Flucloxacillin (oral route)


    Description

    Flucloxacillin is used to treat bacterial infections. This medicine belongs to the group of medicines known as penicillin antibiotics. It works by killing the bacteria and 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

    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 flucloxacillin in children. Safety and efficacy have been established.

    Geriatric

    No information is available on the relationship of age to the effects of flucloxacillin in geriatric patients.

    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 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.

    • Acetaminophen
    • Amifampridine
    • Bupropion
    • Clomipramine
    • Donepezil
    • Hydroxychloroquine
    • Methotrexate
    • Tramadol
    • Voriconazole

    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 penicillin or cephalosporin antibiotics or
    • Liver disease caused by previous use of flucloxacillin—Should not be used in patients with these conditions.
    • Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
    • Kidney disease or
    • Liver disease or
    • Malnutrition—Use with caution. May make these conditions 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.

    Take this medicine at least 1 hour before or 2 hours after a meal with a full glass of water.

    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.

    Do not lie down right away after taking this medicine.

    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):
      • For bacterial infections:
        • Adults and children older than 10 years of age—250 to 500 milligrams (mg) 3 times a day.
        • Children 2 to 10 years of age—125 to 250 mg 3 times a day.
        • Children younger than 2 years of age—62.5 to 125 mg 3 times a day.

    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.


    Precautions

    It is important that your doctor check your progress at regular visits to see if the medicine is working properly and to decide if you should continue to use it. Blood tests may be needed to check for unwanted effects.

    If your condition does not improve, or if it becomes worse, discuss this with your doctor.

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

    Check with your doctor right away if your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

    This medicine may increase the risk of hyperbilirubinemia (high bilirubin in the blood) in newborn babies. Check with your doctor right away if your child has yellow eyes or skin.

    This medicine may cause serious skin reactions, including acute generalized exanthematous pustulosis (AGEP). 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.

    This medicine may cause hypokalemia (low potassium in the blood). Check with your doctor right away if you have decreased urine, dry mouth, irregular heartbeat, increased thirst, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, trouble breathing, or unusual tiredness or weakness.

    This medicine may cause trouble in controlling movement or not thinking clearly. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

    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:

    Rare

    • Black, tarry stools
    • bleeding gums
    • blistering, peeling, or loosening of the skin
    • bloating
    • blood in the urine or stools
    • chest tightness
    • chills
    • cough
    • dark urine
    • decreased amount of urine
    • diarrhea, watery and severe, which may also be bloody
    • difficulty swallowing
    • dizziness
    • fast heartbeat
    • fever
    • headache
    • hives, itching, skin rash
    • increased blood pressure
    • increased thirst
    • joint or muscle pain
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • light-colored stools
    • loss of appetite
    • loss of bladder control
    • lower back or side pain
    • muscle spasm or jerking of all extremities
    • nausea
    • painful or difficult urination
    • pale skin
    • pinpoint red spots on the skin
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • red irritated eyes
    • red skin lesions, often with a purple center
    • sore throat
    • stomach cramps or pain
    • sudden loss of consciousness
    • swelling of the face, fingers, or lower legs
    • trouble breathing
    • ulcers, sores, or white spots in the mouth
    • unpleasant breath odor
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • vomiting
    • vomiting of blood
    • weight gain
    • yellow eyes and skin

    Incidence not known

    • Mood changes
    • muscle pain or cramps
    • numbness or tingling in the hands, feet, or lips

    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

    • 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.






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