Imitrex Nasal Spray

/ GSK

This drug should not be used prophylactically. The recommended dose should not be exceeded. Recommended as monotherapy for the acute treatment of a migraine attack and should not be given concomitantly with ergotamine or derivatives of ergotamine (including methysergide). It is advisable that this formuation 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 is 20 mg for administration into one nostril. If a patient does not respond to the first dose 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. Imitrex Nasal Spray 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 20 mg Nasal Spray should be taken in any 24-hour period.
Children (under 18 years of age): The use of this drug is not recommended in patients under the age of 18 years.
Elderly (over 65): There is no experience of the use of this drug 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.  

Acute treatment of migraine attacks with or without aura.

Hypersensitivity to sumatriptan or to any of the excipients. 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. The concomitant administration of ergotamine, or derivatives of ergotamine (including methysergide) or any triptan/5-hydroxytryptamine1 (5-HT1) receptor agonist is contraindicated. Concurrent administration of monoamine oxidase inhibitors (MAOIs) and sumatriptan is contraindicated. The drug must not be used within 2 weeks of discontinuation of therapy with monoamine oxidase inhibitors.     

Should only be used where there is a clear diagnosis of migraine. Recommended doses should not be exceeded. Patients in whom unrecognized cardiac disease is likely without a prior evaluation of underlying cardiovascular disease. Post-menopausal women, males over 40, patients with risk factors for coronary artery disease. Controlled hypertension. Impaired hepatic or renal function. Patients with a history of epilepsy or structural brain lesions which lower their convulsion threshold. Known hypersensitivity to sulphonamides.
Pregnancy and lactation: Administration should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. Caution should be exercised when administered to nursing mothers.

This drug 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. 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. It should be noted that migraineurs may be at increased risk of certain cerebrovascular events (e.g. CVA, TIA). Following administration, sumatriptan can be associated with transient symptoms including chest pain and tightness, which may be intense and involve the throat. 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.
Sumatriptan should not be given to patients with risk factors for ischaemic heart disease, including those patients who are heavy smokers or users of nicotine substitution therapies, without prior cardiovascular evaluation. 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 and in adolescents. Sumatriptan should be given with caution in patients with mild controlled hypertension, since transient increases in blood pressure and peripheral vascular resistance have been observed in a small proportion of patients. 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) and triptan with tricyclic antidepressants (TCAs). If concomitant treatment with sumatriptan and an SSRI/SNRI is clinically warranted, appropriate observation of the patient is advised. Sumatriptan should be administered with caution to patients with conditions that may affect significantly the absorption, metabolism, or excretion of the drug, e.g. impaired hepatic (mild to moderate impairment). Sumatriptan should be used with caution in patients with a history of seizures or other risk factors which lower the seizure threshold, as seizures have been reported in association with sumatriptan. 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. Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1 agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT1 agonists have not been clearly established.
See prescribing information for full details.

There are limited data on an interaction with preparations containing ergotamine or another triptan/5-HT1 receptor agonist. The increased risk of coronary vasospasm is a theoretical possibility and concomitant administration is contraindicated. The period of time that should elapse between the use of sumatriptan and ergotamine-containing preparations or another triptan/5-HT1 receptor agonist is not known. This will also depend on the doses and types of products used. The effects may be additive. It is advised to wait at least 24 hours following the use of ergotamine-containing preparations or another triptan/5-HT1 receptor agonist before administering sumatriptan. Conversely, it is advised to wait at least 6 hours following use of sumatriptan before administering an ergotamine-containing product and at least 24 hours before administering another triptan/5-HT1 receptor agonist. An interaction may occur between sumatriptan and MAOIs and concomitant administration is contraindicated. 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 SSRIs and sumatriptan. Serotonin syndrome has also been reported following concomitant treatment with triptans and SNRIs and triptan with tricyclic antidepressants (TCAs).

Pregnancy: Caution should be exercised by considering the expected benefit to the mother against possible risk to the foetus. Post-marketing data from multiple prospective pregnancy registries have documented the pregnancy outcomes in over 1,000 women exposed to sumatriptan. Although there is insufficient information to draw definitive conclusions, the findings have not detected an increase in the frequency of birth defects nor a consistent pattern of birth defects, amongst women exposed to sumatriptan compared with the general population.
Lactation:  It has been demonstrated that following subcutaneous administration sumatriptan is excreted into breast milk. Therefore caution should be exercised when considering the administration of sumatriptan Nasal Spray to nursing mothers. Infant exposure can be minimised by avoiding breast feeding for 12 hours after treatment.

Single doses of Sumatriptan up to 40mg intranasally have not been associated with side-effects other than those mentioned. In clinical studies volunteers have received 20mg of Sumatriptan by the intranasal route three times a day for a period of four days without significant adverse effects.
Treatmen: If overdose occurs, the patient should be monitored for at least ten hours and standard supportive treatment applied as required. It is unknown what effect haemodialysis or peritoneal dialysis has on the plasma concentrations of sumatriptan.