Roflumilast oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulation of roflumilast.
Drugs List
Therapeutic Indications
Uses
Chronic obstructive pulmonary disease (FEV1<50% predicted normal)
Maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
Dosage
Roflumilast may need to be taken for several weeks to achieve its effect.
The lower sub-therapeutic starting dose for 28 days is to reduce side effects and patient discontinuation when first starting therapy. This starting dose is followed by a higher maintenance dose.
The tablet should be swallowed with water and taken at the same time every day. The tablet can be taken with or without food.
Adults
Starting Dose
250micrograms once daily for 28 days.
Maintenance Dose
500micrograms once daily.
Contraindications
Children under 18 years
Immunosuppression
Infectious diseases
Suicidal ideation
Active malignancies, except cutaneous basal cell carcinoma
Breastfeeding
Galactosaemia
Hepatic impairment - Child-Pugh score greater than 6
History of depression
Multiple sclerosis
New York Heart Association class III failure
New York Heart Association class IV failure
Positive HIV status
Pregnancy
Progressive multifocal leukoencephalopathy (PML)
Severe immunological disease
Systemic lupus erythematosus
Precautions and Warnings
Females of childbearing potential
Herpes zoster
Weight below 60kg
Glucose-galactose malabsorption syndrome
Hepatic impairment - Child-Pugh score less than 7
Hepatitis
Herpes simplex keratitis
Lactose intolerance
Tuberculosis
Not suitable for acute treatment of bronchospasm
Ensure patient has a fast acting bronchodilator available
Increased risk of sleep disorders in patient below 60kg
Treatment to be initiated by specialist
Contains lactose
Advise patient/carer to record bodyweight regularly on their patient card
Underweight patients: Monitor body weight regularly
Advise patients/carers to seek medical advice if changes in behaviour/mood
Advise patients/carers to seek medical advice if suicidal intent develops
Discontinue if psychiatric disturbances develop
Patient should be made aware of possible adverse effects on mood/behaviour
Discontinue if substantial undesirable weight loss occurs
Discontinue in patients showing depressive behaviour
Discontinue in patients showing suicidal behaviour
Several weeks of treatment may be needed to achieve effect
Advise patient not to take St John's wort concurrently
Female: Ensure adequate contraception during treatment
Advise patient not to use for relief of acute attacks
Pregnancy and Lactation
Pregnancy
Roflumilast is contraindicated during pregnancy.
The manufacturer does not recommend using roflumilast during pregnancy.
The manufacturer has noted that there is a limited amount of data from the use of roflumilast in pregnant women.
Studies in animals have shown reproductive toxicity.
Roflumilast has been demonstrated to cross the placenta in animal studies.
Lactation
Roflumilast is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking roflumilast.
The manufacturer has noted that available pharmacokinetic data in animals has shown excretion of roflumilast or its metabolites in milk. A risk to the suckling child cannot be excluded.
Side Effects
Abdominal pain
Angioedema
Anxiety
Aspartate aminotransferase increased
Asthenia
Back pain
Behavioural disturbances
Constipation
Creatine phosphokinase increased
Decreased appetite
Depression
Diarrhoea
Dizziness
Dysgeusia
Dyspepsia
Fatigue
Gamma glutamyl transferase (GGT) increased
Gastritis
Gastroesophageal reflux disease
Gynaecomastia
Haematochezia
Headache
Hypersensitivity reactions
Insomnia
Malaise
Muscle spasm
Muscle weakness
Myalgia
Nausea
Nervousness
Palpitations
Panic attack
Rash
Respiratory tract infection
Suicidal tendencies
Tremor
Urticaria
Vertigo
Vomiting
Weight loss
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: December 2020
Reference Sources
Summary of Product Characteristics: Daxas 250microgram tablets. AstraZeneca UK Limited. Revised May 2020.
Summary of Product Characteristics: Daxas 500microgram tablets. AstraZeneca UK Limited. Revised May 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 October 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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