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Find Discounted Prices at Local U. This may take seconds. 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.
Sumatriptan should be administered with caution to patients with mild controlled hypertension, since transient increases in blood pressure and peripheral vascular resistance have been observed in a small proportion of patients see section 4. 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. Sumatriptan should be administered with caution to patients with conditions which may affect significantly the absorption, metabolism or excretion of drugs, e.
A 50mg dose should be considered in patients with hepatic 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 see section 4. 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. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine as it contains lactose.
Studies in healthy subjects show that sumatriptan does not interact with propranolol, flunarizine, pizotifen or alcohol. The increased risk of coronary vasospasm is a theoretical possibility and concomitant administration is contraindicated see section 4.
This will also depend on the doses and types of products used. The effects may be additive. An interaction may occur between sumatriptan and monoamine oxidase inhibitors MAOIs and concomitant administration is contraindicated see section 4. 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 see section 4.
Post-marketing data from the use of sumatriptan during the first trimester in over 1, women are available. Although these data contain insufficient information to draw definitive conclusions, they do not point to an increased risk of congenital defects. Experience with the use of sumatriptan in the second and third trimester is limited. Evaluation of experimental animal studies does not indicate direct teratogenic effects or harmful effects on peri- and postnatal development.
However, embryofoetal viability might be affected in the rabbit see section 5. Administration of sumatriptan should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus. It has been demonstrated that following subcutaneous administration, sumatriptan is excreted into breast milk. Infant exposure can be minimised by avoiding breast feeding for 12 hours after treatment, during which time any breast milk expressed should be discarded.
No studies on the effects on the ability to drive and use machines have been performed. Drowsiness may occur as a result of migraine or treatment with sumatriptan. This may influence the ability to drive and to operate machinery. Adverse events are listed below by system organ class and frequency . Frequencies are defined as: Some of the symptoms reported as undesirable effects may be associated symptoms of migraine.
Nausea and vomiting occurred in some patients but it is unclear if this is related to sumatriptan or the underlying condition. Sensations of heaviness usually transient and may be intense and can affect any part of the body including the chest and throat.
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. 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.
Flickering, diplopia, reduced vision. Loss of vision including reports of permanent defects. However, visual disorders may also occur during a migraine attack itself. Bradycardia, tachycardia, palpitations, cardiac arrhythmias, transient ischaemic ECG changes, coronary artery vasospasm, angina, myocardial infarction see sections 4.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: Doses in excess of mg orally were not associated with side effects other than those mentioned. If overdosage 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 Imigran. The vascular 5-HT 1D receptor is found predominantly in cranial blood vessels and mediates vasoconstriction. In animals, sumatriptan selectively constricts the carotid arterial circulation but does not alter cerebral blood flow. In addition, evidence from animal studies suggests that sumatriptan inhibits trigeminal nerve activity.
Both these actions cranial vasoconstriction and inhibition of trigeminal nerve activity may contribute to the anti-migraine action of sumatriptan in humans. Sumatriptan remains effective in treating menstrual migraine i. Sumatriptan should be taken as soon as possible in an attack.
Although the recommended dose of oral sumatriptan is 50mg, migraine attacks vary in severity both within and between patients. Doses of mg have shown greater efficacy than placebo in clinical trials, but 25mg is statistically significantly less effective than 50 and mg. A number of placebo-controlled clinical studies assessed the safety and efficacy of oral sumatriptan standard tablets in over child and adolescent migraineurs aged 10 - 17 years.
These studies failed to demonstrate a statistically significant difference in headache relief at 2 hours between placebo and any sumatriptan dose. The undesirable effects profile of oral sumatriptan in children and adolescents aged 10 - 17 years was similar to that reported from studies in the adult population. The elimination phase half-life is approximately 2 hours, although there is an indication of a longer terminal phase.
Sumatriptan is eliminated primarily by oxidative metabolism mediated by monoamine oxidase A. Sumatriptan pharmacokinetics after an oral dose 50 mg and a subcutaneous dose 6 mg were studied in 8 patients with mild to moderate hepatic impairment matched for sex, age, and weight with 8 healthy subjects. There was no difference between the patients with hepatic impairment and control subjects after the s. This indicates that mild to moderate hepatic impairment reduces presystemic clearance and increases the bioavailability and exposure to sumatriptan compared to healthy subjects.
Following oral administration, pre-systemic clearance is reduced in patients with mild to moderate hepatic impairment and systemic exposure is almost doubled. The pharmacokinetics in patients with severe hepatic impairment have not been studied see Section 4. The major metabolite, the indole acetic acid analogue of Sumatriptan is mainly excreted in the urine, where it is present as a free acid and the glucuronide conjugate.
It has no known 5HT 1 or 5HT 2 activity. Minor metabolites have not been identified. The pharmacokinetics of oral Sumatriptan do not appear to be significantly affected by migraine attacks. In a pilot study, no significant differences were found in the pharmacokinetic parameters between the elderly and young healthy volunteers.
Sumatriptan was devoid of genotoxic and carcinogenic activity in in-vitro systems and animal studies. In a rat fertility study oral doses of sumatriptan resulting in plasma levels approximately times those seen in man after a mg oral dose were associated with a reduction in the success of insemination.
This effect did not occur during a subcutaneous study where maximum plasma levels achieved approximately times those in man by the oral route. In rabbits embryolethality, without marked teratogenic defects, was seen. The relevance for humans of these findings is unknown. Lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, methylhydroxypropylcellulose, titanium dioxide, triacetin and iron oxide.
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Imigran tablets are indicated for the acute relief of migraine attacks, with or without aura. Imigran The recommended dose of oral Imigran is a 50mg tablet. Patients not responding to a 50 mg dose may benefit from dose increases. Dose changes should be made in steps of 50 mg at intervals of at least one week. Each film-coated tablet contains 50 mg of diclofenac potassium. Also contains Lecithin Soya E This medicine contains mmol (mg) potassium per .