Chemical formula: C₂₅H₃₁NO₆ Molecular mass: 441.524 g/mol PubChem compound: 189821
The ability of corticosteroids to cross the placenta varies between individual drugs, however, deflazacort does cross 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 intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important. 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 normal pregnancies may be treated as though they were in the non-gravid state.
Corticosteroids are excreted in breast milk, although no data are available for deflazacort. Doses of up to 50 mg daily of deflazacort are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression but the benefits of breast feeding are likely to outweigh any theoretical risk.
No data is available on Deflazacort and its effects on fertility.
The effect of corticosteroids on the ability to drive or use machinery has not been systematically evaluated. Vertigo is a possible undesirable effect after treatment with deflazacort. If affected, patients should not drive or operate machinery.
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.
The following CIOMS frequency rating is used: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10 000 to <1/1000); very rare (<1/10 000), not known (cannot be estimated from the available data).
Uncommon: suppression of the hypothalamic-pituitary-adrenal axis, amenorrhoea, Cushingoid facies.
Not known: growth suppression in infancy, childhood and adolescence.
Common: weight gain.
Uncommon: impaired carbohydrate tolerance with increased requirement for anti-diabetic therapy, sodium and water retention with hypertension, potassium loss and hypokalaemic alkalosis when co-administered with beta 2-agonist and xanthines.
Not known: negative protein and calcium balance, increased appetite.
Uncommon: increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis.
Not known: candidiasis.
Uncommon: osteoporosis, vertebral and long bone fractures.
Rare: muscle wasting.
Not known: avascular osteonecrosis, tendonitis and tendon rupture when co-administered with quinolones, myopathy (acute myopathy may be precipitated by non-depolarising muscle relaxants), negative nitrogen balance.
Not known: menstrual irregularity.
Not known: heart failure, hypertrophic cardiomyopathy in preterm infants.
Uncommon: headache, vertigo.
Not known: restlessness, Increased intra-cranial pressure with papilloedema in children (pseudotumour cerebri), usually after treatment withdrawal, aggravation of epilepsy.
A wide range of psychiatric reactions including affective disorders such as:
Uncommon: depressed and labile mood.
Not known: irritable, euphoric, suicidal thoughts.
Psychotic reactions including:
Not known: mania, delusions, hallucinations, aggravation of schizophrenia
Other reactions including:
Uncommon: behavioural disturbances.
Not known: 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.
Not known: vision blurred, increased intra-ocular pressure, glaucoma, papilloedema, posterior subcapsular cataracts especially in children, chorioretinopathy, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal diseases.
Uncommon: dyspepsia, peptic ulceration, haemorrhage, nausea.
Not known: perforation of peptic ulcer, acute pancreatitis (especially in children), candidiasis.
Uncommon: hirsutism, striae, acne.
Rare: bruising.
Not known: Skin atrophy, telangiectasia.
Uncommon: oedema.
Not known: impaired healing.
Uncommon: hypersensitivity including anaphylaxis has been reported.
Not known: Leukocytosis.
Not known: Thromboembolism in particular in patients with underlying conditions associated with increased thrombotic tendency, rare incidence of benign intracranial hypertension.
Not known: 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. This may occur in patients even without evidence of adrenal insufficiency.
Pheochromocytoma crisis has been reported with other systemic corticosteroids and is a known class effect.
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