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Of the 2, births with first-trimester exposure to sumatriptan, infants were born with malformations relative risk 0. A study using linked data from the Medical Birth Registry of Norway to the Norwegian Prescription Database compared pregnancy outcomes in women who redeemed prescriptions for triptans during pregnancy, as well as a migraine disease comparison group who redeemed prescriptions for sumatriptan before pregnancy only, compared with a population control group.

Of the women who redeemed prescriptions for sumatriptan during the first trimester, 15 had infants with major congenital malformations OR 1. Additional smaller observational studies evaluating use of sumatriptan during pregnancy have not suggested an increased risk of teratogenicity. Animal Data: Oral administration of sumatriptan to pregnant rats during the period of organogenesis resulted in an increased incidence of fetal blood vessel cervicothoracic and umbilical abnormalities. Oral administration of sumatriptan to pregnant rabbits during the period of organogenesis resulted in increased incidences of embryolethality and fetal cervicothoracic vascular and skeletal abnormalities.

Intravenous administration of sumatriptan to pregnant rabbits during the period of organogenesis resulted in an increased incidence of embryolethality. The highest oral and intravenous no-effect doses for developmental toxicity in rabbits were 15 and 0. Oral administration of sumatriptan to rats prior to and throughout gestation resulted in embryofetal toxicity decreased body weight, decreased ossification, increased incidence of skeletal abnormalities.

In offspring of pregnant rats treated orally with sumatriptan during organogenesis, there was a decrease in pup survival. Oral treatment of pregnant rats with sumatriptan during the latter part of gestation and throughout lactation resulted in a decrease in pup survival.

Sumatriptan is excreted in human milk following subcutaneous administration see Data. There is no information regarding sumatriptan concentrations in milk from lactating women following administration of IMITREX nasal spray.

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There are no data on the effects of sumatriptan on the breastfed infant or the effects of sumatriptan on milk production. Safety and effectiveness in pediatric patients have not been established. Adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults. The frequency of all adverse reactions in these patients appeared to be both dose- and age-dependent, with younger patients reporting reactions more commonly than older adolescents. These reports include reactions similar in nature to those reported rarely in adults, including stroke, visual loss, and death.

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Clinical data to determine the frequency of serious adverse reactions in pediatric patients who might receive subcutaneous, oral, or intranasal IMITREX are not presently available. Clinical trials of IMITREX nasal spray did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors e. Overdose in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation.

It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan. Sumatriptan is chemically designated as 3-[2- dimethylamino ethyl]-N-methyl-indolemethanesulfonamide, and it has the following structure:. Sumatriptan is a white to off-white powder that is readily soluble in water and in saline.

The pH of the solution is approximately 5. Significant elevation in blood pressure, including hypertensive crisis, has been reported in patients with and without a history of hypertension [see Warnings and Precautions 5. Clinical and pharmacokinetic data indicate that administration of two 5-mg doses, 1 dose in each nostril, is equivalent to administration of a single mg dose in 1 nostril. The effect of sumatriptan on the protein binding of other drugs has not been evaluated.

The apparent volume of distribution is 2.

In vitro studies with human microsomes suggest that sumatriptan is metabolized by MAO, predominantly the A isoenzyme. Most of a radiolabeled dose of sumatriptan excreted in the urine is the major metabolite indole acetic acid IAA or the IAA glucuronide, both of which are inactive. Intranasal sumatriptan has not been evaluated for age differences.

Patients with Renal Impairment: The effect of renal impairment on the pharmacokinetics of sumatriptan has not been examined. Patients with Hepatic Impairment: The effect of mild to moderate hepatic disease on the pharmacokinetics of the intranasal formulation of sumatriptan has not been evaluated. Similar changes can be expected following intranasal administration. The pharmacokinetics of sumatriptan in patients with severe hepatic impairment has not been studied.

Intranasal sumatriptan has not been evaluated for race differences. MAO inhibitors interaction studies have not been performed with intranasal sumatriptan. Due to gut and hepatic metabolic first-pass effects, the increase of systemic exposure after coadministration of an MAO-A inhibitor with oral sumatriptan is greater than after coadministration of the MAO inhibitors with subcutaneous sumatriptan. The effects of an MAO inhibitor on systemic exposure after intranasal sumatriptan would be expected to be greater than the effect after subcutaneous sumatriptan but smaller than the effect after oral sumatriptan because only swallowed drug would be subject to first-pass effects.

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A small trial evaluating the effect of pretreatment with an MAO-A inhibitor on the bioavailability from a mg oral sumatriptan tablet resulted in an approximately 7-fold increase in systemic exposure. Xylometazoline: An in vivo drug interaction trial indicated that 3 drops of xylometazoline 0. In carcinogenicity studies in mouse and rat in which sumatriptan was administered orally for 78 and weeks, respectively, there was no evidence in either species of an increase in tumors related to sumatriptan administration.

It is not clear whether this finding was due to an effect on males or females or both. Dogs receiving oral sumatriptan developed corneal opacities and defects in the corneal epithelium. Earlier examinations for these toxicities were not conducted and no-effect doses were not established. The efficacy of IMITREX nasal spray in the acute treatment of migraine headaches was demonstrated in 8 randomized, double-blind, placebo-controlled trials, of which 5 used the recommended dosing regimen and used the marketed formulation.

Patients were instructed to treat a moderate to severe headache. Associated symptoms such as nausea, photophobia, and phonophobia were also assessed. The frequency and time to use of these additional treatments were also determined. Patients received doses as a single spray into 1 nostril. In 2 trials, a 5-mg dose was also evaluated. There were no statistically significant differences between the 5- and mg dose groups in any trial. The results from the 5 controlled clinical trials are summarized in Table 2. Note that, in general, comparisons of results obtained in trials conducted under different conditions by different investigators with different samples of patients are ordinarily unreliable for purposes of quantitative comparison.

Figure 1. The averages displayed are based on pooled data from the 5 clinical controlled trials providing evidence of efficacy. Figure 2. Plot also includes patients who had no response to the initial dose. There was no evidence to suggest that treatment with sumatriptan was associated with an increase in the severity of recurrent headaches. The efficacy of IMITREX nasal spray was unaffected by presence of aura; duration of headache prior to treatment; gender, age, or weight of the subject; or concomitant use of common migraine prophylactic drugs e.

There were insufficient data to assess the impact of race on efficacy. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech and should ask for medical advice if any indicative sign or symptoms are observed. Apprise patients of the importance of this follow-up [see Warnings and Precautions 5.

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