Drugs Details

Drugs Info of Medrol, Medrol Dosepak, MethylPREDNISolone Dose Pack
Drugs Details
  • Drugs Type  : FDA
  • Date : 9th Mar 2015 12:09 am
  • Brand Name : Medrol, Medrol Dosepak, MethylPREDNISolone Dose Pack
  • Generic Name : methylprednisolone (Pronunciation: METH il pred NIS oh lone)
Descriptions

MEDROL Tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in alcohol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water.

The chemical name for methylprednisolone is pregna - 1,4 - diene - 3,20-dione, 11, 17, 21-trihydroxy-6-methyl-, (6α, 11β)-and the molecular weight is 374.48. The structural for-mula is represented below:

 

Medrol® (methylprednisolone) structural formula illustration

 

Each MEDROL (methylprednisolone) Tablet for oral administration contains 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone.
Inactive ingredients:

2 mg
Calcium Stearate
Corn Starch
Erythrosine Sodium
Lactose
Mineral Oil
Sorbic Acid
Sucrose

4 and 16 mg
Calcium Stearate
Corn Starch
Lactose
Mineral Oil
Sorbic Acid
Sucrose

8 and 32 mg
Calcium Stearate
Corn Starch
F D & C Yellow No. 6
Lactose
Mineral Oil
Sorbic Acid
Sucrose

 

What are the possible side effects of methylprednisolone (Medrol, Medrol Dosepak, MethylPREDNISolone Dose Pack)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • problems with your vision;
  • swelling, rapid weight gain, feeling short of breath;
  • severe depression, unusual thoughts or behavior, seizure (convulsions);
  • bloody or tarry stools, coughing up blood;
  • pancreatitis (severe pain in your upper stomach spreading to your...

Read All Potential Side Effects and See Pictures of Medrol »

What are the precautions when taking methylprednisolone (Medrol)?

Before taking methylprednisolone, tell your doctor or pharmacist if you are allergic to it; or to prednisone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, blood clots, brittle bones (osteoporosis), diabetes, eye diseases (such as cataracts, glaucoma, herpes infection of the eye), heart problems (such as recent heart attack, congestive heart failure), high blood pressure, current/past infections (such as those caused by tuberculosis, threadworm, herpes, fungus), kidney disease, liver disease, mental/mood conditions (such as psychosis,...

Read All Potential Precautions of Medrol »

 

This monograph has been modified to include the generic and brand name in many instances.

Indications

MEDROL (methylprednisolone) Tablets are indicated in the following conditions:

1.  Endocrine Disorders

Primary or secondary adrenocortical insufficiency (hydrocortisone orcortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).
Congenital adrenal hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer

2. Rheumatic Disorders

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
Ankylosing spondylitis
Acute and subacute bursitis
Synovitis of osteoarthritis
Acute nonspecific tenosynovitis
Post-traumatic osteoarthritis
Psoriatic arthritis
Epicondylitis
Acute gouty arthritis

3. Collagen Diseases

During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Systemic dermatomyositis (polymyositis)
Acute rheumatic carditis

4. Dermatologic Diseases

Bullous dermatitis herpetiformis
Severe erythema multiforme
(Stevens-Johnson syndrome)
Severe seborrheic dermatitis
Exfoliative dermatitis
Mycosis fungoides
Pemphigus
Severe psoriasis

5. Allergic States

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitis
Drug hypersensitivity reactions
Serum sickness
Contact dermatitis
Bronchial asthma
Atopic dermatitis

6. Ophthalmic Diseases

Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers
Herpes zoster ophthalmicus
Anterior segment inflammation
Diffuse posterior uveitis and choroiditis
Sympathetic ophthalmia
Keratitis
Optic neuritis
Allergic conjunctivitis
Chorioretinitis
Iritis and iridocyclitis

7. Respiratory Diseases

Symptomatic sarcoidosis
Berylliosis
Loeffler's syndrome not manageable by other means
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
Aspiration pneumonitis

8. Hematologic Disorders

Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Acquired (autoimmune) hemolytic anemia
Erythroblastopenia (RBC anemia)
Congenital (erythroid) hypoplastic anemia

9.  Neoplastic Diseases

For palliative management of:
Leukemias and lymphomas in adults
Acute leukemia of childhood

10. Edematous States

To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.

11. Gastrointestinal Diseases

To tide the patient over a critical period of the disease in:
Ulcerative colitis
Regional enteritis

12. Nervous System

Acute exacerbations of multiple sclerosis

13. Miscellaneous

Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
Trichinosis with neurologic or myocardial involvement.

Dosage Administration

The initial dosage of MEDROL Tablets may vary from 4 mg to 48 mg of methylprednisolone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, MEDROL (methylprednisolone) should be discontinued and the patient transferred to other appropriate therapy.

IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT.After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of MEDROL (methylprednisolone) for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

Multiple Sclerosis

In treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (4 mg of methylprednisolone is equivalent to 5 mg of prednisolone).

ADT® (Alternate Day Therapy)

Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.

The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for reestablishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.

A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisolstimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm. Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenal cortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenal cortical activity. There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight.

The diurnal rhythm of the HPA axis is lost in Cushing's disease, a syndrome of adrenal cortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during long-term pharmacologic dose corticoid therapy administered in conventional daily divided doses. It would appear, then, that a disturbance in the diurnal cycle with maintenance of elevated corticoid values during the night may play a significant role in the development of undesirable corticoid effects. Escape from these constantly elevated plasma levels for even short periods of time may be instrumental in protecting against undesirable pharmacologic effects.

During conventional pharmacologic dose corticosteroid therapy, ACTH production is inhibited with subsequent suppression of cortisol production by the adrenal cortex. Recovery time for normal HPA activity is variable depending upon the dose and duration of treatment. During this time the patient is vulnerable to any stressful situation. Although it has been shown that there is considerably less adrenal suppression following a single morning dose of prednisolone (10 mg) as opposed to a quarter of that dose administered every six hours, there is evidence that some suppressive effect on adrenal activity may be carried over into the following day when pharmacologic doses are used. Further, it has been shown that a single dose of certain corticosteroids will produce adrenal cortical suppression for two or more days. Other corticoids, including methylprednisolone, hydrocortisone, prednisone, and prednisolone, are considered to be short acting (producing adrenal cortical suppression for 1¼ to 1½ days following a single dose) and thus are recommended for alternate day therapy.

The following should be kept in mind when considering alternate day therapy:

  1. Basic principles and indications for corticosteroid therapy should apply. The benefits of ADT should not encourage the indiscriminate use of steroids.
  2. ADT is a therapeutic technique primarily designed for patients in whom long-term pharmacologic corticoid therapy is anticipated.
  3. In less severe disease processes in which corticoid therapy is indicated, it may be possible to initiate treatment with ADT. More severe disease states usually will require daily divided high dose therapy for initial control of the disease process. The initial suppressive dose level should be continued until satisfactory clinical response is obtained, usually four to ten days in the case of many allergic and collagen diseases. It is important to keep the period of initial suppressive dose as brief as possible particularly when subsequent use of alternate day therapy is intended.
    Once control has been established, two courses are available: (a) change to ADT and then gradually reduce the amount of corticoid given every other day or (b) following control of the disease process reduce the daily dose of corticoid to the lowest effective level as rapidly as possible and then change over to an alternate day schedule. Theoretically, course (a) may be preferable.
  4. Because of the advantages of ADT, it may be desirable to try patients on this form of therapy who have been on daily corticoids for long periods of time (eg, patients with rheumatoid arthritis). Since these patients may already have a suppressed HPA axis, establishing them on ADT may be difficult and not always successful. However, it is recommended that regular attempts be made to change them over. It may be helpful to triple or even quadruple the daily maintenance dose and administer this every other day rather than just doubling the daily dose if difficulty is encountered. Once the patient is again controlled, an attempt should be made to reduce this dose to a minimum.
  5. As indicated above, certain corticosteroids, because of their prolonged suppressive effect on adrenal activity, are not recommended for alternate day therapy (eg, dexamethasone and betamethasone).
  6. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocortical activity the least, when given at the time of maximal activity (am).
  7. In using ADT it is important, as in all therapeutic situations to individualize and tailor the therapy to each patient. Complete control of symptoms will not be possible in all patients. An explanation of the benefits of ADT will help the patient to understand and tolerate the possible flare-up in symptoms which may occur in the latter part of the off-steroid day. Other symptomatic therapy may be added or increased at this time if needed.
  8. In the event of an acute flare-up of the disease process, it may be necessary to return to a full suppressive daily divided corticoid dose for control. Once control is again established alternate day therapy may be reinstituted.
    1. Although many of the undesirable features of corticosteroid therapy can be minimized by ADT, as in any therapeutic situation, the physician must carefully weigh the benefit-risk ratio for each patient in whom corticoid therapy is being considered.
 
 

How Supplied

MEDROL (methylprednisolone) Tablets are available in the following strengths and package sizes:

2 mg (pink, elliptical, scored, imprinted MEDROL (methylprednisolone) 2)
Bottles of 100                                   NDC 0009-0049-02

4 mg (white, elliptical, scored, imprinted MEDROL (methylprednisolone) 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 (peach, elliptical, scored, imprinted MEDROL (methylprednisolone) 8)
Bottles of 25                                     NDC 0009-0022-01

16 mg (white, elliptical, scored, imprinted MEDROL (methylprednisolone) 16)
Bottles of 50                                     NDC 0009-0073-01

32 mg (peach, elliptical, scored, imprinted MEDROL (methylprednisolone) 32)
Bottles of 25                                     NDC 0009-0176-01

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

Manufactured for: Pharmacia & Upjohn Company., A subsidiary of Pharmacia Corporation, Kalamazoo, MI 49001, USA
By: MOVA Pharmaceuticals., Manati, PR 00674
Revised May 2002
FDA rev date: 10/25/2002

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Fluid and Electrolyte Disturbances
Sodium retention
Congestive heart failure in susceptible patients
Hypertension
Fluid retention
Potassium loss
Hypokalemic alkalosis

Musculoskeletal
Muscle weakness
Loss of muscle mass
Steroid myopathy
Osteoporosis
Tendon rupture, particularly of the Achilles tendon
Vertebral compression fractures
Aseptic necrosis of femoral and humeral heads
Pathologic fracture of long bones

Gastrointestinal
Peptic ulcer with possible perforation and hemorrhage
Pancreatitis
Abdominal distention
Ulcerative esophagitis
Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT), and alkaline phosphatase have been observed followingcorticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.

Dermatologic
Impaired wound healingPetechiae and ecchymoses
May suppress reactions to skin tests
Thin fragile skin
Facial erythema
Increased sweating

Neurological
Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment
Convulsions
Vertigo
Headache

Endocrine
Development of Cushingoid state
Suppression of growth in children
Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness
Menstrual irregularities
Decreased carbohydrate tolerance
Manifestations of latent diabetes mellitus
Increased requirements of insulin or oral hypoglycemic agents in diabetics

Ophthalmic
Posterior subcapsular cataracts
Increased intraocular pressure
Glaucoma
Exophthalmos

Metabolic
Negative nitrogen balance due to protein catabolism
The following additional reactions have been reported following oral as well as parenteral therapy: Urticaria and other allergic, anaphylactic or hypersensitivity reactions.

Read the Medrol (methylprednisolone) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

The pharmacokinetic interactions listed below are potentially clinically important. Mutual inhibition of metabolism occurs with concurrent use of cyclosporin and methylprednisolone; therefore, it is possible that adverse events associated with the individual use of either drug may be more apt to occur. Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin. Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of methylprednisolone and may require increases in methylprednisolone dose to achieve the desired response. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of methylprednisolone and thus decrease its clearance. Therefore, the dose of methylprednisolone should be titrated to avoid steroid toxicity.

Methylprednisolone may increase the clearance of chronic high dose aspirin. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when methylprednisolone is withdrawn. Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia.

The effect of methylprednisolone on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulant when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.

Read the Medrol Drug Interactions Center for a complete guide to possible interactions

Learn More »
 

This monograph has been modified to include the generic and brand name in many instances.

Warnings

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.

Corticosteroids may mask some signs of infection, and new infections may appear during their use. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, in any location of the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function.1

These infections may be mild, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases.2 There may be decreased resistance and inability to localize infec-tion when corticosteroids are used.

Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

Usage in pregnancy: Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of child-bearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism.

Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the response to such vaccines may be diminished. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids.

The use of MEDROL (methylprednisolone) Tablets in active tuberculosisshould be restricted to those cases of fulminating or disseminatedtuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.

If corticosteroids are indicated in patients with latent tuberculosis ortuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed, to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chicken pox develops, treatment with antiviral agents may be considered. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatalgram-negative septicemia.

Precautions

General Precautions

Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

There is an enhanced effect of corticosteroids on patients withhypothyroidism and in those with cirrhosis.

Corticosteroids should be used cautiously in patients with ocular herpessimplex because of possible corneal perforation.

The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual.

Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.

Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection;diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renalinsufficiency; hypertension; osteoporosis; and myasthenia gravis.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.

Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.

Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that corticosteroids affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION.)

Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treat-ment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.

REFERENCES

1 Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases. Philadelphia: WBSaunders Company 1992:1050-1.

2 Stuck AE, Minder CE, Frey FJ. Risk of infectious compli-cations in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954-63.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

Systemic fungal infections and known hypersensitivity to components.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

ACTIONS

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.

Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

METHYLPREDNISOLONE - ORAL

 

(METH-il-pred-NIS-oh-lone)

 

COMMON BRAND NAME(S): Medrol

 

USES: Methylprednisolone is used to treat conditions such as arthritis, blood disorders, severe allergic reactions, certain cancers, eye conditions, skin/kidney/intestinal/lung diseases, and immune system disorders. It decreases your immune system's response to various diseases to reduce symptoms such as swelling, pain, and allergic-type reactions. This medication is a corticosteroid hormone.

Methylprednisolone may also be used with other medications in hormone disorders.

 

HOW TO USE: Take this medication by mouth as directed by your doctor, usually with food or milk. Follow your dosing instructions carefully. The dosage and length of treatment are based on your medical condition and response to treatment. Different dosing schedules exist for this medication. If you are not taking the same dose each day or if you take this medication every other day, it may help to mark your calendar with a reminder. Consult your doctor or pharmacist if you have any questions.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Do not stop taking this medication without consulting your doctor. Some conditions may worsen or you may experience withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness) when this drug is suddenly stopped. To prevent these withdrawal symptoms when stopping methylprednisolone, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details and report any withdrawal reactions immediately. See also Precautions section.

Tell your doctor if your condition does not improve or if it worsens.

 

 

 

Consumer Overview Side Effect

SIDE EFFECTS: Nausea, vomiting, heartburn, headache, dizziness, trouble sleeping, appetite changes, increased sweating, or acne may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough, white patches in the mouth).

Tell your doctor right away if you have any serious side effects, including: unusual weight gain, menstrual period changes, bone/joint pain, easy bruising/bleeding, mental/mood changes (such as mood swings, depression, agitation), muscle weakness/pain, puffy face, slow wound healing, swelling of the ankles/feet/hands, thinning skin, unusual hair/skin growth, vision problems, fast/slow/irregular heartbeat.

This drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. If you notice any of the following unlikely but serious side effects, consult your doctor or pharmacist immediately: black/bloody stools, vomit that looks like coffee grounds, persistent stomach/abdominal pain.

Get medical help right away if you have any very serious side effects, including: seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Medrol (methylprednisolone) Side Effects Center for a complete guide to possible side effects

Learn More »
 

PRECAUTIONS: Before taking methylprednisolone, tell your doctor or pharmacist if you are allergic to it; or to prednisone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, blood clots, brittle bones (osteoporosis), diabetes, eye diseases (such as cataracts, glaucoma, herpes infection of the eye), heart problems (such as recent heart attack, congestive heart failure), high blood pressure, current/past infections (such as those caused by tuberculosis, threadworm, herpes, fungus), kidney disease, liver disease, mental/mood conditions (such as psychosis, depression, anxiety), stomach/intestinal problems (such as diverticulitis, ulcer, ulcerative colitis), seizures.

Methylprednisolone may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

This medicine may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding.

Limit alcoholic beverages to decrease risk of dizziness and stomach bleeding. Consult your doctor or pharmacist for more information.

Methylprednisolone can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

This medication may cause vaccines to not work as well. Live vaccines may cause serious problems (such as infection) if given while you are using this medication. Do not have immunizations/vaccinations/skin tests without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication. See also Medical Alert section.

Older adults may be more sensitive to the side effects of this drug, especially brittle bones (osteoporosis). Talk to your doctor about the ways to prevent osteoporosis. See also Notes section.

This medication may slow down a child's growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child's height and growth can be checked.

During pregnancy, this medication should be used only when clearly needed. It may rarely harm an unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for a long time may have hormone problems. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: aldesleukin, mifepristone, other drugs that can also cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as warfarin/dabigatran, NSAIDs such as ibuprofen, celecoxib, aspirin, salicylates).

If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Other medications can affect the removal of methylprednisolone from your body, which may affect how methylprednisolone works. Examples include azole antifungals (such as ketoconazole), boceprevir, cyclosporine, estrogens, HIV protease inhibitors (such as ritonavir), macrolide antibiotics (such as erythromycin), rifamycins (such as rifampin), St. John's wort, some drugs used to treat seizures (such as phenytoin, phenobarbital, carbamazepine), telaprevir, among others.

This medication may interfere with certain laboratory tests (such as skin tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

If this medication is used for a long time, laboratory and/or medical tests (such as blood sugar/mineral levels, blood pressure, eye exams, bone density tests, height/weight measurements) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Taking this medication for a long time may cause brittle bones (osteoporosis). Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, getting enough calcium and vitamin D, and limiting alcohol. Consult your doctor for specific advice.

 

MISSED DOSE: If you are taking this medication once daily and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

If you do not take the same dose each day or if you take this medication every other day, ask your doctor or pharmacist what you should do if you miss a dose.

 

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

 

Information last revised July 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Medrol, Medrol Dosepak, MethylPREDNISolone Dose Pack

Generic Name: methylprednisolone (Pronunciation: METH il pred NIS oh lone)

  • What is methylprednisolone (Medrol)?
  • What are the possible side effects of methylprednisolone (Medrol)?
  • What is the most important information I should know about methylprednisolone (Medrol)?
  • What should I discuss with my healthcare provider before taking methylprednisolone (Medrol)?
  • How should I take methylprednisolone (Medrol)?
  • What happens if I miss a dose (Medrol)?
  • What happens if I overdose (Medrol)?
  • What should I avoid while taking methylprednisolone (Medrol)?
  • What other drugs will affect methylprednisolone (Medrol)?
  • Where can I get more information?

What is methylprednisolone (Medrol)?

 

Methylprednisolone is a steroid that prevents the release of substances in the body that cause inflammation.

Methylprednisolone is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.

Methylprednisolone may also be used for purposes not listed in this medication guide.

Methylprednisolone 4 mg-BAR

oval, white, imprinted with dp 301

What are the possible side effects of methylprednisolone (Medrol)?

 

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • problems with your vision;
  • swelling, rapid weight gain, feeling short of breath;
  • severe depression, unusual thoughts or behavior, seizure (convulsions);
  • bloody or tarry stools, coughing up blood;
  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • sleep problems (insomnia), mood changes;
  • acne, dry skin, thinning skin, bruising or discoloration;
  • slow wound healing;
  • increased sweating;
  • headache, dizziness, spinning sensation;
  • nausea, stomach pain, bloating; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Medrol (methylprednisolone) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about methylprednisolone (Medrol)?

 

You should not use this medication if you are allergic to methylprednisolone, or if you have a fungal infection anywhere in your body.

Before taking methylprednisolone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

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. Do not receive a "live" vaccine while using methylprednisolone. The vaccine may not work as well during this time, and may not fully protect you from disease.

Do not stop using methylprednisolone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Wear a medical alert tag or carry an ID card stating that you take methylprednisolone. Any doctor, dentist, or emergency medical professional who treats you should know that you take steroid medication.

Side Effects Centers
  • Medrol

Patient Detailed How Take

What should I discuss with my healthcare provider before taking methylprednisolone (Medrol)?

 

You should not use this medication if you are allergic to methylprednisolone, or if you have a fungal infection anywhere in your body.

Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.

To make sure you can safely take methylprednisolone, tell your doctor if you have any of these other conditions:

  • liver disease (such as cirrhosis);
  • kidney disease;
  • a thyroid disorder;
  • diabetes;
  • a history of malaria;
  • tuberculosis;
  • osteoporosis;
  • a muscle disorder such as myasthenia gravis;
  • glaucoma or cataracts;
  • herpes infection of the eyes;
  • stomach ulcers, ulcerative colitis, or diverticulitis;
  • depression or mental illness;
  • congestive heart failure; or
  • high blood pressure

FDA pregnancy category C. It is not known whether methylprednisolone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Methylprednisolone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How should I take methylprednisolone (Medrol)?

 

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Your steroid medication needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using methylprednisolone.

Do not stop using methylprednisolone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using methylprednisolone.

Wear a medical alert tag or carry an ID card stating that you take methylprednisolone. doctor, dentist, or emergency medical professional who treats you should know that you take steroid medication.

Store at room temperature away from moisture and heat.

Side Effects Centers
  • Medrol

Patient Detailed Avoid Taking

What happens if I miss a dose (Medrol)?

 

Call your doctor for instructions if you miss a dose of methylprednisolone.

What happens if I overdose (Medrol)?

 

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.

What should I avoid while taking methylprednisolone (Medrol)?

 

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 methylprednisolone. 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), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Avoid drinking alcohol while you are taking methylprednisolone.

What other drugs will affect methylprednisolone (Medrol)?

 

There are many other medicines that can interact with steroids. Below is only a partial list of these medicines:

  • aspirin (taken on a daily basis or at high doses);
  • a diuretic (water pill);
  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • insulin or oral diabetes medication;
  • ketoconazole (Nizoral);
  • rifampin (Rifadin, Rifater, Rifamate, Rimactane); or
  • seizure medications such as phenytoin (Dilantin) or phenobarbital (Solfoton).

This list is not complete and other drugs may interact with methylprednisolone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

 

Your pharmacist can provide more information about methylprednisolone.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 6.01. Revision date: 6/2/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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