Philcort-16 Special Precautions

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 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 to dose and duration of treatment and as to whether daily or intermittent therapy should be used.
Immunosuppressive Effects/Increased Susceptibility to Infections: Due to their suppression of the inflammatory response and immune function, corticosteroids may increase susceptibility to fungal, bacterial and viral infections and their severity. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. How the doses, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chicken pox, they should seek urgent medical attention. Passive immunisation is recommended if non-immune patients who come into contact with chicken pox. If a diagnosis of chicken pox is confirmed the illness warrants specialist care and urgent treatment.
The immunosuppressive effects of corticosteroids may also result in activation of latent infection or exacerbation of existing infection. Corticosteroids should be used with great care in patients with known or suspected parasitic infections such as Strongyloides infestation.
In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.
It is important to note that corticosteroids may increase susceptibility to infection, may mask some signs of infection, which may reach an advanced stage before the infection is recognised, and new infections may appear during their use. There may be decreased resistance and inability to localise infection when corticosteroids are used. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic organisms, in any location in the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. These infections may be mild but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases.
Methylprednisolone Tablet is not recommended for use in patients with septic shock or sepsis syndrome. The role of corticosteroids in septic shock has been controversial, with early studies reporting both beneficial and detrimental effects. More recently, supplemental corticosteroids have been suggested to be beneficial in patients with established septic shock who exhibit adrenal insufficiency. However, a systematic review concluded that short-course, high-dose corticosteroids did not support their use. However, meta-analyses and a review suggests that longer courses (5-11 days) of low-dose corticosteroids might reduce mortality, especially in those with vasopressor-dependent septic shock.
Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids and should be postponed until at least three months after stopping corticosteroid therapy. Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the response to such vaccines may be diminished. Indicated immunisation procedures may be undertaken in patients receiving non-immunosuppressive doses of corticosteroids.
The use of methylprednisolone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.
If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur.
During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.
Immune System Effects: Allergic reactions (e.g. angioedema) may occur.
Because rare instances of skin reactions and anaphylactic/anaphylactoid reactions (e.g. bronchospasm) have occurred in patients receiving corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.
This medicine contains lactose produced from cow's milk. Caution should be exercised in patients with a known or suspected hypersensitivity to cow's milk or its components or other dairy products because it may contain trace amounts of milk ingredients.
Endocrine Effects: In patients on corticosteroid therapy (or those who have discontinued treatment but continue to experience symptoms of adrenal insufficiency) who are subjected to unusual stress such as intercurrent illness, trauma or surgery, increased dosage (or reinstitution) of rapidly acting corticosteroids may be required.
Pharmacologic doses of corticosteroids administered for prolonged periods may result in hypothalamic-pituitary-adrenal (HPA) suppression (secondary adrenocortical insufficiency). The degree and duration of adrenocortical insufficiency produced is variable among patients and depends on the dose, frequency, time of administration, and duration of glucocorticoid therapy. This effect may be minimised by use of alternate-day therapy.
In addition, acute adrenal insufficiency leading to a fatal outcome may occur if glucocorticoids are withdrawn abruptly. Therefore, withdrawal of corticosteroid should always be gradual.
Symptoms of adrenal insufficiency include: malaise, muscle weakness, mental changes, muscle and joint pain, desquamation of the skin, dyspnoea, anorexia, nausea and vomiting, fever, hypoglycaemia, hypotension and dehydration.
Drug-induced adrenocortical insufficiency may be minimised by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy, therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted.
A steroid "withdrawal syndrome", seemingly unrelated to adrenocortical insufficiency, may occur following abrupt discontinuance of glucocorticoids. This syndrome include symptoms such as anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, weight loss, and/or hypotension. These effects are thought to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid levels.
Because glucocorticoids can produce or aggravate Cushing's syndrome, glucocorticoids should be avoided in patients with Cushing's disease.
Corticosteroids should be used with caution in patients with hypothyroidism as there is potential for an enhanced effect of corticosteroids in these patients.
Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation.
Metabolism and Nutrition: Corticosteroids, including methylprednisolone, can increase blood glucose, worsen pre-existing diabetes and predisposes those on long term corticosteroid therapy to diabetes mellitus. Therefore, corticosteroids should be used with caution in patients with diabetes mellitus or a family history of diabetes mellitus.
Psychiatric Effects: Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Therefore, particular care is required when considering the use of corticosteroids in patients with existing or previous history of severe affective disorders.
Potentially severe psychiatric adverse reactions may occur with systemic corticosteroids. Symptoms typically emerge within a few days or weeks of starting treatment. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary.
Psychological effects have been reported upon withdrawal of corticosteroids; the frequency is unknown. Patients/caregivers should be encouraged to seek medical attention if psychological symptoms develop in the patient, especially if depressed mood or suicidal ideation is suspected. Patients/caregivers should be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids.
Nervous System Effects: Corticosteroids should be used with caution in patients with seizure disorders.
Corticosteroids should be used with caution in patients with myasthenia gravis.
Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do show that corticosteroids affect the ultimate outcome or natural history of the disease. The studies do not show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect.
There have been reports of epidural lipomatosis in patients taking corticosteroids, typically with long-term use at high doses.
Ocular Effects: Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible risk of corneal scarring, loss of vision and corneal perforation.
Prolonged use of corticosteroids may produce posterior subcapsular cataracts and nuclear cataracts (particularly in children), exophthalmos, or increased intraocular pressure, which may result in glaucoma with possible damage to the optic nerves. Establishment of secondary fungal and viral infections of the eye may also be enhanced in patients receiving glucocorticoids.
Corticosteroid therapy has been associated with central serous chorioretinopathy, which may lead to retinal detachment.
Visual Disturbance: Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Cardiac Effects: Adverse effects of glucocorticoids on the cardiovascular system, such as dyslipidemia and hypertension, may predispose treated patients with existing cardiovascular risk factors to additional cardiovascular effects, if high doses and prolonged courses are used. Accordingly, corticosteroids should be employed judiciously in such patients and attention should be paid to risk modification and additional cardiac monitoring if needed. Low dose and alternate day therapy may reduce the incidence of complications in corticosteroid therapy.
Systemic corticosteroids should be used with caution, and only if strictly necessary, in cases of congestive heart failure.
Vascular Effects: Thrombosis including venous thromboembolism has been reported to occur with corticosteroids. As a result corticosteroids should be used with caution in patients who have or may be predisposed to thromboembolic disorders.
Corticosteroids should be used with caution in patients with hypertension.
Gastrointestinal Effects: High doses of corticosteroids may produce acute pancreatitis.
There is no universal agreement on whether corticosteroids per se are responsible for peptic ulcers encountered during therapy; however, glucocorticoid therapy may mask the symptoms of peptic ulcer so that perforation or haemorrhage may occur without significant pain. Glucocorticoid therapy may mask peritonitis or other signs or symptoms associated with gastrointestinal disorders such as perforation, obstruction or pancreatitis. In combination with NSAIDs, the risk of developing gastrointestinal ulcers is increased.
Corticosteroids should be used with caution in non-specific ulcerative colitis if there is a probability of impending perforation, abscess or other pyogenic infection, diverticulitis, fresh intestinal anastomoses, or active or latent peptic ulcer.
Hepatobiliary Effects: Corticosteroids should be used with caution in patients with hepatic failure.
Hepatobiliary disorders have been reported which may be reversible after discontinuation of therapy. Therefore, appropriate monitoring is required.
There is an enhanced effect of corticosteroids in patients with cirrhosis.
Musculoskeletal Effects: Corticosteroids should be used with caution in patients with myasthenia gravis who are receiving anticholinesterase therapy as corticosteroid use may decrease plasma anticholinesterase activity.
An acute myopathy has been reported with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g. myasthenia gravis) or in patients receiving concomitant therapy with anticholinergics, such as neuromuscular blocking drugs (e.g. pancuronium). This acute myopathy is generalised, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevations of creatine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years.
Corticosteroids should be used with caution in patients with osteoporosis. Osteoporosis is a common but infrequently recognised adverse effect associated with a long-term use of large doses of glucocorticoid.
Corticosteroid should be used with caution in patients with Duchenne's muscular dystrophy since transient rhabdomyolysis and myoglobinuria have been reported following strenuous activities. Corticosteroids should be used with caution in patients with previous steroid myopathy.
Renal and Urinary Disorders: Caution is required in patients with systemic sclerosis because an increased incidence of scleroderma renal crisis has been observed with corticosteroids, including methylprednisolone.
Corticosteroids should be used with caution in patients with renal insufficiency.
Investigations: Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.
Discontinuation.
Injury, Poisoning and Procedural Complications: Systemic corticosteroids are not indicated for and should therefore not be used to treat traumatic brain injury. A multicentre study revealed an increased mortality at 2 weeks and 6 months after injury in patients administered methylprednisolone compared to placebo. A causal association with methylprednisolone treatment has not been established.
Other: Aspirin and nonsteroidal anti-inflammatory agents should be used cautiously in conjunction with corticosteroids.
Use in Children: Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Corticosteroids may cause growth retardation in infancy, childhood and adolescence. The effects may be irreversible, therefore long-term daily-divided doses of corticosteroids should be avoided in these patients.
In infants, children and adolescents, corticosteroid treatment should be administered where possible as a single dose on alternate days for the shortest possible duration.
If prolonged therapy is necessary, growth and development of these patients should be carefully monitored.
Increased intracranial pressure with papilloedema (pseudotumour cerebri) in children has been reported, usually after treatment withdrawal of methylprednisolone. Infants and children on prolonged corticosteroid therapy are at special risk from raised intracranial pressure.
High doses of corticosteroids may produce pancreatitis in children.
Use in the Elderly: The use of corticosteroids, particularly long-term use, in the elderly should be planned bearing in mind the more serious consequences of the common side effects, especially: osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions.