects were treated for uncomplicated gonorrhea.
The adverse reactions in Table 6 were for subjects treated with a single dose of 1,000 mg CEFTIN in US clinical trials.
Table 6: Adverse Reactions ( ≥ 1%) after
Single-dose Regimen with 1,000-mg CEFTIN Tablets for Uncomplicated Gonorrhea
(n = 1,061)
The following adverse reactions occurred in less than 1% but greater than 0.1% of subjects (n = 1,061) treated with a single dose of CEFTIN 1,000 mg for uncomplicated gonorrhea in US clinical trials.
Infections and Infestations: Vaginal candidiasis.
Nervous System Disorders: Headache, dizziness, somnolence.
Cardiac Disorders: Tightness/pain in chest, tachycardia.
Gastrointestinal Disorders: Abdominal pain, dyspepsia.
Musculoskeletal and Connective Tissue Disorders: Muscle cramps, muscle stiffness, muscle spasm of neck, lockjaw-type reaction.
Reproductive System and Breast Disorders: Vaginal itch, vaginal discharge.
In clinical trials using multiple doses of CEFTIN, pediatric subjects (96.7% were younger than 12 years) were treated with CEFTIN (20 to 30 mg/kg/day divided twice daily up to a maximum dose of 500 or 1,000 mg/day, respectively). Eleven (1.2%) US subjects discontinued medication due to adverse reactions. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or vomiting. Thirteen (1.4%) US pediatric subjects discontinued therapy due to the taste and/or problems with drug administration.
The adverse reactions in Table 7 are for US subjects (n = 931) treated with CEFTIN in multiple-dose clinical trials.
Table 7: Adverse Reactions ( ≥ 1%) after
Multiple-dose Regimens with CEFTIN for Oral Suspension
(n = 931)
|Dislike of taste||5%|
|Skin and subcutaneous tissue disorders|
The following adverse reactions occurred in less than 1% but greater than 0.1% of US subjects (n = 931) treated with CEFTIN for oral suspension in multiple-dose clinical trials.
Blood and Lymphatic System Disorders: Eosinophilia.
Psychiatric Disorders: Hyperactivity, irritable behavior.
Gastrointestinal Disorders: Abdominal pain, flatulence, ptyalism.
Skin and Subcutaneous Tissue Disorders: Rash.
Musculoskeletal and Connective Tissue Disorders: Joint swelling, arthralgia.
Reproductive System and Breast Disorders: Vaginal irritation.
General Disorders and Administration Site Conditions: Cough, fever.
Investigations: Elevated liver enzymes, positive Coombs' test.
The following adverse reactions have been identified during post-approval use of CEFTIN. 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.
Blood and Lymphatic System Disorders
Immune System Disorders
Anaphylaxis, serum sickness-like reaction.
Increased prothrombin time.
Nervous System Disorders
Renal and Urinary Disorders
Skin and Subcutaneous Tissue Disorders
Read the Ceftin (cefuroxime axetil) Side Effects Center for a complete guide to possible side effects
Cefuroxime axetil may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. Counsel patients to consider alternate supplementary (non-hormonal) contraceptive measures during treatment.
Drugs That Reduce Gastric Acidity
Drugs that reduce gastric acidity may result in a lower bioavailability of CEFTIN compared with administration in the fasting state. Administration of drugs that reduce gastric acidity may negate the food effect of increased absorption of CEFTIN when administered in the postprandial state. Administer CEFTIN at least 1 hour before or 2 hours after administration of short-acting antacids. Histamine-2 (H2) antagonists and proton pump inhibitors should be avoided.
Concomitant administration of probenecid with cefuroxime axetil tablets increases serum concentrations of cefuroxime [see CLINICAL PHARMACOLOGY]. Co-administration of probenecid with cefuroxime axetil is not recommended.
Drug/Laboratory Test Interactions
A false-positive reaction for glucose in the urine may occur with copper reduction tests (e.g., Benedict's or Fehling's solution), but not with enzyme-based tests for glycosuria. As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood/plasma glucose levels in patients receiving cefuroxime axetil. The presence of cefuroxime does not interfere with the assay of serum and urine creatinine by the alkaline picrate method.
Read the Ceftin Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 11/28/2016
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