Methylprednisolone

Registered South African indications:

• Anti-inflammatory
• Immune-modulation

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Systemic fungal infections
• Traumatic brain injury
• Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Parasitic infections
• Active tuberculosis
• Hypothyroidism
• Diabetes mellitus
• Psychiatric disorders
• Epilepsy
• Ocular herpes simplex
• Glaucoma
• Hypertension
• Dyslipidaemia
• Recent myocardial infarction
• Thromboembolic disorders
• Peptic ulceration
• Ulcerative colitis
• Diverticulitis
• Osteoporosis
• Fresh intestinal anastomosis
• Galactose intolerance
• Glucose-galactose malabsorption
• Lapp lactase deficiency
• Sucrase-isomaltase insufficiency
• Fructose intolerance

Forms avail. in SA and covered in this monograph: tab

Anti-inflammatory
Immune-modulation

• Oral (tab): Initial: 4-48mg, 6-24hrly

Specific doses based on individual indications: 

Allergic conditions

• Oral (tab): Initial: 12-40mg, dly

Systemic dermatomyositis

• Oral (tab): Initial: 48mg, dly

Rheumatoid arthritis 

• Oral (tab): Initial: 4-16mg, dly

Systemic lupus erythematosus 

• Oral (tab): Initial: 20-100mg, dly

Acute rheumatic fever

• Oral (tab): 48mg, dly until ESR normal for 1 week

Acute asthma

• Oral (tab): Initial: 40-60mg, 12-24hrly; duration 3-10 days

Chronic asthma

• Oral (tab): Up to 64mg, dly; Alternate day dose max: 100mg

Ophthalmic disease

• Oral (tab): Initial: 12-40mg, dly

Haematological disease
Leukaemia
Lymphoma 

• Oral (tab): Initial: 16-100mg, dly

Ulcerative colitis

• Oral (tab): Initial: 16-60mg, dly

Crohn's disease

• Oral (tab): Initial: 48mg, dly

Organ transplant

• Oral (tab): up to 3.6mg/kg, dly

Pulmonary sarcoid

• Oral (tab): Initial: 32-48mg, alternate days

Giant cell arteritis
Polymyalgia rheumatica

• Oral (tab): Initial: 64mg, dly

Pemphigus vulgaris

• Oral (tab): Initial: 80-360mg, dly

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See link: General prescribing points for steroids

Paed. forms avail. in SA and covered in this monograph: tab

Anti-inflammatory
Immune-modulation

• Oral (tab): 1-2mg/kg/day

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See link: General prescribing points for steroids

Pregnancy

• Caution
• The ability of corticosteroids to cross the placenta varies between individual medicines, however, methylprednisolone does cross the placenta. In humans, the risk of low birth weight appears to be dose-related and may be minimized by administering lower corticosteroid doses
• Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate, intra-uterine growth retardation and effects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate in man, however, when administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation
• Infants born to mothers, who have received substantial doses of corticosteroids during pregnancy must be carefully observed and evaluated for signs of adrenal insufficiency. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important
• Since adequate human reproductive studies have not been done, methylprednisolone, as with all medicines, should be used during pregnancy only after a careful assessment of the benefit-risk ratio to the mother, embryo, foetus or child. When corticosteroids are essential, however, patients with normal pregnancies may be treated as though they were in the non-gravid state. Cataracts have been observed in infants born to mothers undergoing long-term treatment with corticosteroids during pregnancy

Breastfeeding

• Caution
• Corticosteroids are excreted in small amounts in breast milk, however, doses of up to 40 mg daily of methylprednisolone are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression. Methylprednisolone should be used during breastfeeding only after a careful assessment of the benefit-risk ratio to the mother and infant

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Possibly porphyrinogenic (PSP)

Drugs in Sport

• Prohibited - In competition

Central Nervous System Disorders

• Psychotic disorders
• Personality change
• Mood swings
• Confusion
• Anxiety
• Insomnia
• Irritability
• Convulsions
• Raised intracranial pressure
• Amnesia
• Cognitive disorder
• Dizziness
• Headache

Cardiovascular Disorders

• Congestive cardiac failure
• Myocardial rupture post-myocardial infarction
• Hypertension
• Hypotension
• Thromboembolic events

Respiratory Disorders

• Pulmonary embolism
• Hiccups

Gastrointestinal Disorders

• Peptic ulcer
• Intestinal perforation
• Gastrointestinal haemorrhage
• Pancreatitis
• Ulcerative oesophagitis
• Abdominal distention
• Abdominal pain
• Diarrhoea
• Nausea

Hepatobiliary Disorders

• Increased hepatic enzymes

Endocrine and Metabolic Disorders

• Cushingoid
• Hypopituitarism
• Steroid withdrawal syndrome
• Sodium retention
• Fluid retention
• Hypokalaemic alkalosis
• Metabolic acidosis
• Impaired glucose tolerance
• Hypokalaemia
• Menstrual irregularity

Musculoskeletal Disorders

• Myopathy
• Myalgia
• Growth retardation
• Pathological fracture
• Osteoporosis
• Osteonecrosis
• Neuropathic arthropathy
• Arthralgia
• Tendon rupture
• Spinal compression fracture

Skin and Subcutaneous Tissue Disorders

• Skin atrophy
• Acne
• Erythema
• Angioedema
• Pruritus
• Urticaria
• Ecchymosis
• Petechiae
• Rash
• Hirsutism
• Hyperhidrosis
• Skin striae
• Telangiectasia
• Impaired wound healing

Immune, Blood and Lymphatic System Disorders

• Susceptibility to infection
• Increased severity of infections
• Recurrence of dormant tuberculosis
• Opportunistic infections
• Kaposi sarcoma
• Leukocytosis

Sensory Disorders

• Subcapsular cataract
• Glaucoma
• Exophthalmos
• Corneal thinning
• Scleral thinning
• Chorioretinopathy
• Vertigo

• CYP450 inhibitors
• CYP450 inducers
• Non-steroidal anti-inflammatory drugs
• Neuromuscular blockers
• Anticholinesterases
• Hypoglycaemic agents
• Anticoagulants
• Potassium-depleting agents
• Live or live attenuated vaccination
• Aromatase inhibitors
• Antidiabetic agents

None routine. Specific cases may require:

• Electrolytes
• Intraocular pressure
• Bone mineral density
• Height (children)

Methylprednisolone is a synthetic glucocorticoid that is a methyl derivative of prednisolone. It acts by binding to intracellular glucocorticoid receptors that result in changes to gene expression. It also exerts effects independently of its ability to alter gene expression. The net effect is a diverse range of alterations to multiple physiological and organ systems primarily causing a decrease in inflammation and maintaining function under stress.

Tablet 4mg

• Medrol (Pfizer) originator

Tablet 16mg

• Medrol (Pfizer) originator

Also available in the following form: Injection.