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Drug Details

IMIGRAN RECOVERY

• Drug Class Description
  Analgesics: Selective 5-HT1 receptor agonists.
• Generic Name
  Sumatriptan
• Presentation
  Pre-filled syringes for use in conjunction with an auto injector for subcutaneous injection.
• Description
  Each pre-filled syringe contains 6mg of sumatriptan base, as the succinate salt, in an isotonic solution of 0.5ml
• Indications
  Subcutaneous Injection is indicated for the acute relief of migraine attacks, with or without aura, and for the acute treatment of cluster headache. Imigran should only be used where there is a clear diagnosis of migraine or cluster headache.
• Adult Dosage
  

  Imigran should not be used prophylactically.

  It is recommended to start the treatment at the first sign of a migraine headache or associated symptoms such as nausea, vomiting or photophobia. It is equally effective at whatever stage of the attack it is administered. Imigran Injection should be injected subcutaneously using an auto-injector. Patients should be advised to observe strictly the instruction leaflet for the Imigran auto-injector especially regarding the safe disposal of syringes and needles.

  Migraine:

  Adult: The recommended adult dose of Imigran is a single 6mg subcutaneous injection. Patients who do not respond to this dose should not take a second dose of Imigran for the same attack. Imigran may be taken for subsequent attacks. Patients who respond initially but whose migraine returns may take a further dose at any time in the next 24 hours provided that one hour has elapsed since the first dose.

  The maximum dose in 24 hours is two 6mg injections (12mg).

  Imigran is recommended as monotherapy for the acute treatment of migraine and should not be given concomitantly with other acute migraine therapies. If a patient fails to respond to a single dose of Imigran there are no reasons, either on theoretical grounds or from limited clinical experience, to withhold products containing aspirin or non-steroidal anti-inflammatory drugs or paracetamol for further treatment of the attack.

  Cluster headache:

  Adult:

  The recommended adult dose is a single 6mg subcutaneous injection for each cluster attack. The maximum dose in 24 hours is two 6mg injections (12mg) with a minimum interval of one hour between the two doses.

• Child Dosage
  

  Children and Adolescents (under 18 years of age):

  Sumatriptan Injection is not recommended for use in children and adolescents as sumatriptan injection has not been studied in these age categories.

• Elderly Dosage
  

  Elderly (over 65):

  Experience of the use of Imigran 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.

• Contra Indications
  

  Hypersensitivity to any component of the preparation.

  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 patients who have symptoms or signs consistent with ischaemic heart disease.

  Sumatriptan should not be administered to patients with a history of cerebovascular 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 with sumatriptan is contraindicated.

  Concurrent administration of monoamine oxidase inhibitors and sumatriptan is contraindicated.

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

• Special Precautions
  

  Warnings: Imigran should only be used where there is a clear diagnosis of migraine or cluster headache.

  Sumatriptan is not indicated for use in the management of hemiplegic, basilar or opthalmoplegic migraine.

  The recommended doses of Sumatriptan should not be exceeded.

  Imigran Injection should not be given intravenously because of its potential to cause vasospasm. The vasospasm may result in arrhythmias, ischaemic ECG changes or myocardial infarction.

  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 risk of certain cerebrovascular events (e.g. cerebrovascular accident, transient ischaemic attack).

  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 appropriate evaluation should be carried out.

  Sumatriptan should not be given to patients with risk factors for ischaemic heart disease without prior cardiovascular evaluation. Special consideration should be given 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.

  If the patient experiences symptoms which are severe or persistent or are consistent with angina, further doses should not be taken until appropriate investigations have been carried out to check for the possibility of ischaemic changes.

  Precautions: Sumatriptan should be administered with caution to patients with controlled hypertension as 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).

  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 which may affect significantly the absorption, metabolism or excretion of the drug e.g. impaired hepatic or renal function.

  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.

• Interactions
  

  Studies in healthy subjects show that Imigran does not interact with propranolol, flunarizine, pizotifen or alcohol.

  Sumatriptan has the potential to interact with monoamine oxidase inhibitors (MAOIs), ergotamine and derivatives of ergotamine.

  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.

  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.

• Adverse Drug Reactions
  

  Adverse events are listed below by system organ class and frequency [4]. Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) and very rare (<1/10,000) including isolated reports.

  Clinical Trial Data

  Nervous System Disorders

  Common: Dizziness, drowsiness, sensory disturbance including paraesthesia and hypoaesthesia.

  Vascular Disorders

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

  Respiratory, Thoracic and Mediastinal Disorders

  Common Dyspnoea.

  Gastrointestinal Disorders

  Common: Nausea and vomiting occurred in some patients but it is unclear if this is related to sumatriptan or the underlying condition.

  Musculoskeletal and Connective Tissue Disorders

  Common: Sensations of heaviness (usually transient and may be intense and can affect any part of the body including the chest and throat).

  General Disorders and Administration Site Conditions

  Very common: Transient injection site pain. Injection site stinging/burning, swelling, erythema, bruising and bleeding have also been reported.

  Common: Pain, sensations of heat or cold, pressure or tightness (these events are usually transient and may be intense and can affect any part of the body including the chest and throat).

  Feelings of weakness, fatigue (both events are mostly mild to moderate in intensity and transient).

  Investigations

  Very rare: Minor disturbances in liver function tests have occasionally been observed

  Post-Marketing Data

  Immune System Disorders

  Very rare: Hypersensitivity reactions ranging from cutaneous hypersensitivity to anaphylaxis.

  Nervous System Disorders

  Very rare: 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

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

  Cardiac Disorders

  Very rare: Bradycardia, tachycardia, palpitations, cardiac arrhythmias, transient ischaemic ECG changes, coronary artery vasospasm, angina, myocardial infarction (see Contraindications, Warnings and Precautions).

  Vascular Disorders

  Very rare: Hypotension, Raynaud's phenomenon.

  Gastrointestinal Disorders

  Very rare: Ischaemic colitis

  Musculoskeletal, Connective Tissue and Bone Disorders

  Very rare: Neck stiffness.