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Ceftin

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Ceftin




Indications
Dosage
How Supplied

INDICATIONS

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.
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 to12 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.

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].

Acute Bacterial Exacerbations Of Chronic Bronchitis And Secondary Bacterial Infections Of Acute 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 and secondary bacterial infections of acute bronchitis caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae (β-lactamase-negative strains), or Haemophilus parainfluenzae (β-lactamase-negative strains).

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.

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.

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 penicillinaseproducing 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.

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.

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 Plactamase- producing strains) or Streptococcus pyogenes.

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.

DOSAGE AND ADMINISTRATION

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].
  • Administer CEFTIN tablets or oral suspension as described in the appropriate dosage guidelines [see below].
  • 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 below].

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
Secondary bacterial infections of acute bronchitis 250 or 500 mg every 12 hours 5 to 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 canswallow 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.

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.

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 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.

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.

Dosage In Patients With Impaired Renal Function

A dosage interval adjustment is required for patients whose creatinine clearance is < 30 mL/min, as listed in Table 4 below, because cefuroxime is eliminated primarily by the kidney [see CLINICAL PHARMACOLOGY].

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 Standard individual dose given every 24 hours
Hemodialysis A single additional standard dose should be given at the end of each dialysis

HOW SUPPLIED

Dosage Forms And Strengths

CEFTIN tablets are white, capsule-shaped, film-coated tablets available in the following strengths:

  • 250 mg of cefuroxime (as cefuroxime axetil) with “GX ES7” engraved on one side and blank on the other side.
  • 500 mg of cefuroxime (as cefuroxime axetil) with “GX EG2” engraved on one side and blank on the other side.

CEFTIN for oral suspension is provided as dry, white to off-white, tutti-frutti-flavored powder. When reconstituted as directed, the suspension provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL.

Storage And Handling

CEFTIN tablets, 250 mg of cefuroxime (as cefuroxime axetil), are white, capsule-shaped, film-coated tablets engraved with “GX ES7” on one side and blank on the other side as follows:

20 Tablets/Bottle NDC 0173-0387-00

CEFTIN tablets, 500 mg of cefuroxime (as cefuroxime axetil), are white, capsule-shaped, film-coated tablets engraved with “GX EG2” on one side and blank on the other side as follows:

20 Tablets/Bottle NDC 0173-0394-00

Store the tablets between 15® and 30®C (59® and 86®F). Replace cap securely after each opening.

CEFTIN for oral suspension is provided as dry, white to off-white, tutti-frutti-flavored powder. When reconstituted as directed, the suspension provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL. It is supplied in amber glass bottles as follows:

125 mg/5 mL

100-mL Suspension NDC 0173-0740-00

250 mg/5 mL

50-mL Suspension NDC 0173-0741-10
100-mL Suspension NDC 0173-0741-00

Before reconstitution, store dry powder between 2° and 30°C (36° and 86°F).

After reconstitution, immediately store suspension refrigerated between 2° and 8°C (36° and 46°F). DISCARD AFTER 10 DAYS.

GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: June 2015

Last reviewed on RxList: 7/13/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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