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`Drugs and Supplements
`
`Methylprednisolone (Oral Route)
`
`Description and Brand Names
`
`Drug information provided by: Micromedex
`
`US Brand Name
`Descriptions
`Medrol
`Medrol Dosepak
`Methylpred-DP
`
`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, asthma, blood or bone marrow problems, eye or vision problems,
`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.
`Pregnancy
`
`Pregnancy
`Category
`
`Explanation
`
`All
`Trimesters
`
`C
`
`Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no
`animal studies have been conducted and there are no adequate studies in pregnant women.
`
`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 not recommended. Your doctor may decide not to treat you with this medication or change
`some of the other medicines you take.
`
`http://www.mayoclinic.org/drugs-supplements/methylprednisolone-oral-route/description/drg-20075237?p=1
`
`MYLAN - EXHIBIT 1093
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, & -01132
`
`

`

`• 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.
`
`Page 2 of 7
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`• Aceclofenac
`• Acemetacin
`• Aldesleukin
`• Amtolmetin Guacil
`• Bemiparin
`• Bromfenac
`• Bufexamac
`• Bupropion
`• Celecoxib
`• Choline Salicylate
`• Clonixin
`• Dexibuprofen
`• Dexketoprofen
`• Diclofenac
`• Diflunisal
`• Dipyrone
`• Droxicam
`• Etodolac
`• Etofenamate
`• Etoricoxib
`• Felbinac
`• Fenoprofen
`• Fepradinol
`• Feprazone
`• Floctafenine
`• Flufenamic Acid
`• Flurbiprofen
`• Ibuprofen
`• Indomethacin
`• Ketoprofen
`• Ketorolac
`• Lornoxicam
`• Loxoprofen
`• Lumiracoxib
`• Meclofenamate
`• Mefenamic Acid
`• Meloxicam
`• Morniflumate
`• Nabumetone
`• Nadroparin
`• Naproxen
`• Nepafenac
`• Niflumic Acid
`• Nimesulide
`• Nimesulide Beta Cyclodextrin
`• Oxaprozin
`• Oxyphenbutazone
`• Parecoxib
`• Phenylbutazone
`• Piketoprofen
`• Piroxicam
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`http://www.mayoclinic.org/drugs-supplements/methylprednisolone-oral-route/description/drg-20075237?p=1
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`• Pixantrone
`• Pranoprofen
`• Proglumetacin
`• Propyphenazone
`• Proquazone
`• Rofecoxib
`• Salicylic Acid
`• Salsalate
`• Sodium Salicylate
`• Sulindac
`• Telaprevir
`• Tenoxicam
`• Tiaprofenic Acid
`• Tolfenamic Acid
`• Tolmetin
`• Valdecoxib
`
`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
`• Aprepitant
`• Aspirin
`• Atracurium
`• Balofloxacin
`• Besifloxacin
`• Carbamazepine
`• Ciprofloxacin
`• Clarithromycin
`• Cyclosporine
`• Dalfopristin
`• Diltiazem
`• Enoxacin
`• Erythromycin
`• Fleroxacin
`• Fluindione
`• Flumequine
`• Gallamine
`• Gatifloxacin
`• Gemifloxacin
`• Hexafluorenium
`• Ketoconazole
`• Levofloxacin
`• Licorice
`• Lomefloxacin
`• Metocurine
`• Mibefradil
`• Moxifloxacin
`• Nadifloxacin
`• Nefazodone
`• Norfloxacin
`• Ofloxacin
`• Pazufloxacin
`• Pefloxacin
`• Phenobarbital
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`http://www.mayoclinic.org/drugs-supplements/methylprednisolone-oral-route/description/drg-20075237?p=1
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`• Primidone
`• Prulifloxacin
`• Quinupristin
`• Rifampin
`• Rufloxacin
`• Saiboku-To
`• Sparfloxacin
`• Tosufloxacin
`• Troleandomycin
`• 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. 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:
`
`• 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 (e.g., bacterial, virus, or fungus) or
`• Mood changes, including depression or
`• Myasthenia gravis (severe muscle weakness) or
`• Osteoporosis (weak bones) or
`• Peptic ulcer, active or history of or
`• Personality changes or
`• Stomach or intestinal problems (e.g., diverticulitis, ulcerative colitis) or
`• Tuberculosis, inactive—Use with caution. May make these conditions worse.
`
`• Fungal infections—Should not be used in patients with this condition.
`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.
`
`http://www.mayoclinic.org/drugs-supplements/methylprednisolone-oral-route/description/drg-20075237?p=1
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`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
`If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any unwanted effects that may be
`caused by this medicine. 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; a 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).
`
`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 taking 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:
`More common
`• Aggression
`• agitation
`• anxiety
`• blurred vision
`• decrease in the amount of urine
`• dizziness
`• fast, slow, pounding, or irregular heartbeat or pulse
`• headache
`• irritability
`• mental depression
`• mood changes
`• nervousness
`• noisy, rattling breathing
`• numbness or tingling in the arms or legs
`• pounding in the ears
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`http://www.mayoclinic.org/drugs-supplements/methylprednisolone-oral-route/description/drg-20075237?p=1
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`Page 6 of 7
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`• shortness of breath
`• swelling of the fingers, hands, feet, or lower legs
`• trouble thinking, speaking, or walking
`• troubled breathing at rest
`• weight gain
`Incidence not known
`• Abdominal cramping and/or burning (severe)
`• abdominal pain
`• backache
`• bloody, black, or tarry stools
`• cough or hoarseness
`• darkening of skin
`• decrease in height
`• decreased vision
`• diarrhea
`• dry mouth
`• eye pain
`• eye tearing
`• facial hair growth in females
`• fainting
`• fatigue
`• fever or chills
`• flushed, dry skin
`• fractures
`• fruit-like breath odor
`• full or round face, neck, or trunk
`• heartburn and/or indigestion (severe and continuous)
`• increased hunger
`• increased thirst
`• increased urination
`• loss of appetite
`• loss of sexual desire or ability
`• lower back or side pain
`• menstrual irregularities
`• muscle pain or tenderness
`• muscle wasting or weakness
`• nausea
`• pain in back, ribs, arms, or legs
`• painful or difficult urination
`• skin rash
`• sleeplessness
`• sweating
`• trouble healing
`• trouble sleeping
`• unexplained weight loss
`• unusual tiredness or weakness
`• vision changes
`• vomiting
`• vomiting of material that looks like coffee grounds
`
`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:
`More common
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`http://www.mayoclinic.org/drugs-supplements/methylprednisolone-oral-route/description/drg-20075237?p=1
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`Page 7 of 7
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`• Increased appetite
`Incidence not known
`• Abnormal fat deposits on the face, neck, and trunk
`• acne
`• dry scalp
`• lightening of normal skin color
`• red face
`• reddish purple lines on the arms, face, legs, trunk, or groin
`• swelling of the stomach area
`• 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.
`
`Portions of this document last updated: March 01, 2017
`
`Original article: http://www.mayoclinic.org/drugs-supplements/methylprednisolone-oral-route/description/drg-20075237
`
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`http://www.mayoclinic.org/drugs-supplements/methylprednisolone-oral-route/description/drg-20075237?p=1
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