Drugs List

Therapeutic Indications

Uses

Acute treatment of migraine attacks with or without aura

Contraindications

Children under 6 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 6 to 18 years
Patients over 65 years
Predisposition to ischaemic heart disease
Breastfeeding
Cardiac arrhythmias
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of seizures
Hypertension
Lactose intolerance
Pregnancy
Reduced seizure threshold
Renal impairment

Not for prophylactic use
Not indicated in hemiplegic, ophthalmoplegic or basilar migraine
Advise patient drowsiness may affect ability to drive or operate machinery
Evaluate patients for cardiovascular disease prior to treatment
Exclude other potentially serious neurological conditions
Some formulations contain lactose
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
Risk of cerebrovascular events
Excessive use may increase frequency of headache, may require withdrawal
If angina-like symptoms occur, discontinue treatment and investigate.
Consider dose reduction in hepatic impairment
Advise patient not to take St John's wort concurrently
Advise patient to see doctor if new or worsening symptoms develop
Patients should not exceed recommended dose

Concurrent SSRIs - if concurrent treatment with sumatriptan is clinically warranted, patients should be closely observed as there have been reports of patients presenting with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following concomitant use.

Controlled hypertension - transient increases in blood pressure and peripheral vascular resistance have been observed in some patients.

In patients with risk factors for ischaemic heart disease, particularly heavy smokers, postmenopausal women and males over 40, sumatriptan should not be used without a cardiovascular evaluation.

Migraineurs in whom the pattern, frequency, persistence or severity of symptoms have changed should seek advice from their doctor. Patients who experience four or more migraines per month should be referred to their doctor for ongoing management.

Patients with atypical symptoms such as double vision, tinnitus, seizure-like movements, unilateral motor weakness, reduced level of consciousness or recent onset of rash with headache should seek advice from their doctor.

Use with caution in patients whose migraine symptoms appear for the first time after age 50, due to the possibility of a serious underlying cause.

Women with migraine who are taking the combined oral contraceptive have an increased risk of stroke and should seek advice from their doctor if migraine attacks started recently (within the last 3 months), migraine symptoms have worsened or they have migraine with aura.

Migraineurs may be at risk of certain cerebrovascular events (e.g. cerebrovascular accident, transient ischaemic attack).

Pregnancy and Lactation

Pregnancy

Use Sumatriptan with caution in pregnancy.

At the time of writing, the information available on exposed pregnancies is deemed insufficient to allow an accurate risk assessment, but does not point to an increased risk of congenital defects. Experience in the second and third trimesters is limited, and the manufacturer advises that administration should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus. Data from over 1000 exposed in the first trimester of pregnancy does not indicate that sumatriptan has teratogenic potential.

Animal studies does not indicate direct teratogenic effects or harmful effects on peri- and postnatal development. Studies in rabbits found sumatriptan to be embryolethal with IV doses at the maximum recommended subcutaneous human dose, and an increased incidence of cervicothoracic vascular and skeletal anomalies at oral doses over 50 times the human dose. There was no embryo/foetal lethality or teratogenicity found in rats with subcutaneous or IV doses at 20 times the maximum human dose, and no foetal adverse effects with oral doses.

Due to its molecular weight, exposure to the foetus is expected to be low. Briggs concludes that the toxicity and malformations seen in rabbits do not present a major teratogenic risk in humans, and that the data is generally reassuring.

Paracetamol is the analgesic of choice. Ibuprofen or aspirin may also be considered for the first 30 weeks. The Clinical Knowledge Summaries contraindicates triptans in pregnancy, Schaefer however regards sumatriptan as suitable for treating severe attacks. Non-drug therapies such as relaxation are preferred when treating migraine in pregnancy.

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 into breast milk in low levels of about 3.5% following subcutaneous administration. Due to its poor oral bioavailability, the infant exposure is only actually about 0.49%, and hence it is not expected to cause any adverse effects in most breastfed infants (Hale 2010). Infant exposure can be further minimised by avoiding breastfeeding for 12 hours after treatment and discarding any milk expressed during this time, particularly in extreme cases such as with premature infants.

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
Cerebrovascular disorders
Coronary vasospasm
Diarrhoea
Diplopia
Dizziness
Drowsiness
Dyspnoea
Dystonia
Eye flickering
Fatigue
Flushing
Hyperhidrosis
Hypersensitivity reactions
Hypoaesthesia
Hypotension
Impaired vision
Increased blood pressure (transient)
Ischaemic colitis
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
Serotonin syndrome
Somnolence
Tachycardia
Tingling sensation
Transient ischaemic ECG changes
Tremor
Vomiting
Weakness

Presentation

Tablets containing sumatriptan

Drugs List

Therapeutic Indications

Uses

Acute treatment of migraine attacks with or without aura

Dosage

Adults

Children

Patients with Hepatic Impairment

Contraindications

Children under 6 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 6 to 18 years
Patients over 65 years
Predisposition to ischaemic heart disease
Breastfeeding
Cardiac arrhythmias
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of seizures
Hypertension
Lactose intolerance
Pregnancy
Reduced seizure threshold
Renal impairment

Not for prophylactic use
Not indicated in hemiplegic, ophthalmoplegic or basilar migraine
Advise patient drowsiness may affect ability to drive or operate machinery
Evaluate patients for cardiovascular disease prior to treatment
Exclude other potentially serious neurological conditions
Some formulations contain lactose
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
Risk of cerebrovascular events
Excessive use may increase frequency of headache, may require withdrawal
If angina-like symptoms occur, discontinue treatment and investigate.
Consider dose reduction in hepatic impairment
Advise patient not to take St John's wort concurrently
Advise patient to see doctor if new or worsening symptoms develop
Patients should not exceed recommended dose

Concurrent SSRIs - if concurrent treatment with sumatriptan is clinically warranted, patients should be closely observed as there have been reports of patients presenting with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following concomitant use.

Controlled hypertension - transient increases in blood pressure and peripheral vascular resistance have been observed in some patients.

In patients with risk factors for ischaemic heart disease, particularly heavy smokers, postmenopausal women and males over 40, sumatriptan should not be used without a cardiovascular evaluation.

Migraineurs in whom the pattern, frequency, persistence or severity of symptoms have changed should seek advice from their doctor. Patients who experience four or more migraines per month should be referred to their doctor for ongoing management.

Patients with atypical symptoms such as double vision, tinnitus, seizure-like movements, unilateral motor weakness, reduced level of consciousness or recent onset of rash with headache should seek advice from their doctor.

Use with caution in patients whose migraine symptoms appear for the first time after age 50, due to the possibility of a serious underlying cause.

Women with migraine who are taking the combined oral contraceptive have an increased risk of stroke and should seek advice from their doctor if migraine attacks started recently (within the last 3 months), migraine symptoms have worsened or they have migraine with aura.

Migraineurs may be at risk of certain cerebrovascular events (e.g. cerebrovascular accident, transient ischaemic attack).

Pregnancy and Lactation

Pregnancy

Use Sumatriptan with caution in pregnancy.

At the time of writing, the information available on exposed pregnancies is deemed insufficient to allow an accurate risk assessment, but does not point to an increased risk of congenital defects. Experience in the second and third trimesters is limited, and the manufacturer advises that administration should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus. Data from over 1000 exposed in the first trimester of pregnancy does not indicate that sumatriptan has teratogenic potential.

Animal studies does not indicate direct teratogenic effects or harmful effects on peri- and postnatal development. Studies in rabbits found sumatriptan to be embryolethal with IV doses at the maximum recommended subcutaneous human dose, and an increased incidence of cervicothoracic vascular and skeletal anomalies at oral doses over 50 times the human dose. There was no embryo/foetal lethality or teratogenicity found in rats with subcutaneous or IV doses at 20 times the maximum human dose, and no foetal adverse effects with oral doses.

Due to its molecular weight, exposure to the foetus is expected to be low. Briggs concludes that the toxicity and malformations seen in rabbits do not present a major teratogenic risk in humans, and that the data is generally reassuring.

Paracetamol is the analgesic of choice. Ibuprofen or aspirin may also be considered for the first 30 weeks. The Clinical Knowledge Summaries contraindicates triptans in pregnancy, Schaefer however regards sumatriptan as suitable for treating severe attacks. Non-drug therapies such as relaxation are preferred when treating migraine in pregnancy.

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 into breast milk in low levels of about 3.5% following subcutaneous administration. Due to its poor oral bioavailability, the infant exposure is only actually about 0.49%, and hence it is not expected to cause any adverse effects in most breastfed infants (Hale 2010). Infant exposure can be further minimised by avoiding breastfeeding for 12 hours after treatment and discarding any milk expressed during this time, particularly in extreme cases such as with premature infants.

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

Counselling

Patients should be advised that drowsiness may occur as a result of migraine or its treatment with sumatriptan. Caution is recommended in patients performing skilled tasks such as driving or operating machinery.

Patients should be advised not to exceed the recommended dose.

Patients should be advised to consult their doctor if they develop symptoms of serotonin syndrome.

Patients should be advised not to use products containing St John's wort.

Patients should be advised to consult their doctor if the pattern, frequency, persistence or severity of symptoms changes, or if they experience atypical symptoms.

Side Effects

Altered liver function tests
Anaphylaxis
Angina
Anxiety
Arrhythmias
Arthralgia
Bradycardia
Cerebrovascular disorders
Coronary vasospasm
Diarrhoea
Diplopia
Dizziness
Drowsiness
Dyspnoea
Dystonia
Eye flickering
Fatigue
Flushing
Hyperhidrosis
Hypersensitivity reactions
Hypoaesthesia
Hypotension
Impaired vision
Increased blood pressure (transient)
Ischaemic colitis
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
Serotonin syndrome
Somnolence
Tachycardia
Tingling sensation
Transient ischaemic ECG changes
Tremor
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: October 2014

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.

Summary of Product Characteristics: Imigran Tablets. GlaxoSmithKline UK. Revised September 2010
Summary of Product Characteristics: Imigran Radis. GlaxoSmithKline UK. Revised September 2010
Summary of Product Characteristics: Imigran Recovery. GlaxoSmithKline Consumer Healthcare. Revised March 2009
Summary of Product Characteristics: Migraitan 50 mg tablets. Bristol Laboratories Ltd. Revised May 2014
Summary of Product Characteristics: Migraleve Ultra 50 mg tablets. McNeil Ltd. Revised April 2009
Summary of Product Characteristics: Sumatriptan Tablets. Aurobindo Pharma Ltd. Revised May 2010

Clinical Knowledge Summaries - Migraine
Scenario: Pregnanant or breastfeeding women
Available at: https://cks.nice.org.uk/migraine
Last accessed: 13 October, 2014

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 June 2017

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Sumatriptan Last revised: 07 Spetember, 2013
Last accessed: 13 October, 2014