Drugs List

Therapeutic Indications

Uses

Acute treatment of migraine attack with or without aura

Unlicensed Uses

Acute treatment of cluster headache

Administration

For administration as a single dose spray into one nostril.

Contraindications

Uncontrolled hypertension

Severe hypertension

Wolff-Parkinson-White syndrome or other arrhythmias associated with other cardiac accessory conduction pathways.

Ischaemic heart disease

Previous myocardial infarction

Coronary vasospasm

Prinzmetal's angina

Patients over 65 years

Children under 12 years

History of cerebrovascular attack (CVA)
History of transient ischaemic attack (TIA)

Pregnancy ( see Pregnancy)

Breastfeeding (see Lactation)

Precautions and Warnings

Children aged 12-18 years - not licensed.

Zolmitriptan should only be used where a clear diagnosis of migraine has been established.

Exclude other potentially serious neurological conditions. There is no data on the use of zolmitriptan in hemiplegic or basilar migraine.

Zolmitriptan is not indicated for prophylactic use.

Cardiovascular evaluation is recommended in patients with risk factors for ischaemic heart disease prior to commencement of treatment since in very rare cases, this class of compounds has been associated with coronary vasospasm and myocardial infarction.

If chest pain or other symptoms of ischaemic heart disease occur treatment should be stopped until appropriate medical evaluation has been carried out.

Use with caution in conditions which predispose to coronary artery disease.

Discontinue treatment and investigate if sensations of tingling, heat, heaviness, pressure or tightness of any part of the body (including throat and chest) are intense, as these may be due to coronary vasoconstriction or to anaphylaxis.

Migraineurs may be at risk of certain cerebrovascular events such as cerebral haemorrhage, subarachnoid haemorrhage, and stroke.

Moderate to severe hepatic impairment (see Dosage - Hepatic impairment )

May cause somnolence. If affected do not drive or operate machinery.

Patients should not exceed recommended dose.

Concurrent St John's Wort: may cause an increase in undesirable effects.

Excessive use of an anti-migraine medicinal product may lead to an increased frequency of headache, potentially requiring withdrawal of treatment.

Observe patient for signs of serotonin syndrome if treatment includes concurrent SSRI or SNRI, particularly during treatment initiation and dosage increase.

Pregnancy and Lactation

Pregnancy

At the time of writing, there is very little data on the use of zolmitriptan in pregnant women. In 28 exposed pregnancies, there were 2 records of major birth defects (microphthalmia plus cataract and ventricular septal defect) but Schaefer concludes that this data is insufficient to allow for risk assessment. It is not known if zolmitriptan crosses the placenta, but it is thought likely, given the low plasma protein binding and molecular weight.

Animal studies have shown no evidence of teratogenicity, but dose-related embryolethality and maternal toxicity were seen in rats and rabbits at 280-5000 times the maximum recommended human dose. The animal data in general suggests low risk, but the actual risk cannot be determined until further experience in human pregnancy is located.

Paracetamol is the analgesic of choice when treating migraine in pregnant women. Sumatriptan should be used for treating severe attacks, other 'triptanes' such as zolmitriptan should only be used when compellingly indicated due to the limited safety data available. However, Schaefer states that if a medication which is not recommended is taken, termination is not justified.

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 14-17 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 ).

Recommended for use in pregnancy? - No

Animal data - Embryolethalitiy and maternal toxicity in rats and rabbits at doses much higher than maximum human dose.

Crosses placenta? - Probably.

Other information - Paracetamol is the drug of choice for treating migraine in pregnancy. Lack of data and experience in human pregnancy mean risk of zolmitriptan cannot be accurately assessed.

Lactation

Zolmitriptan is excreted into human breast milk. The effect on the infant of this exposure is unknown. The manufacturer recommends caution when administering zolmitriptan to breastfeeding women, due to the lack of data available. LactMed states that if it is required by the mother, this is not a reason to discontinue breastfeeding, but an alternative may be preferred, particularly if the infant is newborn or premature. The Clinical Knowledge Summaries recommends avoiding breastfeeding for 24 hours after administration. Sumatriptan is preferred as there is more data available.

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

Drug excreted in breast milk? - Yes.

UK Drugs in Lactation Advisory Service Classification - Not listed but sumatriptan classed as to be used only if infant and mother can be monitored, as there is insufficient information relating to breastfeeding available to allow classification as a safe drug.

Drug substance licensed in infants? - No.

Other information - Sumatriptan is the preferred 'triptan' due to lack of experience with zolmitriptan.

Side Effects

Disturbances of sensation
Dizziness
Headache
Hyperaesthesia
Paraesthesia
Somnolence
Sensation of warmth
Palpitations
Epistaxis
Abdominal pain
Dry mouth
Nausea
Vomiting
Muscle weakness
Myalgia
Asthenia
Tightness of chest and/or throat
Sensation of heaviness
Sensation of pressure
Tachycardia
Increased blood pressure (transient)
Polyuria
Urinary frequency
Anaphylaxis
Hypersensitivity reactions
Angioedema
Urticaria
Angina pectoris
Vasospasm
Myocardial infarction
Diarrhoea - bloody
Intestinal infarction
Bowel necrosis
Intestinal ischaemia
Ischaemic colitis
Splenic infarction
Urinary urgency
Drowsiness
Flushing
Weakness
Fatigue
Taste disturbances
Nasal irritation
Angina

Presentation

Nasal spray containing an aqueous solution of zolmitriptan 50mg/ml.
Each device delivers a unit dose of 5mg zolmitriptan

Drugs List

Therapeutic Indications

Uses

Acute treatment of migraine attack with or without aura

Unlicensed Uses

Acute treatment of cluster headache

Dosage

Adults

Elderly

Adolescents

Patients with Hepatic Impairment

Additional Dosage Information

Administration

For administration as a single dose spray into one nostril.

Contraindications

Uncontrolled hypertension

Severe hypertension

Wolff-Parkinson-White syndrome or other arrhythmias associated with other cardiac accessory conduction pathways.

Ischaemic heart disease

Previous myocardial infarction

Coronary vasospasm

Prinzmetal's angina

Patients over 65 years

Children under 12 years

History of cerebrovascular attack (CVA)
History of transient ischaemic attack (TIA)

Pregnancy ( see Pregnancy)

Breastfeeding (see Lactation)

Precautions and Warnings

Children aged 12-18 years - not licensed.

Zolmitriptan should only be used where a clear diagnosis of migraine has been established.

Exclude other potentially serious neurological conditions. There is no data on the use of zolmitriptan in hemiplegic or basilar migraine.

Zolmitriptan is not indicated for prophylactic use.

Cardiovascular evaluation is recommended in patients with risk factors for ischaemic heart disease prior to commencement of treatment since in very rare cases, this class of compounds has been associated with coronary vasospasm and myocardial infarction.

If chest pain or other symptoms of ischaemic heart disease occur treatment should be stopped until appropriate medical evaluation has been carried out.

Use with caution in conditions which predispose to coronary artery disease.

Discontinue treatment and investigate if sensations of tingling, heat, heaviness, pressure or tightness of any part of the body (including throat and chest) are intense, as these may be due to coronary vasoconstriction or to anaphylaxis.

Migraineurs may be at risk of certain cerebrovascular events such as cerebral haemorrhage, subarachnoid haemorrhage, and stroke.

Moderate to severe hepatic impairment (see Dosage - Hepatic impairment )

May cause somnolence. If affected do not drive or operate machinery.

Patients should not exceed recommended dose.

Concurrent St John's Wort: may cause an increase in undesirable effects.

Excessive use of an anti-migraine medicinal product may lead to an increased frequency of headache, potentially requiring withdrawal of treatment.

Observe patient for signs of serotonin syndrome if treatment includes concurrent SSRI or SNRI, particularly during treatment initiation and dosage increase.

Pregnancy and Lactation

Pregnancy

At the time of writing, there is very little data on the use of zolmitriptan in pregnant women. In 28 exposed pregnancies, there were 2 records of major birth defects (microphthalmia plus cataract and ventricular septal defect) but Schaefer concludes that this data is insufficient to allow for risk assessment. It is not known if zolmitriptan crosses the placenta, but it is thought likely, given the low plasma protein binding and molecular weight.

Animal studies have shown no evidence of teratogenicity, but dose-related embryolethality and maternal toxicity were seen in rats and rabbits at 280-5000 times the maximum recommended human dose. The animal data in general suggests low risk, but the actual risk cannot be determined until further experience in human pregnancy is located.

Paracetamol is the analgesic of choice when treating migraine in pregnant women. Sumatriptan should be used for treating severe attacks, other 'triptanes' such as zolmitriptan should only be used when compellingly indicated due to the limited safety data available. However, Schaefer states that if a medication which is not recommended is taken, termination is not justified.

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 14-17 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 ).

Recommended for use in pregnancy? - No

Animal data - Embryolethalitiy and maternal toxicity in rats and rabbits at doses much higher than maximum human dose.

Crosses placenta? - Probably.

Other information - Paracetamol is the drug of choice for treating migraine in pregnancy. Lack of data and experience in human pregnancy mean risk of zolmitriptan cannot be accurately assessed.

Lactation

Zolmitriptan is excreted into human breast milk. The effect on the infant of this exposure is unknown. The manufacturer recommends caution when administering zolmitriptan to breastfeeding women, due to the lack of data available. LactMed states that if it is required by the mother, this is not a reason to discontinue breastfeeding, but an alternative may be preferred, particularly if the infant is newborn or premature. The Clinical Knowledge Summaries recommends avoiding breastfeeding for 24 hours after administration. Sumatriptan is preferred as there is more data available.

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

Drug excreted in breast milk? - Yes.

UK Drugs in Lactation Advisory Service Classification - Not listed but sumatriptan classed as to be used only if infant and mother can be monitored, as there is insufficient information relating to breastfeeding available to allow classification as a safe drug.

Drug substance licensed in infants? - No.

Other information - Sumatriptan is the preferred 'triptan' due to lack of experience with zolmitriptan.

Effects on Ability to Drive and Operate Machinery

Use is unlikely to affect the patient's ability to drive or operate machinery, however it should be taken into account that somnolence may occur.

Counselling

Advise patients that zolmitriptan may cause somnolence - if affected, do not drive or operate machinery.

Advise patients not to exceed the recommended dose.

Advise patients that concurrent St John's Wort may increase undesirable effects.

Side Effects

Disturbances of sensation
Dizziness
Headache
Hyperaesthesia
Paraesthesia
Somnolence
Sensation of warmth
Palpitations
Epistaxis
Abdominal pain
Dry mouth
Nausea
Vomiting
Muscle weakness
Myalgia
Asthenia
Tightness of chest and/or throat
Sensation of heaviness
Sensation of pressure
Tachycardia
Increased blood pressure (transient)
Polyuria
Urinary frequency
Anaphylaxis
Hypersensitivity reactions
Angioedema
Urticaria
Angina pectoris
Vasospasm
Myocardial infarction
Diarrhoea - bloody
Intestinal infarction
Bowel necrosis
Intestinal ischaemia
Ischaemic colitis
Splenic infarction
Urinary urgency
Drowsiness
Flushing
Weakness
Fatigue
Taste disturbances
Nasal irritation
Angina

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 ).

Shelf Life and Storage

Do not store above 25 degrees C

Further Information

Last Full Review Date: March 2012

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.

Summary of Product Characteristics: Zomig 5mg nasal spray. Astra Zeneca UK Ltd. Revised January 2017.

Clinical Knowledge Summaries - Migraine
Scenario: Pregnancy and breastfeeding
Available at: https://cks.library.nhs.uk/migraine/management/quick_answers/scenario_pregnancy_and_breastfeeding
Last accessed: July 14, 2008

UK Drugs in Lactation Advisory Service.
Available at: https://www.ukmicentral.nhs.uk/drugpreg/qrg_p1.asp
Last accessed: October 6, 2008

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed). Record 579 - Zolmitriptan
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Last revised: December 27, 2007
Last accessed: October 6, 2008

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 August 2017