Imigran FDT

Imigran FDT Special Precautions

sumatriptan

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
IMIGRAN should only be used where there is clear diagnosis of migraine.
IMIGRAN is not indicated for use in the management of hemiplegic, basilar or ophthalmoplegic migraine.
Before treating with IMIGRAN, care should be taken to exclude potentially serious neurological conditions. (e.g. CVA, TIA) if the patient presents with atypical symptoms or if they have not received an appropriate diagnosis for IMIGRAN use.
Following administration, IMIGRAN can be associated with transient symptoms including chest pain and tightness which may be intense and involve the throat (see Adverse Reactions). Where such symptoms are thought to indicate IHD, appropriate evaluation should be carried out.
IMIGRAN should not be given to patients in whom unrecognised cardiac disease is likely without a prior evaluation for underlying cardiovascular disease. Such patients include postmenopausal women, males over 40 and patients with risk factors for coronary artery disease. However, these evaluations 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.
IMIGRAN 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 IMIGRAN and an SSRI/SNRI is clinically warranted, appropriate observation of the patient is advised (see Interactions).
The concomitant administration of any triptan/5-HT1 agonist with sumatriptan is not recommended.
IMIGRAN should be administered with caution to patients with conditions that may affect significantly the absorption, metabolism or excretion of sumatriptan e.g. impaired hepatic (Child Pugh grade A or B; see Pharmacology: Pharmacokinetics: Special Patient Populations under Actions) or renal function.
IMIGRAN should be used with caution in patients with a history of seizures or other risk factors which lower the seizure threshold.
Patients with known hypersensitivity to sulphonamides may exhibit an allergic reaction following administration of IMIGRAN. Reactions may range from cutaneous hypersensitivity to anaphylaxis. Evidence of cross-sensitivity is limited, however, caution should be exercised before using IMIGRAN in these patients.
Overuse of acute headache treatments has been associated with the exacerbation of headache (medication overuse headache, MOH) in susceptible patients. Withdrawal of the treatment may be necessary.
Effects on the Ability to Drive and Use Machines: Drowsiness may occur as a result of migraine or its treatment with IMIGRAN.
Caution is recommended in patients performing skilled tasks e.g. driving or operating machinery.
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