IMIGRAN NASAL

Imigran Nasal Spray should not be used prophylactically. The recommended dose of Imigran should not be exceeded. 3). It is advisable that Imigran 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.

Adults (18 years of age and over) The optimal dose of Imigran Nasal Spray is 20 mg for administration into one nostril. However, due to inter/intra patient variability of both the migraine attacks and the absorption of sumatriptan, 10 mg may be effective in some patients.

If a patient does not respond to the first dose of Imigran, 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.

Imigran 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 following 24 hours, provided that there is a minimum interval of 2 hours between the two doses.

No more than two doses of Imigran 20 mg Nasal Spray should be taken in any 24-hour period. Adolescents (12–17 years of age) Use of sumatriptan in adolescents should be on the recommendation of a specialist or physician who has significant experience in treating migraine, taking into account local guidance.

The recommended dose of Imigran Nasal Spray is 10 mg for administration into one nostril. If a patient does not respond to the first dose of Imigran, 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.

Imigran 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 following 24 hours, provided that there is a minimum interval of 2 hours between the two doses.

No more than two doses of Imigran 10 mg Nasal Spray should be taken in any 24-hour period. Children (under 12 years of age) Imigran Nasal Spray is not recommended for use in children under 12 years of age due to insufficient data on safety and efficacy.

Elderly (over 65) There is no experience of the use of Imigran Nasal Spray in patients over 65. The pharmacokinetics in elderly patients have not been sufficiently studied. Therefore the use of sumatriptan is not recommended until further data are available.

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 (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000) very rare (<1/10000), not known (cannot be estimated from the available data).

Some of the symptoms reported as undesirable effects may be associated symptoms of migraine. Adverse events reported in adults have also been observed in adolescents. 4).

Immune system disorders Not known:

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

Nervous system disorders Very common:

Dysgeusia/unpleasant taste.

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:

Imigran Nasal Spray should only be used where there is a clear diagnosis of migraine. Sumatriptan is not indicated for use in the management of hemiplegic, basilar or ophthalmoplegic migraine. g. CVA, TIA) if the patient presents with atypical symptoms or if they have not received an appropriate diagnosis for sumatriptan use.

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. Special consideration should be give to postmenopausal women and males over 40 with these risk factors.

8). 3). 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). 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.

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. Imigran must not be used within 2 weeks of discontinuation of therapy with monoamine oxidase inhibitors.