Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2021 Publisher: Pfizer New Zealand Ltd, PO Box 3998, Auckland, NEW ZEALAND, Toll Free Number: 0800 736 363
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
During an exacerbation or as maintenance therapy in selected cases of:
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:
Severe acute and chronic allergic and inflammatory processes involving the eye, such as:
To tide the patient over a critical period of the disease in:
SOLU-MEDROL is beneficial as adjunctive therapy in the treatment of AIDS patients with moderate to severe pneumocystis jiroveci pneumonia when given in the first 72 hours of initial anti-pneumocystis treatment. Due to the increased rate of reactivation of tuberculosis in AIDS patients, consideration should be given to the administration of antimycobacterial therapy if corticosteroids are used in this high risk group. The patient should also be observed for activation of other latent infections.
contraindicated)
For palliative management of:
To improve quality of life in patients with terminal cancer.
To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uraemia, of the idiopathic type or that due to lupus erythematosus.
Shock secondary to adrenocortical insufficiency or shock unresponsive to conventional therapy when adrenal cortical insufficiency may be present (Hydrocortisone is generally the drug of choice. When mineralocorticoid activity is undesirable, methylprednisolone may be preferred).
concurrently with appropriate anti-tuberculous chemotherapy.
WARNING – SOME SOLU-MEDROL FORMULATIONS CONTAIN BENZYL ALCOHOL. BENZYL ALCOHOL (AS CONTAINED IN THE ACCOMPANYING DILUENT FOR THE 1 G AND 2 G VIALS) HAS BEEN REPORTED TO BE ASSOCIATED WITH A FATAL “GASPING SYNDROME” IN PREMATURE INFANTS (SEE SECTIONS 2 AND 4.4, PAEDIATRIC USE).
Because of possible physical incompatibilities, SOLU-MEDROLshould not be diluted or mixed with other solutions.
Use only the accompanying diluent (bacteriostatic Water for Injections with benzyl alcohol or the sterile Water for Injection when reconstituting SOLU-MEDROL) (see Preparation of solutions).
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
SOLU-MEDROL (methylprednisolone sodium succinate) may be administered by intravenous or intramuscular injection, or by intravenous infusion. The preferred method for initial emergency use is intravenous injection. To administer by intravenous (or intramuscular) injection, prepare solution with the diluent provided.
Dosage requirements are variable and must be individualised on the basis of the disease under treatment, its severity and the response of the patient over the entire duration of treatment. A risk/benefit decision must be made in each individual case on an ongoing basis.
The lowest possible dose of corticosteroid should be used to control the condition under treatment for the minimum period. 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.
If after long-term therapy the drug is to be stopped, it needs to be withdrawn gradually rather than abruptly (see section 4.4, Endocrine Effects).
Following the initial emergency period, consideration should be given to employing a longer acting injectable preparation or an oral preparation.
As adjunctive therapy in life-threatening conditions, the recommended dose of SOLU-MEDROL sterile powder is 30 mg/kg of methylprednisolone sodium succinate, given IV over a period of at least 30 minutes. This dose may be repeated every 4-6 hours for up to 48 hours.
Methylprednisolone IV pulses, consisting of administration of 250 mg/day or above for a few days (usually ≤ 5 days) may be suitable during exacerbation episodes or conditions unresponsive to standard therapy, such as: rheumatic disorders, systemic lupus erythematosus, oedematous states, such as glomerulonephritis or lupus nephritis. In multiple sclerosis unresponsive to standard therapy (or during exacerbation episodes), administer pulses of 500 mg or 1 g/day for 3 or 5 days over 30 minutes.
There are reports of cardiac arrhythmias, and/or circulatory collapse, and/or cardiac arrest following the rapid administration of large IV doses of SOLU-MEDROL (greater than 500 mg 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 (see section 4.4, Cardiac Effects).
As adjunctive therapy in other conditions, initial dosage will vary from 10-500 mg intravenously, depending on the clinical condition. Larger doses may be required for short-term management of severe, acute conditions. Initial doses up to 250 mg should be administered intravenously over a period of at least five minutes, while larger doses should be administered over at least 30 minutes. Subsequent doses may be administered intravenously or intramuscularly at intervals dictated by the patient’s response and clinical condition. Corticosteroid therapy is an adjunct to, and not a replacement for, conventional therapy.
Dosage may be reduced for infants and children but should be selected based on the severity of the condition and the response of the patient rather than on the age or weight of the patient. The paediatric dosage should not be less than 0.5 mg/kg every 24 hours.
Benzyl alcohol has been associated with “gasping syndrome” in premature infants (see section 4.4, Paediatric Use).
1. Tap to ensure that the powder is at base of vial and away from the centralstopper.
2. Place the Act-O-Vial on a flat, stable surface and hold with one hand.
3. Press down firmly on the plastic activator with the palm of the other hand to force diluent into the lower compartment.
4. Gently mix the solution by turning the vial upside down a number of times. DO NOT SHAKE THE VIAL.
5. Remove plastic tab covering centre of stopper.
6. Sterilise top of stopper with an alcohol swab.
Note: Steps 1-6 must be completed before proceeding.
7. Whilst on a flat surface, insert needle squarely through centre of stopper until tip is just visible.
8. Invert vial to allow the solution to flow into the top compartment and withdraw the dose.
To prepare solutions for intravenous infusion, first reconstitute SOLU-MEDROL (methylprednisolone sodium succinate) with the diluent provided. This solution may then be added to Glucose Intravenous Infusion 5%, Sodium Chloride Intravenous Infusion 0.9%, Sodium Chloride 0.45% and Glucose 5% Intravenous Infusion or Sodium Chloride 0.9% and Glucose 5% Intravenous Infusion; the resulting admixtures should be used immediately. This solution is for SINGLE USE ONLY. Therapy may be initiated by administering SOLU-MEDROL (methylprednisolone sodium succinate) intravenously over a period of at least five minutes (e.g., doses up to 250 mg) to at least 30 minutes (e.g., doses of 250 mg or more). Parenteral products should be inspected visually for particulate matter and discolouration prior to administration wherever solution and container permit.
When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8 and the tonicities are, for the 40 mg per mL solution, 0.50 osmolar; for the 125 mg per 2 mL, 500 mg per 8 mL and 1 g per 16 mL solutions, 0.40 osmolar; for the 2 g per 31.2 mL solutions, 0.42 osmolar (Isotonic saline = 0.28 osmolar).
IMPORTANT – When reconstituting SOLU-MEDROL, use only the accompanying diluent. The diluent with the Act-O-Vial system is sterile Water for Injections and is preservative free. The diluent provided with SOLU-MEDROL 1 g and 2 g is a bacteriostatic Water for Injections containing benzyl alcohol.
Reports of acute toxicity and metabolic disturbances with glucocorticoids are rare but do occur. There is no clinical syndrome of acute overdosage with SOLU-MEDROL powder for injection. Acute overdose may possibly aggravate pre-existing disease states such as ulceration of the gastrointestinal tract, electrolyte disturbances, infections, diabetes and oedema. Repeated high doses of methylprednisolone have caused hepatic necrosis and an increase in amylase. Bradyarrhythmias, ventricular arrhythmias and cardiac arrest have been observed in cases of intravenous administration of high doses of methylprednisolone.
Repeated frequent doses (daily or several times per week) over a protracted period may result in a Cushingoid state. The possibility of adrenal suppression should be guarded against by gradual diminution of dose levels over a period of time.
In the event of an overdose, no specific antidote is available; treatment is symptomatic and supportive, including respiratory and cardiovascular function. In chronic toxicity, fluids and electrolytes should be monitored closely. Serum levels are not clinically useful. Methylprednisolone is dialysable.
For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).
SOLU-MEDROL ACT-O-VIAL 40 mg/mL powder for injection: 24 months.
SOLU-MEDROL ACT-O-VIAL 125 mg/2 mL powder for injection: 36 months.
SOLU-MEDROL ACT-O-VIAL 500 mg/4 mL injection with diluent: 36 months.
SOLU-MEDROL 1 g powder for injection: 60 months.
SOLU-MEDROL 2 g powder for injection: 60 months.
Store unreconstituted product below 25°C. Protect from light.
When reconstituted use only the accompanying diluent. The diluent provided with the ACT-O-VIAL system is sterile Water for Injections. The diluent provided with the 1 g and 2 g vials is bacteriostatic Water for Injections with benzyl alcohol. The resulting solution should be used immediately. Discard any unused portion.
SOLU-MEDROL is available in the following pack sizes:
Not all presentations may be marketed.
SOLU-MEDROL is available in preservative and preservative-free formulations.
No special requirements.
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