Ceftin

Dosage Forms & Strengths

oral suspension (discontinued; anticipated final availability early 2018)

• 125mg/5mL
• 250mg/5mL

powder for injection

• 750mg
• 1.5g
• 7.5g
• 75g
• 225g

tablet

• 250mg
• 500mg

Pharyngitis/Tonsillitis

250 mg PO q12hr for 10 days

Acute Bacterial Maxillary Sinusitis

250 mg PO q12hr for 10 days

Acute Bacterial Exacerbations of Chronic Bronchitis

250-500 mg PO q12hr for 10 days

500-750 mg IV q8hr; switch to oral therapy as soon as clinically possible

Secondary Bacterial Infections of Acute Bronchitis

250-500 mg PO q12hr for 5-10 days

Uncomplicated Pneumonia

750 mg IV/IM q8hr

Uncomplicated Skin/Skin Structure Infections

250-500 mg PO q12hr for 10 days

750 mg IV/IM q8hr; switch to oral therapy as soon as clinically possible

Uncomplicated Urinary Tract Infections

125-250 mg PO q12hr for 7-10 days

750 mg IV/IM q8hr; switch to oral therapy as soon as clinically possible

Gonorrhea

Uncomplicated: 1 g PO once or 1.5 g IM once at 2 different sites with 1 g probenecid PO

Disseminated: 750 mg IV/IM q8hr

Early Lyme Disease

500 mg PO q12hr for 20 days

Severe or Complicated Infections

1.5 g IV/IM q8hr; may be administered q6hr in life-threatening situations

Dosage Modifications

Renal impairment

• CrCl >30 mL/min: No adjustment necessary
• CrCl 10-30 mL/min: Administer dose q24hr
• CrCl <10 mL/min: Administer dose q48hr

Dosing Considerations

Susceptible organisms

• Borrelia burgdorferi, Escherichia coli, Haemophilus influenzae, Klebsiella spp, Moraxella catarrhalis, Neisseria gonorrhoeae, Proteus mirabilis, Streptococcus pneumoniae, Streptococcus pyogenes

Dosage Forms & Strengths

oral suspension (discontinued; anticipated final availability early 2018)

• 125mg/5mL
• 250mg/5mL

powder for injection

• 750mg
• 1.5g
• 7.5g
• 75g
• 225g

tablet

• 250mg
• 500mg

Acute Bacterial Maxillary Sinusitis

<3 months: Safety and efficacy not established

3 months-12 years: 30 mg/kg/day suspension PO divided q12hr for 10 days; not to exceed 1000 mg/day; alternatively, 75-150 mg/kg/day IV/IM divided q8hr; not to exceed 6 g/day 

>12 years: 250 mg tablet PO q12hr for 10 days

Acute Otitis Media

<3 months: Safety and efficacy not established

3 months-12 years: 30 mg/kg/day suspension PO divided q12hr for 10 days; not to exceed 1000 mg/day; alternatively, 75-150 mg/kg/day IV/IM divided q8hr; not to exceed 6 g/day 

Alternativley: 125-250 mg PO q12hr for 10 days

>12 years: 250-500 mg tablet PO q12hr for 10 days

Impetigo

<3 months: Safety and efficacy not established

3 months-12 years: 30 mg/kg/day suspension PO divided q12hr for 10 days; not to exceed 1000 mg/day or 75-100mg/kg/day IV/IM divided q8hr; not to exceed 6 g/day 

Alternativley: 125-250 mg PO q12hr for 10 days

>12 years: 250-500 mg tablet PO q12hr for 10 days

Pharyngitis/Tonsillitis

<3 months: Safety and efficacy not established

3 months-12 years: 20 mg/kg/day PO divided q12hr for 10 days; not to exceed 500 mg/day or 75-150 mg/kg/day IV/IM divided q8hr; not to exceed 6 g/day 

Alternativley: 125-250 mg PO q12hr for 10 days

>12 years: 250 mg PO q12hr for 10 days

Severe or Serious Infections (Off-label)

<6 days, <2 kg: 100 mg/kg/day IV/IM divided q12hr  

<6 days, >2 kg: 150 mg/kg/day IV/IM divided q8hr

>7 days: 150 mg/kg/day IV/IM divided q8hr

Cefuroxime is also sometimes used to treat pneumonia. Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Cefuroxime is generally well tolerated, and side effects are usually transient. Commonly reported side effects are:

• diarrhea,
• nausea,
• vomiting,
• abdominal pain,
• headache,
• rash,
• hives,
• vaginitis, and
• mouth ulcers.

Other important side effects include:

• Allergic reactions,
• severe skin reactions,
• anemia, and
• seizures.

Since cefuroxime is chemically related to penicillin, patients allergic to penicillin may develop an allergic reaction (sometimes even anaphylaxis) to cefuroxime. Cefuroxime like other antibiotics can alter the colon's normal bacteria, leading to overgrowth of a bacterium called Clostridium difficile. Overgrowth of this bacterium leads to the release of toxins that contribute to the development of Clostridium difficile-associated diarrhea, which may range in severity from mild diarrhea to fatal pseudomembranous colitis.

Cephalosporins are usually considered safe for use during pregnancy.

Cefuroxime is excreted in breast milk and may cause adverse effects in the infant. Cefuroxime is approved for pediatric patients 3 months and older.

• Tablets: 125, 250 and 500 mg.
• Powder for Oral Suspension: 125 or 250 mg per 5 ml (teaspoon).
• Injection: 750 mg, 1.5 g and 7.5 g.

• Tablets should be stored at room temperature between 15 C - 30 C (59 F - 86 F).
• The oral suspension should be stored between 2 C - 30 C (36 F - 86 F) prior to mixing and refrigerated between 2 C - 8 C (36 F - 46 F) after mixing. The suspension should be discarded after 10 days.

Serious side effects have been reported with Ceftin. See the “Ceftin Precautions” section.

Common side effects of oral and injectable Ceftin include the following:

• Upset stomach
• Vomiting
• Diarrhea
• Stomach pain

This is not a complete list of Ceftin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Oral:

Serious side effects have been reported with Ceftin including the following:

Allergic reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of an allergic reaction:

• Rash
• Hives
• Difficulty breathing or swallowing
• Wheezing
• Painful sores in the mouth or throat

Injectable:

Serious side effects have been reported with Ceftin including the following:

Allergic reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of an allergic reaction:

• Rash
• Hives
• Difficulty breathing or swallowing
• Wheezing
• Painful sores in the mouth or throat
• Vaginal itching and discharge

Ceftin can cause drowsiness. Do not drive or operate heavy machinery until you know how Ceftin affects you.

Do not take Ceftin if you:

• are allergic to Ceftin or to any of its ingredients
• are allergic to any other cephalosporin antibiotic

Oral:

Take Ceftin exactly as prescribed.

This medication comes in oral tablet and suspension forms and is usually taken twice a day. They tablet may be taken with or without food, but the liquid suspension must be taken with food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Ceftin at the same time.

Injectable:

This medication is also available in an injectable form to be given directly into a vein (IV) or a muscle (IM) by a healthcare professional. 

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For infections:
  • For oral dosage form (film-coated tablets):
    • Adults and teenagers—250 to 500 milligrams (mg) two times a day for 10 days. Gonorrhea is treated with a single 1-gram (g) dose.
    • Children (who can swallow the tablets)—250 mg two times a day for 10 days.
    • Children (who cannot swallow the tablets)—Use is not recommended.
  • For oral dosage form (suspension):
    • Children 3 months to 12 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 20 to 30 milligrams (mg) per kilogram (kg) of body weight per day divided into two doses, taken for 10 days. However, the dose is usually not more than 1000 mg.
    • Infants up to 3 months—Use and dose must be determined by your doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of cefuroxime in children. However, safety and efficacy have not been established in infants younger than 3 months of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cefuroxime in the elderly.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Colitis (inflammation in gut), history of or
• Diarrhea, severe, history of—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

• Phenylketonuria (PKU)—The oral liquid form of this medicine contains phenylalanine, which can make this condition worse.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Ceftin® oral liquid works differently than Ceftin® tablets, even at the same dose (number of milligrams). Do not switch from the tablets to the oral liquid unless your doctor tells you to.

The oral liquid form must be taken with meals, while the tablet form may be given with or without food.

Swallow the tablets whole. Do not break, crush, or chew it.

Shake the oral liquid well before each use. Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For infections:
  • For oral dosage form (film-coated tablets):
    • Adults and teenagers—250 to 500 milligrams (mg) two times a day for 10 days. Gonorrhea is treated with a single 1-gram (g) dose.
    • Children (who can swallow the tablets)—250 mg two times a day for 10 days.
    • Children (who cannot swallow the tablets)—Use is not recommended.
  • For oral dosage form (suspension):
    • Children 3 months to 12 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 20 to 30 milligrams (mg) per kilogram (kg) of body weight per day divided into two doses, taken for 10 days. However, the dose is usually not more than 1000 mg.
    • Infants up to 3 months—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the oral liquid in the refrigerator. Throw away any unused medicine after 10 days.

Store the tablets in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Chills
• diarrhea
• fever
• general feeling of illness or discomfort
• headache
• itching of the vagina or genital area
• pain during sexual intercourse
• rigidity
• sweating
• thick, white vaginal discharge with no odor or with a mild odor

• Black, tarry stools
• chest pain
• cough
• loose stools
• painful or difficult urination
• shortness of breath
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• unusual bleeding or bruising
• unusual tiredness or weakness

• Back, leg, or stomach pains
• bladder pain
• bleeding gums
• bloody or cloudy urine
• body aches or pain
• burning while urinating
• dark urine
• difficulty with breathing
• ear congestion
• fast, pounding, or irregular heartbeat or pulse
• frequent urge to urinate
• general body swelling
• loss of appetite
• loss of voice
• lower back or side pain
• nasal congestion
• nausea or vomiting
• nosebleeds
• pain or tenderness around the eyes and cheekbones
• pale skin
• pink or red urine
• sneezing
• stuffy or runny nose
• swelling of the joints
• swollen glands
• tightness of chest or wheezing
• white or brownish vaginal discharge
• white patches in the mouth or throat or on the tongue
• white patches with diaper rash
• yellowing of the eyes or skin

• Blistering, peeling, or loosening of the skin
• bloody, black, or tarry stools
• clay-colored stools
• cough or hoarseness
• coughing up blood
• decrease in urine output or decrease in urine-concentrating ability
• feeling of discomfort
• fever with or without chills
• general feeling of tiredness or weakness
• high fever
• hives
• increased menstrual flow or vaginal bleeding
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• paralysis
• prolonged bleeding from cuts
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red or black, tarry stools
• red or dark brown urine
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• swollen lymph glands
• swollen or painful glands
• unpleasant breath odor
• upper right abdominal or stomach pain
• vomiting of blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bad, unusual, or unpleasant (after) taste
• change in taste
• diaper rash

• Abdominal or stomach cramps
• acid or sour stomach
• belching
• bloated
• difficulty with moving
• excess air or gas in the stomach or intestines
• flushing or redness of the skin
• full feeling
• gas in the stomach
• heartburn
• indigestion
• irritability
• irritation or soreness of the mouth
• itching skin
• muscle pain or stiffness
• muscle spasm of the neck
• passing gas
• restlessness
• sleepiness or unusual drowsiness
• stomach discomfort, upset, or pain
• swelling of the tongue
• thirst
• trouble sitting still
• unusually warm skin
• watering of the mouth and drooling
• weight loss

• Hives or welts
• redness of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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

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.

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).

Uncomplicated Skin and SkinStructure 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 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.

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 β-lactamase–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.

Ceftin tablets are white, capsule‑shaped, film‑coated tablets available in the following strengths:

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.

Ceftin tablets and Ceftin for oral suspension contain cefuroxime as cefuroxime axetil. Ceftin is a semisynthetic, cephalosporin antibacterial drug for oral administration.

The chemical name of cefuroxime axetil (1‑(acetyloxy) ethyl ester of cefuroxime) is (RS)-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72-(Z)-(O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48.

Cefuroxime axetil is in the amorphous form and has the following structural formula:

Tablets are film‑coated and contain the equivalent of 250 or 500 mg of cefuroxime as cefuroxime axetil. Tablets contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, methylparaben, microcrystalline cellulose, propylene glycol, propylparaben, sodium benzoate, sodium lauryl sulfate, and titanium dioxide.

Oral suspension, when reconstituted with water, provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL. Oral suspension contains the inactive ingredients acesulfame potassium, aspartame, povidone K30, stearic acid, sucrose, tutti‑frutti flavoring, and xanthan gum.

Ceftin (cefuroxime) is a cephalosporin (SEF a low spor in) antibiotic. It works by fighting bacteria in your body.

Ceftin is used to treat many kinds of bacterial infections, including severe or life-threatening forms.

Ceftin may also be used for purposes not listed in this medication guide.

Take Ceftin exactly as it was prescribed for you. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Ceftin tablets with or without meals. Do not crush the tablet or it could have an unpleasant bitter taste.

Ceftin oral suspension (liquid) must be taken with food.

Shake the liquid well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If you switch from using the tablet form to using the liquid form, you may not need to use the same exact dosage in number of milligrams. This medicine may not be as effective unless you use the exact form and strength your doctor has prescribed.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Ceftin will not treat a viral infection such as the flu or a common cold.

This medicine can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Ceftin.

Store the tablets at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Store the liquid medicine in the refrigerator. Do not allow it to freeze. Throw away any unused Ceftin liquid that is older than 10 days.