Ceftin (Cefuroxime Axetil) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

CEFTIN TABLETS IN CLINICAL TRIALS

7 to 10 Days Dosing

Multiple-Dose Dosing Regimens

Using multiple doses of cefuroxime axetil tablets, 912 patients were treated with cefuroxime axetil (125 to 500 mg twice daily). There were no deaths or permanent disabilities thought related to drug toxicity. Twenty (2.2%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. Seventeen (85%) of the 20 patients who discontinued therapy did sobecause of gastrointestinal disturbances, including diarrhea, nausea, vomiting, and abdominal pain. The percentage of cefuroxime axetil tablet-treated patients who discontinued study drug because of adverse events was very 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 events increased with the higher recommended doses.

The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroximeaxetil tablets in multiple-dose clinical trials (n = 912 cefuroxime axetil-treated patients).

Table 4. Adverse Reactions—CEFTIN Tablets Multiple-Dose Dosing Regimens—Clinical Trials

Incidence≥1%	Diarrhea/loose stools 3.7% Nausea/vomiting 3.0% Transient elevation in AST 2.0% Transient elevation in ALT 1.6% Eosinophilia 1.1% Transient elevation in LDH 1.0%
Incidence <1% but >0.1%	Abdominal pain Abdominal cramps Flatulence Indigestion Headache Vaginitis Vulvar itch Rash Hives Itch Dysuria Chills Chest pain Shortness of breath Mouth ulcers Swollen tongue Sleepiness Thirst Anorexia Positive Coombs test

5-Day Experience (see CLINICAL STUDIES section)

In clinical trials using CEFTIN in a dose of 250 mg twice daily in the treatment of secondary bacterial infections of acute bronchitis, 399 patients were treated for 5 days and 402 patients were treated for 10 days. No difference in the occurrence of adverse events was found between the 2 regimens.

In Clinical Trials for Early Lyme Disease With 20 Days Dosing

Two multicenter trials assessed cefuroxime axetil tablets 500 mg twice a day for 20 days. The most common drug-related adverse experiences were diarrhea (10.6% of patients), 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 dose of cefuroxime axetil tablets, 1,061 patients were treated with the recommended dosage of cefuroxime axetil (1,000 mg) for the treatment of uncomplicated gonorrhea. There were no deaths or permanent disabilities thought related to drug toxicity in these studies.

The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroxime axetil in 1,000-mg single-dose clinical trials of cefuroxime axetil tablets in the treatment of uncomplicated gonorrhea conducted in the United States.

Table 5. Adverse Reactions—CEFTIN Tablets 1-g Single­Dose Regimen for Uncomplicated Gonorrhea—Clinical Trials

Incidence≥1%	Nausea/vomiting 6.8% Diarrhea 4.2%
Incidence <1% but >0.1%	Abdominal pain Dyspepsia Erythema Rash Pruritus Vaginal candidiasis Vaginal itch Vaginal discharge Headache Dizziness Somnolence Muscle cramps Muscle stiffness Muscle spasm of neck Tightness/pain in chest Bleeding/pain in urethra Kidney pain Tachycardia Lockjaw­type reaction

CEFTIN FOR ORAL SUSPENSION IN CLINICAL TRIALS

In clinical trials using multiple doses of cefuroxime axetil powder for oral suspension, pediatric patients (96.7% of whom were younger than 12 years of age) were treated with the recommended dosages of cefuroxime axetil (20 to 30 mg/kg/day divided twice a day up to a maximum dose of 500 or 1,000 mg/day, respectively). There were no deaths or permanent disabilities in any of the patients in these studies. Eleven US patients (1.2%) discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or vomiting. During clinical trials, discontinuation of therapy due to the taste and/or problems with administering this drug occurred in 13 (1.4%) pediatric patients enrolled at centers in the United States.

The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroxime axetil for oral suspension in multiple-dose clinical trials (n = 931 cefuroxime axetil-treated US patients).

Table 6. Adverse Reactions—CEFTIN for Oral Suspension: Multiple­Dose Dosing Regimens—Clinical Trials

Incidence≥1%	Diarrhea/loose stools 8.6% Dislike of taste 5.0% Diaper rash 3.4% Nausea/vomiting 2.6%
Incidence <1% but >0.1%	Abdominal pain Flatulence Gastrointestinal infection Candidiasis Vaginal irritation Rash Hyperactivity Irritable behavior Eosinophilia Positive direct Coombs test Elevated liver enzymes Viral illness Upper respiratory infection Sinusitis Cough Urinary tract infection Joint swelling Arthralgia Fever Ptyalism

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO CEFTIN

Possible Ceftin side effects / adverse reactions in 88 year old female

Reported by a consumer/non-health professional from United States on 2007-01-31

Patient: 88 year old female weighing 54.4 kg (119.7 pounds)

Reactions: Blood Urine Present, Vomiting, Wheezing, Rash Erythematous, Faecal Incontinence, Oedema, Asthenia, Faeces Discoloured

Adverse event resulted in: hospitalization

Suspect drug(s):
Ceftin
    Dosage: one twice daily orally
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2007-01-01
    End date: 2007-01-15

Ceftin
    Dosage: one twice daily orally
    Administration route: Oral
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2007-01-01
    End date: 2007-01-15

Avelox
    Dosage: one tablet once daily orally
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2007-01-16
    End date: 2007-01-23

Other drugs received by patient: Oxygen

Possible Ceftin side effects / adverse reactions in 32 year old female

Reported by a consumer/non-health professional from United States on 2007-02-05

Patient: 32 year old female weighing 68.2 kg (150.0 pounds)

Reactions: Skin Exfoliation, Corneal Scar, Blindness, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Ceftin

Other drugs received by patient: Ibuprofen; Dexamethasone; Rocephin; Excedrin (Migraine)

Possible Ceftin side effects / adverse reactions in 33 year old male

Reported by a consumer/non-health professional from United States on 2007-03-13

Patient: 33 year old male weighing 86.2 kg (189.6 pounds)

Reactions: Fatigue, Diarrhoea, Haemorrhoids, Impaired Work Ability, Asthenia, Muscle Spasms

Suspect drug(s):
Ceftin