Iloprost parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Infusions of iloprost.
Drugs List
Therapeutic Indications
Uses
Raynaud's syndrome
Severe chronic ischaemia of lower limbs in patients at risk of amputation
Treatment of severe chronic ischaemia of lower limbs in patients at risk of amputation, in whom surgical revascularisation or angioplasty has failed or is not indicated, following an interdisciplinary meeting of physicians, surgeons and radiologists.
Treatment of severe Raynaud's phenomena in patients with progressive trophic disorders.
Dosage
Adults
Treatment of severe chronic ischaemia of the lower limbs
Dose varies between 0.5 to 2nanograms/kg/minute for an infusion of 6 hours per day, depending on the patient's tolerance. Treatment should be started at 0.5nanograms/kg/minute and increased at intervals of 30 minutes by 0.5nanograms/kg/minute to reach the maximum tolerated dose by the patient (maximum dose of 2nanograms/kg/minute).
Continue treatment for four weeks, using the tolerated dose determined during the first two or three days of treatment.
Treatment of Severe Raynaud's Phenomenon
Dose varies between 1.5 to 2nanograms/kg/minute, depending on the patient's tolerance. Treatment should be started at 0.5nanograms/kg/minute and increased at intervals of 30 minutes by 0.5nanograms/kg/minute to reach the maximum tolerated dose by the patient (maximum dose of 2nanograms/kg/minute). The duration of the infusion will be 6 hours per day for 5 consecutive days using the maximum tolerated dose determined during the first days of treatment.
Repeat cycles should preferably take place at intervals of 6 to 12 weeks and never less than 4 weeks.
Children
Treatment of Raynaud's Phenomenon (unlicensed)
Children aged 12 to 18 years
Dose varies between 1 to 2nanograms/kg/minute, depending on the patient's tolerance. Treatment should be started at 0.5nanograms/kg/minute and increased gradually. The duration of the infusion will be 6 hours per day for 3 to 5 days.
Patients with Renal Impairment
Renal insufficiency requiring dialysis
Half the usual initial dose (see Dosage; Adult).
Patients with Hepatic Impairment
Severe hepatic impairment
Half the usual initial dose (see Dosage; Adult).
Administration
Solution after dilution to be administered by slow intravenous infusion over 6 hours via a peripheral vein or a central venous catheter.
Contraindications
Children under 12 years
Predisposition to haemorrhage
Recent trauma
Breastfeeding
Decompensated cardiac failure
Intracranial haemorrhage
New York Heart Association class II failure
New York Heart Association class III failure
New York Heart Association class IV failure
Peptic ulcer
Pregnancy
Pulmonary oedema
Serious cardiac arrhythmias
Severe ischaemic heart disease
Unstable angina
Valvular defects with associated myocardial function disorder
Within 3 months of a cerebrovascular accident
Within 6 months of a myocardial infarction
Precautions and Warnings
Children aged 12 to 18 years
Hepatic cirrhosis
Hypotension
Recent cerebrovascular accident
Renal dialysis
Severe cardiovascular disorder
Severe hepatic impairment
Reduce dose in patients on renal dialysis
Reduce dose in patients with severe hepatic impairment
Avoid contact with mucous membranes
Avoid contact with skin or eyes
Must be diluted before use
Exclude pregnancy prior to initiation of treatment
Monitor blood pressure
Monitor heart rate
Monitor patients with cardiovascular conditions
Not licensed for all indications in all age groups
Female: Ensure adequate contraception during treatment
Advise patient on giving up smoking
Pregnancy and Lactation
Pregnancy
Iloprost infusion is contraindicated in pregnancy.
The manufacturer notes that there is little data from the use of iloprost in pregnant women. Studies in animals have shown embryotoxicity in rats but not in rabbits and monkeys.
Lactation
Iloprost infusion is contraindicated in breastfeeding.
The manufacturer notes that a decision must be made whether to discontinue breastfeeding or to discontinue the therapy, taking into account the benefit of breastfeeding for the child and the benefit of the therapy for the woman.
Side Effects
Abdominal discomfort
Abdominal pain
Angina pectoris
Anxiety
Arrhythmias
Arthralgia
Asthenia
Asthma
Blurred vision
Bradycardia
Bradypsychia
Burning sensation
Cardiac failure
Cerebral ischaemia
Cerebrovascular accident
Chills
Confusion
Constipation
Convulsions
Cough
Decreased appetite
Deep vein thrombosis (DVT)
Depression
Diarrhoea
Dizziness
Drowsiness
Dry mouth
Dysgeusia
Dyspepsia
Dysphagia
Dyspnoea
Dysuria
Erythema at injection site
Extrasystoles
Eye irritation
Eye pain
Feeling hot
Flushing
Hallucinations
Headache
Hepatic impairment
Hyperaesthesia
Hyperhidrosis
Hypersensitivity reactions
Hypotension
Increased blood pressure
Injection site reactions
Jaw pain
Local pain (injection site)
Migraine
Muscle spasm
Myalgia
Myocardial infarction
Nausea
Pain
Palpitations
Paraesthesia
Phlebitis (injection site)
Proctitis
Pruritus
Pulmonary embolism
Pulmonary oedema
Pyrexia
Rectal haemorrhage
Rectal tenesmus
Renal pain
Restlessness
Rise in body temperature
Syncope
Tachycardia
Tetany
Thirst
Thrombocytopenia
Tremor
Trismus
Vertigo
Vomiting
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: March 2019
Reference Sources
Summary of Product Characteristics: Iloprost 100micrograms/ml concentrate for solution for infusion. Colonis Pharma Ltd. Revised January 2019.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 09 August 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.