Drugs List

Therapeutic Indications

Uses

Acute treatment of migraine attacks with or without aura

Contraindications

Children under 12 years
Breastfeeding
Cardiac conduction defects
Coronary vasospasm
History of cerebrovascular accident
History of myocardial infarction
History of transient ischaemic attack
Ischaemic heart disease
Pregnancy
Prinzmetal's angina
Uncontrolled hypertension
Wolff-Parkinson-White syndrome

Precautions and Warnings

Children aged 12 to 18 years
Patients over 65 years
Predisposition to ischaemic heart disease
Galactosaemia
Glucose-galactose malabsorption syndrome
Lactose intolerance
Moderate hepatic impairment
Phenylketonuria
Renal impairment - creatinine clearance below 15ml/minute

Not for prophylactic use
Reduce dose in patients with hepatic impairment
Some formulations contain aspartame - caution in phenylketonuria
Advise ability to drive/operate machinery may be affected by side effects
Evaluate patients for cardiovascular disease prior to treatment
Exclude other potentially serious neurological conditions
Some formulations contain lactose
Only for use where a clear diagnosis of migraine has been established
When used with SSRIs, risk of Serotonin syndrome
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

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.

Pregnancy and Lactation

Pregnancy

Zolmitriptan is contraindicated in 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 to 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 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

Zolmitriptan is contraindicated in breastfeeding.

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. Sumatriptan is the preferred triptan for treatment in breastfeeding.

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

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

Presentation

Oral formulations of zolmitriptan.

Drugs List

Therapeutic Indications

Uses

Acute treatment of migraine attacks with or without aura

Dosage

Adults

Adolescents

Patients with Hepatic Impairment

Contraindications

Children under 12 years
Breastfeeding
Cardiac conduction defects
Coronary vasospasm
History of cerebrovascular accident
History of myocardial infarction
History of transient ischaemic attack
Ischaemic heart disease
Pregnancy
Prinzmetal's angina
Uncontrolled hypertension
Wolff-Parkinson-White syndrome

Precautions and Warnings

Children aged 12 to 18 years
Patients over 65 years
Predisposition to ischaemic heart disease
Galactosaemia
Glucose-galactose malabsorption syndrome
Lactose intolerance
Moderate hepatic impairment
Phenylketonuria
Renal impairment - creatinine clearance below 15ml/minute

Not for prophylactic use
Reduce dose in patients with hepatic impairment
Some formulations contain aspartame - caution in phenylketonuria
Advise ability to drive/operate machinery may be affected by side effects
Evaluate patients for cardiovascular disease prior to treatment
Exclude other potentially serious neurological conditions
Some formulations contain lactose
Only for use where a clear diagnosis of migraine has been established
When used with SSRIs, risk of Serotonin syndrome
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

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.

Pregnancy and Lactation

Pregnancy

Zolmitriptan is contraindicated in 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 to 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 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

Zolmitriptan is contraindicated in breastfeeding.

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. Sumatriptan is the preferred triptan for treatment in breastfeeding.

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

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

Summary of Product Characteristics: Zolmitriptan 5mg film coated tablets. Glenmark Generics (Europe) Ltd. Revised March 2014.
Summary of Product Characteristics: Zomig Rapimelt 2.5mg. Astra Zeneca UK Limited. Revised January 2017.
Summary of Product Characteristics: Zomig Rapimelt 5mg. Astra Zeneca UK Limited. Revised January 2017.
Summary of Product Characteristics: Zomig tablets 2.5mg. Astra Zeneca UK Limited. Revised January 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
Zolmitriptan. Last revised: September 7, 2013
Last accessed: August 13, 2014

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