Chemical formula: C₂₁H₂₈O₅ Molecular mass: 360.444 g/mol PubChem compound: 5755
Prednisolone interacts in the following cases:
Concomitant use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) with corticosteroids increases the risk of gastro-intestinal bleeding and ulceration.
The renal clearance of salicylates is increased by corticosteroids and steroid withdrawal may result in salicylate intoxication.
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
Caution is necessary when corticosteroids, including prednisolone, are prescribed to patients with liver failure and frequent patient monitoring is necessary.
Caution is necessary when corticosteroids, including prednisolone, are prescribed to patients with renal insufficiency and frequent patient monitoring is necessary.
The desired effects of hypoglycaemic agents (including insulin) are antagonised by corticosteroids.
The efficacy of coumarin anticoagulants and warfarin may be enhanced by concurrent corticosteroid therapy and close monitoring of the INR or prothrombin time is required to avoid spontaneous bleeding.
The toxicity of cardiac glycosides is increased if hypokalaemia occurs with corticosteroids.
The desired effects of anti-hypertensives are antagonised by corticosteroids.
The desired effects of diuretics are antagonised by corticosteroids.
The hypokalaemic effects of thiazide diuretics are enhanced by corticosteroids.
The hypokalaemic effects of loop diuretics are enhanced by corticosteroids.
Corticosteroids should not be used concurrently with retinoids and tetracyclines due to increased intracranial pressure.
Oestrogens and other oral contraceptives may potentiate the effects of glucocorticoids and dosage adjustments may be required if oral contraceptives are added to or withdrawn from a stable dosage regimen.
Steroids may reduce the effects of anticholinesterases in myasthenia gravis and cholecystographic x-ray media.
Corticosteroids may alter the motility and number of spermatozoa in certain patients.
The hypokalaemic effects of acetazolamide are enhanced by corticosteroids.
Acetylsalicylic acid should be used cautiously in conjunction with glucocorticoids in patients with hypoprothrombinaemia. Concurrent use of acetylsalicylic acid and prednisolone may result in an increased risk of gastrointestinal ulceration and sub therapeutic acetylsalicylic acid serum concentrations.
Aminogluthetimide enhances the metabolism of corticosteroids and its therapeutic effects may be reduced. Therefore, it may be necessary to adjust the dose of prednisolone accordingly.
There is an increased risk of hypokalaemia with amphotericin, and concomitant use with prednisolone should be avoided.
Carbamazepine enhances the metabolism of corticosteroids and its therapeutic effects may be reduced. Therefore, it may be necessary to adjust the dose of prednisolone accordingly.
The hypokalaemic effects of carbenoxolone are enhanced by corticosteroids.
Ciclosporin increases plasma concentration of prednisolone.
Ephedrine enhances the metabolism of corticosteroids and its therapeutic effects may be reduced. Therefore, it may be necessary to adjust the dose of prednisolone accordingly.
Erythromycin may inhibit the metabolism of some corticosteroids.
Etoposide metabolism may be inhibited by corticosteroids in vitro. This may lead to an increase in both efficacy and toxicity of etoposide. Monitoring would be prudent.
Ketoconazole reduces the metabolic and renal clearance of methylprednisolone and this may also occur with prednisolone.
Concomitant use of prednisolone with methotrexate may increase the risk of haematological toxicity.
Mifepristone may reduce the effect of corticosteroids for 3-4 days.
Phenobarbital enhances the metabolism of corticosteroids and its therapeutic effects may be reduced. Therefore, it may be necessary to adjust the dose of prednisolone accordingly.
Phenytoin enhances the metabolism of corticosteroids and its therapeutic effects may be reduced. Therefore, it may be necessary to adjust the dose of prednisolone accordingly.
Primidone enhances the metabolism of corticosteroids and its therapeutic effects may be reduced. Therefore, it may be necessary to adjust the dose of prednisolone accordingly.
Rifabutin enhances the metabolism of corticosteroids and its therapeutic effects may be reduced. Therefore, it may be necessary to adjust the dose of prednisolone accordingly.
Rifampicin enhances the metabolism of corticosteroids and its therapeutic effects may be reduced. Therefore, it may be necessary to adjust the dose of prednisolone accordingly.
Ritonavir may increases plasma concentration of prednisolone.
The growth promoting effect of somatropin may be inhibited by the concomitant use of corticosteroids.
There is also an increased risk of hypokalaemia with the simultaneous use of theophylline and if high doses of corticosteroids are given with high doses of bambuterol, fenoterol, formoterol, ritodrine, salbutamol, salmeterol and terbutaline.
Caution is necessary when corticosteroids, including prednisolone, are prescribed to patients with peptic ulceration and frequent patient monitoring is necessary.
Caution is necessary when corticosteroids, including prednisolone, are prescribed to patients with recent myocardial infarction (rupture) and frequent patient monitoring is necessary.
Caution is required in patients with systemic sclerosis because of an increased incidence of (possibly fatal) scleroderma renal crisis with hypertension and decreased urinary output observed with a daily dose of 15 mg or more prednisolone. Blood pressure and renal function (s-creatinine) should therefore be routinely checked. When renal crisis is suspected, blood pressure should be carefully controlled.
Adrenal cortical atrophy develops during prolonged therapy with prednisolone and may persist for years after stopping treatment.
Caution is necessary when corticosteroids, including prednisolone, are prescribed to patients with glaucoma or in those with a family history of glaucoma and frequent patient monitoring is necessary.
Caution is necessary when corticosteroids, including prednisolone, are prescribed to patients with previous steroid myopathy and frequent patient monitoring is necessary.
Caution is necessary when corticosteroids, including prednisolone, are prescribed to patients with hypertension and frequent patient monitoring is necessary.
The effect of corticosteroids may be enhanced in patients with hypothyroidism in those with chronic liver disease with impaired hepatic function.
Caution is necessary when corticosteroids, including prednisolone, are prescribed to patients with congestive heart failure and frequent patient monitoring is necessary.
Caution is necessary when corticosteroids, including prednisolone, are prescribed to patients with a history of, or X-ray changes characteristic of tuberculosis. The emergence of active tuberculosis can, however, be prevented by the prophylactic use of antituberculous therapy.
Caution is necessary when corticosteroids, including prednisolone, are prescribed to patients withs oteoporosis and frequent patient monitoring is necessary. This is of special importance in post-menopausal females who are at particular risk.
Caution is necessary when corticosteroids, including prednisolone, are prescribed to patients with a history of severe affective disorders and particularly those with a previous history of corticosteroid induced psychoses and frequent patient monitoring is necessary.
Caution is necessary when corticosteroids, including prednisolone, are prescribed to patients with diabetes mellitus or in those with a family history of diabetes and frequent patient monitoring is necessary.
Caution is necessary when corticosteroids, including prednisolone, are prescribed to patients with epilepsy and frequent patient monitoring is necessary.
The ability of corticosteroids to cross the placenta varies between individual drugs, however 88% of prednisolone is inactivated as it crosses the placenta.
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/lip in man. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intrauterine growth retardation. Hypoadrenalism may occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important. Cataracts have also been rarely reported. As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential, however, patients with abnormal pregnancies may be treated as though they were in the non-gravid state.
Patients with pre-eclampsia or fluid retention require close monitoring.
Depression of hormone levels has been described in pregnancy but the significance of this finding is not clear.
Corticosteroids are excreted in small amounts in breast milk where they may suppress growth and interfere with endogenous glucocorticoid production in nursing infants. Since adequate reproductive studies have not been performed in humans with glucocorticoids, these drugs should be administered to nursing mothers only if the benefits of therapy are judged to outweigh the potential risks to the infant.
The concentration of the steroid in the milk can be between 5 and 25% of those in the serum.
There are no reports found regarding neonatal toxicity following exposure to corticosteroids during lactation, however if maternal doses >40mg/day of prednisolone is prescribed, the infant should be monitored for adrenal suppression.
Corticosteroids may alter the motility and number of spermatozoa in certain patients.
The effect of prednisolone on the ability to drive or use machinery has not been evaluated. There is no evidence to suggest that prednisolone may affect these abilities.
This medicine has no or negligible influence on the ability to drive and use machines.
The incidence of predictable undesirable effects, including hypothalamo-pituitary-adrenal (HPA) suppression, correlates with the relative potency of the drug, dosage, timing of administration and the duration of treatment.
The following side effects may be associated with the long-term systemic use of corticosteroids with the following frequency: Not known (cannot be estimated from available data).
Not known: Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis.
Not known: Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.
Not known: Leukocytosis.
Not known: Hypersensitivity including anaphylaxis has been reported.
Not known: Suppression of the HPA axis. Cushingoid. Impaired carbohydrate intolerance with increased requirement for anti-diabetic therapy, manifestation of latent diabetes mellitus.
Not known: Sodium and water retention, hypokalaemia, hypokalaemic alkalosis, increased appetite, negative protein and calcium balance.
Not known: Euphoric mood, psychological dependence, depressed mood, insomnia, aggravation of schizophrenia.
Not known: Dizziness, headache. Aggravation of epilepsy.
Not known: Glaucoma, papilloedema, posterior subcapsular cataracts, central serous chorioretinopathy, exophthalmos, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal diseases and vision, blurred.
Not known: Vertigo.
Not known: Myocardial rupture following recent myocardial infarction. Congestive cardiac failure (in susceptible patients).
Not known: Hypertension, embolism.
Not known: Hiccups.
Not known: Dyspepsia, nausea, vomiting, abdominal distension, abdominal pain, diarrhoea, oesophageal ulceration, candidiasis, pancreatitis acute. Peptic ulceration with perforation and haemorrhage.
Not known: Skin Atrophy, skin striae, acne, telangiectasia, hyperhidrosis, rash, pruritus, urticaria, hirsutism.
Not known: Myopathy, osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, myalgia.
Not known: Scleroderma renal crisis*
Not known: Menstruation irregular, amenorrhoea.
Not known: Impaired healing, malaise.
Not known: Weight increased.
Not known: Tendon rupture, contusion (bruising).
a A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances and cognitive dysfunction including confusion and amnesia have been reported. Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown.
* Scleroderma renal crisis: Amongst the different subpopulations the occurrence of scleroderma renal crisis varies. The highest risk has been reported in patients with diffuse systemic sclerosis. The lowest risk has been reported in patients with limited systemic sclerosis (2%) and juvenile onset systemic sclerosis (1%).
Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death.
A ‘withdrawal syndrome’ may also occur including fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight.
In some instances, withdrawal symptoms may involve or resemble a clinical relapse of the disease for which the patient has been undergoing treatment.
Other effects that may occur during withdrawal or change of corticosteroid therapy include benign intracranial hypertension with headache and vomiting and papilloedema caused by cerebral oedema.
Latent rhinitis or eczema may be unmasked.
Increased intracranial pressure with papilloedema in children (pseudotumour cerebri) - usually after treatment withdrawal.
Growth retardation in infancy, childhood and adolescence.
A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported. Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown.
The incidence of predictable undesirable effects, including hypothalamic-pituitary adrenal suppression correlates with the relative potency of the drug, dosage, timing of administration and the duration of treatment.
Undesirable effects are listed by MedDRA System Organ Classes.
Assessment of undesirable effects is based on the following frequency groupings: very common: ≥1/10, common: ≥1/100 to <1/10, uncommon: ≥1/1,000 to <1/100, rare: ≥1/10,000 to <1/1,000, very rare: <1/10,000, not known: cannot be estimated from the available data.
Not known: Increases susceptibility to, and severity of infections1, opportunistic infections, recurrence of dormant tuberculosis, oesophageal candidiasis.
Not known: Leucocytosis.
Not known: Hypersensitivity including anaphylaxis.
Not known: Suppression of the hypothalamo-pituitary adrenal axis2, cushingoid facies, impaired carbohydrate tolerance with increased requirement for antidiabetic therapy, manifestation of latent diabetes mellitus.
Not known: Sodium and water retention, hypokalaemic alkalosis, potassium loss, negative nitrogen and calcium balance, glucose intolerance and protein catabolism. Increase both high and low density lipoprotein cholesterol concentration in the blood. Increased appetite3. Weight gain, obesity, hyperglycaemia, dyslipidaemia.
Very rare: Calciphylaxis
Common: Irritability, depressed and labile mood, suicidal thoughts, psychotic reactions, mania, delusions, hallucinations, and aggravation of schizophrenia. behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia.
Not known: Euphoria, psychological dependence, depression.
Not known: Depression, insomnia, dizziness, headache, vertigo. Raised intracranial pressure with papilloedema (pseudotumor cerebri)4. Aggravation of epilepsy, epidural lipomatosis. vertebrobasilar stroke5
Not known: Vision blurred, glaucoma, papilloedema, posterior subcapsular cataracts, nuclear cataracts (particularly in children), exophthalmos, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal disease.
Severe exacerbation of bullous exudative retinal detachment; central serous chorioretinopathy or lasting visual loss in some patients with idiopathic central serous chorioretinopathy.
Not known: Vertigo.
Not known: Congestive heart failure in susceptible patients, hypertension, increased risk of heart failure. Increased risk of cardiovascular disease, including myocardial infarction6.
Not known: Thromboembolism.
Not known: Dyspepsia, nausea, peptic ulceration with perforation and haemorrhage, abdominal distension, abdominal pain, diarrhoea, oesophageal ulceration, acute pancreatitis.
Not known: Hirsutism, skin atrophy, bruising, striae, telangiectasia, acne, increased sweating, pruritis, rash, urticaria.
Not known: Proximal myopathy, osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture, tendinopathies (particularly of the Achilles and patellar tendons), myalgia, growth suppression in infancy, childhood and adolescence.
Not known: Scleroderma renal crisis7
Not known: Menstrual irregularity, amenorrhoea.
Not known: Fatigue, malaise, impaired healing
Not known: Increased intra-ocular pressure, may suppress reactions to skin tests.
1 with suppression of clinical symptoms and signs.
2 particularly in times of stress, as in trauma, surgery or illness.
3 which may result in weight gain
4 usually after treatment withdrawal
5 exacerbation of giant cell arteritis, with clinical signs of evolving stroke has been attributed to prednisolone.
6 with high dose therapy
7 amongst the different subpopulations the occurrence of scleroderma renal crises varies. The highest risk has been reported in patients with diffuse systemic sclerosis. The lowest risk has been reported in patients with limited systemic sclerosis (2%) and juvenile onset systemic sclerosis (1%)
Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death. A steroid “withdrawal syndrome” seemingly unrelated to adrenocortical insufficiency may also occur following abrupt discontinuance of glucocorticoids. This syndrome includes symptoms such as: anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules 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. Psychological effects have been reported on withdrawal of corticosteroids.
A wide range of psychiatric reactions including affective disorder (such as irritable, euphoric, depressed and labile mood and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances and cognitive dysfunction including confusion and amnesia have been reported. Reactions are common any may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to the 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is Not known.
The incidence of predictable undesirable effects, including hypothalamic-pituitary-adrenal (HPA) axis suppression correlates with the relative systemic potency of the drug, dosage, timing of administration and the duration of treatment.
Not known: Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis.
Not known: leukemoid reactions, Leucocytosis
Not known: Hypersensitivity including anaphylaxis has been reported.
Not known: Menstrual irregularity and amenorrhoea, Cushingoid facies, hirsutism, impaired carbohydrate tolerance with increased requirement for antidiabetic therapy. Negative protein and calcium balance.
Not known: Sodium and water retention, potassium loss, hypokalaemic alkalosis, increased appetite, weight gain, alteration in lipid levels (increases in total cholesterol, low density lipoproteins and triglycerides)
Not known: Psychological dependence
Not known: Dizziness, headache, aggravation of epilepsy
Not known: Increased intra-ocular pressure, glaucoma, papilloedema, posterior subcapsular cataracts, corneal or scleral thinning and exacerbation of ophthalmic viral or fungal diseases. Chorioretinopathy. Vision, blurred
Not known: Myocardial rupture following recent myocardial infarction.
Not known: Hypertension, Thromboembolism
Not known: Nausea, hiccups, dyspepsia, peptic ulceration with perforation and haemorrhage, acute pancreatitis, candidiasis.
Not known: Skin atrophy, bruising, telangiectasia, striae, acne, dermatitis and toxic epidermal necrolysis.
Not known: Osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture, proximal myopathy.
Not known: Impaired healing
Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and in severe cases this could be fatal.
A ‘withdrawal syndrome’ may also occur including; fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight.
Suppression of the hypothalamic-pituitary-adrenal axis, growth suppression in infancy, childhood and adolescence.
Increased intracranial pressure with papilloedema in children (pseudotumor cerebri), usually after treatment withdrawal.
Not known: vision, blurred
Prolonged treatment with corticosteroids in high dosage is occasionally associated with cataract.
The systemic effects of steroids are possible following the use of prednisolone, but are, however, unlikely due to the reduced absorption of topical eye drops.
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
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