SUMATRIPTAN

General recommendations with regard to use and administration:

Sumatriptan should not be used prophylactically. 3). It is advisable that sumatriptan be given as early as possible after the onset of a migraine headache. It is equally effective at whatever stage of the attack it is administered. The following recommended dosages of Sumatriptan should not be exceeded.

Adults The recommended dose of oral sumatriptan is a single 50 mg tablet. Some patients may require 100 mg. Although the recommended oral dose of sumatriptan is 50 mg, it must be taken into account that the severity of migraine attacks varies both within and between patients.

Doses of 25 mg-100 mg have shown to be more effective than placebo in clinical trials but 25 mg is statistically significantly less effective than 50 mg and 100 mg. If the patient does not respond to the first dose of sumatriptan, a second dose should not be taken for the same attack.

In these cases the attack can be treated with paracetamol, acetylsalicylic acid, or non-steroidal anti-inflammatory drugs. Sumatriptan tablets may be taken for subsequent attacks. If the patient has responded to the first dose, but the symptoms recur a second dose may be given in the next 24 hours, provided that there is a minimum interval of 2 hours between the two doses.

No more than 300 mg should be taken in any 24 hour period. For the different dosage regimens Sumatriptan is available in the strength of 100 mg also. Paediatric population The efficacy and safety of Sumatriptan tablets in children aged less than 10 years have not been established.

No clinical data are available in this age group. The efficacy and safety of Sumatriptan tablets in children 10 to 17 years of age have not been demonstrated in the clinical trials performed in this age group. 1). • Elderly (over 65 years of age) Experience of the use of sumatriptan tablets in patients aged over 65 years is limited.

The pharmacokinetics do not differ significantly from a younger population, but until further clinical data are available, the use of sumatriptan in patients aged over 65 years is not recommended. Patients with hepatic insufficiency In patients with mild to moderate hepatic insufficiency low doses of 25-50 mg sumatriptan should be considered.

Adverse events are listed below by system organ class and frequency.

Frequencies are defined as:

Very common (≥ 1/10) Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), not known (cannot be estimated from the available data). Some of the symptoms reported as undesirable effects may be associated symptoms of migraine.

Immune system disorders Not known:

Hypersensitivity reactions ranging from cutaneous hypersensitivity (such as urticaria) to anaphylaxis.

Nervous system disorders Common:

Dizziness, drowsiness, sensory disturbance including paraesthesia and hypoaesthesia.

Not known:

Seizures, although some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. There are also reports in patients where no such predisposing factors are apparent; Tremor, dystonia, nystagmus, scotoma.

Eye disorders Not known:

Flickering, diplopia, reduced vision. Loss of vision including reports of permanent defects. However, visual disorders may also occur during a migraine attack itself. 4).

Vascular disorders Common:

Transient increases in blood pressure arising soon after treatment. Flushing.

Not known:

Hypotension, Raynaud’s phenomenon.

Respiratory, thoracic and mediastinal disorders Common:

Sumatriptan should only be used where there is a clear diagnosis of migraine. Sumatriptan is not indicated for use in management of, hemiplegic, basilar or ophthalmoplegic migraine. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions.

g. CVA, TIA). 8). Where such symptoms are thought to indicate ischaemic heart disease, no further doses of sumatriptan should be given, and an appropriate evaluation should be carried out. There have been rare post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan.

Serotonin syndrome has been reported following concomitant treatment with triptans and serotonin noradrenaline reuptake inhibitors (SNRIs). 3). g. 2). 8). Patients with known hypersensitivity to sulphonamides may exhibit an allergic reaction following administration of sumatriptan.

Reactions may range from cutaneous hypersensitivity to anaphylaxis. Evidence of cross sensitivity is limited, however, caution should be exercised before using sumatriptan in these patients. Undesirable effects may be more common during concomitant use of triptans and herbal preparations containing St John’s Wort (Hypericum perforatum).

Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

The recommended dose of sumatriptan should not be exceeded. 3). Special consideration should be give to postmenopausal women and males over 40 with these risk factors. These evaluations however, may not identify every patient who has cardiac disease and, in very rare cases, serious cardiac events have occurred in patients without underlying cardiovascular disease.

1. • Sumatriptan should not be given to patients who have had myocardial infarction or have ischaemic heart disease, coronary vasospasm (Prinzmetal’s angina), peripheral vascular disease or symptoms or signs consistent with ischaemic heart disease.

• Sumatriptan should not be administered to patients with a history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA). • Sumatriptan should not be administered to patients with severe hepatic impairment. • The use of sumatriptan in patients with moderate and severe hypertension and mild uncontrolled hypertension is contraindicated.

5). • Concurrent administration of monoamine oxidase inhibitors (MAOIs) and sumatriptan is contraindicated. • Sumatriptan must not be used within 2 weeks of discontinuation of therapy with monoamine oxidase inhibitors.