(and dosage form):
Each tablet contains
Hydrocortisone 10 mg
A 21.5.1 Corticosterolds and analogues.
Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex.
Addison's disease or chronic adrenocortical insufficiency secondary to hypopituitarism.
Patients with peptic ulcer, osteoporosis, psychosis or severe psychoneuroses.
Covocort is contra-indicated in the presence of acute infections, including herpes zoster and herpes simplex ulceration of the eye. Contra-indicated in patients with active or doubtfully quiescent tuberculosis. Concomitant vaccination with live vaccine is contraindicated.
DOSAGE AND DIRECTIONS FOR USE:
The normal dosage is 10 - 30 mg daily, in Addison's disease.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects result from excessive action on electrolyte balance, excessive action on other aspects of metabolism including gluconeogenesis, the action on tissue repair and healing and an inhibitory effect on the secretion of corticotrophin by the anterior lobe of the pituitary gland.
Increased susceptibility to all kinds of infection, including sepsis, fungous infections, and viral infections has been reported. Growth retardation in Children has been reported. The insulin requirements of diabetic patients may be increased.
Large doses may produce symptoms typical of hyperactivity of the adrenal cortex, with moonface, sometimes hirsutism, buffalo hump, flushing and acne, sometimes leading to a fully developed Cushings syndrome.
Other effects include amenorrhoea, hyperhydrosis, mental and neurological disturbances, intracranial hypertension, acute pancreatitis and aseptic necrosis of bone. Thromboembolic complications may be encountered.
Infections may be masked and a feeling of well-being may be produced. Hydrocortisone may also cause a reduction in the number of circulating lymphocytes. Muscular weakness may occur.
Concurrent administration of barbiturates, phenytoin, or rifampicin may enhance the metabolism and reduce the effects of hydrocortisone. Response to anticoagulants may be reduced and on some occasions enhanced. Concurrent administration of hydrocortisone and potassium depleting diuretics may cause excessive potassium loss.
Sudden withdrawal or reduction in dosage may precipitate acute adrenal insufficiency with symptoms such as malaise, muscle weakness, mental changes, muscle and joint pain, desquamation of the skin, dyspnoea, anorexia, nausea and vomiting, fever, hypoglycaemia, hypotension and dehydration.
Hydrocortisone withdrawal should always be gradual, the rate depending upon the individual patient's response, the dose, and the duration of therapy.
Covocort should be used with caution in the presence of congestive heart failure, in patients with diabetes mellitus, infectious diseases, chronic renal failure and uraemia, and in elderly patients.
SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects for symptoms.
The adverse effects of hydrocortisone are nearly always due to its use in excess of normal physiological requirements. They should be treated symptomatically, where possible the dosage should be reduced or the drug slowly withdrawn.
White biconvexed, scored tablet.
Containers with 100 tablets.
Store below 25°C in a dry, dark place.
KEEP OUT OF REACH OFCHILDREN
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext. 77
Private Bag X69, Bryanston, 2021
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
14 April 1988
New addition to this site: April 2004
Source: Pharmaceutical Industry
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