Medrol

: Methylprednisolone has not been adequately evaluated in pregnant women.

Methylprednisolone has not been adequately evaluated in nursing mothers.

Medrol is a prescription medication used to treat:

• arthritis
• allergic conditions
• asthma
• certain conditions affecting the lungs, skin, eyes, kidneys, blood, thyroid, stomach, and intestines. Medrol frequently treats diseases of these organs by reducing inflammation.
• some types of cancer

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Medrol. See “Medrol Precautions” section.

Common side effects of Medrol include:

• upset stomach
• stomach irritation
• vomiting
• headache
• dizziness
• insomnia
• restlessness
• depression
• anxiety
• acne
• increased hair growth
• easy bruising
• irregular or absent menstrual periods

This is not a complete list of Medrol side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Serious side effects have been reported with Medrol including:

• Hypersensitivity reaction: Medrol may trigger an allergic response. Symptoms of a hypersensitivity reaction include:
  • hives
  • difficulty breathing or swallowing
  • swelling
  • rash
  • itching
• Cardiac and renal problems: Medrol can increase blood pressure, cause water and sodium retention, and increase potassium and calcium excretion. Tell your doctor if you have a history of heart or kidney disease.
• Immunosuppression: Medrol decreases your body’s immune response to infections. In addition, Medrol can increase sensitivity to vaccines since the immune response is reduced with Medrol use.
• Reactivation of tuberculosis: Tell your doctor if you have had tuberculosis.
• Perforation of the gastrointestinal tract: Medrol can cause holes in the stomach or intestinal lining.  Tell your doctor if you have a history of ulcers or other digestive system problems.
• Decreased bone formation: Medrol can prevent the formation of bones, which may result in decreased bone density and osteoporosis.
• Eye damage: Long-term use may lead to cataracts, glaucoma, damage to the optic (eye) nerves, and may worsen an eye infection.
• Electrolyte changes: Corticosteroids can cause a rise sodium and a decrease of potassium. Corticosteroids also cause a loss in calcium.
• Extreme mood changes: Tell your healthcare provider right away if you have some or all of the following symptoms...
  • euphoria (intense feeling of happiness or joy)
  • insomnia
  • mood swings
  • personality changes
  • severe depression
• Stunted growth in children: Growth should be monitored with long-term use of Medrol.
• Kaposi's sarcoma: This type of cancer has been reported to occur in patients receiving corticosteroid therapy. Stopping its use may result in clinical remission.
• Steroid withdrawal: To avoid withdrawal side effects, do not stop taking Medrol suddenly. Discuss with your doctor about slowly decreasing the dose before stopping use of this medication altogether.

Medrol can cause dizziness. Do not drive or operate heavy machinery until you know how Medrol affects you.

Do not take Medrol if you:

• have an active fungal infection
• are allergic to Medrol, aspirin, or any ingredient within this medication product

Take Medrol exactly as prescribed.

Medrol comes as a tablet to be given directly by a healthcare professional.

Medrol can be taken with or without food. It is recommended to take with food to prevent stomach irritation.

To avoid steroid withdrawal side effects, do not stop taking Medrol suddenly. Discuss with your doctor about slowly decreasing the dose before stopping use of this medication altogether.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Medrol at the same time.

Take Medrol exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Your doctor will determine the appropriate dosage and schedule depending the disease being treated and your response to the medication. The starting dosage of Medrol may vary from 4 mg to 48 mg a day depending on reason for use.

If you take too much Medrol, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at room temperature.
• Keep this and all medicines out of the reach of children.

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

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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
• 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
• 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
• Carbamazepine
• Clarithromycin
• Cyclosporine
• Dalfopristin
• Diltiazem
• Erythromycin
• Fluindione
• Gallamine
• Hexafluorenium
• Ketoconazole
• Licorice
• Metocurine
• Mibefradil
• Nefazodone
• Phenobarbital
• Primidone
• Quinupristin
• Rifampin
• Saiboku-To
• Troleandomycin
• Warfarin

Interactions with Food/Tobacco/Alcohol

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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Medrol or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Medrol. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Systemic fungal infections and known hypersensitivity to components.

Medrol Tablets are available in the following strengths and package sizes:

2 mg (pink, elliptical, scored, imprinted Medrol 2)

  Bottles of 100                                                   NDC 0009-0049-02

2 mg (white, elliptical, scored, imprinted Medrol 2)

  Bottles of 100                                                   NDC 0009-0020-01

4 mg (white, elliptical, scored, imprinted Medrol 4)

  Bottles of 100                                                   NDC 0009-0056-02

  Bottles of 500                                                   NDC 0009-0056-03

  Unit dose packages of 100                            NDC 0009-0056-05

  DOSEPAK™ Unit of Use (21 tablets)           NDC 0009-0056-04

8 mg (white, elliptical, scored, imprinted Medrol 8)

  Bottles of 25                                                     NDC 0009-0022-01

16 mg (white, elliptical, scored, imprinted Medrol 16)

  Bottles of 50                                                     NDC 0009-0073-01

32 mg (white, elliptical, scored, imprinted Medrol 32)

  Bottles of 25                                                     NDC 0009-0176-01

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Pfizer

NDC 0009-0022-01

Medrol®
methylprednisolone
tablets, USP

8 mg

25 Tablets
Rx only

Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017

Pfizer

NDC 0009-0073-01

Medrol®
methylprednisolone
tablets, USP

16 mg

50 Tablets
Rx only

Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017

Applies to methylprednisolone: compounding powder, injectable powder for injection, injectable suspension, oral tablet

General

The most commonly occurring side effects have included fluid retention, alteration in glucose tolerance, increased blood pressure, behavioral and mood changes, increased appetite, and weight gain; the incidence generally correlates with dosage, timing of administration, and duration of treatment.[Ref]

Hypersensitivity

Frequency not reported: Allergic or hypersensitivity reactions; anaphylactoid reaction, anaphylaxis, angioedema[Ref]

Cardiovascular

Frequency not reported: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis, edema, hypotension[Ref]

Endocrine

Frequency not reported: Cushingoid state, hirsutism, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), moon face[Ref]

Gastrointestinal

Frequency not reported: Abdominal distention, nausea, pancreatitis, peptic ulcer, perforation of the small and large intestine, ulcerative esophagitis, gastric hemorrhage, vomiting, abdominal pain, diarrhea, dyspepsia, nausea[Ref]

Hepatic

Frequency not reported: Hepatomegaly, elevation in liver enzymes, toxic hepatitis[Ref]

Reversible transaminase elevations (AST, ALT) have been observed following corticosteroid therapy. These changes have generally been small and not associated with any clinical syndrome. Toxic hepatitis has been reported with high doses of cyclically pulsed IV therapy, onset has been several weeks or longer. Resolution has been reported with discontinuation; however, recurrence has been reported with rechallenge.[Ref]

Metabolic

Frequency not reported: Decreased carbohydrate and glucose tolerance, manifestations of latent diabetes, hypokalemic alkalosis, potassium loss, sodium retention, increased appetite, negative nitrogen balance due to protein catabolism, weight gain, metabolic acidosis, dyslipidemia, lipomatosis[Ref]

Musculoskeletal

Frequency not reported: Suppression of growth in pediatric patients, aseptic necrosis of femoral and humeral heads, calcinosis, Charcot-like atrophy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare, steroid myopathy, tendon rupture, particularly of the Achilles tendon, vertebral compression fractures, myalgia, muscle atrophy, osteonecrosis, neuropathic arthralgia, growth retardation[Ref]

Hematologic

Frequency not reported: Leucocytosis[Ref]

Immunologic

Frequency not reported: Opportunistic infection[Ref]

Ocular

Blindness has been reported with corticosteroid injection to scalp, tonsillar fauces, sphenopalatine ganglion.[Ref]

Frequency not reported: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, blindness, chorioretinopathy[Ref]

Psychiatric

Frequency not reported: Depression, emotional instability, euphoria, insomnia, mood swings, personality changes, psychic disorders, confusional states, anxiety, abnormal behavior, irritability[Ref]

Dermatologic

Frequency not reported: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymosis, petechiae, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria, hypertrichosis, angioedema, skin atrophy, hyperhidrosis, pruritus[Ref]

Local

Frequency not reported: Injection site infections, injection site reactions[Ref]

Nervous system

Frequency not reported: Convulsions, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, neuritis, neuropathy, paresthesia, amnesia, dizziness[Ref]

Other

Frequency not reported: Vertigo, abnormal fat deposits, malaise, sterile abscess, impaired healing, fatigue[Ref]

Oncologic

Frequency not reported: Kaposi's sarcoma[Ref]

Respiratory

Frequency not reported: Pulmonary edema, pulmonary embolism, hiccups[Ref]

Genitourinary

Frequency not reported: Menstrual irregularities, increased or decreased motility and number of spermatozoa, increased urine calcium, glycosuria[Ref]

Some side effects of Medrol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of methylprednisolone is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a "live" vaccine while using Medrol. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Other drugs may interact with methylprednisolone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.