Medrol Dosepak

This section provides information on the proper use of a number of products that contain methylprednisolone. It may not be specific to Medrol Dosepak. Please read with care.

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Do not keep outdated medicine or medicine no longer needed.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.

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.

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

Call your doctor at once if you have:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• bruising, thinning skin, or any wound that will not heal;

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• severe depression, changes in personality, unusual thoughts or behavior;

• new or unusual pain in an arm or leg or in your back;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• seizure (convulsions); or

• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling.

Steroids can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

• fluid retention (swelling in your hands or ankles);

• dizziness, spinning sensation;

• changes in your menstrual periods;

• headache;

• mild muscle pain or weakness; or

• stomach discomfort, bloating.

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.

Applies to methylprednisolone: oral tablet

Other dosage forms:

• injection powder for solution, injection suspension

Along with its needed effects, methylprednisolone (the active ingredient contained in Medrol Dosepak) 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 while taking methylprednisolone:

• 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
• shortness of breath
• swelling of the fingers, hands, feet, or lower legs
• trouble thinking, speaking, or walking
• troubled breathing at rest
• weight gain

• 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 of methylprednisolone 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:

• Increased appetite

• 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

SYSTEMIC Effect:
Oral:
Initial dose: 4 to 48 mg orally once a day or in divided doses
-Adjust or maintain initial dose until a satisfactory response is obtained; then, gradually in small decrements at appropriate intervals decrease to the lowest dose that maintains an adequate clinical response

Parenteral: Acetate suspension: Provides prolonged systemic effect
Maintenance dose: 40 to 120 mg IM once a week

Comments:
-Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity; consider time of maximal adrenal cortex activity (2 AM to 8 AM) when dosing.
-Alternate day therapy may be considered in patients requiring long-term treatment; it may be necessary to return to a full suppressive daily dose in the event of acute flare-ups.

LOCAL Effect:
INTRA-ARTICULAR INJECTION: Acetate suspension:
General guidance: Actual doses may vary with severity of condition
-Large joints (knee, angles, shoulders): 20 to 80 mg via intra-articular injection
-Medium joints (elbows, wrists): 10 to 40 mg via intra-articular injection
-Small joints (metacarpophalangeal, interphalangeal, sternoclavicular, acromioclavicular): 4 to 10 mg via intra-articular injection
Injections may be repeated every 1 to 5 or more weeks, depending upon the degree of relief obtained from the original injection.

Use: For the treatment of rheumatoid arthritis; short-term intra-articular administration may be used to tide patients over an acute episode or exacerbation

160 mg orally once a day for 1 week; then 64 mg orally every other day for 1 month

-When oral therapy is not feasible, may administer IM (sodium succinate or acetate) or IV (sodium succinate); dosing will be the same as oral.

Comments:
-Controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, although they have not been shown to affect the natural history of the disease.

Use: For the treatment of acute exacerbations of multiple sclerosis.

Dosing should be individualized based on disease and patient response; in children, dosage may be reduced but this decision should be governed more by the severity of the condition and the response of the patient than by age or size

Oral:
Initial dose: 4 to 48 mg orally once a day or in divided doses
-Adjust or maintain initial dose until a satisfactory response is obtained; then, gradually in small decrements at appropriate intervals decrease to the lowest dose that maintains an adequate clinical response

Parenteral:
When oral therapy is not feasible IV (succinate) or IM therapy (acetate or succinate) may be used.

Succinate:
Initial dose: 0.11 to 1.6 mg/kg/day IV or IM in 3 or 4 divided doses
Alternatively, 3.2 to 4.8 mg/m2/day

Acetate:
Initial dose: 0.11 to 1.6 mg/kg/day IM once a day

Comments:
-Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity; consider time of maximal adrenal cortex activity (2 AM to 8 AM) when dosing.
-Alternate day therapy may be considered in patients requiring long-term treatment; it may be necessary to return to a full suppressive daily dose in the event of acute flare-ups.

Uses: For the systemic treatment of dermatologic disorders; intralesional injections maybe used to locally treat alopecia areata, discoid lupus erythematosus, keloids, lichen planus, lichen simplex chronicus (neurodermatitis), psoriatic plaques, necrobiosis lipoidica diabeticorum, and localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare.
-Intralesional injections may also be useful in treating cystic tumors of an aponeurosis or tendon (ganglia).

Dosing should be individualized based on disease and patient response; in children, dosage may be reduced but this decision should be governed more by the severity of the condition and the response of the patient than by age or size

Oral:
Initial dose: 4 to 48 mg orally once a day or in divided doses
-Adjust or maintain initial dose until a satisfactory response is obtained; then, gradually in small decrements at appropriate intervals decrease to the lowest dose that maintains an adequate clinical response

Parenteral:
When oral therapy is not feasible IV (succinate) or IM therapy (acetate or succinate) may be used.

Succinate:
Initial dose: 0.11 to 1.6 mg/kg/day IV or IM in 3 or 4 divided doses
Alternatively, 3.2 to 4.8 mg/m2/day

Acetate:
Initial dose: 0.11 to 1.6 mg/kg/day IM once a day

Comments:
-Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity; consider time of maximal adrenal cortex activity (2 AM to 8 AM) when dosing.
-Alternate day therapy may be considered in patients requiring long-term treatment; it may be necessary to return to a full suppressive daily dose in the event of acute flare-ups.

Uses: For the systemic treatment of dermatologic disorders; intralesional injections maybe used to locally treat alopecia areata, discoid lupus erythematosus, keloids, lichen planus, lichen simplex chronicus (neurodermatitis), psoriatic plaques, necrobiosis lipoidica diabeticorum, and localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare.
-Intralesional injections may also be useful in treating cystic tumors of an aponeurosis or tendon (ganglia).

Dosing should be individualized based on disease and patient response; in children, dosage may be reduced but this decision should be governed more by the severity of the condition and the response of the patient than by age or size

Oral:
Initial dose: 4 to 48 mg orally once a day or in divided doses
-Adjust or maintain initial dose until a satisfactory response is obtained; then, gradually in small decrements at appropriate intervals decrease to the lowest dose that maintains an adequate clinical response

Parenteral:
When oral therapy is not feasible IV (succinate) or IM therapy (acetate or succinate) may be used.

Succinate:
Initial dose: 0.11 to 1.6 mg/kg/day IV or IM in 3 or 4 divided doses
Alternatively, 3.2 to 4.8 mg/m2/day

Acetate:
Initial dose: 0.11 to 1.6 mg/kg/day IM once a day

Comments:
-Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity; consider time of maximal adrenal cortex activity (2 AM to 8 AM) when dosing.
-Alternate day therapy may be considered in patients requiring long-term treatment; it may be necessary to return to a full suppressive daily dose in the event of acute flare-ups.

Uses: For the systemic treatment of dermatologic disorders; intralesional injections maybe used to locally treat alopecia areata, discoid lupus erythematosus, keloids, lichen planus, lichen simplex chronicus (neurodermatitis), psoriatic plaques, necrobiosis lipoidica diabeticorum, and localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare.
-Intralesional injections may also be useful in treating cystic tumors of an aponeurosis or tendon (ganglia).

Dosing should be individualized based on disease and patient response; in children, dosage may be reduced but this decision should be governed more by the severity of the condition and the response of the patient than by age or size

Oral:
Initial dose: 4 to 48 mg orally once a day or in divided doses
-Adjust or maintain initial dose until a satisfactory response is obtained; then, gradually in small decrements at appropriate intervals decrease to the lowest dose that maintains an adequate clinical response

Parenteral:
When oral therapy is not feasible IV (succinate) or IM therapy (acetate or succinate) may be used.

Succinate:
Initial dose: 0.11 to 1.6 mg/kg/day IV or IM in 3 or 4 divided doses
Alternatively, 3.2 to 4.8 mg/m2/day

Acetate:
Initial dose: 0.11 to 1.6 mg/kg/day IM once a day

Comments:
-Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity; consider time of maximal adrenal cortex activity (2 AM to 8 AM) when dosing.
-Alternate day therapy may be considered in patients requiring long-term treatment; it may be necessary to return to a full suppressive daily dose in the event of acute flare-ups.

Uses: For the systemic treatment of dermatologic disorders; intralesional injections maybe used to locally treat alopecia areata, discoid lupus erythematosus, keloids, lichen planus, lichen simplex chronicus (neurodermatitis), psoriatic plaques, necrobiosis lipoidica diabeticorum, and localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare.
-Intralesional injections may also be useful in treating cystic tumors of an aponeurosis or tendon (ganglia).