Iloprost nebulised
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for nebulisation containing iloprost.
Drugs List
Therapeutic Indications
Uses
Primary pulmonary hypertension - grade 3 functional status
Dosage
Adults
Dose per inhalation session
Initial dose: 2.5micrograms (as delivered at the mouthpiece of the nebuliser).
Maintenance dose: If initial dose is well tolerated, increase to 5micrograms and maintain at that dose. In case of poor tolerability of the 5microgram dose, reduce dose to 2.5micrograms.
Daily dose
The dose per inhalation session should be administered six to nine times daily, depending on individual need and tolerability.
Duration of treatment
The duration of treatment depends on the patients clinical response. If the individual's condition deteriorates during therapy, intravenous prostacyclin treatment should be considered.
Children
Idiopathic or familial pulmonary arterial hypertension (unlicensed)
Children aged 8 to 18 years
Initial dose: 2.5micrograms (as delivered at the mouthpiece of the nebuliser).
Maintenance dose: 5micrograms for one dose. If well tolerated, continue at 5micrograms six to nine times a day. In case of poor tolerability of the 5microgram dose, reduce dose to 2.5micrograms.
Patients with Renal Impairment
Creatinine clearance less than or equal to 30ml/minute
Initial doses should be 2.5micrograms administered at intervals of 3 to 4 hours (maximum of 6 doses per day). Intervals may then be shortened according to individual tolerability and response. If a larger dose of 5micrograms is required initially administer with intervals of 3 to 4 hours between and cautiously shorten the intervals if required.
The Renal Drug Handbook states that for GFR below 50ml/minute that no dosage adjustment is required.
Patients with Hepatic Impairment
Initial doses should be 2.5micrograms administered at intervals of 3 to 4 hours (maximum of 6 doses per day). Intervals may then be shortened according to individual tolerability and response. If a larger dose of 5micrograms is required initially administer with intervals of 3 to 4 hours between and cautiously shorten the intervals if required.
Administration
For inhalation via an appropriate dosimetric nebuliser (see individual manufacturers instructions).
As the various nebuliser systems are not necessarily equivalent it is advised not to switch to another nebuliser without supervision.
Contraindications
Children under 8 years
Predisposition to haemorrhage
Recent trauma
Systolic blood pressure < 85mmHg at initiation
Breastfeeding
Decompensated cardiac failure
Intracranial haemorrhage
Peptic ulcer
Pulmonary hypertension secondary to venous occlusive disorder
Serious cardiac arrhythmias
Severe ischaemic heart disease
Unstable angina
Unstable pulmonary hypertension with advanced right ventricular failure
Valvular defects with associated myocardial function disorder
Within 3 months of a cerebrovascular accident
Within 3 months of a transient ischaemic attack
Within 6 months of a myocardial infarction
Precautions and Warnings
Children aged 8 to 18 years
Predisposition to syncope
Acute pulmonary infection
Chronic obstructive pulmonary disease
Hepatic cirrhosis
Hepatic impairment
Hypotension
Pregnancy
Renal dialysis
Renal impairment - creatinine clearance below 30 ml/minute
Severe asthma
Reduce dose in patients with creatinine clearance below 30ml/min
Reduce dose in patients with hepatic impairment
Advise patient not to drive or operate machinery until assessed
Treatment to be initiated and supervised by a specialist
Contains alcohol
Avoid contact with skin or eyes
Discard any unused portion
Use caution if changing nebuliser device, delivery characteristics may vary
Use in a well ventilated area
Monitor fasting serum glucose levels during prolonged treatment
Monitor patients with acute pulmonary infections
Supervise patient closely during drug withdrawal
Consider veno-occlusive disease if pulmonary oedema occurs
Nocturnal/exertion syncope-indicates need to change/adapt therapy
Discontinue if pulmonary oedema occurs
Discontinue if worsening symptoms of cardiac failure develop
Female: Ensure adequate contraception during treatment
Advise patient to inhale from nebuliser via mouthpiece
Advise patient to take dose prior to physical activity
Tendency for syncope associated with pulmonary hypertension, patient should avoid exceptional straining (e.g. physical exertion).
Iloprost has a short duration of action (1 to 2 hours), therefore an inhalation session before physical exertion may be useful.
In cases of interruption of iloprost therapy, the risk of a rebound effect cannot be ruled out. Closely monitor patients discontinuing therapy and consider an alternate treatment in critically ill patients. Sudden withdrawal should be avoided.
Animal studies indicate an association between prolonged oral iloprost clathrate treatment and slightly increased fasting serum glucose levels. This must be considered a possible risk in humans taking iloprost trometamol long term.
Minimise accidental exposure to iloprost by using a recommended nebuliser with inhalation-triggered systems.
Newborns, infants and pregnant women should not be subjected to iloprost in the room air.
Pregnancy and Lactation
Pregnancy
Use iloprost with caution during pregnancy.
The manufacturer advises caution if iloprost is used during pregnancy. At the time of writing there is limited published information regarding the use of iloprost during pregnancy. Women with pulmonary hypertension should avoid pregnancy as may lead to life threatening exacerbation of the disease. If pregnancy occurs the use of iloprost may be considered only after careful evaluation of risks and benefits in women who choose to continue with their pregnancy despite the risks of pulmonary hypertension in pregnancy.
Lactation
Iloprost is contraindicated during breastfeeding.
The manufacturer recommends breastfeeding is avoided whilst taking iloprost. At the time of writing there is limited published information regarding the use of iloprost during breastfeeding. Very low levels have been detected in animal studies but presence in human milk is unknown. The small molecular weight suggests excretion is possible but due to the short plasma half life, it will probably be limited. Should ingestion occur, effects on the exposed infant are unknown.
Side Effects
Bronchospasm
Chest pain
Cough increased
Diarrhoea
Dizziness
Dysgeusia
Dyspnoea
Epistaxis
Flushing
Haemoptysis
Haemorrhage
Headache
Hyperglycaemia
Hypersensitivity reactions
Hypotension
Jaw pain
Mouth irritation
Nausea
Palpitations
Peripheral oedema
Pharyngolaryngeal pain
Rash
Syncope
Tachycardia
Throat irritation
Thrombocytopenia
Tongue irritation
Trismus
Vasodilation
Vomiting
Wheezing
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: January 2018
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Ventavis 10 microgram/ml nebuliser solution. Bayer plc. Revised June 2017.
Summary of Product Characteristics: Ventavis 20 microgram/ml nebuliser solution. Bayer plc. Revised February 2019.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 January 2018.
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