Drugs Details

Drugs Info of Imitrex, Imitrex Nasal
Drugs Details
  • Drugs Type  : Multum
  • Date : 10th Feb 2015 05:23 am
  • Brand Name : Imitrex, Imitrex Nasal
  • Generic Name : sumatriptan (oral/nasal) (Pronunciation: soo ma TRIP tan)
Descriptions

IMITREX Tablets contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole- 5-methanesulfonamide succinate (1:1), and it has the following structure:

 

IMITREX (sumatriptan succinate) Structural Formula Illustration

The empirical formula is C14H21N3O2S•C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline.

Each 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 tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium bicarbonate. Each 100-mg tablet also contains hypromellose, iron oxide, titanium dioxide, and triacetin.

What are the possible side effects of sumatriptan (Imitrex, Imitrex Nasal)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sumatriptan and call your doctor if you have a serious side effect such as:

  • feeling of pain or tightness in your jaw, neck, or throat;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision,...

Read All Potential Side Effects and See Pictures of Imitrex »

What are the precautions when taking sumatriptan succinate (Imitrex)?

Before using sumatriptan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (for example, in your legs, arms/hands, or stomach), certain types of headaches (hemiplegic or basilar migraine), heart problems (such as chest pain, irregular heartbeat, previous heart attack), liver disease, seizure, stroke or "mini-stroke" (transient ischemic attack).

Certain conditions can increase your risk for heart problems. Tell your doctor if you have any of these conditions,...

Read All Potential Precautions of Imitrex »
This monograph has been modified to include the generic and brand name in many instances.

Indications

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

Limitations Of Use

  • Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with IMITREX, reconsider the diagnosis of migraine before IMITREX is administered to treat any subsequent attacks.
  • IMITREX is not indicated for the prevention of migraine attacks.
  • Safety and effectiveness of IMITREX Tablets have not been established for cluster headache.

Dosage Administration

Dosing Information

The recommended dose of IMITREX Tablets is 25 mg, 50 mg, or 100 mg. Doses of 50 mg and 100 mg may provide a greater effect than the 25-mg dose, but doses of 100 mg may not provide a greater effect than the 50-mg dose. Higher doses may have a greater risk of adverse reactions [see Clinical Studies].

If the migraine has not resolved by 2 hours after taking IMITREX Tablets, or returns after a transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose is 200 mg in a 24-hour period.

Use after IMITREX Injection

If the migraine returns following an initial treatment with IMITREX (sumatriptan succinate) 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.

Dosing In Patients With Hepatic Impairment

If treatment is deemed advisable in the presence of mild to moderate hepatic impairment, the maximum single dose should not exceed 50 mg [see Use in Specific Populations and CLINICAL PHARMACOLOGY].

How Supplied

Dosage Forms And Strengths

25 mg Tablets: White, triangular-shaped, film-coated, and debossed with “I” on one side and “25” on the other.

50 mg Tablets: White, triangular-shaped, film-coated, and debossed with “IMITREX 50” on one side and a chevron shape (A) on the other.

100 mg Tablets: Pink, triangular-shaped, film-coated, and debossed with “IMITREX 100” on one side and a chevron shape (A) on the other.

Storage And Handling

IMITREX Tablets, 25 mg, 50 mg, and 100 mg of sumatriptan (base) as the succinate.

IMITREX Tablets, 25 mg, are white, triangular-shaped, film-coated tablets debossed with “I” on one side and “25” on the other in blister packs of 9 tablets (NDC 0173-0735-00).

IMITREX Tablets, 50 mg, are white, triangular-shaped, film-coated tablets debossed with “IMITREX 50” on one side and a chevron shape (A) on the other in blister packs of 9 tablets (NDC 0173-0736-01).

IMITREX Tablets, 100 mg, are pink, triangular-shaped, film-coated tablets debossed with “IMITREX 100” on one side and a chevron shape (A) on the other in blister packs of 9 tablets (NDC 0173-0737-01).

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

GlaxoSmithKline, Research Triangle Park, NC 27709
This monograph has been modified to include the generic and brand name in many instances.

Side Effects

The following adverse reactions are discussed in more detail in other sections of the prescribing information:

  • Myocardial ischemia, myocardial infarction, and Prinzmetal's angina [see WARNINGS AND PRECAUTIONS]
  • Arrhythmias [see WARNINGS AND PRECAUTIONS]
  • Chest, throat, neck, and/or jaw pain/tightness/pressure [see WARNINGS AND PRECAUTIONS]
  • Cerebrovascular events [see WARNINGS AND PRECAUTIONS]
  • Other vasospasm reactions [see WARNINGS AND PRECAUTIONS]
  • Medication overuse headache [see WARNINGS AND PRECAUTIONS]
  • Serotonin syndrome [see WARNINGS AND PRECAUTIONS]
  • Increase in blood pressure [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinic trials of another drug and may not reflect the rates observed in practice.

Table 1 lists adverse reactions that occurred in placebo-controlled clinical trials in patients who took at least 1 dose of study drug. Only treatment-emergent adverse reactions that occurred at a frequency of 2% or more in any group treated with IMITREX Tablets and that occurred at a frequency greater than the placebo group are included in Table 1.

Table 1: Adverse Reactions Reported by at Least 2% of Patients Treated With IMITREX Tablets and at a Greater Frequency Than Placebo

Adverse Reaction Percent of Patients Reporting
IMITREX Tablets 25 mg
(n = 417)
IMITREX Tablets 50 mg
(n = 771)
IMITREX Tablets 100 mg
(n = 437)
Placebo
(n = 309)
Atypical sensations 5 6 6 4
  Paresthesia (all types) 3 5 3 2
  Sensation warm/cold 3 2 3 2
Pain and other pressure sensations 6 6 8 4
  Chest - pain/tightness/pressure and/or heaviness 1 2 2 1
  Neck/throat/jaw - pain/tightness/pressure < 1 2 3 < 1
  Pain - location specified 2 1 1 1
  Other - pressure/tightness/heaviness 1 1 3 2
Neurological
  Vertigo < 1 < 1 2 < 1
Other
  Malaise/fatigue 2 2 3 < 1

The incidence of adverse reactions in controlled clinical 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 reactions.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of IMITREX Tablets, IMITREX Nasal Spray, and IMITREX Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to IMITREX or a combination of these factors.

Cardiovascular: Hypotension, palpitations.

Neurological: Dystonia, tremor.

Read the Imitrex (sumatriptan succinate) Side Effects Center for a complete guide to possible side effects

Interactions

Ergot-Containing Drugs

Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and IMITREX Tablets within 24 hours of each other is contraindicated.

Monoamine Oxidase-A Inhibitors

MAO-A inhibitors increase systemic exposure by 7-fold. Therefore, the use of IMITREX Tablets in patients receiving MAO-A inhibitors is contraindicated [see CLINICAL PHARMACOLOGY].

Other 5-HT 1 Agonists

Because their vasospastic effects may be additive, co-administration of IMITREX Tablets and other 5-HT1 agonists (e.g., triptans) within 24 hours of each other is contraindicated.

Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome

Cases of serotonin syndrome have been reported during co-administration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [see WARNINGS AND PRECAUTIONS].


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Myocardial Ischemia, Myocardial Infarction, And Prinzmetal's Angina

The use of IMITREX Tablets is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of IMITREX Tablets. Some of these reactions occurred in patients without known CAD. IMITREX Tablets may cause coronary artery vasospasm (Prinzmetal's angina), even in patients without a history of CAD.

Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving IMITREX Tablets. If there is evidence of CAD or coronary artery vasospasm, IMITREX Tablets are contraindicated. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of IMITREX Tablets in a medically supervised setting and performing an electrocardiogram (ECG) immediately following administration of IMITREX Tablets. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of IMITREX Tablets.

Arrhythmias

Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue IMITREX Tablets if these disturbances occur. IMITREX Tablets are contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders.

Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure

Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with IMITREX Tablets and are usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk. The use of IMITREX Tablets is contraindicated in patients with CAD and those with Prinzmetal's variant angina.

Cerebrovascular Events

Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine when they were not. Also, patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA). Discontinue IMITREX Tablets if a cerebrovascular event occurs.

Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, exclude other potentially serious neurological conditions. IMITREX Tablets are contraindicated in patients with a history of stroke or TIA.

Other Vasospasm Reactions

IMITREX Tablets may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud's syndrome. In patients who experience symptoms or signs suggestive of non-coronary vasospasm reaction following the use of any 5-HT1 agonist, rule out a vasospastic reaction before receiving additional IMITREX Tablets.

Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HTi agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT1 agonists have not been clearly established.

Medication Overuse Headache

Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.

Serotonin Syndrome

Serotonin syndrome may occur with IMITREX Tablets, particularly during coadministration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors [see DRUG INTERACTIONS]. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Discontinue IMITREX Tablets if serotonin syndrome is suspected.

Increase In Blood Pressure

Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with IMITREX. IMITREX Tablets are contraindicated in patients with uncontrolled hypertension.

Anaphylactic/Anaphylactoid Reactions

Anaphylactic/anaphylactoid reactions have occurred in patients receiving IMITREX. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens. IMITREX Tablets are contraindicated in patients with a history of hypersensitivity reaction to IMITREX.

Seizures

Seizures have been reported following administration of IMITREX. 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. IMITREX Tablets should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Risk of Myocardial Ischemia and/or Infarction, Prinzmetal's Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events

Inform patients that IMITREX Tablets may cause serious cardiovascular side effects such as myocardial infarction or stroke. 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].

Anaphylactic/Anaphylactoid Reactions

Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving IMITREX Tablets. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Concomitant Use With Other Triptans or Ergot Medications

Inform patients that use of IMITREX Tablets within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated [see CONTRAINDICATIONS, DRUG INTERACTIONS].

Serotonin Syndrome

Caution patients about the risk of serotonin syndrome with the use of IMITREX Tablets or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS].

Medication Overuse Headache

Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see WARNINGS AND PRECAUTIONS].

Pregnancy

Inform patients that IMITREX Tablets should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus [see Use In Specific Populations].

Nursing Mothers

Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations].

Ability to Perform Complex Tasks

Treatment with IMITREX Tablets may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of IMITREX Tablets.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenesis

In carcinogenicity studies in mouse and rat, sumatriptan was administered orally for 78 and 104 weeks, respectively, at doses up to 160 mg/kg/day (the high dose in rat was reduced from 360 mg/kg/day during week 21). There was no evidence in either species of an increase in tumors related to sumatriptan administration. Plasma exposures (AUC) at the highest doses tested were 20 and 8 times that in humans at the maximum recommended human dose (MRHD) of 200 mg/day.

Mutagenesis

Sumatriptan was negative in in vitro (bacterial reverse mutation [Ames], gene cell mutation in Chinese hamster V79/HGPRT, chromosomal aberration in human lymphocytes) and in vivo (rat micronucleus) assays.

Impairment Of Fertility

When sumatriptan (5, 50, 500 mg/kg/day) was administered orally to male and female rats prior to and throughout the mating period, there was a treatmentrelated decrease in fertility secondary to a decrease in mating in animals treated with doses greater than 5 mg/kg/day (less than the MRHD on a mg/m basis). It is not clear whether this finding was due to an effect on males or females or both.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled trials in pregnant women. In developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal. IMITREX Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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. The highest no-effect dose for embryofetal developmental toxicity in rats was 60 mg/kg/day, or approximately 3 times the maximum recommended human dose (MRHD) of 200 mg/day on a mg/m basis. 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 (approximately 2 times the MRHD on a mg/m basis) and 0.75 mg/kg/day, respectively.

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). The highest no-effect dose was 50 mg/kg/day, or approximately 2 times the MRHD on a mg/m basis. In offspring of pregnant rats treated orally with sumatriptan during organogenesis, there was a decrease in pup survival. The highest no-effect dose for this effect was 60 mg/kg/day, or approximately 3 times the MRHD on a mg/m basis. Oral treatment of pregnant rats with sumatriptan during the latter part of gestation and throughout lactation resulted in a decrease in pup survival. The highest no-effect dose for this finding was 100 mg/kg/day, or approximately 5 times the MRHD on a mg/m basis.

Nursing Mothers

Sumatriptan is excreted in human milk following subcutaneous administration. Infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hours after treatment with IMITREX Tablets.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. IMITREX Tablets are not recommended for use in patients younger than 18 years of age.

Two controlled clinical trials evaluated IMITREX Nasal Spray (5 to 20 mg) in 1,248 adolescent migraineurs aged 12 to 17 years who treated a single attack. The trials did not establish the efficacy of IMITREX Nasal Spray compared with placebo in the treatment of migraine in adolescents. Adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults.

Five controlled clinical trials (2 single-attack trials, 3 multiple-attack trials) evaluating oral IMITREX (25 to 100 mg) in pediatric patients aged 12 to 17 years enrolled a total of 701 adolescent migraineurs. These trials did not establish the efficacy of oral IMITREX compared with placebo in the treatment of migraine in adolescents. 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.

Postmarketing experience documents that serious adverse reactions have occurred in the pediatric population after use of subcutaneous, oral, and/or intranasal IMITREX. These reports include reactions similar in nature to those reported rarely in adults, including stroke, visual loss, and death. A myocardial infarction has been reported in a 14-year-old male following the use of oral IMITREX; clinical signs occurred within 1 day of drug administration. 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.

Geriatric Use

Clinical trials of IMITREX Tablets 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.g., diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving IMITREX Tablets [see WARNINGS AND PRECAUTIONS].

Hepatic Impairment

The maximum single dose in patients with mild to moderate hepatic impairment should not exceed 50 mg. IMITREX Tablets are contraindicated in patients with severe hepatic impairment [see CLINICAL PHARMACOLOGY].
This monograph has been modified to include the generic and brand name in many instances.

OverDose

Patients in clinical trials (N = 670) received single oral doses of 140 to 300 mg without significant adverse reactions. Volunteers (N = 174) received single oral doses of 140 to 400 mg without serious adverse reactions.

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 sumatriptan is approximately 2.5 hours [see CLINICAL PHARMACOLOGY], 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 sumatriptan.

ContrainDications

IMITREX Tablets are contraindicated in patients with:

  • Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal's angina [see WARNINGS AND PRECAUTIONS]
  • Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see WARNINGS AND PRECAUTIONS]
  • History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see WARNINGS AND PRECAUTIONS]
  • Peripheral vascular disease [see WARNINGS AND PRECAUTIONS]
  • Ischemic bowel disease [see WARNINGS AND PRECAUTIONS]
  • Uncontrolled hypertension [see WARNINGS AND PRECAUTIONS]
  • Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT1) agoni st [see DRUG INTERACTIONS]
  • Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY]
  • Hypersensitivity to IMITREX (angioedema and anaphylaxis seen) [see WARNINGS AND PRECAUTIONS]
  • Severe hepatic impairment [see Use in Specific Populations and CLINICAL PHARMACOLOGY]


This monograph has been modified to include the generic and brand name in many instances.

 

Clinical Pharamacology

Mechanism of Action

Sumatriptan binds with high affinity to human cloned 5-HT1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.

Pharmacodynamics

Blood Pressure

Significant elevation in blood pressure, including hypertensive crisis, has been reported in patients with and without a history of hypertension [see WARNINGS AND PRECAUTIONS].

Peripheral (Small) Arteries

In healthy volunteers (N = 18), a trial evaluating the effects of sumatriptan on peripheral (small vessel) arterial reactivity failed to detect a clinically significant increase in peripheral resistance.

Heart Rate

Transient increases in blood pressure observed in some patients in clinical trials carried out during sumatriptan's development as a treatment for migraine were not accompanied by any clinically significant changes in heart rate.

Pharmacokinetics

Absorption and Bioavailability

The mean maximum concentration 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 sumatriptan. This compares with a Cmax of 5 and 16 ng/Ml following dosing with a 5- and 20-mg intranasal dose, respectively. The mean Cmax following a 6-mg subcutaneous injection 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 Cmax is similar during a migraine attack and during a migraine-free period, but the Tmax is slightly later during the attack, approximately 2.5 hours compared with 2.0 hours. When given as a single dose, sumatriptan displays dose proportionality in its extent of absorption (area under the curve [AUC]) over the dose range of 25 to 200 mg, but the Cmax after 100 mg is approximately 25% less than expected (based on the 25-mg dose).

A food effect trial involving administration of IMITREX Tablets 100 mg to healthy volunteers under fasting conditions and with a high-fat meal indicated that the Cmax and AUC were increased by 15% and 12%, respectively, when administered in the fed state.

Distribution

Protein binding, determined by equilibrium dialysis over the concentration range of 10 to 1,000 ng/mL is low, approximately 14% to 21%. The effect of sumatriptan on the protein binding of other drugs has not been evaluated. The apparent volume of distribution is 2.7 L/kg.

Metabolism

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.

Elimination

The elimination half-life of sumatriptan is approximately 2.5 hours. Radiolabeled 14C-sumatriptan administered orally is largely renally excreted (about 60%) with about 40% found in the feces. Most of the radiolabeled compound excreted in the urine is the major metabolite, indole acetic acid (IAA), which is inactive, or the IAA glucuronide. Only 3% of the dose can be recovered as unchanged sumatriptan.

Special Populations

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

Renal Impairment: The effect of renal impairment on the pharmacokinetics of sumatriptan has not been examined.

Hepatic Impairment: The liver plays an important role in the presystemic clearance of orally administered sumatriptan. Accordingly, the bioavailability of sumatriptan following oral administration may be markedly increased in patients with liver disease. In one small trial of patients with moderate liver impairment (n = 8) matched for sex, age, and weight with healthy subjects (n = 8), the hepatically-impaired patients had an approximately 70% increase in AUC and Cmax and a Tmax 40 minutes earlier compared to the healthy subjects.

The pharmacokinetics of sumatriptan in patients with severe hepatic impairment has not been studied. The use of IMITREX Tablets in this population is contraindicated [see CONTRAINDICATIONS and Use in Specific Populations].

Gender: In a trial comparing females to males, no pharmacokinetic differences were observed between genders for AUC, Cmax, Tmax, and half-life.

Race: The systemic clearance and Cmax of subcutaneous sumatriptan were similar in black (n = 34) and Caucasian (n = 38) healthy male subjects. Oral sumatriptan has not been evaluated for race differences.

Drug Interaction Studies

Monoamine Oxidase-A Inhibitors: Treatment with MAOA inhibitors generally leads to an increase of sumatriptan plasma levels [see CONTRAINDICATIONS and DRUG INTERACTIONS].

Due to gut and hepatic metabolic first-pass effects, the increase of systemic exposure after co-administration of an MAO-A inhibitor with oral sumatriptan is greater than after coadministration of the MAO inhibitors with subcutaneous sumatriptan.

In a trial of 14 healthy females, pretreatment with an MAO-A inhibitor decreased the clearance of subcutaneous sumatriptan, resulting in a 2-fold increase in the area under the sumatriptan plasma concentration-time curve (AUC), corresponding to a 40% increase in elimination half-life.

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

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

Animal Toxicology And/Or Pharmacology

Corneal Opacities

Dogs receiving oral sumatriptan developed corneal opacities and defects in the corneal epithelium. Corneal opacities were seen at the lowest dose tested, 2 mg/kg/day, and were present after 1 month of treatment. Defects in the corneal epithelium were noted in a 60-week study. Earlier examinations for these toxicities were not conducted and no-effect doses were not established. Plasma exposure at the lowest dose tested was approximately 2 times that in humans at the MRHD.

Clinical Studies

The efficacy of IMITREX Tablets in the acute treatment of migraine headaches was demonstrated in 3, randomized, double-blind, placebo-controlled trials. Patients enrolled in these 3 trials were predominately female (87%) and Caucasian (97%), with a mean age of 40 years (range of 18 to 65 years). Patients were instructed to treat a moderate to severe headache. 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 dosing. Associated symptoms such as nausea, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24 hours postdose. 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 Trials 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 for recurrent headache or as rescue in all 3 trials. The frequency and time to use of these additional treatments were also determined. In all trials, doses of 25, 50, and 100 mg were compared with placebo in the treatment of migraine attacks. In 1 trial, doses of 25, 50, and 100 mg were also compared with each other.

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

Table 2: Percentage of Patients With Headache Response (Mild or No Headache) 2 and 4 Hours Following Treatment

  IMITREX Tablets 25 mg IMITREX Tablets 50 mg IMITREX Tablets 100 mg Placebo
2 hr 4 hr 2 hr 4 hr 2 hr 4 hr 2 hr 4 hr
Trial 1 52%a 67%a 61%a,b 78%a,b 62%a,b 79%a,b 27% 38%
(n = 298) (n = 296) (n = 296) (n=94)
Trial 2 52%a 70%a 50%a 68%a 56%a 71%a 26% 38%
(n = 66) (n = 62) (n = 66) (n =65)
Trial 3 52%a 65%a 54%a 72%a 57%a 78%a 17% 19%
(n = 48) (n = 46) (n = 46) (n = 47)
a P < 0.05 in comparison with placebo.
b P < 0.05 in comparison with 25 mg.

The estimated probability of achieving an initial headache response over the 4 hours following treatment in pooled Trials 1, 2, and 3 is depicted in Figure 1.

Figure 1: Estimated Probability of Achieving Initial Headache Response Within 4 Hours of Treatment in Pooled Trials 1, 2, and 3a

View Enlarged Table

a The figure shows the probability over time of obtaining headache response (no or mild pain) following treatment with oral sumatriptan. The averages displayed are based on pooled data from the 3 clinical controlled trials providing evidence of efficacy. Kaplan-Meier plot with patients not achieving response and/or taking rescue within 240 minutes censored to 240 minutes.

For patients with migraine-associated nausea, photophobia, and/or phonophobia at baseline, there was a lower incidence of these symptoms at 2 hours (Trial 1) and at 4 hours (Trials 1, 2, and 3) following administration of IMITREX Tablets compared with placebo.

As early as 2 hours in Trials 2 and 3, or as early as 4 hours in Trial 1, through 24 hours following the initial dose of study treatment, patients were allowed to use additional treatment for pain relief in the form of a second dose of study treatment or other medication. The estimated probability of patients taking a second dose or other medication for migraine over the 24 hours following the initial dose of study treatment is summarized in Figure 2.

Figure 2: The Estimated Probability of Patients Taking a Second Dose of IMITREX Tablets or Other Medication to Treat Migraine Over the 24 Hours Following the Initial Dose of Study Treatment in Pooled Trials 1, 2, and 3a

View Enlarged Table

a Kaplan-Meier plot based on data obtained in the 3 clinical controlled trials providing evidence of efficacy with patients not using additional treatments censored to 24 hours. Plot also includes patients who had no response to the initial dose. No remedication was allowed within 2 hours postdose.

There is evidence that doses above 50 mg do not provide a greater effect than 50 mg. There was no evidence to suggest that treatment with IMITREX Tablets 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 subject; 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.
This monograph has been modified to include the generic and brand name in many instances.

 

Patient Information

IMITREX®
(IM-i-trex)
(sumatriptan succinate) Tablets

Read this Patient Information before you start taking IMITREX and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is the most important information I should know about IMITREX?

IMITREX can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death.

Stop taking IMITREX and get emergency medical help right away if you have any of the following symptoms of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

IMITREX is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:

  • have high blood pressure
  • have high cholesterol levels
  • smoke
  • are overweight
  • have diabetes
  • have a family history of heart disease

What is IMITREX?

IMITREX is a prescription medicine used to treat acute migraine headaches with or without aura in adults.

IMITREX is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines.

IMITREX is not used to prevent or decrease the number of migraine headaches you have.

It is not known if IMITREX is safe and effective to treat cluster headaches.

It is not known if IMITREX is safe and effective in children under 18 years of age.

Who should not take IMITREX?

Do not take IMITREX if you have:

  • heart problems or a history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidneys (peripheral vascular disease)
  • uncontrolled high blood pressure
  • severe liver problems
  • hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
  • taken any of the following medicines in the last 24 hours:
    • almotriptan (AXERT®)
    • eletriptan (RELPAX®)
    • frovatriptan (FROVA®)
    • naratriptan (AMERGE®)
    • rizatriptan (MAXALT®, MAXALT-MLT®)
    • sumatriptan and naproxen (TREXIMET®)
    • ergotamines (CAFERGOT®, ERGOMAR®, MIGERGOT®)
    • dihydroergotamine (D.H.E. 45®, MIGRANAL®)
      Ask your healthcare provider if you are not sure if your medicine is listed above.
  • an allergy to sumatriptan or any of the ingredients in IMITREX. See the end of this leaflet for a complete list of ingredients in IMITREX.

What should I tell my healthcare provider before taking IMITREX?

Before you take IMITREX, tell your healthcare provider about all of your medical conditions, including if you:

  • have high blood pressure
  • have high cholesterol
  • have diabetes
  • smoke
  • are overweight
  • have heart problems or family history of heart problems or stroke
  • have kidney problems
  • have liver problems
  • have had epilepsy or seizures
  • are not using effective birth control
  • become pregnant while taking IMITREX.
  • are breastfeeding or plan to breastfeed. IMITREX passes into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take IMITREX.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

IMITREX and certain other medicines can affect each other, causing serious side effects.

Especially tell your healthcare provider if you take anti-depressant medicines called:

  • selective serotonin reuptake inhibitors (SSRIs)
  • serotonin norepinephrine reuptake inhibitors (SNRIs)
  • tricyclic antidepressants (TCAs)
  • monoamine oxidase inhibitors (MAOIs)

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take IMITREX?

  • Certain people should take their first dose of IMITREX in their healthcare provider's office or in another medical setting. Ask your healthcare provider if you should take your first dose in a medical setting.
  • Take IMITREX exactly as your healthcare provider tells you to take it.
  • Your healthcare provider may change your dose. Do not change your dose without first talking to your healthcare provider.
  • Take IMITREX Tablets whole with water or other liquids.
  • If you do not get any relief after your first tablet, do not take a second tablet without first talking with your healthcare provider.
  • If your headache comes back or you only get some relief from your headache, you can take a second tablet 2 hours after the first tablet.
  • Do not take more than 200 mg of IMITREX Tablets in a 24-hour period.
  • If you take too much IMITREX, call your healthcare provider or go to the nearest hospital emergency room right away.
  • You should write down when you have headaches and when you take IMITREX so you can talk with your healthcare provider about how IMITREX is working for you.

What should I avoid while taking IMITREX?

IMITREX can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.

What are the possible side effects of IMITREX?

IMITREX may cause serious side effects. See "What is the most important information I should know about IMITREX?"

These serious side effects include:

  • changes in color or sensation in your fingers and toes (Raynaud's syndrome)
  • stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:
    • sudden or severe stomach pain
    • stomach pain after meals
    • weight loss
    • nausea or vomiting
    • constipation or diarrhea
    • bloody diarrhea
    • fever
  • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
    • cramping and pain in your legs or hips
    • feeling of heaviness or tightness in your leg muscles
    • burning or aching pain in your feet or toes while resting
    • numbness, tingling, or weakness in your legs
    • cold feeling or color changes in 1 or both legs or feet
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • medication overuse headaches. Some people who use too many IMITREX tablets may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with IMITREX.
  • serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using IMITREX, especially if IMITREX is used with anti-depressant medicines called SSRIs or SNRIs.
    Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:
    • mental changes such as seeing things that are not there (hallucinations), agitation, or coma
    • fast heartbeat
    • changes in blood pressure
    • high body temperature
    • tight muscles
    • trouble walking
  • seizures. Seizures have happened in people taking IMITREX who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take IMITREX.

The most common side effects of IMITREX Tablets include:

  • tingling or numbness in your fingers or toes
  • warm or cold feeling
  • feeling weak, drowsy, or tired
  • pain, discomfort, or stiffness in your neck, throat, jaw, or chest
  • dizziness

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of IMITREX. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store IMITREX Tablets?

Store IMITREX between 36°F to 86°F (2°C to 30°C).

Keep IMITREX and all medicines out of the reach of children.

General information about the safe and effective use of IMITREX.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use IMITREX for a condition for which it was not prescribed. Do not give IMITREX to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about IMITREX. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about IMITREX that is written for healthcare professionals.

For more information, go to www.gsk.com or call 1-888-825-5249.

What are the ingredients in IMITREX Tablets?

Active ingredient: sumatriptan succinate

Inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium bicarbonate 100-mg tablets also contain hypromellose, iron oxide, titanium dioxide, and triacetin.

This Patient Information has been approved by the U.S. Food and Drug Administration.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

SUMATRIPTAN TABLET - ORAL

 

(SOO-ma-TRIP-tan)

 

COMMON BRAND NAME(S): Imitrex

 

USES: Sumatriptan is used to treat migraines. It helps to relieve headache, pain, and other migraine symptoms (including nausea, vomiting, sensitivity to light/sound). Prompt treatment helps you return to your normal routine and may decrease your need for other pain medications. Sumatriptan belongs to a class of drugs known as triptans. It affects a certain natural substance (serotonin) that causes narrowing of blood vessels in the brain. It may also relieve pain by affecting certain nerves in the brain.

Sumatriptan does not prevent future migraines or lessen how often you get migraine attacks.

 

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking sumatriptan and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, at the first sign of a migraine. The dosage is based on your medical condition and response to treatment. If there is no improvement in your symptoms, do not take more doses of this medication before talking to your doctor. If your symptoms are only partly relieved, or if your headache comes back, you may take another dose at least two hours after the first dose. Do not take more than 200 milligrams in a 24-hour period.

This medication may also be used as a backup for sumatriptan injection. If your symptoms are only partly relieved or your headache comes back, you may take a dose of sumatriptan by mouth at least two hours after the injection, up to a maximum of 100 milligrams in a 24-hour period.

If you have a higher risk for heart problems (see Precautions), your doctor may perform a heart exam before you start taking sumatriptan. He/she may also direct you to take your first dose of this medication in the office/clinic to monitor for serious side effects (such as chest pain). Talk to your doctor for details.

Overuse of drugs to treat sudden migraine attacks can sometimes lead to worsening of headache (medication overuse headache) or rebound headache. Therefore, do not use this medication more often or for longer than prescribed. Tell your doctor if you need to use this medication more often, if the medication is not working as well, or if you have more frequent or worse headaches. Your doctor may need to change your medication and/or add another medication to help prevent headaches.

Consumer Overview Side Effect

SIDE EFFECTS: Flushing, feelings of tingling/numbness/prickling/heat, tiredness, weakness, drowsiness, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: blue fingers/toes/nails, cold hands/feet, hearing changes, mental/mood changes.

Chest/jaw/neck tightness can commonly occur soon after using sumatriptan. Only rarely are these signs of a serious condition. However, you may not be able to tell it apart from a serious reaction due to a lack of blood flow to the heart, brain, or other parts of the body. Get medical help right away if you have any very serious side effects, including: chest pain, jaw/left arm pain, fainting, fast/irregular/pounding heartbeat, vision changes, weakness on one side of the body, confusion, slurred speech, sudden or severe stomach/abdominal pain, bloody diarrhea, change in the amount of urine.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Imitrex (sumatriptan succinate) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using sumatriptan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (for example, in your legs, arms/hands, or stomach), certain types of headaches (hemiplegic or basilar migraine), heart problems (such as chest pain, irregular heartbeat, previous heart attack), liver disease, seizure, stroke or "mini-stroke" (transient ischemic attack).

Certain conditions can increase your risk for heart problems. Tell your doctor if you have any of these conditions, including: high blood pressure, high cholesterol, diabetes, family history of heart disease, overweight, smoker, postmenopausal (women), age more than 40 years (men).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

The risk of heart disease, liver disease, and high blood pressure increases with age. Older adults may be more sensitive to the side effects of this drug, especially increased blood pressure and heart problems.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk in small amounts. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Do not take any MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

If you also take any ergotamine medication (such as dihydroergotamine or methysergide) or other "triptan" drugs (such as zolmitriptan, rizatriptan), you will need to separate your sumatriptan dose from your dose of these other medications to lessen the chance of serious side effects. Ask your doctor how long you should wait between your doses of these drugs.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

Certain foods, beverages, or food additives (such as red wine, cheese, chocolate, monosodium glutamate) as well as lifestyle patterns such as irregular eating/sleeping habits or stress may bring on a migraine headache. Avoiding these "triggers" may help lessen migraine attacks. Consult your doctor for more details.

Laboratory and/or medical tests (such as blood pressure) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: Not applicable. (See How to Use section.)

 

STORAGE: Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

Information last revised October 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Imitrex, Imitrex Nasal

Generic Name: sumatriptan (oral/nasal) (Pronunciation: soo ma TRIP tan)

  • What is sumatriptan (Imitrex)?
  • What are the possible side effects of sumatriptan (Imitrex)?
  • What is the most important information I should know about sumatriptan (Imitrex)?
  • What should I discuss with my healthcare provider before using sumatriptan (Imitrex)?
  • How should I use sumatriptan (Imitrex)?
  • What happens if I miss a dose (Imitrex)?
  • What happens if I overdose (Imitrex)?
  • What should I avoid while using sumatriptan (Imitrex)?
  • What other drugs will affect sumatriptan (Imitrex)?
  • Where can I get more information?

What is sumatriptan (Imitrex)?

Sumatriptan is a headache medicine that narrows blood vessels around the brain. Sumatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Sumatriptan is used to treat migraine headaches. Sumatriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Sumatriptan should not be used to treat a common tension headache, a headache that causes loss of movement on one side of your body, or any headache that seems to be different from your usual migraine headaches. Use this medication only if your condition has been confirmed by a doctor as migraine headaches.

Sumatriptan may also be used for purposes not listed in this medication guide.

Imitrex 100 mg

triangular, pink, imprinted with IMITREX, 100

What are the possible side effects of sumatriptan (Imitrex)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sumatriptan and call your doctor if you have a serious side effect such as:

  • feeling of pain or tightness in your jaw, neck, or throat;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • sudden and severe stomach pain and bloody diarrhea;
  • seizure (convulsions);
  • numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or
  • (if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Less serious side effects may include:

  • mild headache (not a migraine);
  • pressure or heavy feeling in any part of your body;
  • feeling hot or cold;
  • dizziness, spinning sensation;
  • drowsiness;
  • nausea, vomiting, drooling;
  • unusual taste in your mouth after using the nasal spray;
  • burning, numbness, pain or other irritation in your nose or throat after using the nasal spray; or
  • warmth, redness, or mild tingling under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Imitrex (sumatriptan succinate) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about sumatriptan (Imitrex)?

You should not use this medication if you are allergic to sumatriptan, if you have any history of heart disease, or if you have coronary heart disease, angina, blood circulation problems, lack of blood supply to the heart, uncontrolled high blood pressure, severe liver disease, ischemic bowel disease, a history of a heart attack or stroke, or if your headache seems to be different from your usual migraine headaches.

Do not use sumatriptan within 24 hours before or after using another migraine headache medicine, including sumatriptan injection, almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), rizatriptan (Maxalt), naratriptan (Amerge), zolmitriptan (Zomig), or ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

Do not use sumatriptan if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days.

Before using sumatriptan, tell your doctor if you have liver or kidney disease, seizures, high blood pressure, a heart rhythm disorder, or coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

Also tell your doctor if you are taking an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

Sumatriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

After taking a sumatriptan tablet, you must wait two (2) hours before taking a second tablet. Do not take more than 200 mg of sumatriptan tablets in 24 hours.

After using sumatriptan nasal spray, you must wait two (2) hours before using a second spray. Do not use more than 40 mg of sumatriptan nasal spray in 24 hours.

Side Effects Centers
  • Imitrex Nasal Spray
  • Imitrex

Patient Detailed How Take

What should I discuss with my healthcare provider before using sumatriptan (Imitrex)?

You should not use this medication if you are allergic to sumatriptan, or if you have:

  • coronary heart disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;
  • a history of heart disease, heart attack, or stroke, including "mini-stroke";
  • severe or uncontrolled high blood pressure;
  • severe liver disease;
  • ischemic bowel disease; or
  • a headache that seems different from your usual migraine headaches.

Do not use sumatriptan if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days.

To make sure you can safely use sumatriptan, tell your doctor if you have any of these other conditions:

  • liver disease;
  • kidney disease;
  • epilepsy or other seizure disorder;
  • high blood pressure, a heart rhythm disorder; or
  • coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

FDA pregnancy category C. It is not known whether sumatriptan will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Your name may need to be listed on a sumatriptan pregnancy registry when you start using this medication.

Sumatriptan can pass into breast milk and may harm a nursing baby. Do not breast-feed within 12 hours after using sumatriptan. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

This medicine should not be given to anyone under 18 or over 65 years of age.

How should I use sumatriptan (Imitrex)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Overuse of migraine headache medicine can actually make your headaches worse.

Use sumatriptan as soon as you notice headache symptoms, or after an attack has already begun.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to see if you have any serious side effects.

Take one sumatriptan tablet whole with a full glass of water. Do not split the tablet.

After taking a tablet: If your headache does not completely go away, or goes away and comes back, take a second tablet two (2) hours after the first. Do not take more than 200 mg of sumatriptan oral tablets in 24 hours. If your symptoms have not improved, contact your doctor before taking any more tablets.

Sumatriptan nasal spray comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. Blow your nose to clear your nasal passages before using the nasal spray. Try not to sneeze or blow your nose just after using the spray.

After using the nasal spray: If your headache does not completely go away after using the spray, call your doctor before using a second spray of sumatriptan. If your headache goes away and then comes back, you may use a second spray if it has been at least two hours since you used the first spray. Do not use more than 40 mg of sumatriptan nasal spray in 24 hours. If your symptoms do not improve, contact your doctor before using any more sprays.

Contact your doctor if you have more than four headaches in one month (30 days).

Store sumatriptan at room temperature away from moisture, heat, and light.

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What happens if I miss a dose (Imitrex)?

Since sumatriptan is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using sumatriptan.

After taking a sumatriptan tablet, you must wait two (2) hours before taking a second tablet. Do not take more than 200 mg of sumatriptan tablets in 24 hours.

After using sumatriptan nasal spray, you must wait two (2) hours before using a second spray. Do not use more than 40 mg of sumatriptan nasal spray in 24 hours.

What happens if I overdose (Imitrex)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include tremors or shaking, skin redness, breathing problems, blue-colored lips or fingernails, vision problems, watery eyes or mouth, weakness, lack of coordination, or seizure (convulsions).

What should I avoid while using sumatriptan (Imitrex)?

Do not use sumatriptan within 24 hours before or after using another migraine headache medicine, including:

  • sumatriptan injection, almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), or zolmitriptan (Zomig); or
  • ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

Sumatriptan may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What other drugs will affect sumatriptan (Imitrex)?

Tell your doctor about all other medicines you use, especially:

  • an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

This list is not complete and other drugs may interact with sumatriptan. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about sumatriptan.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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