Imitrex

Item	Count		Retail	Price	Order
Imitrex 25 mg	9	tablets	$269.70	$224.75
Imitrex 25 mg	27	tablets	$696.90	$580.75
Imitrex 50 mg	9	tablets	$293.70	$244.75
Imitrex 50 mg	27	tablets	$653.70	$544.75
Imitrex 100 mg	9	tablets	$305.70	$254.75
Imitrex 100 mg	27	tablets	$713.70	$594.75

Tablets
Chemical Name: SUMATRIPTAN (SOO-ma-trip-tan)

Common uses
imitrex is a cerebral vasoconstrictor used to relieve migraine headache attacks as they occur. It will not prevent or reduce the number of attacks you experience.

Before using
Some medicines or medical conditions may interact with imitrex . INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE imitrex if you are also taking monoamine oxidase inhibitors (MAOIs). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking ergot alkaloids. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding. USE OF imitrex IS NOT RECOMMENDED if you have a history of chest pain, heart conditions, arrhythmias, high blood pressure, or stroke. Contact your doctor or pharmacist if you have any questions or concerns about taking imitrex .

Directions
Follow the directions for using imitrex provided by your doctor. SWALLOW WHOLE. Do not break, crush, or chew before swallowing. IT IS BEST TO TAKE A DOSE OF imitrex as soon as you notice symptoms of a migraine attack. Allow 2 hours between taking doses of imitrex . DO NOT TAKE ADDITIONAL DOSES if you do not get a response from the first dose. STORE imitrex at room temperature in a tightly-closed container, away from heat and light.

Cautions
imitrex IS NOT INTENDED to prevent or reduce the number of migraine attacks that you experience. IF YOU HAVE A HEADACHE THAT IS DIFFERENT than your usual migraine attacks, check with your doctor before using imitrex . BEFORE YOU BEGIN USING imitrex , give your doctor and pharmacist a list of all prescription and non-prescription medicines that you are using to treat and prevent migraine attacks. Do Not Use ERGOT-CONTAINING MEDICINES within 24 hours of using imitrex . If you have questions about which medicines contain ergot, ask your doctor or pharmacist. BEFORE USING imitrex ALSO TELL YOUR DOCTOR if you have chest pains, heart disease, shortness of breath, irregular heartbeats, high blood pressure, high cholesterol, or diabetes. Also tell your doctor if you smoke, if you have had a heart attack, if you have liver or kidney disease, are post-menopausal, or have had any seizures. Keep your doctor informed if you develop any of these conditions while you are taking imitrex . imitrex MAY CAUSE DIZZINESS. Using imitrex alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Ask your doctor or pharmacist if you have questions about which medicines can cause dizziness. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using imitrex during pregnancy. imitrex IS EXCRETED IN BREAST MILK. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using imitrex , check with your doctor or pharmacist to discuss the risks to your baby.

imitrex Possible side effects
SIDE EFFECTS, that may go away during treatment, include nausea, vomiting, dizziness, drowsiness, or feeling sick. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR BEFORE USING ADDITIONAL DOSES if you experience wheezing; tightness in the jaw, neck, or chest; chest pain; or heart throbbing. CONTACT YOUR DOCTOR IMMEDIATELY AND Do Not Use ANY MORE OF imitrex if you experience shortness of breath, swelling of the eyelids, face, or lips, or develop a skin rash or hives. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Drug interactions
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions

If you take too much
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include tremor, chest pain, slowed breathing, and seizures.

Additional information
If imitrex does not stop or decrease the severity of your migraine attack or if your symptoms become worse, check with your doctor. Do Not Share imitrex with others for whom it was not prescribed. Do Not Use imitrex for other health conditions. KEEP imitrex out of the reach of children and pets. If using imitrex for an extended period of time, obtain refills before your supply runs out.

IMITREX)
(sumatriptan succinate)
Tablets

DESCRIPTION

Imitrex tablets contain sumatriptan a selective 5-hydroxytryptamine receptor subtype agonist. Imitrex is used to treat migraine headache attacks once they occur. It is not effective in preventing migraines. Imitrex is not to be used for other types of headaches.

Imitrex tablet for oral administration contains 35, 70, or 140 mg of sumatriptan succinate equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each Imitrex tablet also contains the inactive ingredients croscarmellose sodium, iron oxide (100-mg tablet only), lactose, magnesium stearate, microcrystalline cellulose, and titanium dioxide.

Pharmacokinetics:   The mean maximum concentration of Imitrex following oral dosing with 25 mg is 18 ng/mL (range, 7 to 47 ng/mL) and 51 ng/mL (range, 28 to 100 ng/mL) following oral dosing with 100 mg of Imitrex. This compares with a C max of 5 and 16 ng/mL following dosing with a 5- and 20-mg intranasal dose, respectively. The mean C max following a 6-mg subcutaneous injection of Imitrex is 71 ng/mL (range, 49 to 110 ng/mL). The bioavailability is approximately 15%, primarily due to presystemic metabolism and partly due to incomplete absorption. The C max is similar during a migraine attack and during a migraine-free period, but the T max is slightly later during the attack, approximately 2.5 hours compared to 2.0 hours. When given as a single dose, Imitrex displays dose proportionality in its extent of absorption (area under the curve [AUC]) over the dose range of 25 to 200 mg, but the C max after 100 mg is approximately 25% less than expected (based on the 25-mg dose). Food has no significant effect on the bioavailability of Imitrex, but delays the T max slightly (by about 0.5 hours).

Special Populations:   Kidney Impairment:   The effect of renal impairment on the pharmacokinetics of Imitrex has not been examined, but little clinical effect would be expected as Imitrex is largely metabolized to an inactive substance.

Liver Impairment:  The liver plays an important role in the presystemic clearance of orally administered Imitrex. Accordingly, the bioavailability of Imitrex following oral administration may be markedly increased in patients with liver disease. In 1 small study of hepatically impaired patients (n = 8) matched for sex, age, and weight with healthy subjects, the hepatically impaired patients had an approximately 70% increase in AUC and C max and a T max 40 minutes earlier compared to the healthy subjects who took Imitrex.

AGE: The pharmacokinetics of oral Imitrex in the elderly (mean age, 72 years; 2 males and 4 females) and in patients with migraine (mean age, 38 years; 25 males and 155 females) were similar to that in healthy male subjects (mean age, 30 years).

Gender:  In a study comparing females to males taking Imitrex, no pharmacokinetic differences were observed between genders for AUC, C max , T max , and half-life.

Race:   The systemic clearance and C max of Imitrex were similar in black (n = 34) and Caucasian (n = 38) healthy male subjects.

Drug Interactions: Monoamine Oxidase Inhibitors: Treatment with MAO-A inhibitors generally leads to an increase of Imitrex plasma levels.

Due to gut and hepatic metabolic first-pass effects, the increase of systemic exposure after coadministration of an MAO-A inhibitor with oral Imitrex is greater than after coadministration of the monoamine oxidase inhibitors (MAOI) with subcutaneous Imitrex. In a study of 14 healthy females, pretreatment with an MAO-A inhibitor decreased the clearance of subcutaneous Imitrex. Under the conditions of this experiment, the result was a 2-fold increase in the area under the Imitrex plasma concentration x time curve (AUC), corresponding to a 40% increase in elimination half-life. This interaction was not evident with an MAO-B inhibitor.

A small study evaluating the effect of pretreatment with an MAO-A inhibitor on the bioavailability from a 25-mg oral Imitrex tablet resulted in an approximately 7-fold increase in systemic exposure.

Alcohol:   Alcohol consumed 30 minutes prior to Imitrex ingestion had no effect on the pharmacokinetics of Imitrex.

CLINICAL STUDIES

The efficacy of Imitrex Tablets in the acute treatment of migraine headaches was demonstrated in 3, randomized, double-blind, placebo-controlled studies. Patients enrolled in these 3 studies were predominately female (87%) and Caucasian (97%), with a mean age of 40 years (range, 18 to 65 years). Patients were instructed to treat a moderate to severe headache with Imitrex. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed up to 4 hours after Imitrex dosing. Associated symptoms such as nausea, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24 hours post Imitrex dose. A second dose of Imitrex Tablets or other medication was allowed 4 to 24 hours after the initial treatment for recurrent headache. Acetaminophen was offered to patients in Studies 2 and 3 beginning at 2 hours after initial treatment if the migraine pain had not improved or worsened. Additional medications were allowed 4 to 24 hours after the initial treatment of Imitrex for recurrent headache or as rescue in all 3 studies. The frequency and time to use of these additional Imitrex treatments were also determined. In all studies, doses of 25, 50, and 100 mg of Imitrex were compared to placebo in the treatment of migraine attacks. In 1 study, doses of 25, 50, and 100 mg of Imitrex were also compared to each other.

In all 3 trials, the percentage of patients achieving headache response 2 and 4 hours after Imitrex treatment was significantly greater among patients receiving Imitrex Tablets at all doses compared to those who received placebo. In 1 of the 3 studies, there was a statistically significant greater percentage of patients with headache response at 2 and 4 hours in the 50- or 100-mg Imitrex group when compared to the 25-mg Imitrex dose groups. There were no statistically significant differences between the 50- and 100-mg dose groups in any study. The results from the 3 controlled clinical trials are summarized in Table 1.

The estimated probability of achieving an initial headache response over the 4 hours following treatment is depicted in Figure 1.

There is evidence that doses above 50 mg of Imitrex do not provide a greater effect than 50 mg. There was no evidence to suggest that treatment with Imitrex was associated with an increase in the severity of recurrent headaches. The efficacy of Imitrex Tablets was unaffected by presence of aura; duration of headache prior to treatment; gender, age, or weight of the patient; relationship to menses; or concomitant use of common migraine prophylactic drugs (e.g., beta-blockers, calcium channel blockers, tricyclic antidepressants). There were insufficient data to assess the impact of race on efficacy on Imitrex .

INDICATIONS AND USAGE

Imitrex Tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.

Imitrex Tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of Imitrex Tablets have not been established for cluster headache, which is present in an older, predominantly male population.

CONTRAINDICATIONS

IMITREX Tablets should not be given to patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes. In addition, patients with other significant underlying cardiovascular diseases should not receive Imitrex Tablets. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort and vasospastic forms of angina such as the Prinzmetal variant), all forms of myocardial infarction, and silent myocardial ischemia. Cerebrovascular syndromes include, but are not limited to, strokes of any type as well as transient ischemic attacks. Peripheral vascular disease includes, but is not limited to, ischemic bowel disease.

Because Imitrex Tablets may increase blood pressure, they should not be given to patients with uncontrolled hypertension.

Concurrent administration of Imitrex and MAO-A inhibitors or use within 2 weeks of discontinuation of MAO-A inhibitor therapy is contraindicated.

Imitrex Tablets should not be administered to patients with hemiplegic or basilar migraine.

Imitrex Tablets and any ergotamine-containing or ergot-type medication (like dihydroergotamine or methysergide) should not be used within 24 hours of each other, nor should Imitrex and another 5-HT 1 agonist.

Imitrex Tablets are contraindicated in patients with hypersensitivity to Imitrex or any of its components.

Imitrex Tablets are contraindicated in patients with severe liver impairment.

WARNINGS

Imitrex Tablets should only be used where a clear diagnosis of migraine headache has been established.

Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events : Imitrex should not be given to patients with documented ischemic or vasospastic coronary artery disease (CAD). It is strongly recommended that Imitrex not be given to patients in whom unrecognized CAD is predicted by the presence of risk factors (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, or male over 40 years of age) unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease. The sensitivity of cardiac diagnostic procedures to detect cardiovascular disease or predisposition to coronary artery vasospasm is modest, at best. If, during the cardiovascular evaluation, the patient's medical history or electrocardiographic investigations reveal findings indicative of, or consistent with, coronary artery vasospasm or myocardial ischemia, Imitrex should not be administered.

For patients with risk factors predictive of CAD, who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of Imitrex tablets take place in the setting of a physician's office or similar medically staffed and equipped facility unless the patient has previously received Imitrex . Because cardiac ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining on the first occasion of use an electrocardiogram (ECG) during the interval immediately following Imitrex Tablets, in these patients with risk factors.

It is recommended that patients who are intermittent long-term users of Imitrex and who have or acquire risk factors predictive of CAD, as described above, undergo periodic interval cardiovascular evaluation as they continue to use Imitrex .

The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease will be inadvertently exposed to Imitrex .

Drug-Associated Cardiac Events and Fatalities :   Serious adverse cardiac events, including acute myocardial infarction, life-threatening disturbances of cardiac rhythm, and death have been reported within a few hours following the administration of Imitrex (sumatriptan succinate) Injection or Imitrex Tablets. Considering the extent of use of Imitrex in patients with migraine, the incidence of these events is extremely low.

The fact that Imitrex can cause coronary vasospasm, that some of these events have occurred in patients with no prior cardiac disease history and with documented absence of CAD, and the close proximity of the events to Imitrex use support the conclusion that some of these cases were caused by Imitrex . In many cases, however, where there has been known underlying coronary artery disease, the relationship is uncertain.

Premarketing Experience With Imitrex :   Of 6,348 patients with migraine who participated in premarketing controlled and uncontrolled clinical trials of oral Imitrex , 2 experienced clinical adverse events shortly after receiving oral Imitrex that may have reflected coronary vasospasm. Neither of these adverse events was associated with a serious clinical outcome.

Among the more than 1,900 patients with migraine who participated in premarketing controlled clinical trials of subcutaneous Imitrex , there were 8 patients who sustained clinical events during or shortly after receiving Imitrex that may have reflected coronary artery vasospasm. Six of these 8 patients had ECG changes consistent with transient ischemia, but without accompanying clinical symptoms or signs. Of these 8 patients, 4 had either findings suggestive of CAD or risk factors predictive of CAD prior to study enrollment.

Among approximately 4,000 patients with migraine who participated in premarketing controlled and uncontrolled clinical trials of Imitrex nasal spray, 1 patient experienced an asymptomatic subendocardial infarction possibly subsequent to a coronary vasospastic event.

Postmarketing Experience With Imitrex :   Serious cardiovascular events, some resulting in death, have been reported in association with the use of IMITREX Injection or IMITREX Tablets. The uncontrolled nature of postmarketing surveillance, however, makes it impossible to determine definitively the proportion of the reported cases that were actually caused by Imitrex or to reliably assess causation in individual cases. On clinical grounds, the longer the latency between the administration of IMITREX and the onset of the clinical event, the less likely the association is to be causative. Accordingly, interest has focused on events beginning within 1 hour of the administration of IMITREX.

Cardiac events that have been observed to have onset within 1 hour of Imitrex administration include: coronary artery vasospasm, transient ischemia, myocardial infarction, ventricular tachycardia and ventricular fibrillation, cardiac arrest, and death.

Some of these events occurred in patients who had no findings of CAD and appear to represent consequences of coronary artery vasospasm. However, among domestic reports of serious cardiac events within 1 hour of Imitrex administration, almost all of the patients had risk factors predictive of CAD and the presence of significant underlying CAD was established in most cases.

Drug-Associated Cerebrovascular Events and Fatalities: Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with oral or subcutaneous Imitrex , and some have resulted in fatalities. The relationship of Imitrex to these events is uncertain. In a number of cases, it appears possible that the cerebrovascular events were primary, Imitrex having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine when they were not. As with other acute migraine therapies, 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 also be noted that patients with migraine may be at increased risk of certain cerebrovascular events (e.g., cerebrovascular accident, transient ischemic attack).

Other Vasospasm-Related Events:    Imitrex may cause vasospastic reactions other than coronary artery vasospasm. Both peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea have been reported.

Increase in Blood Pressure:   Significant elevation in blood pressure, including hypertensive crisis, has been reported on rare occasions in patients with and without a history of hypertension who take Imitrex . Imitrex is contraindicated in patients with uncontrolled hypertension. Imitrex 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.

Concomitant Drug Use:   In patients taking MAO-A inhibitors, Imitrex plasma levels attained after treatment with recommended doses are 7-fold higher following oral administration than those obtained under other conditions. Accordingly, the coadministration of IMITREX Tablets and an MAO-A inhibitor is contraindicated.

Hypersensitivity:   Hypersensitivity (anaphylaxis/anaphylactoid) reactions have occurred on rare occasions in patients receiving Imitrex . Such reactions can be life threatening or fatal. In general, hypersensitivity reactions to Imitrex are more likely to occur in individuals with a history of sensitivity to multiple allergens.

PRECAUTIONS

General:   Chest discomfort and jaw or neck tightness have been reported following use of IMITREX Tablets and have also been reported infrequently following administration of IMITREX Nasal Spray. Chest, jaw, or neck tightness is relatively common after administration of IMITREX Injection. Only rarely have these symptoms been associated with ischemic ECG changes. However, because Imitrex may cause coronary artery vasospasm, patients who experience signs or symptoms suggestive of angina following Imitrex should be evaluated for the presence of CAD or a predisposition to Prinzmetal variant angina before receiving additional doses of Imitrex , and should be monitored electrocardiographically if dosing is resumed and similar symptoms recur. Similarly, patients who experience other symptoms or signs suggestive of decreased arterial flow, such as ischemic bowel syndrome or Raynaud syndrome following Imitrex should be evaluated for atherosclerosis or predisposition to vasospasm.

IMITREX should also be administered with caution to patients with diseases that may alter the absorption, metabolism, or excretion of drugs, such as impaired hepatic or renal function.

There have been rare reports of seizure following administration of Imitrex . Imitrex should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.

Care should be taken to exclude other potentially serious neurologic conditions before treating headache with Imitrex in patients not previously diagnosed with migraine headache or who experience a headache that is atypical for them. There have been rare reports where patients received Imitrex for severe headaches that were subsequently shown to have been secondary to an evolving neurologic lesion.

For a given attack, if a patient does not respond to the first dose of Imitrex , the diagnosis of migraine should be reconsidered before administration of a second dose.

Corneal Opacities:    Imitrex causes corneal opacities and defects in the corneal epithelium in dogs; this raises the possibility that these changes may occur in humans. While patients were not systematically evaluated for these changes in Imitrex clinical trials, and no specific recommendations for monitoring are being offered, doctors should be aware of the possibility of these changes with Imitrex .

Laboratory Tests:   No specific laboratory tests are recommended for monitoring patients prior to and/or after treatment with Imitrex .

Drug Interactions:   Ergot-containing drugs have been reported to cause prolonged vasospastic reactions in patients taking Imitrex . Because there is a theoretical basis that these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and Imitrex within 24 hours of each other should be avoided.

MAO-A inhibitors reduce Imitrex clearance, significantly increasing systemic exposure. Therefore, the use of IMITREX Tablets in patients receiving MAO-A inhibitors is contraindicated.

Selective serotonin reuptake inhibitors (SSRIs) (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline) have been reported, rarely, to cause weakness, hyperreflexia, and incoordination when coadministered with Imitrex . If concomitant treatment with Imitrex and an SSRI is clinically warranted, appropriate observation of the patient is advised.

Drug/Laboratory Test Interactions:   IMITREX Tablets are not known to interfere with commonly employed clinical laboratory tests.

Impairment of Fertility:   In a study in which male and female rats were dosed daily with oral Imitrex prior to and throughout the mating period, there was a treatment-related decrease in fertility secondary to a decrease in mating in animals treated with 50 and 500 mg/kg/day. The highest no-effect dose for this finding was 5 mg/kg/day of Imitrex , or approximately one half of the maximum recommended single Imitrex human oral dose of 100 mg on a mg/m 2 basis. It is not clear whether the problem is associated with treatment of the males or females or both combined. In a similar study of Imitrex by the subcutaneous route there was no evidence of impaired fertility at 60 mg/kg/day, the maximum dose tested, which is equivalent to approximately 6 times the maximum recommended single human oral dose of 100 mg on a mg/m 2 basis.

Pregnancy:  Pregnancy Category C.  In reproductive toxicity studies in rats and rabbits, oral treatment with Imitrex was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to rabbits, Imitrex has been shown to be embryolethal. There are no adequate and well-controlled studies in pregnant women. Therefore, IMITREX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In assessing this information, the following findings should be considered.

Embryolethality:   When given orally or intravenously to pregnant rabbits daily throughout the period of organogenesis, Imitrex caused embryolethality at doses at or close to those producing maternal toxicity. In the oral studies this dose was 100 mg/kg/day, and in the intravenous studies this dose was 2.0 mg/kg/day. The mechanism of the embryolethality is not known. The highest no-effect dose for embryolethality with Imitrex by the oral route was 50 mg/kg/day, which is approximately 9 times the maximum single recommended human oral dose of 100 mg of Imitrex on a mg/m 2 basis. Imitrex by the intravenous route, the highest no-effect dose was 0.75 mg/kg/day, or approximately one tenth of the maximum single recommended human oral dose of 100 mg on a mg/m 2 basis.

The intravenous administration of Imitrex to pregnant rats throughout organogenesis at 12.5 mg/kg/day, the maximum dose tested, did not cause embryolethality. This dose is equivalent to the maximum single recommended human oral dose of 100 mg on a mg/m 2 basis. Additionally, in a study in rats given subcutaneous Imitrex daily prior to and throughout pregnancy at 60 mg/kg/day, the maximum dose tested, there was no evidence of increased embryo/fetal lethality. This dose is equivalent to approximately 6 times the maximum recommended single human oral dose of 100 mg on a mg/m 2 basis.

Teratogenicity:   Oral treatment of pregnant rats with Imitrex during the period of organogenesis resulted in an increased incidence of blood vessel abnormalities (cervicothoracic and umbilical) at doses of approximately 250 mg/kg/day or higher. The highest no-effect dose of Imitrex was approximately 60 mg/kg/day, which is approximately 6 times the maximum single recommended Imitrex human oral dose of 100 mg on a mg/m 2 basis. Oral treatment of pregnant rabbits with Imitrex during the period of organogenesis resulted in an increased incidence of cervicothoracic vascular and skeletal abnormalities. The highest no-effect Imitrex dose for these effects was 15 mg/kg/day, or approximately 3 times the maximum single recommended human oral dose of 100 mg on a mg/m 2 basis.

A study in which rats were dosed daily with oral Imitrex prior to and throughout gestation demonstrated embryo/fetal toxicity (decreased body weight, decreased ossification, increased incidence of rib variations) and an increased incidence of a syndrome of malformations (short tail/short body and vertebral disorganization) at 500 mg/kg/day. The highest no-effect Imitrex dose was 50 mg/kg/day, or approximately 5 times the maximum single recommended human oral dose of 100 mg on a mg/m 2 basis. In a study in rats dosed daily with subcutaneous Imitrex prior to and throughout pregnancy, at a dose of 60 mg/kg/day, the maximum dose tested, there was no evidence of teratogenicity. This dose is equivalent to approximately 6 times the maximum recommended single human oral dose of 100 mg on a mg/m 2 basis.

Nursing Mothers:    Imitrex is excreted in human breast milk. Therefore, caution should be exercised when considering the administration of IMITREX Tablets to a nursing woman.

Pediatric Use:   Safety and effectiveness of IMITREX Tablets in pediatric patients have not been established.

Completed placebo-controlled clinical trials evaluating oral Imitrex (25 to 100 mg) in pediatric patients aged 12 to 17 years enrolled a total of 701 adolescent migraineurs. These studies did not establish the efficacy of oral Imitrex compared to placebo in the treatment of migraine in adolescents. Adverse events observed in these clinical trials were similar in nature to those reported in clinical trials of Imitrex in adults. The frequency of all adverse events in these patients appeared to be both dose- and age-dependent, with younger patients reporting events more commonly than older adolescents. Postmarketing Imitrex experience includes a limited number of reports that describe pediatric patients who have experienced adverse events, some clinically serious, after use of subcutaneous Imitrex and/or oral Imitrex . These reports include events similar in nature to those reported rarely in adults. A myocardial infarct has been reported in a 14-year-old male following the use of oral Imitrex ; clinical signs occurred within 1 day of drug administration. Since clinical data to determine the frequency of serious adverse events in pediatric patients who might receive injectable, oral, or intranasal Imitrex are not presently available, the use of Imitrex in patients aged younger than 18 years is not recommended.

Geriatric Use:   The use of Imitrex in elderly patients is not recommended because elderly patients are more likely to have decreased hepatic function, they are at higher risk for CAD, and blood pressure increases may be more pronounced in the elderly.

ADVERSE REACTIONS

Serious cardiac events, including some that have been fatal, have occurred following the use of IMITREX Injection or Tablets. These events are extremely rare and most have been reported in patients with risk factors predictive of CAD. Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation .

Significant hypertensive episodes, including hypertensive crises, have been reported on rare occasions with Imitrex in patients with or without a history of hypertension.

Incidence in Controlled Clinical Trials:  Table 2 lists adverse events that occurred in placebo-controlled clinical trials in patients who took at least 1 dose of Imitrex . Only events that occurred at a frequency of 2% or more in any group treated with IMITREX Tablets and were more frequent in that group than in the placebo group are included in Table 2. The events cited reflect experience gained under closely monitored conditions of Imitrex clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ.

Other events that occurred in more than 1% of patients receiving IMITREX Tablets and at least as often on placebo included nausea and/or vomiting, migraine, headache, hyposalivation, dizziness, and drowsiness/sleepiness.

IMITREX Tablets are generally well tolerated. Across all Imitrex doses, most adverse reactions were mild and transient and did not lead to long-lasting effects. The incidence of adverse events in controlled clinical Imitrex trials was not affected by gender or age of the patients. There were insufficient data to assess the impact of race on the incidence of adverse events.

Other Events Observed in Association With the Administration of IMITREX Tablets:   In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented. Because the reports include events observed in open and uncontrolled studies, the role of IMITREX Tablets in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used IMITREX Tablets (25, 50, or 100 mg) and reported an event divided by the total number of patients (n = 6,348) exposed to IMITREX Tablets. All reported events are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients, infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, and rare adverse events are those occurring in fewer than 1/1,000 patients.

Atypical Sensations with Imitrex :   Frequent were burning sensation and numbness. Infrequent was tight feeling in head. Rare were dysesthesia.

Cardiovascular with Imitrex :   Frequent were palpitations, syncope, decreased blood pressure, and increased blood pressure. Infrequent were arrhythmia, changes in ECG, hypertension, hypotension, pallor, pulsating sensations, and tachycardia. Rare were angina, atherosclerosis, bradycardia, cerebral ischemia, cerebrovascular lesion, heart block, peripheral cyanosis, thrombosis, transient myocardial ischemia, and vasodilation.

Ear, Nose, and Throat with Imitrex:   Frequent were sinusitis, tinnitus; allergic rhinitis; upper respiratory inflammation; ear, nose, and throat hemorrhage; external otitis; hearing loss; nasal inflammation; and sensitivity to noise. Infrequent were hearing disturbances and otalgia. Rare was feeling of fullness in the ear(s).

Endocrine and Metabolic with Imitrex:   Infrequent was thirst. Rare were elevated thyrotropin stimulating hormone (TSH) levels; galactorrhea; hyperglycemia; hypoglycemia; hypothyroidism; polydipsia; weight gain; weight loss; endocrine cysts, lumps, and masses; and fluid disturbances.

Eye Reactions with Imitrex:   Rare were disorders of sclera, mydriasis, blindness and low vision, visual disturbances, eye edema and swelling, eye irritation and itching, accommodation disorders, external ocular muscle disorders, eye hemorrhage, eye pain, and keratitis and conjunctivitis.

Gastrointestinal reactions with Imitrex:   Frequent were diarrhea and gastric symptoms. Infrequent were constipation, dysphagia, and gastroesophageal reflux. Rare were gastrointestinal bleeding, hematemesis, melena, peptic ulcer, gastrointestinal pain, dyspeptic symptoms, dental pain, feelings of gastrointestinal pressure, gastroesophageal reflux, gastritis, gastroenteritis, hypersalivation, abdominal distention, oral itching and irritation, salivary gland swelling, and swallowing disorders.

Hematological Disorders with Imitrex:   Rare was anemia.

Musculoskeletal with Imitrex:   Frequent was myalgia. Infrequent was muscle cramps. Rare were tetany; muscle atrophy, weakness, and tiredness; arthralgia and articular rheumatitis; acquired musculoskeletal deformity; muscle stiffness, tightness, and rigidity; and musculoskeletal inflammation.

Neurological with Imitrex:   Frequent were phonophobia and photophobia. Infrequent were confusion, depression, difficulty concentrating, disturbance of smell, dysarthria, euphoria, facial pain, heat sensitivity, incoordination, lacrimation, monoplegia, sleep disturbance, shivering, syncope, and tremor. Rare were aggressiveness, apathy, bradylogia, cluster headache, convulsions, decreased appetite, drug abuse, dystonic reaction, facial paralysis, hallucinations, hunger, hyperesthesia, hysteria, increased alertness, memory disturbance, neuralgia, paralysis, personality change, phobia, radiculopathy, rigidity, suicide, twitching, agitation, anxiety, depressive disorders, detachment, motor dysfunction, neurotic disorders, psychomotor disorders, taste disturbances, and raised intracranial pressure.

Respiratory with Imitrex:   Frequent was dyspnea. Infrequent was asthma. Rare were hiccoughs, breathing disorders, cough, and bronchitis.

Skin with Imitrex:   Frequent was sweating. Infrequent were erythema, pruritus, rash, and skin tenderness. Rare were dry/scaly skin, tightness of skin, wrinkling of skin, eczema, seborrheic dermatitis, and skin nodules.

Breasts with Imitrex:   Infrequent was tenderness. Rare were nipple discharge; breast swelling; cysts, lumps, and masses of breasts; and primary malignant breast neoplasm.

Urogenital with Imitrex:   Infrequent were dysmenorrhea, increased urination, and intermenstrual bleeding. Rare were abortion and hematuria, urinary frequency, bladder inflammation, micturition disorders, urethritis, urinary infections, menstruation symptoms, abnormal menstrual cycle, inflammation of fallopian tubes, and menstrual cycle symptoms.

Miscellaneous with Imitrex:   Frequent was hypersensitivity. Infrequent were fever, fluid retention, and overdose. Rare were edema, hematoma, lymphadenopathy, speech disturbance, voice disturbances, contusions.

Other Events Observed in the Clinical Development ofIMITREX:   The following adverse events occurred in clinical trials with IMITREX Injection and IMITREX Nasal Spray. Because the reports include events observed in open and uncontrolled studies, the role of IMITREX in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.

Atypical Sensations with Imitrex:   Feeling strange, prickling sensation, tingling, and hot sensation.

Cardiovascular with Imitrex:   Abdominal aortic aneurysm, abnormal pulse, flushing, phlebitis, Raynaud syndrome, and various transient ECG changes (nonspecific ST or T wave changes, prolongation of PR or QTc intervals, sinus arrhythmia, nonsustained ventricular premature beats, isolated junctional ectopic beats, atrial ectopic beats, delayed activation of the right ventricle).

Chest Symptoms with Imitrex:   Chest discomfort.

Endocrine and Metabolic with Imitrex:   Dehydration.

Ear, Nose, and Throat with Imitrex:   Disorder/discomfort nasal cavity and sinuses, ear infection, Meniere disease, and throat discomfort.

Eye with Imitrex:   Vision alterations.

Gastrointestinal with Imitrex:   Abdominal discomfort, colitis, disturbance of liver function tests, flatulence/eructation, gallstones, intestinal obstruction, pancreatitis, and retching.

Injection Site Reaction

Miscellaneous with Imitrex:   Difficulty in walking, hypersensitivity to various agents, jaw discomfort, miscellaneous laboratory abnormalities, "serotonin agonist effect," swelling of the extremities, and swelling of the face.

Mouth and Teeth with Imitrex:   Disorder of mouth and tongue (e.g., burning of tongue, numbness of tongue, dry mouth).

Musculoskeletal with Imitrex:   Arthritis, backache, intervertebral disc disorder, neck pain/stiffness, need to flex calf muscles, and various joint disturbances (pain, stiffness, swelling, ache).

Neurological with Imitrex:   Bad/unusual taste, chills, diplegia, disturbance of emotions, sedation, globus hystericus, intoxication, myoclonia, neoplasm of pituitary, relaxation, sensation of lightness, simultaneous hot and cold sensations, stinging sensations, stress, tickling sensations, transient hemiplegia, and yawning.

Respiratory with Imitrex:   Influenza and diseases of the lower respiratory tract and lower respiratory tract infection.

Skin with Imitrex:   Skin eruption, herpes, and peeling of the skin.

Urogenital with Imitrex:   Disorder of breasts, endometriosis, and renal calculus.

Postmarketing Experience (Reports for Subcutaneous or Oral Imitrex ):   The following section enumerates potentially important adverse events that have occurred in clinical practice with Imitrex and that have been reported spontaneously to various surveillance systems. The events enumerated represent reports arising from both domestic and nondomestic use of oral or subcutaneous dosage forms of Imitrex. The events enumerated include all except those already listed in the ADVERSE REACTIONS section above or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of Imitrex in their causation cannot be reliably determined. It is assumed, however, that systemic reactions following Imitrex use are likely to be similar regardless of route of administration.

Blood with Imitrex:   Hemolytic anemia, pancytopenia, thrombocytopenia.

Cardiovascular with Imitrex:   Atrial fibrillation, cardiomyopathy, colonic ischemia (see WARNINGS ), Prinzmetal variant angina, pulmonary embolism, shock, thrombophlebitis.

Ear, Nose, and Throat with Imitrex:   Deafness.

Eye with Imitrex:   Ischemic optic neuropathy, retinal artery occlusion, retinal vein thrombosis, loss of vision.

Gastrointestinal with Imitrex:   Ischemic colitis with rectal bleeding (see WARNINGS ), xerostomia.

Hepatic with Imitrex:   Elevated liver function tests.

Neurological with Imitrex:   Central nervous system vasculitis, cerebrovascular accident, dysphasia, subarachnoid hemorrhage.

Non-Site Specific with Imitrex:   Angioneurotic edema, cyanosis, death, temporal arteritis.

Psychiatry with Imitrex:   Panic disorder.

Respiratory with Imitrex:   Bronchospasm in patients with and without a history of asthma.

Skin with Imitrex:   Exacerbation of sunburn, hypersensitivity reactions (allergic vasculitis, erythema, pruritus, rash, shortness of breath, urticaria; in addition, severe anaphylaxis/anaphylactoid reactions have been reported, photosensitivity.

Urogenital with Imitrex:   Acute renal failure.

DRUG ABUSE AND DEPENDENCE

One clinical study with IMITREX (sumatriptan succinate) Injection enrolling 12 patients with a history of substance abuse failed to induce subjective behavior and/or physiologic response ordinarily associated with drugs that have an established potential for abuse.

OVERDOSAGE

Patients (n = 670) have received single oral doses of 140 to 300 mg without significant adverse effects. Volunteers (n = 174) have received single oral doses of 140 to 400 mg without serious adverse events.

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. The elimination half-life of Imitrex is approximately 2.5 hours, and therefore monitoring of patients after overdose with IMITREX Tablets should continue for at least 12 hours or while symptoms or signs persist.

It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of Imitrex.

DOSAGE AND ADMINISTRATION

In controlled clinical trials, single doses of 25, 50, or 100 mg of IMITREX Tablets were effective for the acute treatment of migraine in adults. There is evidence that doses of 50 and 100 mg of Imitrex may provide a greater effect than 25 mg of Imitrex. There is also evidence that doses of 100 mg do not provide a greater effect than 50 mg. Individuals may vary in response to doses of IMITREX Tablets. The choice of dose should therefore be made on an individual basis, weighing the possible benefit of a higher dose with the potential for a greater risk of adverse events.

If the headache returns or the patient has a partial response to the initial dose, the dose may be repeated after 2 hours, not to exceed a total daily dose of 200 mg. If a headache returns following an initial treatment with IMITREX Injection, additional single IMITREX Tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses. The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

Because of the potential of MAO-A inhibitors to cause unpredictable elevations in the bioavailability of oral Imitrex, their combined use is contraindicated.

Hepatic disease/functional impairment may also cause unpredictable elevations in the bioavailability of orally administered Imitrex. Consequently, if treatment is deemed advisable in the presence of liver disease, the maximum single dose should in general not exceed 50 mg.

Store Imitrex between 36° and 86°F (2° and 30°C).

PATIENT INFORMATION

Information for the Patient

IMITREX (sumatriptan succinate) Tablets

Please read this carefully before you take IMITREX Tablets. This provides a summary of the information available on your medicine.

Information About Your Imitrex:

The name of your medicine is IMITREX (sumatriptan succinate) Tablets. It can be obtained only by prescription from your doctor. The decision to use IMITREX Tablets is one that you and your doctor should make jointly, taking into account your individual preferences and medical circumstances. If you have risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or you are postmenopausal or a male over 40 years of age), you should tell your doctor, who should evaluate you for heart disease in order to determine if IMITREX is appropriate for you. Although the vast majority of those who have taken IMITREX have not experienced any significant side effects, some individuals have experienced serious heart problems and, rarely, considering the extensiveness of IMITREX use worldwide, deaths have been reported. In all but a few instances, however, serious problems occurred in people with known heart disease and it was not clear whether IMITREX was a contributory factor in these deaths.

•  The Purpose of Your Medicine:
IMITREX Tablets are intended to relieve your migraine, but not to prevent or reduce the number of attacks you experience. Use IMITREX Tablets only to treat an actual migraine attack.

•  Important Questions to Consider Before Taking IMITREX Tablets:
If the answer to any of the following questions is YES or if you do not know the answer, then please discuss it with your doctor before you use IMITREX Tablets.

•  Are you pregnant? Do you think you might be pregnant? Are you trying to become pregnant? Are you using inadequate contraception? Are you breastfeeding?

•  Do you have any chest pain, heart disease, shortness of breath, or irregular heartbeats? Have you had a heart attack?

•  Do you have risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or you are postmenopausal or a male over 40 years of age)?

•  Have you had a stroke, transient ischemic attacks (TIAs), or Raynaud syndrome?

•  Do you have high blood pressure?

•  Have you ever had to stop taking this or any other medicine because of an allergy or other problems?

•  Are you taking any other migraine medicines, including other 5-HT 1 agonists or any other medicines containing ergotamine, dihydroergotamine, or methysergide?

•  Are you taking any medicine for depression (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors [SSRIs])?

•  Have you had, or do you have, any disease of the liver or kidney?

•  Have you had, or do you have, epilepsy or seizures?

•  Is this headache different from your usual migraine attacks?
Remember, if you answered YES to any of the above questions, then discuss it with your doctor.

•  The Use of IMITREX Tablets During Pregnancy:
Do Not Use IMITREX Tablets if you are pregnant, think you might be pregnant, are trying to become pregnant, or are not using adequate contraception, unless you have discussed this with your doctor.

•  How to Use IMITREX Tablets:
For adults, the usual dose is a single tablet taken whole with fluids. A second tablet may be taken if your symptoms of migraine come back or if you have a partial response to the initial dose, but not sooner than 2 hours following the first tablet. For a given attack, if you have no response to the first tablet, do not take a second tablet without first consulting with your doctor. Do not take more than a total of 200 mg of IMITREX Tablets in any 24-hour period. The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

•  Imitrex Side Effects to Watch for:

•  Some patients experience pain or tightness in the chest or throat when using IMITREX Tablets. If this happens to you, then discuss it with your doctor before using any more IMITREX Tablets. If the chest pain is severe or does not go away, call your doctor immediately.

•  If you have sudden and/or severe abdominal pain following IMITREX Tablets, call your doctor immediately.

•  Shortness of breath; wheeziness; heart throbbing; swelling of eyelids, face, or lips; or a skin rash, skin lumps, or hives happens rarely. If it happens to you, then tell your doctor immediately. Do not take any more IMITREX Tablets unless your doctor tells you to do so.

•  Some people may have feelings of tingling, heat, flushing (redness of face lasting a short time), heaviness or pressure after treatment with IMITREX Tablets. A few people may feel drowsy, dizzy, tired, or sick. Tell your doctor of these symptoms at your next visit.

•  If you feel unwell in any other way or have any symptoms that you do not understand, you should contact your doctor immediately.

•  What to Do if an Overdose is Taken:
If you have taken more medicine than you have been told, contact either your doctor, hospital emergency department, or nearest poison control center immediately.

•  Storing Your Medicine:
Keep Imitrex in a safe place where children cannot reach it. It may be harmful to children. Store your medicine away from heat and light. Do not store at temperatures above 86°F (30°C), or below 36°F (2°C). If your Imitrex has expired (the expiration date is printed on the treatment pack), throw it away as instructed. If your doctor decides to stop your treatment, do not keep any leftover medicine unless your doctor tells you to. Throw away your Imitrex as instructed.

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