DEPO-MEDROL Suspension for injection (2020)

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1. Name of the medicinal product

DEPO-MEDROL 40 mg/mL Suspension for Injection.

2. Qualitative and quantitative composition

Each 1 mL vial contians 40 mg/mL methylprednisolone acetate. Excipients with known effects: Sodium Macrogol For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Depo-Medrol is a white, aqueous,sterile suspension.

4.1. Therapeutic indications

A. For Intramuscular Administration When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, ...

4.2. Posology and method of administration

Dose Because complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as ...

4.3. Contraindications

Known hypersensitivity to methylprednisolone or any component of the formulation. Systemic fungal infections. Intrathecal administration due to its potential for neurotoxicity. Epidural administration. ...

4.4. Special warnings and precautions for use

The lowest possible dose of corticosteroid should be used to control the condition under treatment and when reduction in dosage is possible, the reduction should be gradual. Since complications of treatment ...

4.5. Interaction with other medicinal products and other forms of interaction

The pharmacokinetic interactions listed below are potentially clinically important. Methylprednisolone is a cytochrome P450 enzyme (CYP) substrate and is metabolised mainly by the CYP3A4 enzyme. CYP3A4 ...

4.6. Fertility, pregnancy and lactation

Pregnancy Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Some animal studies have shown that corticosteroids (such as methylprednisolone), ...

4.7. Effects on ability to drive and use machines

The effect of corticosteroids on the ability to drive or use machinery has not been systematically evaluated. Undesirable effects, such as dizziness, vertigo, visual disturbances, and fatigue are possible ...

4.8. Undesirable effects

Administration by other than indicated routes has been associated with reports of serious medical events including: arachnoiditis, meningitis, paraparesis/paraplegia, sensory disturbances, headache, functional ...

4.9. Overdose

There is no clinical syndrome of acute overdosage with Depo-Medrol (methylprednisolone acetate). Repeated frequent doses (daily or several times per week) over a protracted period may result in a Cushingoid ...

5.1. Pharmacodynamic properties

The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11ß). The structural formula is shown below: Molecular formula: C24 ...

5.2. Pharmacokinetic properties

Absorption Methylprednisolone acetate is hydrolysed to its active form by serum cholinesterases. The intracellular activity of glucocorticoids results in a clear difference between plasma half-life and ...

5.3. Preclinical safety data

Genotoxicity Methylprednisolone acetate has not been formally evaluated for genotoxicity. However, methylprednisolone sulfonate, which is structurally similar to methylprednisolone, was not mutagenic in ...

6.1. List of excipients

Hydrochloric acid Macrogol 3350 Miripirium chloride (0.02%) as a preservative Sodium chloride Sodium hydroxide Water for injection

6.2. Incompatibilities

Because of possible physical incompatibilities, Depo-Medrol sterile aqueous suspension (methylprednisolone acetate) should not be diluted or mixed with other solutions.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store below 30ºC. Depo-Medrol is for single use in a single patient only. Discard any unused product.

6.5. Nature and contents of container

40 mg/mL 1 1 mL vial; 5 1 mL

6.6. Special precautions for disposal and other handling

No special requirement.

7. Marketing authorization holder

Pfizer New Zealand Ltd, PO Box 3998, Auckland, New Zealand, 1140

9. Date of first authorization / renewal of the authorization

16 June 1976

10. Date of revision of the text

18 November 2020