Brand Name

    US Brand Name

    Bio-Cef

    Keflex

    Panixine DisperDose

    Canadian Brand Name

    Novo-Lexin


    Description

    Cephalexin is used to treat bacterial infections in many different parts of the body (eg, bones, ears, lungs, skin, urinary tract). Cephalexin belongs to the group 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:

    • Capsule
    • 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 have not been performed on the relationship of age to the effects of cephalexin in children younger than 1 year of age. Safety and efficacy have not been established.

    Geriatric

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

    Breastfeeding

    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.

    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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Dofetilide

    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
    • Exenatide
    • Furosemide
    • Methotrexate
    • Probenecid

    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.

    • Cholestyramine
    • Warfarin

    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:

    • Allergy to beta-lactams or penicillins, history of or
    • Colitis (inflammation in gut), history of or
    • Diarrhea, severe, history of or
    • Liver disease or
    • Seizures, history of or
    • Undernourished condition—Use with caution. May make these conditions worse.
    • Allergy to cephalosporins—Should not be used in patients with this condition.
    • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

    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 (capsules or suspension):
      • For infections:
        • Adults and children 15 years of age and older—250 milligrams (mg) every 6 hours or 500 mg every 12 hours for 7 to 14 days. However, the dose is usually not more than 4 grams (g) per day.
        • Children 1 year of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 25 to 100 milligrams (mg) per kilogram (kg) per day, taken in divided doses for 7 to 14 days.
        • Children younger than 1 year 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

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

    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.


    Precautions

    It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

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

    This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you take this medicine.

    Serious skin reactions, including Stevens-Johnson syndrome, erythema multiforme, or toxic epidermal necrolysis can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness while you are using this medicine.

    Cephalexin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. 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.

    This medicine may cause seizures. Check with your doctor right away if you have loss of bladder control, muscle spasm or jerking of all extremities, or sudden loss of consciousness.

    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 (eg, Coombs' test) may be affected by this medicine.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    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:

    More common

    • Diarrhea

    Rare

    • Blistering, peeling, or loosening of the skin
    • chills
    • clay-colored stools
    • cough
    • dark urine
    • diarrhea
    • dizziness
    • fever
    • general tiredness and weakness
    • headache
    • itching or rash
    • joint or muscle pain
    • light-colored stools
    • loss of appetite
    • nausea and vomiting
    • red skin lesions, often with a purple center
    • red, irritated eyes
    • sore throat
    • sores, ulcers, or white spots in the mouth or on the lips
    • stomach pain
    • unpleasant breath odor
    • unusual tiredness or weakness
    • upper right abdominal or stomach pain
    • vomiting of blood
    • yellow eyes or skin

    Incidence not known

    • Back or leg pain
    • black, tarry stools
    • bleeding gums
    • bloating
    • blood in the urine or stools
    • chest pain or tightness
    • coughing up blood
    • diarrhea, watery and severe, which may also be bloody
    • difficulty with breathing or swallowing
    • fast heartbeat
    • general body swelling
    • hives
    • increased menstrual flow or vaginal bleeding
    • increased thirst
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • loss of appetite
    • nosebleeds
    • pain
    • painful or difficult urination
    • pale skin
    • paralysis
    • pinpoint red spots on the skin
    • 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
    • stomach cramps or tenderness
    • swollen or painful glands
    • unusual bleeding or bruising
    • unusual weight loss
    • watery or bloody diarrhea

    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:

    Incidence not known

    • Acid or sour stomach
    • anxiety
    • belching
    • burning feeling in the chest or stomach
    • difficulty with moving
    • dry mouth
    • heartburn
    • hyperventilation
    • indigestion
    • irregular heartbeats
    • irritability
    • itching of the vagina or genital area
    • muscle pain or stiffness
    • nervousness
    • pain during sexual intercourse
    • pain, swelling, or redness in the joints
    • redness of the skin
    • restlessness
    • seeing, hearing, or feeling things that are not there
    • shaking
    • stomach upset
    • trouble sleeping
    • white or brownish vaginal discharge

    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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