Methylprednisolone sodium succinate

Methylprednisolone sodium succinate

[1gm vial $42.57]

ADMINISTRATION ROUTES:

  • IV

ALTERNATIVE NAMES:

  • Solu-Medrol

ICU INDICATIONS:

  1. steroid responsive lung diseases
  2. ARDS
  3. Stevens Johnson syndrome

PRESENTATION AND ADMINISTRATION:

  • IV:
    40mg/ml (Act-O-Vial), 125mg/2ml (Act-O-Vial), 500mg/4ml (Act-O-Vial), 1gm (+15.6ml solv)
    Note: there is a depo product (Depo-Medrol); make sure you are using SOLU-Medrol for IV use

    Directions for mixing Act-O-Vial:
    Press down on plastic activator. This forces diluent into the lower compartment. Gently agitate to dissolve powder. To withdraw solution remove plastic tab covering the centre of stopper. Wipe top of stopper with alcohol swab. Insert needle squarely through centre of stopper until tip is just visible. Invert vial and withdraw dose.

    Directions for mixing other vial preparations:
    Add 1gm to 15.6ml of supplied diluent provided to make a final 62.5mg/ml. Gently agitate to dissolve powder.

    Doses of up to 250mg can be injected slowly by direct IV injection over at least 5 minutes
    Doses of 125mg to 3gm may be diluted in 50ml of compatible IV fluid and administered over 30 minutes.
    When reconstituted with water for injection use immediately and discard any unused solution. Small volume dilutions (50-100ml) are stable for 6 hours at room temperature. Large volume dilutions (250-1000ml) are stable for 24 hours at room temperature.
    Compatible in the following IV fluids:
    normal saline, 5% dextrose, glucose and sodium chloride

DOSAGE:

  • IV:
    Doses vary widely depending in indication.
    Currently, the best available evidence for ARDS suggests dosages of 1-2mg/kg daily are the most appropriate. Doses of up to 30mg/kg have been used.
    For prophylaxis against laryngeal oedema in high risk patients, the recommended dose is 20mg 4 hourly for 4 doses beginning 12 hours prior to planned extubation.

DOSAGE IN RENAL FAILURE AND RENAL REPLACEMENT THERAPY:

  • Dose as in normal renal function

DOSAGE IN PAEDIATRICS:

  • Doses vary widely depending in indication. Currently, the best available evidence for ARDS suggests dosages of 1-2mg/kg daily are the most appropriate. Doses of up to 30mg/kg have been used.

CLINICAL PHARMACOLOGY:

  • Methylprednisolone is a potent anti-inflammatory steroid synthesized in a laboratory.
    1mg methylprednisolone equals 5mg hydrocortisone in glucocorticoid activity and 0.5mg in mineralocorticoid activity

CONTRAINDICATIONS:

  1. The use of methylprednisolone sodium succinate sterile powder is contraindicated in premature infants because the 40, 125, 500, 1 g, and the accompanying diluent for the 500 mg and 2 g vials contain benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal “Gasping Syndrome” in premature infants.
  2. Systemic fungal infections
  3. known hypersensitivity to the product and its constituents.

WARNINGS

  • In patients on corticosteroid therapy subjected to any 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.

PRECAUTIONS

  • General:
    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 with hypothyroidism and in those with cirrhosis. 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.
    An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevations of creatine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years.
  • Laboratory Tests: No tests additional to usual ICU tests are required
  • Drug/Laboratory Test Interactions: None of note

IMPORTANT DRUG INTERACTIONS FOR THE ICU

  • 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.

ADVERSE REACTIONS

  • Fluid and Electrolyte Disturbances:
    Sodium retention, potassium loss, fluid retention, hypokalemic alkalosis, congestive heart failure in susceptible patients, hypertension.
  • Musculoskeletal:
    Muscle weakness, aseptic necrosis of femoral and humeral heads, steroid myopathy, loss of muscle mass, pathologic fracture of long bones, severe arthralgia, osteoporosis, vertebral compression fractures, tendon rupture (particularly of the Achilles tendon).
  • Gastrointestinal:
    Peptic ulcer with possible perforation and hemorrhage, abdominal distention, ulcerative esophagitis, pancreatitis. Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT), and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.
    Dermatologic:

    Impaired wound healing, facial erythema, thin fragile skin, increased sweating, petechiae and ecchymoses, may suppress reactions to skin tests. Neurological: Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment, convulsions, vertigo, headache.
  • Endocrine:
    Development of Cushingoid state, menstrual irregularities, suppression of growth in children, decreased carbohydrate tolerance, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness), manifestations of latent diabetes mellitus, increased requirements for insulin or oral hypoglycemic agents in diabetics.

Critical Care Drug Manual

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