Description and Brand NamesBefore UsingProper UsePrecautionsSide Effects Descriptions 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. This product is available in the following dosage forms: • Powder for Suspension Tablet 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 Information about this cefuroxime-oral-route Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breastfeeding Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding. Drug Interactions 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. 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. 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. 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. 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 17. Hives or welts 18. 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.