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4.4. Special warnings and precautions for use
In order to minimise the side effects of a topical corticosteroid, it is important to apply it thinly to the affected areas only. Topical corticosteroids should not be applied with an occlusive dressing to large areas of the body. Absorption is greatest on thin/raw skin, intertriginous areas, and under occlusion. Skin thinning is more likely if corticosteroids are applied under occlusion.
Absorption of topical corticosteroids through the skin can rarely cause adrenal suppression and even Cushing’s syndrome (see Section 4.8 ‘Undesirable effects’ and Section 4.9 ‘Overdose’), depending on the area of the body being treated and the duration of treatment.
Avoid prolonged exposure on the face and keep away from the eyes. Use with
caution on broken skin.
On discontinuation of topical corticosteroids a rebound exacerbation of the condition may occur. Prolonged use of compound preparations such as Timodine Cream can increase the likelihood of resistance and of sensitization. Mixing topical preparations on the skin should be avoided where possible; several minutes should elapse between application of different preparations.
Topical corticosteroids are not recommended for acne vulgaris, may worsen secondary infected lesions, and should not be used indiscriminately in pruritis.
Timodine Cream contains butylated hydroxyanisole (E320), cetostearyl alcohol, and sorbic acid which may cause local skin reactions (e.g. contact dermatitis). Butylated hydroxyanisole (E320) may cause irritation to the eyes and mucous membranes. Timodine Cream also contains propyl hydroxybenzoate (E216) and methyl hydroxybenzoate (E218), both of which may cause allergic reactions, which may be delayed. Nystatin can rarely cause contact dermatitis, and allergic reactions can occur after use of benzalkonium chloride.
The elderly
The skin of the elderly is often relatively atrophic so that local and systemic side effects of hydrocortisone are more likely.
Patients with hepatic failure
The reduced metabolism of hydrocortisone in patients with hepatic failure increases the theoretical risk of adrenal suppression.
Paediatric population
Avoid prolonged use in children.
Caution is required in dermatoses of infancy including nappy rash. Care should be taken as the nappy can act as an occlusive dressing and thus allow an increase in absorption of the steroid component of the cream.
In infants, long-term continuous topical steroid therapy should be avoided since this can lead to adrenal suppression even without occlusion. A course of treatment should not normally exceed seven days.
Use of hydrocortisone should be avoided in neonates. Any proposed use of hydrocortisone in neonates should be carefully assessed, as the high body surface area:weight ratio allows a proportionate increase in percutaneous absorption. Consideration should be given to the relative fragility of neonatal skin.
4.6. Pregnancy, pregnancy and lactation
Fertility
No data available
Pregnancy
Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established. However, topical steroids should not be used extensively in pregnancy, i.e. in large amounts or for prolonged periods.
Lactation
Although poorly absorbed, it is not known whether nystatin enters breast milk. Caution should be exercised when nystatin is prescribed for nursing mothers.
Corticosteroids cross the placenta to varying degrees and may be distributed in small amounts in breast milk. Any topically applied hydrocortisone should be wiped off thoroughly prior to nursing if it is being applied to the breast or nipple area.
4.8. Undesirable effects
Undesirable effects are listed by MedRA 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
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System Organ Class
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Frequency
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Undesirable Effect
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Endocrine disorders
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Not known
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· adrenal suppression (see Section 4.4 ‘Special warnings and precautions for use’)
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Immune system disorders
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Not known
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· hypersensitivity reactions1
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Infections and infestations
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Not known
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· spread and worsening of untreated infection (see Section 4.4 ‘Special warnings and precautions for use’)
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Metabolism and nutrition disorders
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Not known
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· Cushing’s syndrome (see Section 4.4 ‘Special warnings and precautions for use’)
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Skin and subcutaneous tissue disorder
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Not known
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· thinning of the skin2 (see Section 4.4 ‘Special warnings and precautions for use’ and Section 4.9 ‘Overdose’)
· irreversible striae atrophicae (see Section 4.9 ‘Overdose’)
· telangiectasia (see Section 4.9 ‘Overdose’)
· contact dermatitis (see Section 4.4 ‘Special warnings and precautions for use’)
· perioral dermatitis
· acne or worsening of acne
· rosacea
· mild depigmentation3
· hypertrichosis
· contact sensitisation
· purpura
· loss of skin collagen and subcutaneous atrophy
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1. if signs of hypersensitivity appear, application should stop immediately
2. thinning of the skin may be restored over a period after stopping treatment but the original structure may never return
3. mild depigmentation may be reversible
Exacerbation of symptoms may occur
4.9. Overdose
Prolonged administration of hydrocortisone, especially to sensitive areas, such as the face and flexures, may result in irreversible adverse effects such as epidermal thinning, telangiectasia and striae. Chronic administration of hydrocortisone may lead to systemic absorption and thereby suppression of the pituitary-adrenal axis. High doses of corticosteroids can cause Cushing’s syndrome.
It is possible that nausea and vomiting or diarrhoea may occur after ingestion of this product. Treat symptomatically. A small glass of milk or water may be helpful.
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