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Legal Classification of medication

POM

Prednisolone tablets or injection can only be obtained in accordance with a prescription given by an appropriate practitioner and therefore the legal status of the medication is prescription only medication (POM).

Formulations

Prednisolone is available as tablets, soluble tablets, and injection suspension. Prednisolone tablets can be obtained as enteric or non-enteric coated tablets. The special coating is a barrier applied to the medication designed to stop irritation of the stomach. The following strengths are available:

• Non-enteric coated tablets. 2.5mg and 5mg
• Enteric coated tablets. 1mg, 5mg, and 25mg
• Soluble tablets. 5mg
• Injection suspension. 25mg/1ml

Class of drug

Prednisolone is a synthetic corticosteroid (is a steroid, though not to be confused with anabolic steroids) of glucocorticoid activity.

Indications

Prednisolone can be used to treat a wide variety of diseases or conditions that require the suppression of inflammation or of the immune system. These include the following:

• Allergy and anaphylaxis. Asthma, drug hypersensitivity reactions, and oedema.
• Arteritis (Inflammation of arteries).
• Blood disorders. Auto-immune anaemia, leukaemia, lymphoma, multiple myeloma, idiopathic thrombocytopenic purpura (ITP)
• Cardiovascular disorders. Rheumatic fever with severe inflammation of the heart, post-myocardial infarction syndrome.
• Endocrine disorders. Disease of the pituitary and or adrenal glands.
• Gastro-intestinal disorders. Crohn’s disease, ulcerative colitis, coeliac syndrome unresponsive to gluten free diet, multisystem disease affecting liver and biliary.
• Hypercalcaemia. Sarcoidosis, vitamin D excess.
• Infection. Helminthic infestations (worm infection), Herxheimer reaction (large toxins released in the blood by bacteria which die), glandular fever, military tuberculosis (small growths inside the body due to the tuberculosis), tuberculosis meningitis, rickettsial disease, and mumps in adults.
• Muscular disorders.
• Neurological disorders. Infantile spasms (occurring commonly in babies), multiple system atrophy (degeneration of nerve cells in certain areas of the brain).
• Ocular disease. Inflammation of any part of the eye and tumours of the eye orbit.
• Renal (kidney) disorders. Inflammation of the renal system.
• Respiratory disease. Occupational asthma, pulmonary alveolitis, drug induced lung disease, and adult respiratory distress syndrome.
• Rheumatic disorders. Rheumatoid arthritis, systemic lupus, connective tissue disease.
• Skin disorders.
• Immunosuppression in organ transplant.

The injection suspension of prednisolone is used in local inflammation of joints and soft tissues, particularly in rheumatoid arthritis.

How does it work?

Prednisolone is a synthetic (artificially made) glucocorticoid steroid. The human body normally produces its own glucocorticoids, which are synthesised by the adrenal gland. The adrenal glands are located just above the kidneys. Glucocorticoid steroids affect carbohydrate, fat, and protein metabolism, and they suppress inflammatory and immune responses, thus acting as powerful anti-inflammatory drugs.

How to take it?

The initial dose of prednisolone can vary from 5mg to 60mg depending on the disorder being treated. Divided daily doses can be used. The adrenal gland secretes corticosteroids between midnight and 9am and for that reason prednisolone should be taken in the morning.

In patients who receive more than 7.5mg for greater than three weeks, withdrawal should not be abrupt. Dose reduction will depend on relapse of the disease being treated and if suppression of the adrenal gland is likely. Abrupt withdrawal with treatment, which has continued for up to three weeks, is appropriate if it is considered that the disease is unlikely to relapse. In the following group of patients gradual withdrawal of therapy should be considered even after courses lasting three weeks or less:

• Patients receiving doses of greater than 40mg a day.
• Patients repeatedly taking doses in the evening.
• Patients who are more likely to develop adrenal suppression.
• When a short course has been prescribed with in one year of cessation of long term therapy.

The dosage of the therapy may required to be increased temporary during periods of stress or during surgery to avoid rapid fall in blood pressure. Patients should always carry a steroid card when on long term therapy.

Pregnancy and Breast feeding

Administration of prednisolone over a prolong period of time can increase the risk of growth retardation. Cataracts have also been observed in infants born to mothers treated with long term prednisolone during pregnancy. Prednisolone should only be prescribed in pregnancy when the benefits to the mother and child overweigh the risks.

Contra-indications

Prednisolone is contra-indicated in patients suffering with infections unless additional appropriate therapy is prescribed for the infection. It should be avoided in patients suffering from viral herpes infection of the eye because of possible perforation.

Prednisolone is excreted in small amounts in breast milk. The steroid excreted in breast milk may suppress growth of the infant. Prednisolone should only be administered if the benefits of the therapy overweigh the potential risks to the infant.

Side-effects

Side-effects of prednisolone include:

• Central obesity and a ‘moon’ face, as fat is distributed.
• Increased levels of glucose in blood which may lead to diabetes, due to altered carbohydrate metabolism.
• Reduction in bone density (osteoporosis) due to breakdown of the protein matrix within the bone.
• Loss of skin structure with easy bruising.
• Suppression of growth in children.
• Muscles weakness and wasting.
• Raised blood pressure
• High levels can cause mood changes or psychotic states.
• Peptic ulceration (ulcers involving the small bowel).
• Eye problems such as cataracts and worsening of existing glaucoma.

Prolong courses of therapy increases susceptibility to infections; in particular patients should take particular care to avoid exposure to measles and chickenpox if they haven’t had it already.

Author: Mr Shiraz Mughal, MPharmS
Editor: Dr Shazan Chughtai, MB BS