Brand Name

    US Brand Name

    Cefzil


    Description

    Cefprozil 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:

    • Tablet
    • Powder for Suspension

    Before Using

    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 cefprozil for otitis media (ear infection) and sinusitis in children 6 months to 12 years of age. However, safety and efficacy have not been established in infants younger than 6 months of age.

    Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of cefprozil for sore throat and skin infections in children 2 to 12 years of age. However, safety and efficacy have not been established in children younger than 2 years of age.

    Because of cefprozil's toxicity, use in newborn babies is not recommended.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cefprozil in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving cefprozil.

    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. 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.

    • Cholera Vaccine, Live
    • Desogestrel
    • Dienogest
    • Drospirenone
    • Estradiol
    • Ethinyl Estradiol
    • Ethynodiol
    • Gestodene
    • Levonorgestrel
    • Mestranol
    • Methotrexate
    • Nomegestrol
    • Norethindrone
    • Norgestimate
    • Norgestrel

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Probenecid

    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

    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.

    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 oral dosage forms (tablets or suspension):
      • For bronchitis:
        • Adults and teenagers—500 milligrams (mg) every 12 hours, taken for 10 days.
        • Children younger than 13 years of age—Use and dose must be determined by your doctor.
      • For ear infections:
        • Children 6 months to 12 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 15 milligrams (mg) per kilogram (kg) of body weight every 12 hours, taken for 10 days.
        • Infants younger than 6 months of age—Use and dose must be determined by your doctor.
      • For sinusitis:
        • Adults and teenagers—250 or 500 milligrams (mg) every 12 hours for 10 days.
        • Children 6 months to 12 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 7.5 to 15 milligrams (mg) per kilogram (kg) of body weight every 12 hours, taken for 10 days.
        • Infants younger than 6 months of age—Use and dose must be determined by your doctor.
      • For skin infections:
        • Adults and teenagers—250 to 500 milligrams (mg) every 12 hours or 500 mg once a day, taken for 10 days.
        • Children 2 to 12 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 20 milligrams (mg) per kilogram (kg) of body weight per day, taken for 10 days.
        • Children younger than 2 years of age—Use and dose must be determined by your doctor.
      • For sore throat and tonsillitis:
        • Adults and teenagers—500 milligrams (mg) once a day for 10 days.
        • Children 2 to 12 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 7.5 milligrams (mg) per kilogram (kg) of body weight every 12 hours, taken for 10 days.
        • Children younger than 2 years of age—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 14 days.

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


    Precautions

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

    Cefprozil 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

    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:

    Less common

    • Black, tarry stools
    • chest pain
    • cough or hoarseness
    • diarrhea
    • fever or chills
    • lower back or side pain
    • 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

    • Abdominal or stomach cramps, pain, or tenderness
    • bleeding gums
    • blistering, peeling, or loosening of the skin
    • bloating
    • blood in the urine or stools
    • clay-colored stools
    • dark urine
    • diarrhea, watery and severe, which may also be bloody
    • difficulty with swallowing
    • dizziness
    • fast heartbeat
    • feeling of discomfort
    • headache
    • hives
    • increased thirst
    • inflammation of the joints
    • itching
    • joint or muscle pain
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • loss of appetite
    • muscle aches
    • nausea or vomiting
    • pain
    • pinpoint red spots on the skin
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • rash
    • red skin lesions, often with a purple center
    • red, irritated eyes
    • shortness of breath
    • swollen lymph glands
    • tightness in the chest
    • unpleasant breath odor
    • unusual weight loss
    • vomiting of blood
    • watery or bloody diarrhea
    • wheezing
    • yellow eyes or skin

    Incidence not known

    • Back, leg, or stomach pains
    • bleeding gums
    • bloody or cloudy urine
    • bloody, black, or tarry stools
    • decrease in urine output or decrease in urine-concentrating ability
    • difficulty with breathing
    • fever with or without chills
    • general body swelling
    • general feeling of tiredness or weakness
    • high fever
    • nosebleeds
    • pale skin
    • sudden decrease in the amount of urine
    • swollen or painful glands

    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

    • Itching or pain of the vagina or genital area
    • pain during sexual intercourse
    • thick, white vaginal discharge with no odor or with a mild odor

    Rare

    • Confusion
    • hives or welts
    • nervousness
    • redness of the skin
    • restlessness
    • sleepiness or unusual drowsiness
    • sleeplessness
    • trouble sitting still
    • trouble with sleeping
    • unable to sleep

    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.






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