Data from FDA - Curated by EPG Health - Last updated 06 November 2017

Indication(s)

1 INDICATIONS AND USAGE CEFTIN is a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1) •Pharyngitis/tonsillitis (adults and pediatric patients) (1.1) •Acute bacterial otitis media (pediatric patients) (1.2) •Acute bacterial maxillary sinusitis (adults and pediatric patients) (1.3) •Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) (1.4) •Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) (1.5) •Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) (1.6) •Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) (1.7) •Early Lyme disease (adults and pediatric patients 13 years and older) (1.8) •Impetigo (pediatric patients) (1.9) To reduce the development of drug-resistant bacteria and maintain the effectiveness of CEFTIN and other antibacterial drugs, CEFTIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.1 Pharyngitis/Tonsillitis CEFTIN tablets are indicated for the treatment of adult patients and pediatric patients (13 years and older) with mild-to-moderate pharyngitis/tonsillitis caused by susceptible strains of Streptococcus pyogenes. CEFTIN for oral suspension is indicated for the treatment of pediatric patients aged 3 months to 12 years with mild-to-moderate pharyngitis/tonsillitis caused by susceptible strains of Streptococcus pyogenes. Limitations of Use •The efficacy of CEFTIN in the prevention of rheumatic fever was not established in clinical trials. •The efficacy of CEFTIN in the treatment of penicillin‑resistant strains of Streptococcus pyogenes has not been demonstrated in clinical trials. 1.2 Acute Bacterial Otitis Media CEFTIN tablets are indicated for the treatment of pediatric patients (who can swallow tablets whole) with acute bacterial otitis media caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase–producing strains), Moraxella catarrhalis (including β-lactamase–producing strains), or Streptococcus pyogenes. CEFTIN for oral suspension is indicated for the treatment of pediatric patients aged 3 months to 12 years with acute bacterial otitis media caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase–producing strains), Moraxella catarrhalis (including β-lactamase–producing strains), or Streptococcus pyogenes. 1.3 Acute Bacterial Maxillary Sinusitis CEFTIN tablets are indicated for the treatment of adult and pediatric patients (13 years and older) with mild-to-moderate acute bacterial maxillary sinusitis caused by susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae (non-β‑lactamase–producing strains only). CEFTIN for oral suspension is indicated for the treatment of pediatric patients aged 3 months to 12 years with mild-to-moderate acute bacterial maxillary sinusitis caused by susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae (non-β‑lactamase–producing strains only). Limitations of Use The effectiveness of CEFTIN for sinus infections caused by β-lactamase–producing Haemophilus influenzae or Moraxella catarrhalis in patients with acute bacterial maxillary sinusitis was not established due to insufficient numbers of these isolates in the clinical trials [see Clinical Studies (14.1)]. 1.4 Acute Bacterial Exacerbations of Chronic Bronchitis CEFTIN tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with mild-to-moderate acute bacterial exacerbations of chronic bronchitis caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae (β‑lactamase–negative strains), or Haemophilus parainfluenzae (β‑lactamase–negative strains). 1.5 Uncomplicated Skin and Skin Structure Infections CEFTIN tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated skin and skin-structure infections caused by susceptible strains of Staphylococcus aureus (including β-lactamase–producing strains) or Streptococcus pyogenes. 1.6 Uncomplicated Urinary Tract Infections CEFTIN tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated urinary tract infections caused by susceptible strains of Escherichia coli or Klebsiella pneumoniae. 1.7 Uncomplicated Gonorrhea CEFTIN tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated gonorrhea, urethral and endocervical, caused by penicillinase-producing and non‑penicillinase–producing susceptible strains of Neisseria gonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by non‑penicillinase–producing susceptible strains of Neisseria gonorrhoeae. 1.8 Early Lyme Disease (erythema migrans) CEFTIN tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with early Lyme disease (erythema migrans) caused by susceptible strains of Borrelia burgdorferi. 1.9 Impetigo CEFTIN for oral suspension is indicated for the treatment of pediatric patients aged 3 months to 12 years with impetigo caused by susceptible strains of Staphylococcus aureus (including β-lactamase–producing strains) or Streptococcus pyogenes. 1.10 Usage To reduce the development of drug‑resistant bacteria and maintain the effectiveness of CEFTIN and other antibacterial drugs, CEFTIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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Advisory information

contraindications
4 CONTRAINDICATIONS CEFTIN is contraindicated in patients with a known hypersensitivity (e.g., anaphylaxis) to CEFTIN or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins). Known hypersensitivity (e.g., anaphylaxis) to CEFTIN or to other β‑lactams (e.g., penicillins and cephalosporins). (4)
Adverse reactions
6 ADVERSE REACTIONS 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 [5.1)] The most common adverse reactions (≥3%) for CEFTIN tablets are diarrhea, nausea/vomiting, Jarisch‑Herxheimer reaction, and vaginitis (early Lyme disease). (6.1) The most common adverse reactions (≥2%) for CEFTIN for oral suspension are diarrhea, dislike of taste, diaper rash, and nausea/vomiting. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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. Tablets 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 Adverse Reaction CEFTIN (n = 912) Blood and lymphatic system disorders Eosinophilia 1% Gastrointestinal disorders Diarrhea 4% Nausea/Vomiting 3% Investigations 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. Gastrointestinal Disorders: Abdominal pain, abdominal cramps, flatulence, indigestion, mouth ulcers. Skin and Subcutaneous Tissue Disorders: Rash, itch. Renal and Urinary Disorders: Dysuria. Reproductive System and Breast Disorders: Vaginitis, vulvar itch. General Disorders and Administration Site Conditions: Chills, sleepiness, thirst. Investigations: Positive Coombs’ test. 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 1,000-mg 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 U.S. clinical trials. Table 6. Adverse Reactions (≥1%) after Single‑Dose Regimen with 1,000-mg CEFTIN Tablets for Uncomplicated Gonorrhea Adverse Reaction CEFTIN (n = 1,061) Gastrointestinal disorders Nausea/Vomiting 7% Diarrhea 4% 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 U.S. 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. Skin and Subcutaneous Tissue Disorders: Erythema, rash, pruritus. Musculoskeletal and Connective Tissue Disorders: Muscle cramps, muscle stiffness, muscle spasm of neck, lockjaw-type reaction. Renal and Urinary Disorders: Bleeding/pain in urethra, kidney pain. Reproductive System and Breast Disorders: Vaginal itch, vaginal discharge. Oral Suspension 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%) U.S. subjects discontinued medication due to adverse reactions. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or vomiting. Thirteen (1.4%) U.S. pediatric subjects discontinued therapy due to the taste and/or problems with drug administration. The adverse reactions in Table 7 are for U.S. 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 Adverse Reaction CEFTIN (n = 931) Gastrointestinal disorders Diarrhea 9% Dislike of taste 5% Nausea/vomiting 3% Skin and subcutaneous tissue disorders Diaper rash 3% The following adverse reactions occurred in less than 1% but greater than 0.1% of U.S. subjects (n = 931) treated with CEFTIN for oral suspension in multiple‑dose clinical trials. Infections and Infestations: Gastrointestinal infection, candidiasis, viral illness, upper respiratory infection, sinusitis, urinary tract infection. 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. 6.2 Postmarketing Experience 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 Hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia. Gastrointestinal Disorders Pseudomembranous colitis [see Warnings and Precautions (5.2)]. Hepatobiliary Disorders Hepatic impairment including hepatitis and cholestasis, jaundice. Immune System Disorders Anaphylaxis, serum sickness‑like reaction. Investigations Increased prothrombin time. Nervous System Disorders Seizure, encephalopathy. Renal and Urinary Disorders Renal dysfunction. Skin and Subcutaneous Tissue Disorders Angioedema, erythema multiforme, Stevens‑Johnson syndrome, toxic epidermal necrolysis, urticaria.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION •Tablets and oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis. (2.1) •Administer tablets with or without food. (2.2) •Administer oral suspension with food. (2.3) •Administer CEFTIN tablets or CEFTIN for oral suspension as described in the dosage guidelines. (2.2, 2.3, 2.4) •Dosage adjustment is required for patients with impaired renal function. (2.5) Adult Patients and Pediatric Patients Dosage Guidelines for CEFTIN Tablets (2.2) Infection Dosage Duration (Days) Adults and Adolescents (13 years and older) Pharyngitis/tonsillitis (mild to moderate) 250 mg every 12 hours 10 Acute bacterial maxillary sinusitis (mild to moderate) 250 mg every 12 hours 10 Acute bacterial exacerbations of chronic bronchitis (mild to moderate) 250 or 500 mg every 12 hours 10 Uncomplicated skin and skin-structure infections 250 or 500 mg every 12 hours 10 Uncomplicated urinary tract infections 250 mg every 12 hours 7 to 10 Uncomplicated gonorrhea 1,000 mg single dose Early Lyme disease 500 mg every 12 hours 20 Pediatric Patients younger than 13 years (who can swallow tablets whole) Acute bacterial otitis media 250 mg every 12 hours 10 Acute bacterial maxillary sinusitis 250 mg every 12 hours 10 Pediatric Patients (3 Months to 12 Years) Dosage Guidelines for CEFTIN for Oral Suspension Infection Recommended Daily Dosea Maximum Daily Dose Duration (Days) Pharyngitis/tonsillitis 20 mg/kg 500 mg 10 Acute bacterial otitis media 30 mg/kg 1,000 mg 10 Acute bacterial maxillary sinusitis (mild to moderate) 30 mg/kg 1,000 mg 10 Impetigo 30 mg/kg 1,000 mg 10 a Total daily dose given twice daily divided in equal doses. 2.1 Important Administration Instructions •CEFTIN tablets and CEFTIN for oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis [see Clinical Pharmacology (12.3)]. •Administer CEFTIN tablets or oral suspension as described in the appropriate dosage guidelines [see Dosage and Administration (2.2, 2.3, 2.4)]. •Administer CEFTIN tablets with or without food. •Administer CEFTIN for oral suspension with food. •Pediatric patients (aged 13 years and older) who cannot swallow the CEFTIN tablets whole should receive CEFTIN for oral suspension because the tablet has a strong, persistent bitter taste when crushed [see Dosage and Administration (2.2)]. 2.2 Dosage for CEFTIN Tablets Administer CEFTIN tablets as described in the dosage guidelines table below with or without food. Table 1. Adult Patients and Pediatric Patients Dosage Guidelines for CEFTIN Tablets Infection Dosage Duration (Days) Adults and Adolescents (13 years and older) Pharyngitis/tonsillitis (mild to moderate) 250 mg every 12 hours 10 Acute bacterial maxillary sinusitis (mild to moderate) 250 mg every 12 hours 10 Acute bacterial exacerbations of chronic bronchitis (mild to moderate) 250 or 500 mg every 12 hours 10a Uncomplicated skin and skin-structure infections 250 or 500 mg every 12 hours 10 Uncomplicated urinary tract infections 250 mg every 12 hours 7 to 10 Uncomplicated gonorrhea 1,000 mg single dose Early Lyme disease 500 mg every 12 hours 20 Pediatric Patients younger than 13 years (who can swallow tablets whole)b Acute bacterial otitis media 250 mg every 12 hours 10 Acute bacterial maxillary sinusitis 250 mg every 12 hours 10 a The safety and effectiveness of CEFTIN administered for less than 10 days in patients with acute exacerbations of chronic bronchitis have not been established. b When crushed, the tablet has a strong, persistent bitter taste. Therefore, patients who cannot swallow the tablet whole should receive the oral suspension. 2.3 Dosage for CEFTIN for Oral Suspension Administer CEFTIN for oral suspension as described in the dosage guidelines table below with food. Table 2. Pediatric Patients (3 Months to 12 Years) Dosage Guidelines for CEFTIN for Oral Suspension Infection Recommended Daily Dosea Maximum Daily Dose Duration (Days) Pharyngitis/tonsillitis 20 mg/kg 500 mg 10 Acute bacterial otitis media 30 mg/kg 1,000 mg 10 Acute bacterial maxillary sinusitis 30 mg/kg 1,000 mg 10 Impetigo 30 mg/kg 1,000 mg 10 a Recommended daily dose given twice daily divided in equal doses 2.4 Preparation and Administration of CEFTIN for Oral Suspension Prepare a suspension at the time of dispensing as follows: 1.Shake the bottle to loosen the powder. 2.Remove the cap. 3. Add the total amount of cold water for reconstitution (Table 3) and replace the cap. 4.Invert the bottle and vigorously rock the bottle from side to side so that water rises through the powder. 5. Once the sound of the powder against the bottle disappears, turn the bottle upright and vigorously shake it in a diagonal direction for at least one minute. 6. After reconstitution, wait one hour before administering suspension to a patient. Table 3. Amount of Water Required for Reconstitution of Labeled Volumes of CEFTIN for Oral Suspension Oral Suspension Amount of Water Required for Reconstitution Labeled Volume after Reconstitution 125 mg/5 mL 37 mL 100 mL 250 mg/5 mL 19 mL 50 mL 35 mL 100 mL •Shake the oral suspension well before each use. •Replace cap securely after each opening. •Store the reconstituted suspension refrigerated between 2° and 8°C (36° and 46°F). •Discard the reconstituted suspension after 10 days. 2.5 Dosage in Patients with Impaired Renal Function A dosage interval adjustment is required for patients whose creatinine clearance is less than 30 mL/min, as listed in Table 4 below, because cefuroxime is eliminated primarily by the kidney [see Clinical Pharmacology (12.3)]. Table 4. Dosing in Adults with Renal Impairment Creatinine Clearance (mL/min) Recommended Dosage ≥30 No dosage adjustment 10 to ˂30 Standard individual dose given every 24 hours ˂10 (without hemodialysis) Standard individual dose given every 48 hours Hemodialysis A single additional standard dose should be given at the end of each dialysis
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category B. There are no adequate and well‑controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, CEFTIN should be used during pregnancy only if clearly needed. Reproduction studies have been performed in mice at doses up to 3,200 mg/kg/day (14 times the recommended maximum human dose based on body surface area) and in rats at doses up to 1,000 mg/kg/day (9 times the recommended maximum human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to cefuroxime axetil. 8.3 Nursing Mothers Because cefuroxime is excreted in human milk, caution should be exercised when CEFTIN is administered to a nursing woman. 8.4 Pediatric Use The safety and effectiveness of CEFTIN have been established for pediatric patients aged 3 months to 12 years for acute bacterial maxillary sinusitis based upon its approval in adults. Use of CEFTIN in pediatric patients is supported by pharmacokinetic and safety data in adults and pediatric patients, and by clinical and microbiological data from adequate and well‑controlled trials of the treatment of acute bacterial maxillary sinusitis in adults and of acute otitis media with effusion in pediatric patients. It is also supported by postmarketing adverse events surveillance. [See Indications and Usage (1), Dosage and Administration (2), Adverse Reactions (6), Clinical Pharmacology (12.3).] 8.5 Geriatric Use Of the total number of subjects who received CEFTIN in 20 clinical trials, 375 were aged 65 and older while 151 were aged 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger adult subjects. Reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. Cefuroxime is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 8.6 Renal Impairment Reducing the dosage of CEFTIN is recommended for adult patients with severe renal impairment (creatinine clearance <30 mL/min) [see Dosage and Administration (2.5), Clinical Pharmacology (12.3)].

Interactions

7 DRUG INTERACTIONS •Oral Contraceptives: Effects on gut flora may lower estrogen reabsorption and reduce efficacy of oral contraceptives. (7.1) •Drugs that reduce gastric acidity may lower the bioavailability of CEFTIN. (7.2) •Coadministration with probenecid increases systemic exposure to CEFTIN and is therefore not recommended. (7.3) 7.1 Oral Contraceptives 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. 7.2 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. 7.3 Probenecid Concomitant administration of probenecid with cefuroxime axetil tablets increases serum concentrations of cefuroxime [see Clinical Pharmacology (12.3)]. Coadministration of probenecid with cefuroxime axetil is not recommended. 7.4 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.

More information

Category Value
Authorisation number NDA050605
Agency product number Z49QDT0J8Z
Orphan designation No
Product NDC 0173-0740,0173-0741,0173-0387
Date Last Revised 20-10-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 309097
Marketing authorisation holder GlaxoSmithKline LLC