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OTC management of migraine

ICP, clock3 Min

OTC management of migraine

ICP, clock3 Min

In Clinical

Crippling headache, nausea and vomiting, and light aversion are all distressing migraine symptoms. Alan Nathan considers OTC treatment of this disabling condition

What's Available?

Drugs in preparations licensed for OTC sale specifically for the treatment of migraine or associated symptoms are:

  • Sumatriptan
  • Ibuprofen lysine
  • Isometheptene mucate
  • Prochlorperazine
  • Buclizine.

Most oral OTC analgesic preparations containing aspirin, paracetamol, ibuprofen, codeine or dihydrocodeine include migraine as an indication. Most migraine headaches respond to simple analgesics. Soluble formulations may speed absorption and overcome the effects of gastric stasis that is commonly part of the condition.

Sumatriptan

Mode of action

Serotonin (5-hydroxytriptamine, 5HT) is a neurotransmitter and mediator of blood vessel and smooth muscle contraction throughout the body. The 5HT1D receptor mediates cerebral vasoconstriction. Triptans are 5HT1B/1D receptor agonists; they cause constriction of the cerebral arteries and counteract the cranial vasodilatation that is thought to be responsible for migraine attacks. Triptans are established as a first- line treatment for migraine.

Licensing conditions

  • Sumatriptan is licensed for acute relief of migraine attacks, with or without aura, in adults aged 18-65.
    Treatment may not be supplied for prophylaxis or for patients who are:
  • Pregnant or breastfeeding
  • Suffering from existing medical conditions, including cardiovascular conditions, hypertension, peripheral vascular disease, liver or kidney disorders
  • Suffering from any neurological condition or symptoms, including epilepsy
  • Allergic to the drug
  • Taking concurrent medication for migraine
  • Assessed as having a high cardiovascular risk.
Dosage
 
One 50mg tablet taken as soon as possible after onset of an attack. A second dose may be taken after two hours if migraine recurs. If there is no response to the first tablet, a second should not be taken for the same attack. Maximum dosage is two tablets in 24 hours.
 
Referral criteria
 
Referral to a doctor should be made if:
  • Attacks last longer than 24 hours
  • Attacks become more frequent or symptoms change
  • The patient generally has four or more attacks per month
  • The patient does not recover completely between attacks
  • The patient is over 50 years of age and is suffering a migraine attack for the first time.
 
Side effects associated with sumatriptan are usually mild and transient. The most common include sensations of tingling, heat, heaviness, pressure or tightness of any part of the body. Flushing, dizziness, feelings of weakness, fatigue, and nausea and vomiting may also be experienced.
 
Interactions Sumatriptan should be avoided by patients taking selective serotonin reuptake inhibitors, monoamine oxidase inhibitors, moclobemide, St John’s Wort, and other vasoconstrictor migraine treatments, especially ergotamine and methysergide. Patients allergic to sulphonamides should not take sumatriptan.
 

Ibuprofen Lysine

Ibuprofen lysine is a salt of ibuprofen that is more readily soluble in water than ibuprofen and has a more rapid onset of action. It is available as tablets containing 342mg and 684mg (equivalent to 200mg and 400mg ibuprofen).

Products are licensed for use in adults and children aged over 12 years. The dose is one tablet every four hours if necessary up to a maximum of three tablets in 24 hours, for up to a maximum of 10 days. Cautions, contraindications, side effects and interactions are as for ibuprofen (see ICP Aug 2014, p13).

Isometheptene Mucate

Isometheptene is a sympathomimetic, used in the treatment of migraine and throbbing headache for its vasoconstrictor effect. It is included in one product at a dose of 65mg in combination with paracetamol 325mg.

Dosage is two capsules at once, followed by one every hour if necessary, up to a maximum of five capsules in 12 hours. The product is not licensed for use in children or during pregnancy or breastfeeding. Cautions, contraindications and interactions are described under sympathomimetics in ICP Dec 2014, p14.

Prochlorperazine

Prochlorperazine maleate buccal 3mg tablets are licensed for nausea and vomiting associated with migraine.

Mode of action

Prochlorperazine is a phenothiazine derivative, closely related chemically to antihistamines such as promethazine and antipsychotics such as chlorpromazine and trifluoperazine. Although it has been used as an antipsychotic, it is generally used at lower doses for the treatment of vertigo and the prevention of nausea and vomiting. And administration via the buccal route can be provided at a lower dose than via the oral, as it avoids both the delayed absorption due to the gastric stasis that often accompanies migraine and first-pass metabolism in the liver.

Licensing conditions
 
Supply is only permitted if migraine has already been diagnosed by a doctor. Use is restricted to adults of 18 years and over. Prochlorperazine is contraindicated in pregnancy and in breastfeeding women, and in patients with impaired hepatic function, narrow-angle glaucoma, prostatic hypertrophy, epilepsy or Parkinson’s disease.
 
Side effects
 
Side effects are typical of phenothiazines (see BNF section 4.2.1), but less likely because of the low dosage. Postural hypotension is possible, particularly in volume-depleted patients, as are extrapyramidal side effects, although unlikely.
 
Dosage
 
Buccal tablets are placed in the buccal cavity, high up between the upper lip and gum, and allowed to dissolve there. One or two tablets may be taken twice daily for up to two days if necessary.
 

Buclizine

Buclizine is a sedating antihistamine. It is included in one product (Migraleve) for its anti-emetic action. Migraleve is licensed specifically for the treatment of migraine. Migraleve Pink tablets contain buclizine 6.25mg together with paracetamol 500mg and codeine 8mg. For adults, two tablets are taken as an initial dose as soon as an attack starts or is felt to be imminent, followed by two Migraleve Yellow tablets, which contain only paracetamol and codeine, four-hourly thereafter if necessary. The dose for children aged 10-14 years is one tablet.
The product is not licensed for use in children aged under 10 years and is not recommended in pregnancy, but can be taken by breastfeeding women.
 

Effectiveness

 A standardised literature review of articles related to acute migraine treatment published between 1998
and 2013 was carried out recently for the American1Headache Society. Conclusions reported in relation to drugs used in OTC treatments were that sumatriptan, paracetamol, aspirin and ibuprofen are effective, and that isometheptene/paracetamol, codeine/paracetamol and prochlorperazine are probably effective.
 
Apart from sumatriptan, there is generally little published evidence on the efficacy of drugs available OTC for the treatment of migraine, and very little recently.

For relevant articles see references.
 
References
1. Marmura MJ, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the American Headache Society evidence assessment of migraine pharmacotherapies. Headache. 2015;55:3-20.
 
2. Derry CJ, Derry S, Moore RA. Sumatriptan (oral route of administration) for acute migraine attacks in adults. The Cochrane Library. 2012; DOI: 10.1002/14651858.CD008615.pub2.
 
3. Ferrari MD, Goadsby PJ, Roon KI, et al. Triptans (serotonin, 5–HT1B/1D agonists) in migraine: detailed results and methods of a meta-analysis of 53 trials. Cephalalgia 2002; 22:633–658.
 
4. Sharma S, Prasad A, Nehru R, et al. Efficacy and tolerability of prochlorperazine buccal tablets in treatment of acute migraine. Headache 2002;42:896–902.

5. Freitag FG, Cady R, DiSerio F, et al. Comparative study of a combination of isometheptene mucate, dichloralphenazone with acetaminophen and sumatriptan succinate in the treatment of migraine. Headache 2001; 41:391–398.

6. Gruffyd-Jones K, Kies B, Middleton A, et al. Zolmitriptan versus sumatriptan for the acute oral treatment of migraine: a randomized, double-blind, international study. Eur J Neurol 2001;8:237–245.

7. Gallagher R, Dennidh G, Spierings E, et al. A comparative trial of zolmitriptan and sumatriptan for the acute oral treatment of migraine. Headache 2000;40:119–128.

8. Adam EI. A treatment (Migraleve) for the acute migraine attack. J Int Med Res 1987;15:71–75.
 
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