Afamedrol® (methylprednisolone) vial

Afamedrol

Methylprednisolone 125 mg and 500 mg

Powder for Solution for IM Injection, IV Injection (over 5 minutes), and IV Infusion

This medication has been prescribed for your current condition. Do not use it for similar conditions or recommend it to others.

General Guidelines:

Consult your doctor before using this medication in the following cases:

• If you have an allergy to this drug or other corticosteroids (like hydrocortisone), or any other substances such as foods, preservatives, or dyes.
• If you have a widespread, untreated fungal infection (e.g., thrush).
• If you have a history of recent vaccination.
• If you have a history of psychotic reactions induced by corticosteroids, or a personal/family history of psychiatric disorders.
• Cerebral edema due to malaria, traumatic brain injury, shingles, measles, herpes, diabetes, epilepsy, seizures, glaucoma, blurred vision, heart diseases and high blood pressure, heart failure, hypothyroidism or hyperthyroidism, stomach ulcers, diverticulitis, liver or kidney problems, muscle weakness or pain, myasthenia gravis, osteoporosis, various cancers, tuberculosis, Cushing’s syndrome, or acute pancreatitis.
• If you are taking medications such as acetazolamide, cyclophosphamide, anticoagulants (e.g., warfarin), anticholinesterases (e.g., neostigmine), antibiotics, diabetes medications, aprepitant, antihypertensives, aspirin, barbiturates, carbamazepine, phenytoin, cyclosporine, digoxin, methotrexate, diltiazem, antivirals, antifungals, oral contraceptives, diuretics, or any vaccines.

Use in Pregnancy and Lactation:

The use of methylprednisolone during pregnancy and breastfeeding is prohibited unless prescribed by a specialist.

Warnings (Hospital Use Only):

• The use of methylprednisolone in the treatment of septic shock is contraindicated.
• If allergic symptoms such as skin reactions, angioedema, anaphylaxis, etc., occur, the medication must be discontinued.
• This medication is only for intramuscular (IM), direct intravenous (IV), or infusion use.
• The use of methylprednisolone in systemic fungal infections and untreated infections is contraindicated.
• Methylprednisolone should not be used in traumatic brain injuries.
• The use of corticosteroids may cause cataracts, glaucoma with potential damage to the optic nerves, and secondary eye infections caused by bacteria, fungi, or viruses. If visual disturbances or eye problems occur during the use of this drug, an ophthalmologist must be consulted.
• Long-term treatment with corticosteroids can increase the risk of osteoporosis and myopathy.
• The clearance of methylprednisolone decreases in hypothyroidism and increases in hyperthyroidism; therefore, dosage adjustments are required in these individuals.
• Individuals undergoing treatment with methylprednisolone must avoid contact with people infected with chickenpox, measles, or other infectious diseases.
• Continuous injection of methylprednisolone can cause muscle atrophy at the injection site.
• Treatment with high doses of methylprednisolone can cause high blood pressure, salt and water retention, and the excretion of potassium and calcium. Therefore, salt intake should be restricted, and potassium and calcium supplements should be used.
• High doses of methylprednisolone (1 gram per day used in the treatment of MS) can cause liver failure.
• High doses increase the risk of recurrent infections.
• Rapid IV injection of high doses is associated with cardiovascular collapse.

Dosage and Administration:

The attending physician determines the drug dosage for each patient. However, the usual dosage is as follows:

• Adults:
  • Suppression of inflammation or treatment of allergic reactions: 10 to 500 mg via IM, slow IV injection, or IV infusion.
  • Acute exacerbation of MS: 1 gram per day for 3 days.
  • Acute transplant rejection: 1 gram per day for up to 3 days, for 10 days via IV infusion.
  • Tumor-induced cerebral edema: Gradual dose tapering schedule to prevent increased intracranial pressure.
• Elderly: The dosage is similar to adults, but patients should be monitored by a physician for side effects.
• Children: Can cause irreversible growth retardation in infants and children. Therefore, the use of methylprednisolone in children should be limited.

Preparation and Dilution Instructions:

• Solution for IM or IV Injection:
  To prepare, dissolve the contents of the vial in 2 ml of Sterile Water for Injection for the 125 mg dose, and 8 ml for the 500 mg dose. Inject via IM or direct IV over at least 5 minutes.
• Solution for Infusion:
  First, dissolve the contents of the vial in 2 ml of Sterile Water for Injection for the 125 mg dose, and 8 ml for the 500 mg dose. Then, dilute the resulting solution again with 0.9% Sodium Chloride Injection or 5% Dextrose in 0.9% Sodium Chloride Injection, and infuse over at least 30 minutes.
• Use the solution immediately after preparation and discard any unused portion.
• The prepared solution must be clear, colorless, and free of any particulate matter. Otherwise, do not inject it.

Side Effects:

Along with its desired therapeutic effects, any medication may cause some unwanted side effects. Inform your doctor if any of the following occur:

• Significant side effects requiring immediate medical attention: Sudden allergic reactions such as swelling of the face, tongue, shortness of breath, skin rashes; symptoms of pancreatitis like abdominal pain, vomiting blood, and decreased level of consciousness; gastrointestinal bleeding, bloody stools; signs of infection like fever and chills; signs of pulmonary embolism such as severe chest pain and coughing up blood.
• Less common side effects: Increased or decreased blood pressure, irregular heartbeat, headache, insomnia, blurred vision, increased intracranial pressure, decreased seizure threshold, tendon rupture, muscle weakness and spasms (due to decreased potassium), edema and salt/water retention, stomach ulcers, nausea, diarrhea, and abdominal pain.

Storage Conditions:

• Store the dry product at a temperature below 30°C, protected from light and moisture, and inside the original box until use.
• Protect from freezing.
• Use the prepared solution immediately, and discard any remaining portion after a single use.
• Do not use expired medication.
• Keep the medication out of the reach of children.
• To protect the environment, do not dispose of any medications in wastewater or non-recyclable trash.

Dosage Forms and Packaging:

• Each Afamedrol 125 vial contains 125 mg of methylprednisolone (as sodium succinate) and is packaged in boxes of 10.
• Each Afamedrol 500 vial contains 500 mg of methylprednisolone (as sodium succinate) and is packaged in boxes of 10.