Pronunciation:

sef-ue-ROX-eem AX-e-til

Brand Names:

• Ceftin

Dosage Forms:

• Tablet
• Powder for Suspension

Classifications:

Therapeutic—

Antibiotic

Pharmacologic—

2nd Generation Cephalosporin

Uses of This Medicine:

Cefuroxime is used to treat bacterial infections in many different parts of the body. It belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Calcium Carbonate
• Calcium Silicate
• Cimetidine
• Dexlansoprazole
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Ebrotidine
• Esomeprazole
• Famotidine
• Lansoprazole
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Peroxide
• Magnesium Trisilicate
• Nizatidine
• Omeprazole
• Pantoprazole
• Rabeprazole
• Ranitidine
• Ranitidine Bismuth Citrate
• Roxatidine
• Sodium Bicarbonate

Other interactions—

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.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Cefuroxime may cause diarrhea, and in some cases it can be severe. Do not take any medicine or give medicine to your child to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Before you or your child have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Side Effects of This Medicine:

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:

More common

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

Less common

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

Rare

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

Incidence not known

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:

Less common

Bad, unusual, or unpleasant (after) taste

change in taste

diaper rash

Rare

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

Incidence not known

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.