SUMATRIPTAN VIATRIS

Posology Adults Sumatriptan is indicated for the acute intermittent treatment of migraine. It should not be used prophylactically. The recommended dose of sumatriptan should not be exceeded. It is advisable that sumatriptan be given as early as possible after the onset of a migraine attack, but it is equally effective at whatever stage of the attack it is administered.

The recommended dose of oral sumatriptan is a 50 mg tablet. Some patients may require 25 mg or 100 mg. The tablet cannot be divided into two equal doses; if necessary, the use of other medicinal product with the same active ingredient, dosage and pharmaceutical form available in divisible tablet should be considered.

If the patient has responded to the first dose but the symptoms recur a second dose may be given provided that there is a minimum interval of two hours between the two doses. No more than 300 mg should be taken in any 24-hour period.

Patients who do not respond to the prescribed dose of sumatriptan should not take a second dose for the same attack. In these cases, the attack can be treated with paracetamol, acetylsalicylic acid or non-steroidal anti-inflammatory drugs.

Sumatriptan may be taken for subsequent attacks. 3). Paediatric population The efficacy and safety of sumatriptan film-coated 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 film-coated 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 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. 2). Method of administration The tablets should be swallowed whole with water.

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 (≥1/10,000 to <1/1000), 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 anaphylactic reactions.

Psychiatric disorders Not known:

Anxiety.

Nervous system disorders Common:

Dizziness, somnolence, 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, visual field defect.

Eye disorders Not known:

Flickering, diplopia, reduced vision. Loss of vision including reports of permanent defects. However, visual impairment 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.

Sumatriptan 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 opthalmoplegic migraine. g. cerebrovascular accident (CVA), transient ischaemic attack (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 appropriate evaluation should be carried out. 3). 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. 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). 5). g. 2). Patients with known hypersensitivity to sulfonamides 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). 8). 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 medication.

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 patients who have 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.

Concurrent administration of reversible and irreversible monoamine oxidase inhibitors and sumatriptan is contraindicated. Sumatriptan tablets must not be used within two weeks of discontinuation of therapy with monoamine oxidase inhibitors.

5).