Sumatriptan aqueous nasal spray
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Nasal spray containing sumatriptan.
Drugs List
Therapeutic Indications
Uses
Acute treatment of migraine attacks with or without aura
Unlicensed Uses
Acute treatment of cluster headache
Dosage
If symptoms recur in 24 hours after the first dose, a second dose may be administered if there is a minimum of 2 hours between the doses.
A second dose must not be administered if the patient does not respond to the first dose.
Adults
20mg into one nostril. (10mg may be effective in some patients).
Maximum daily dose is 40mg in any 24 hour period.
Children
Children aged 12 to 18 years
10mg into one nostril.
Maximum daily dose is 20mg in any 24 hour period.
Acute cluster headache (unlicensed)
Children aged 12 to 18 years
10mg to 20mg into one nostril.
If symptoms recur in the next 24 hours, a second dose may be administered if there is a minimum of 2 hours between the doses.
A second dose must not be administered if the patient does not respond to the first dose.
Maximum daily dose is 40mg in any 24 hour period.
Contraindications
Children under 12 years
Suspected ischaemic heart disease
Within 2 weeks of discontinuing MAOIs
Coronary vasospasm
History of cerebrovascular accident
History of myocardial infarction
History of transient ischaemic attack
Ischaemic heart disease
Moderate hypertension
Peripheral vascular disease
Prinzmetal's angina
Severe hepatic impairment
Uncontrolled hypertension
Precautions and Warnings
Children aged 12 to 18 years
Patients over 65 years
Predisposition to ischaemic heart disease
Breastfeeding
Hepatic impairment
History of seizures
Hypertension
Pregnancy
Reduced seizure threshold
Renal impairment
Not for prophylactic use
Advise patient drowsiness may affect ability to drive or operate machinery
Children under 18: Treatment to be initiated/supervised by a specialist
Evaluate patients for cardiovascular disease prior to treatment
Exclude other potentially serious neurological conditions
Avoid ergotamine-type medication for 6 hrs after sumatriptan administration
Avoid sumatriptan for 24hrs after ergotamine-type medication administration
Only for use where a clear diagnosis of migraine has been established
Excessive use may increase frequency of headache, may require withdrawal
If angina-like symptoms occur, discontinue treatment and investigate.
Advise patient not to take St John's wort concurrently
Patients should not exceed recommended dose
Patients taking concomitant treatment with sumatriptan and a selective serotonin reuptake inhibitor (SSRI) should be under careful observation due to the potential risk of developing serotonin syndrome.
Pregnancy and Lactation
Pregnancy
Use sumatriptan with caution in pregnancy.
Studies on the use of sumatriptan during pregnancy have not shown any increased risks of foetal teratogenic effects in humans (Schaefer et al, 2015). Briggs (2015) states that some animal studies have shown congenital defects, particularly rabbits, when administrated sumatriptan during pregnancy, however the risk of developing teratogenic effects in humans is low. The manufacturer suggests sumatriptan should only be used in pregnancy if the potential benefit to the mother outweighs the potential risk to the foetus.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Use sumatriptan with caution in breastfeeding.
Sumatriptan is excreted in breast milk, Briggs (2015) states to discard any milk expressed for 8 hours after treatment. However Schaefer (2015) states that if conventional treatment fails, a single dose of sumatriptan is considered relatively safe during breastfeeding. Hale (2015) also states the use of sumatriptan during breastfeeding is unlikely to cause harm to the infant, although the drug has been detected in excreted breast milk for up to 8 hours after treatment. The manufacturer suggests to avoid infant exposure to sumatriptan during breastfeeding discard any breast milk expressed for 12 hours after treatment.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Altered liver function tests
Anaphylaxis
Angina
Anxiety
Arrhythmias
Arthralgia
Bradycardia
Burning sensation (local)
Coronary vasospasm
Diarrhoea
Diplopia
Dizziness
Drowsiness
Dysgeusia
Dyspnoea
Dystonia
Epistaxis
Eye flickering
Fatigue
Flushing
Hyperhidrosis
Hypersensitivity reactions
Hypoaesthesia
Hypotension
Impaired vision
Increased blood pressure (transient)
Ischaemic colitis
Local irritation of throat and nose
Loss of vision
Myalgia
Myocardial infarction
Nausea
Neck stiffness
Nystagmus
Pain
Palpitations
Paraesthesia
Raynaud's phenomenon
Scotoma
Seizures
Sensation of cold
Sensation of heat
Sensation of heaviness
Sensation of pressure
Sensation of tightness
Sensory disturbances
Tachycardia
Transient ischaemic ECG changes
Tremor
Unpleasant taste
Urticaria
Vomiting
Weakness
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 2017
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.
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Summary of Product Characteristics: Imigran 10 mg and 20 mg Nasal Spray. Glaxo Wellcome UK Ltd. Revised November 2014.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 19 June 2017
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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