Drug Action
Roflumilast is a phosphodiesterase type-4 inhibitor with anti-inflammatory properties. Respiratory system
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Drug reference
Roflumilast is a phosphodiesterase type-4 inhibitor with anti-inflammatory properties. Respiratory system
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Adjunct to bronchodilators for the maintenance treatment of patients with severe chronic obstructive pulmonary disease associated with chronic bronchitis and a history of frequent exacerbations ▶BY MOUTH ▶Adult: Initially 250 micrograms once daily for 28 days, then maintenance 500 micrograms once daily
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Cancer (except basal cell carcinoma) . concomitant treatment with immunosuppressive drugs (except short-term systemic corticosteroids). history of depression associated with suicidal ideation or behaviour. moderate to severe cardiac failure. severe acute infectious disease. severe immunological disease
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History of psychiatric illness (discontinue if new or worsening psychiatric symptoms occur). latent infection (such as tuberculosis, viral hepatitis, herpes infection)
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NICE decisions ▶Roflumilast for treating chronic obstructive pulmonary disease (July 2017) NICE TA461 Roflumilast (Daxas ®), as an add-on to bronchodilator therapy, is recommended as an option for treating severe chronic obstructive pulmonary disease in patients with chronic bronchitis, only if: . the disease is severe, defined as a forced expiratory volume in one second (FEV1) after a bronchodilator of less than 50% of predicted normal, and . the person has had two or more exacerbations in the previous 12 months despite triple inhaled therapy with a long-acting muscarinic antagonist, a long-acting beta-2 agonist and an inhaled corticosteroid. Treatment with roflumilast should be started by a specialist in respiratory medicine. Patients currently receiving roflumilast whose disease does not meet the above criteria should be able to continue treatment until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta461 Scottish Medicines Consortium (SMC) decisions SMC No. 635/10 The Scottish Medicines Consortium has advised (September 2017) that roflumilast (Daxas ®) is not recommended for use within NHS Scotland for maintenance treatment of severe chronic obstructive pulmonary disease (forced expiratory volume in one second [FEV1] after a bronchodilator of less than 50% predicted) associated with chronic bronchitis in adults with a history of frequent exacerbations as add on to bronchodilator treatment as there was insufficient evidence submitted and the economic case was not demonstrated.
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→Appendix 1: roflumilast
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▶Common or very common Appetite decreased. diarrhoea. gastrointestinal discomfort. headache. insomnia. nausea. weight decreased ▶Uncommon Anxiety. asthenia. back pain. dizziness. gastrointestinal disorders. malaise. muscle complaints. muscle weakness. palpitations. skin reactions. tremor. vertigo. vomiting ▶Rare or very rare Angioedema. constipation. depression. gynaecomastia. haematochezia. respiratory tract infection. suicidal tendencies. taste altered
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Women of child- bearing age should use effective contraception.
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Manufacturer advises avoid—toxicity in animal studies.
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Manufacturer advises avoid—present in milk in animal studies.
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Manufacturer advises caution in mild impairment; avoid in moderate to severe impairment.
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Monitor body-weight.
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There can be variation in the licensing of different medicines containing the same drug. Tablet ▶Daxas (AstraZeneca UK Ltd) A Roflumilast 250 microgram Daxas 250microgram tablets | 28 tablet P £35.20 DT = £35.20 Roflumilast 500 microgram Daxas 500microgram tablets | 30 tablet P £37.71 DT = £37.71 SYMPATHOMIMETICS › VASOCONSTRICTOR
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Manufacturer advises patients and carers should be instructed to report changes in behaviour or mood and any suicidal ideation. Patient card Patients should be given a patient card before starting treatment and advised to record body-weight at regular intervals.
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Initially 250 micrograms once daily for 28 days,
First-line fragment. Read the complete Indications and Dose section above.
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