Prednisone

Registered South African indications:

• Suppressive and palliative therapy in rheumatoid arthritis
• Nephrotic syndrome
  - Attributable to systemic lupus erythematosus or to primary renal disease, except renal amyloidosis
• Collagen diseases
• Fulminating systemic lupus erythematosus
• Manifestations of allergic conditions which do not react to anti-histaminic treatment
• Bronchial asthma
  - Acute, or severe chronic asthma, uncontrolled by other measures
• Acute skin diseases
• Exacerbations of chronic skin diseases
• Severely ill patients with chronic ulcerative colitis
• Thrombocytopenia
• Organ transplantations

Contraindications

• Known hypersensitivity to prednisone or to any of the excipients
• Liver disease
• Peptic ulcer
• Osteoporosis
• Psychosis or severe psychoneurosis
• Systemic administration is usually contraindicated in the presence of acute bacterial and viral infections (because of interference with antibody formation)

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Immunosuppression
• Acute viral infections
• History of tuberculosis
• Strongyloids infections
• Gastrointestinal disease
• Osteoporosis
• Hypertension
• Psychiatric disorders
• Ocular disease
• Adrenal suppression
• Diabetes mellitus
• Cardiovascular disease
• Congestive cardiac failure
• Uraemia
• Ulcerative colitis
• Physiological stess
• Lactose intolerance

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

Dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Rheumatoid arthritis
- Progressive despite intensive conventional treatment

• Oral (tab): Initial: 10mg, daily; Increase slowly until the desired degree of control is attained

Nephrotic syndrome
- Attributable to systemic lupus erythematosus or primary renal disease (except renal amyloidosis)

• Oral (tab): Initial: 60mg, daily in divided doses for 3-4 weeks; Maintenance: For the first 3 days of each week for up to a year if remission with diuresis and decreased proteinuria occur during the initial treatment

Collagen diseases
- Most manifestations, excluding scleroderma
- Polyarteritis nodosa
- Wegener's granulomatosis

• Oral (tab): Initial: 1mg/kg, daily until remission is induced; Decrease the dose to minimal effective level after remission

Fulminating systemic lupus erythematosus
- Life-threatening condition which requires prompt suppression with large doses

• Oral (tab): Initial: 1mg/kg, daily; Can be increased in 20mg increments daily until a favourable response occurs; After control has been obtained, dosage should be reduced by small steps of 5mg per week until further reductions elucidate symptoms

Manifestations of allergic conditions which do not react to anti-histaminic treatment

• Oral (tab): Adequate doses or as a supplement to primary therapy

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Severe reactions such as anaphylaxis require immediate adrenaline subcutaneously

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Bronchial asthma
- Acute or severe chronic asthma, uncontrolled by other measures

• Oral (tab): After control is obtained with intravenous cortisol for status asthmaticus: 10mg daily for 4-5 days; The dose is then reduced in steps to be withdrawn 10 days after initiation of therapy; Severe chronic cases: To reduce severity without eliminating the manifestations of the disease: 5-10mg daily in divided doses in combination with the usual medication

Acute skin diseases and exacerbations of chronic skin diseases

• Oral (tab): 40mg per day; Up to 120mg per day may be life-saving in pemphigus

Chronic ulcerative colitis
- Severely ill patients

• Oral (tab): 60-120mg per day

Thrombocytopenia
- To decrease the bleeding tendency

• Oral (tab): 0.5mg/kg

Organ transplantations

• Oral (tab): Initial: 50-100mg at the time of surgery; Maintenance: 10-20mg per day indefinitely; Increase the dosage if rejection is threatened

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The dose must be determined individually by the seriousness of the disease and the reaction of the patient

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Administration of large doses for short courses cause fewer side effects than long-term therapy with small doses. Long courses of therapy at high dosage should be reserved for life-threatening diseases

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In long-term therapy, the dose must be the smallest one to achieve a desired effect. Complete relief is not sought

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The dosage should be reduced and therapy discontinued gradually if therapy is continued for more than a few days. Abrupt cessation of prolonged, high dosage therapy may produce adrenal insufficiency of sufficient severity to be threatening to life

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See link: General prescribing points for steroids

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

Dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Nephrotic syndrome
- Attributable to systemic lupus erythematosus or primary renal disease (except renal amyloidosis)

• Oral (tab): Initial: 2mg/kg (oedema-free body mass), daily in divided doses, for 3-4 weeks; Maintenance: For the first 3 days of each week for up to a year if remission with diuresis and decreased proteinuria occur during the initial treatment

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No specific recommendations have been provided for paediatrics for other indications

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The dose must be determined individually by the seriousness of the disease and the reaction of the patient

---

Administration of large doses for short courses cause fewer side effects than long-term therapy with small doses. Long courses of therapy at high dosage should be reserved for life-threatening diseases

---

In long-term therapy, the dose must be the smallest one to achieve a desired effect. Complete relief is not sought

---

The dosage should be reduced and therapy discontinued gradually if therapy is continued for more than a few days. Abrupt cessation of prolonged, high dosage therapy may produce adrenal insufficiency of sufficient severity to be threatening to life

---

See link: General prescribing points for steroids

Pregnancy

• Caution
• During pregnancy, prednisone should only be used when the benefits outweigh the potential risks. The lowest effective dose of prednisone needed to maintain adequate disease control should be used
• Animal studies indicate that administration of pharmacological doses of glucocorticoids during pregnancy may increase the foetus risk of intrauterine growth retardation, adult cardiovascular and/or metabolic disease and may have an effect on the glucocorticoid receptor density, and neurotransmitter turnover or neurobehavioural development
• Prednisone has caused cleft palate formation in animal experiments. There is an ongoing discussion on the possibility of an increased risk of oral cleft formation in the human foetus as a result of the administration of glucocorticoids during the first trimester
• If glucocorticoids are administered towards the end of pregnancy, there is a risk of atrophy of the foetal adrenal cortex, which may necessitate replacement therapy in the newborn, which has to be slowly reduced

Breastfeeding

• Caution; not recommended
• Glucocorticoids pass in small amounts into breast milk (up to 0.23 % of an individual dose). For doses up to 10 mg daily, the amount taken via breast milk lies below the detection threshold. So far, no damage to infants has been reported. Nevertheless, glucocorticoids should only be prescribed when the benefits to mother and child outweigh the risks
• Because the milk/plasma concentration ratio increases with doses above 10 mg/day (e.g. 25 % of the serum concentration are found in the breast milk with 80 mg prednisone daily), it is recommended to discontinue breastfeeding in such cases

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

South African recommendations

• Caution; no dose adjustment recommended
  Prednisone is contraindicated in liver disease

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Possibly porphyrinogenic (PSP)

Drugs in Sport

• Prohibited - In competition

Central Nervous System Disorders 

• Insomnia
• Depression
• Irritability
• Euphoria
• Psychosis
• Headache
• Pseudotumor cerebri
• Seizures
• Intracranial hypertension

Cardiovascular Disorders 

• Tachycardia
• Hypertension
• Increased risk of arteriosclerosis and thrombosis
• Vasculitis 

Gastrointestinal Disorders 

• Gastrointestinal ulcerations
• Gastrointestinal haemorrhages
• Pancreatitis
• Nausea and vomiting
• Diarrhoea

Endocrine and Metabolic Disorders 

• Adrenal suppression
• Induction of Cushing's syndrome 
• Disturbed sexual hormone secretion 
• Disturbance of the thyroid function
• Sodium retention with oedema
• Hypokalaemia
• Hypokalaemic acidosis 
• Increased appetite
• Weight gain
• Impaired glucose tolerance
• Hypercholesterolaemia
• Hypertriglyceridaemia
• Reversible epidural, epicardial or mediastinal lipomatosis
• Hypokalaemic alkalosis
• Amenorrhoea

Musculoskeletal Disorders 

• Muscular atrophy and weakness
• Osteoporosis
• Aseptic osteonecrosis
• Steroid myopathy
• Tendon rupture
• Vertebral and long bone fractures
• Rhematoid arthritis

Skin and Subcutaneous Tissue Disorders 

• Striae rubrae
• Atrophy
• Telangiectasia
• Increased capillary fragility
• Petechiae
• Ecchymoses
• Hypertrichosis
• Steroid acne
• Delayed healing of wounds
• Rosacea-like (perioral) dermatitis
• Changes in skin pigmentation
• Hypersensitivity reactions
• Hirsutism

Immune, Blood and Lymphatic System Disorders 

• Moderate leucocytosis
• Lymphopoenia
• Eosinopoenia
• Polycythaemia
• Reduced immune defence
• Masking of infections
• Exacerbation of latent infections
• Allergic reactions

Sensory Disorders 

• Cataract
• Glaucoma
• Aggravation of symptoms associated with corneal ulcer
• Promotion of viral, fungal and bacterial eye inflammation
• Central serous chorioretinopathy

• Cardiac glycosides
• Saluretics/laxatives
• Antidiabetic agents
• Warfarin
• Non-steroidal anti-inflammatory drugs
• Non-depolarising muscle relaxants
• Anticholinergics
• Praziquantel
• Antimalarial agents
• Somatropin
• Oestrogens
• Liquorice
• Rifampicin
• Phenytoin
• Barbiturates
• Bupropion
• Primidone
• Cyclosporine
• Amphotericine B
• Cyclophosphamide
• Angiotensin-converting enzyme inhibitors
• Aluminium and magnesium antacids
• Phenylbutazone
• Immnunizations

• Blood Pressure

Specific cases may require

• Blood glucose
• Electrolytes
• Intraocular pressure
• Growth (children)

Prednisone is metabolised in the liver to its active form prednisolone. Prednisolone crosses cell membranes and binds to specific cytoplasmic receptors. This results in inhibition of leukocyte infiltration at the site of inflammation, interference in the function of mediators of inflammatory response, suppression of humeral immune responses and a reduction in oedema and scar tissue. The anti-inflammatory actions involves phospholipase A2 inhibitory proteins (lipocortins). Lipocortins control biosynthesis of potent mediators of inflammation, such as prostaglandins and leukotrienes.

Tablet 5mg 

• Be-Tabs prednisone (Ranbaxy)
• Meticorten (MSD) originator
• Panafcort (Adcock)
• Trolic (Gulf Drug)

Tablet 20mg

• Pulmison (Ingelheim) originator (Discontinued)

Tablet 50mg 

• Meticorten (MSD) originator (Discontinued)