Methylprednisolone (oral route)


    Brand Name

    US Brand Name

    Medrol

    Medrol Dosepak

    Methylpred-DP


    Description

    Methylprednisolone provides relief for inflamed areas of the body. It is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, blood or bone marrow problems, eye or vision problems, lung or breathing problems (eg, asthma), lupus, skin conditions, kidney problems, ulcerative colitis, and flare-ups of multiple sclerosis. Methylprednisolone is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help relieve swelling, redness, itching, and allergic reactions.

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

    This product is available in the following dosage forms:

    • Tablet

    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

    No information is available on the relationship of age to the effects of methylprednisolone in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    No information is available on the relationship of age to the effects of methylprednisolone 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Desmopressin
    • Rotavirus Vaccine, Live

    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.

    • Aceclofenac
    • Acemetacin
    • Aldesleukin
    • Amtolmetin Guacil
    • Aspirin
    • Atazanavir
    • Avacopan
    • Balofloxacin
    • Bemiparin
    • Benzhydrocodone
    • Besifloxacin
    • Bromfenac
    • Bufexamac
    • Bupropion
    • Carbamazepine
    • Celecoxib
    • Choline Salicylate
    • Ciprofloxacin
    • Clarithromycin
    • Clonixin
    • Cobicistat
    • Codeine
    • Cosyntropin
    • Cyclosporine
    • Darunavir
    • Dexibuprofen
    • Dexketoprofen
    • Diclofenac
    • Diflunisal
    • Dihydrocodeine
    • Dipyrone
    • Droxicam
    • Enoxacin
    • Ethinyl Estradiol
    • Etodolac
    • Etofenamate
    • Etonogestrel
    • Etoricoxib
    • Felbinac
    • Fenoprofen

    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.

    • Acenocoumarol
    • Alcuronium
    • Apixaban
    • Aprepitant
    • Atracurium
    • Auranofin
    • Dalfopristin
    • Diltiazem
    • Erythromycin
    • Fluindione
    • Fosaprepitant
    • Gallamine
    • Hexafluorenium
    • Ketoconazole
    • Licorice
    • Metocurine
    • Mibefradil
    • Nefazodone
    • Phenobarbital
    • Primidone
    • Quinupristin
    • Rifampin
    • Rivaroxaban
    • Saiboku-To
    • Troleandomycin

    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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    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:

    • Cancer (eg, blood cancer, solid tumor) or
    • Cataracts or
    • Congestive heart failure or
    • Cushing's syndrome (adrenal gland problem) or
    • Diabetes or
    • Eye infection or
    • Glaucoma or
    • Hyperglycemia (high blood sugar) or
    • Hypertension (high blood pressure) or
    • Infection (eg, bacterial, virus, or fungus) or
    • Liver disease or
    • Mental problems (eg, depression) or
    • Myasthenia gravis (severe muscle weakness) or
    • Osteoporosis (weak bones) or
    • Stomach or bowel problems (eg, diverticulitis, ulcers, ulcerative colitis) or
    • Thyroid problems or
    • Tuberculosis, inactive or
    • Weak immune system (eg, Kaposi sarcoma)—Use with caution. May make these conditions worse.
    • Fungal infections, systemic—Should not be used in patients with this condition.
    • Infection (bacteria, virus, fungus, parasite, or protozoa)—May decrease your body's ability to fight infection.

    Proper Use

    Take this medicine exactly 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. To do so may increase the chance for unwanted effects.

    If you use this medicine for a long time, do not suddenly stop using it without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely.

    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 form (tablets):
      • Dose depends on medical condition:
        • Adults—At first, 4 to 48 milligrams (mg) per day. Your doctor may adjust your dose as needed.
        • Children—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.


    Precautions

    It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to decide if you should continue to receive it. Blood or urine tests may be needed to check for unwanted effects.

    Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

    If you are using this medicine for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress. Your dose of this medicine might need to be changed for a short time while you have extra stress.

    Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are using this medicine: blurred vision, dizziness or fainting, fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

    This medicine may cause you to get more infections than usual. Avoid people who are sick or have infections and wash your hands often. If you are exposed to chickenpox or measles, tell your doctor right away. If you start to have a fever, chills, sore throat, or any other sign of an infection, call your doctor right away.

    Check with your doctor right away if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

    This medicine may increase your risk for cancer, including Kaposi's sarcoma. Tell your doctor right away if you have flat, painless spots that are red or purple on white skin or bluish, brownish, or black on dark skin.

    This medicine may cause a serious type of reaction called tumor lysis syndrome. Call your doctor right away if you have a decrease or change in the amount of urine, joint pain, stiffness, swelling, lower back, side, or stomach pain, rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

    While you are being treated with methylprednisolone, do not have any immunizations (vaccines) without your doctor's approval. Methylprednisolone may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

    This medicine may cause changes in mood or behavior for some patients. Tell your doctor right away if you have depression, mood swings, a false or unusual sense of well-being, trouble with sleeping, or personality changes while using this medicine.

    This medicine might cause thinning of the bones (osteoporosis) or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have an increased risk for osteoporosis. If your child is using this medicine, tell the doctor if you think your child is not growing properly.

    Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain skin tests.

    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:

    Incidence not known

    • Black, tarry stools
    • blindness
    • bloating
    • bloody vomit
    • blurred vision
    • bone pain
    • change in vision
    • chest pain or tightness
    • chills
    • confusion
    • constipation
    • cough
    • dark urine
    • darkening of the skin
    • decrease in height
    • decrease in the amount of urine
    • decreased range of motion
    • decreased vision
    • diarrhea
    • difficulty in swallowing
    • dilated neck veins
    • dizziness or lightheadedness
    • dry mouth
    • extreme tiredness or weakness
    • eye pain
    • eye tearing
    • eyeballs bulge out of the eye sockets
    • fainting
    • feeling of constant movement of self or surroundings
    • fever
    • flushed, dry skin
    • fruit-like breath odor
    • full or bloated feeling
    • headache
    • heartburn
    • hives, itching, skin rash
    • impaired wound healing
    • increased hunger
    • increased thirst
    • increased urination
    • indigestion
    • irregular breathing
    • irregular heartbeat
    • joint pain, stiffness, or swelling
    • limp
    • loss of appetite
    • loss of consciousness
    • lower back or side pain
    • mental depression
    • mood changes
    • muscle pain, cramps, or weakness
    • nausea
    • nervousness
    • noisy, rattling breathing
    • numbness or tingling in the hands, feet, or lips
    • pain in the back, ribs, arms, or legs
    • pain or burning in the throat
    • pain or swelling in the arms or legs without any injury
    • painful or difficult urination
    • painful, swollen joints
    • pains in the stomach, side, or abdomen, possibly radiating to the back
    • pounding in the ears
    • pressure in the stomach
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • seizures
    • sensation of spinning
    • severe or continuing stomach pain
    • slow growth in children
    • slow or fast heartbeat
    • sores, ulcers, or white spots on the lips or tongue or inside the mouth
    • swelling of the face, fingers, feet, abdominal or stomach area, or lower legs
    • tearing
    • trouble breathing
    • unexplained weight loss
    • unusual tiredness or weakness
    • vomiting
    • vomiting of material that looks like coffee grounds
    • yellow eyes or skin

    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

    • Abnormal fat deposits on the face, neck, and trunk
    • acne
    • bruising
    • dry scalp
    • increased sweating
    • large, flat, blue or purplish patches in the skin
    • lightening of normal skin color
    • menstrual changes
    • reddish purple lines on the arms, face, legs, trunk, or groin
    • redness of the face
    • small, red or purple spots on the skin
    • swelling of the stomach area
    • thin, fragile skin
    • thinning of the scalp hair

    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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