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Corticosteroids - topical (skin), nose, and eyes - Management
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What should I consider when initiating intranasal corticosteroids?
- Intranasal corticosteroids are available as drops and sprays. The risk of systemic adverse effects is considered more likely with drops (as they are more likely to be administered incorrectly).
- The intranasal corticosteroids that are available in the UK are equally effective.
- However, for children, consider prescribing a preparation containing fluticasone propionate, mometasone, budesonide, or triamcinolone.
Basis for recommendation
These recommendations are based on published expert opinion [Schenkel et al, 2000; Yawn, 2006; London New Drugs Group, 2008], and the British National Formulary [BNF 59, 2010].
- The BNF states that the risk of systemic adverse effects may be greater with nasal drops than with nasal sprays; drops are administered incorrectly more often than sprays [BNF 59, 2010].
- Choice of intranasal corticosteroid for children
- Experts recommend budesonide, fluticasone, and mometasone for children [Schenkel et al, 2000; Yawn, 2006]. The BNF also recommend these intranasal corticosteroids in children, as well as triamcinolone.
- Intranasal beclometasone affects growth in children [BNF 59, 2010].
- CKS found several small studies comparing intranasal corticosteroids with placebo in children with allergic rhinitis.
- A year-long randomized controlled trial (RCT), in 100 children 6–9 years of age, compared intranasal beclometasone (168 micrograms twice daily) with placebo. Rate of growth was significantly slower in the beclometasone group than the placebo group, (0.013 cm/day compared with 0.017 cm/day). After 12 months, the children in the beclometasone group had grown 5 cm and those in the placebo group 5.9 cm [Skoner et al, 2000].
- A year-long RCT, in 98 children 3–9 years of age, compared intranasal mometasone with placebo. After 12 months, the mean increase in height was 6.95 cm in the mometasone group, compared with 6.35 cm in the placebo group (p = 0.02) [Schenkel et al, 2000].
- A year-long RCT, in 150 children 3.5–9 years of age, which compared intranasal fluticasone (200 micrograms daily) with placebo, found a 6.4-cm height increase in both groups [Allen et al, 2002].
- A year-long RCT compared intranasal budesonide (64 micrograms once daily) with placebo in 229 children 4–8 years of age. After 1 year, the mean growth velocity was 5.91 cm/year in the budesonide group and 6.19 cm/year in the placebo group. However, the mean difference (0.27 cm) was not statistically significant [Murphy et al, 2006].
- In a small study of 24 children (6–14 years of age) using intranasal triamcinolone, the children followed their age-appropriate growth velocities [Ober et al, 2004].
- In conclusion, these studies show that twice daily beclometasone can slow growth velocity in children, whilst once daily mometasone, triamcinolone, fluticasone, and budesonide do not affect growth. However, it is not known whether once daily beclometasone also affects growth [London New Drugs Group, 2008].
- It is questionable whether the effect seen in these small studies for beclometasone will result in reduced adult height [London New Drugs Group, 2008].
What contraindications and cautions are associated with intranasal corticosteroids?
- Contraindications
- Intranasal corticosteroids should not be used in:
- The presence of untreated nasal infections (intranasal corticosteroids can be used if the infection is being treated).
- After nasal surgery, unless on specialist advice. Intranasal corticosteroids can be used after healing has occurred.
- Pulmonary tuberculosis.
Basis for recommendation
These recommendations are based on the British National Formulary [BNF 59, 2010] and a drug reference database [Sweetman, 2009].
Can I prescribe inhaled corticosteroids to a woman who is pregnant, planning a pregnancy, or breastfeeding?
- Pregnancy
- Intranasal corticosteroids can be used in pregnancy. It is unlikely that systemic concentrations will reach clinically important levels.
- Breastfeeding
- Intranasal corticosteroids can be used during breastfeeding.
Basis for recommendation
- CKS found no studies on the effects of intranasal corticosteroids on pregnancy and breastfeeding.
- The manufacturer of Nasonex® (mometasone furoate) recommends that, as with other nasal corticosteroids, it should not be used in pregnancy or lactation unless the potential benefit to the woman justifies any potential risk to the woman and the fetus or infant [ABPI Medicines Compendium, 2008a].
- There are no adequate or well-controlled studies in pregnant women. Following intranasal administration of the maximal recommended clinical dose, the plasma concentration of mometasone is not measurable; thus fetal exposure is expected to be negligible and the potential for reproductive toxicity very low [ABPI Medicines Compendium, 2008a].
- The manufacturer of Flixonase® (fluticasone propionate) recommends that the possible benefits of the drug is weighed against the possible hazards before using it in pregnancy or breastfeeding [ABPI Medicines Compendium, 2010a].
- Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development (including cleft palate and intra-uterine growth retardation). However, these effects occurred after very high systemic exposure. In contrast, direct intranasal application ensures minimal systemic exposure.
- There may be a very small risk of such effects in the human fetus [ABPI Medicines Compendium, 2010a].
What are the adverse effects of intranasal corticosteroids?
- Local adverse effects
- Approximately 10% of people using intranasal corticosteroids develop local adverse effects (including dryness, irritation, and nosebleed; this may require stopping treatment for a while).
- Reddening of the skin, rash, itching, headache, and disturbance of smell and taste may also occur.
- Nasal ulceration has been reported, mostly with preparations containing fluticasone furoate or mometasone furoate.
- Systemic adverse effects
- Systemic adverse effects are rare but may occur, especially with high doses prescribed for a long period of time. Adrenal suppression, decreased bone mineral density, increased intra-ocular pressure, cataract, and glaucoma have been reported in people receiving long-term intranasal corticosteroids.
- Psychological and behavioural effects (such as psychomotor hyperactivity, sleep disorders, anxiety, depression, and aggression [particularly in children]) have also been reported.
- Growth retardation has been reported in children and adolescents receiving licensed doses. Cushing's syndrome has been reported in children receiving long-term corticosteroid nasal drops.
- The risk of systemic effects is considered more likely with drops than with sprays, as drops are more likely to be administered incorrectly.
Basis for recommendation
- Information on local and systemic adverse effects is from the British National formulary [BNF 59, 2010] and a drug reference database [Sweetman, 2009].
- More recently, the Medicines and Healthcare Regulatory Agency (MHRA) has issued a warning to prescribers that psychological and behavioural side effects may occur in association with the use of intranasal corticosteroids [MHRA, 2010].
How do I minimize the risks of adverse effects in people using intranasal corticosteroids?
- To minimize the adverse effects of intranasal corticosteroids:
- Prescribe a nasal spray instead of drops. If nasal drops are indicated or preferred, ensure that they are used correctly.
- Prescribe the weakest potency possible, for the shortest period of time.
- In children receiving prolonged treatment with high doses of intranasal corticosteroids (especially drops):
- Monitor height regularly, using a growth chart. Any slowing of growth rate should prompt a reduction in dose if possible, or referral to a specialist, or both.
Techniques
- Nasal spray technique
- Advise the person to:
- Gently blow the nose to clear it.
- Shake the bottle well.
- Close off one nostril and put the nozzle in the other, directing it away from the midline. Tilt the head forward slightly and keep the bottle upright.
- Squeeze a fine mist into the nose while breathing in slowly. The person should not sniff hard.
- Breathe out through the mouth.
- Take a second spray in the same nostril then repeat this procedure for the other nostril.
- Nasal drops technique
- Advise the person to:
- Gently blow the nose to clear it.
- Shake the container well.
- Tilt the head backwards.
- Place the drops in the nostril (squeeze the container gently if necessary).
- Keep the head tilted and sniff gently to let the drops penetrate.
- Repeat for the other nostril if required.
Basis for recommendation
Most of the recommendations on minimizing adverse effects are based on published expert opinion [Scadding et al, 2008], the British National Formulary [BNF 59, 2010], and a drug reference database [Sweetman, 2009].
- Nasal drops — betamethasone drops have a higher systemic bioavailability, and therefore a greater potential for adverse effects, than other intranasal corticosteroids [Scadding et al, 2008]. The risk of systemic effects is more likely with drops than sprays, as these are more likely to be administered incorrectly [BNF 59, 2010]. Fluticasone nasal drops are considered to have an extremely low systemic bioavailability [ABPI Medicines Compendium, 2009b].
- The Commission on Human Medicines (formerly the Committee on Safety of Medicines) recommends that the height of children receiving high doses of intranasal steroids over extended periods be frequently monitored, and treatment reviewed if any effect on growth is observed [CSM, 1998].
- Techniques for the use of nasal drops and sprays is from a manufacturer's Patient Information Leaflets [ABPI Medicines Compendium, 2008b; ABPI Medicines Compendium, 2010b].
What information and advice should I give to a person receiving intranasal corticosteroids?
- Advise the person that:
- Intranasal corticosteroids should be used regularly, once or twice daily, for effective control of symptoms.
- They may not notice any benefit from the treatment for 3–4 days (maximum benefits may require several weeks of continuous treatment).
- Intranasal corticosteroids (especially drops) should be used correctly to avoid systemic absorption and adverse effects.
- They should stop using the intranasal corticosteroid if they experience local adverse effects (such as nose bleed or nasal irritation).
- Treatment can be recommenced when the adverse effects settle. However, if this occurs regularly, they should seek advice.
Basis for recommendation
These recommendations are based on the British National Formulary [BNF 59, 2010].
- The recommendation to stop intranasal corticosteroid if local adverse effects occur, and continuing when the adverse effects settle, is based on what CKS considers to be good practice.
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