Solu-Medrol

Methylprednisolone family of products include methylprednisolone, methylprednisolone acetate (Medrol, Depo-medrol), and methylprednisolone sodium acetate (Solu-medrol). They will be called methylprednisolone in this monograph. They are synthetic (man-made) corticosteroids. Corticosteroids are naturally-occurring chemicals produced by the adrenal glands located adjacent to the kidneys. Corticosteroids affect metabolism in various ways and modify the immune system. Corticosteroids also block inflammation and are used in a wide variety of inflammatory diseases affecting many organs. The FDA approved methylprednisolone in October 1957.

Adverse effects of methylprednisolone depend on dose, duration and frequency of administration. Short courses of methylprednisolone are usually well-tolerated with few, mild side effects. Long term, high doses of methylprednisolone may produce predictable and potentially serious side effects. Whenever possible, the lowest effective doses of methylprednisolone should be used for the shortest length of time to minimize side effects. Alternate day dosing also can help reduce side effects.

Side effects of methylprednisolone and other corticosteroids range from mild annoyances to serious irreversible bodily damage. Commonly reported side effects include:

• fluid retention,
• weight gain,
• high blood pressure,
• potassium loss,
• headache,
• muscle weakness,
• puffiness of the face,
• hair growth on the face,
• thinning and easy bruising of the skin,
• glaucoma,
• cataracts,
• peptic ulceration,
• worsening of diabetes,
• irregular menses,
• growth retardation in children,
• convulsions, and
• psychic disturbances.

Important psychic disturbances may include:

• depression,
• euphoria,
• insomnia,
• mood swings,
• personality changes, and
• psychotic behavior.

• Treating RA With Biologics
• Care for Your RA
• Are You Ready for Back Surgery?

• 13 Best Quit-Smoking Tips Ever
• What Stress Does to Your Mouth
• Healthy Home: To Buy or Not to Buy Organic?

• Frequent Constipation?
• Greater Food Accessibility

Methylprednisolone is a prescription medication used to treat:

• low corticosteroid levels. Corticosteroids are steroids naturally produced by the body that are required for normal body function.
• arthritis
• allergic reactions
• asthma
• multiple sclerosis. Multiple sclerosis is a disease in which nerves do not function properly due to inflammation.
• lupus. Lupus is a disease in which the body’s immune system attacks itself.
• severe psoriasis. Psoriasis is a disease in which the skin becomes red, irritated, and flaky.
• certain conditions affecting the lungs, skin, eyes, kidneys, blood, thyroid, stomach, and intestines. Methylprednisolone frequently treats diseases of these organs by reducing inflammation.
• some types of cancer such as leukemia (cancer in bone marrow) and lymphoma (cancer of white blood cells)

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

 

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• cyclosporine (Sandimmune, Neoral, Restasis, Gengraf)
• phenobarbital (Donnatal)
• phenytoin (Dilantin)
• rifampin (Rifadin, Rimactane)
• ketoconazole (Nizoral)
• aspirin (Ecotrin)

This is not a complete list of methylprednisolone drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with methylprednisolone including:

• Hypersensitivity reaction: Methylprednisolone may trigger an allergic response. Symptoms of a hypersensitivity reaction include:
  • hives
  • difficulty breathing or swallowing
  • swelling
  • rash
  • itching
• Cardiac and renal problems: Methylprednisolone 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: Methylprednisolone decreases your body’s immune response to infections. In addition, methylprednisolone can increase sensitivity to vaccines since the immune response is reduced with methylprednisolone use.
• Reactivation of tuberculosis: Tell your doctor if you have had tuberculosis.
• Perforation of the gastrointestinal tract: Methylprednisolone 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: Methylprednisolone 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 methylprednisolone.
• 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 methylprednisolone suddenly. Discuss with your doctor about slowly decreasing the dose before stopping use of this medication altogether.

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

Do not take methylprednisolone if you:

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

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of Cushing's disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Feeling very tired, weak, or touchy; trembling; having a fast heartbeat, confusion, sweating, or dizziness if you missed a dose or recently stopped Solu-Medrol (methylprednisolone injection).
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Chest pain or pressure.
• Period (menstrual) changes.
• Bone or joint pain.
• Change in eyesight.
• Change in the way you act.
• Low mood (depression).
• Seizures.
• A burning, numbness, or tingling feeling that is not normal.
• Any unexplained bruising or bleeding.
• Very bad belly pain.
• Black, tarry, or bloody stools.
• Throwing up blood or throw up that looks like coffee grounds.

NOTE: Some of the Solu-Medrol formulations contain benzyl alcohol (see DESCRIPTION, WARNINGS, and, PRECAUTIONS, Pediatric Use)

Because of possible physical incompatibilities, Solu-Medrol should not be diluted or mixed with other solutions.

Use only the accompanying diluent or Bacteriostatic Water For Injection with Benzyl Alcohol when reconstituting Solu-Medrol (see DESCRIPTION). Use within 48 hours after mixing.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

This preparation may be administered by intravenous injection, by intravenous infusion, or by intramuscular injection, the preferred method for initial emergency use being intravenous injection. Following the initial emergency period, consideration should be given to employing a longer acting injectable preparation or an oral preparation.

There are reports of cardiac arrhythmias and/or cardiac arrest following the rapid administration of large intravenous doses of Solu-Medrol  (greater than 0.5 gram administered over a period of less than 10 minutes). Bradycardia has been reported during or after the administration of large doses of methylprednisolone sodium succinate, and may be unrelated to the speed or duration of infusion. When high dose therapy is desired, the recommended dose of Solu-Medrol Sterile Powder is 30 mg/kg administered intravenously over at least 30 minutes. This does may be repeated every 4 to 6 hours for 48 hours.

In general, high dose corticosteroid therapy should be continued only until the patient’s condition has stabilized; usually not beyond 48 to 72 hours.

In other indications, initial dosage will vary from 10 to 40 mg of methylprednisolone depending on the specific disease entity being treated. However, in certain overwhelming, acute, life-threatening situations, administrations in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages. 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. 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 the corticosteroids 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.

Solu-Medrol may be administered by intravenous or intramuscular injection or by intravenous infusion, the preferred method for initial emergency use being intravenous injection. To administer by intravenous (or intramuscular) injection, prepare solution as directed. The desired dose may be administered intravenously over a period of several minutes. If desired, the medication may be administered in diluted solutions by adding Water for Injection or other suitable diluent (see below) to the Act-O-Vial and withdrawing the indicated dose.

To prepare solutions for intravenous infusion, first prepare the solution for injection as directed. This solution may then be added to indicated amounts of 5% dextrose in water, isotonic saline solution, or 5% dextrose in isotonic solution.

In pediatric patients, the initial dose of methylprednisolone may vary depending on the specific disease entity being treated. The range of initial doses is 0.11 to 1.6 mg/kg/day in three or four divided doses (3.2 to 48 mg/m2bsa/day).

The National Heart, Lung, and Blood Institute (NHLB) recommended dosing for systemic prednisone, prednisolone, or methylprednisolone in pediatric patients whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1-2 mg/kg/day in single or divided doses. It is further recommended that short course, or “burst” therapy, be continued until the patient achieves a peak expiratory flow rate of 80% of his or her personal best or until symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.

Dosage may be reduced for infants and children but should be governed more by the severity of the condition and response of the patient than by age or size. It should not be less than 0.5 mg per kg every 24 hours.

Dosage must be decreased or discontinued gradually when the drug has been administered for more than a few days. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. Routine laboratory studies, such as urinalysis, two-hour postprandial blood sugar, determination of blood pressure and body weight, and a chest X-ray should be made at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with an ulcer history or significant dyspepsia.

In treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of methylprednisolone for a week followed by 64 mg every other day for 1 month have been shown to be effective  (see PRECAUTIONS, Neurologic-psychiatric).

For the purpose of comparison, the following is the equivalent milligram dosage of the various glucocorticoids:

DIRECTIONS FOR USING THE ACT-O-VIAL SYSTEM

1. Press down on the plastic activator to force diluent into the lower compartment.

2. Gently agitate to effect solution.

3. Remove plastic tab covering center of stopper.

4. Sterilize top of stopper with a suitable germicide.

5. Insert needle squarely through center of stopper until tip is just visible. Invert vial and withdraw dose.