Imitrex

Yes

• The recommended oral dose is 25-100 mg and the maximum dose is 200 mg daily.
• The recommended intranasal dose is 5-20 mg and the maximum dose is 40 mg daily.
• The recommended injection dose is 4 or 6 mg injected under the skin. T
• he maximum dose is two 6 mg injections separated by 1 hour.
• The recommended dose for the Zecuity patch is one patch applied to dry intact, non-irritated skin on the upper arm or thigh on a site that is relatively hair free and is without scars, tattoos, abrasions, or other skin conditions.

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.

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

Sumatriptan and other medicines may affect each other, causing side effects.

Especially tell your healthcare provider if you take:

• selective serotonin reuptake inhibitors (SSRIs) such as escitalopram (Lexapro), sertraline (Zoloft), citalopram (Celexa), paroxetine (Paxil), fluoxetine (Prozac, Sarafem), and fluvoxamine (Luvox)
• serotonin-norepinephrine reuptake inhibitors (SNRIs) such as duloxetine (Cymbalta) venlafaxine (Effexor)
• monoamine oxidase inhibitors (MAOIs) such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• other ergot-containing medications such as dihydroergotamine (D.H.E. 45, MIGRANAL) or methysergide
• other triptans such as sumatriptan (Imitrex, Treximet), eletriptan (Relpax), almotriptan (Axert), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), and zolmitriptan (Zomig)

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.

If you have taken more sumatriptan than has been prescribed for you, contact either your doctor, hospital emergency department, or your local Poison Control Center.

Selective serotonin (5-hydroxytryptamine; 5-HT) type 1B and 1D receptor agonist (“triptan”).1 2 3 4 5 6 7 8 223 224 268

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sumatriptan nasal powder and spray in the pediatric population. Safety and efficacy have not been established.

Geriatric

Use of sumatriptan nasal powder and spray are not recommended in elderly patients with kidney problems, heart or blood vessel disease, or high blood pressure, and should not be used by elderly patients with liver problems.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Almotriptan
• Bromocriptine
• Dihydroergotamine
• Eletriptan
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Frovatriptan
• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Methylergonovine
• Methysergide
• Moclobemide
• Naratriptan
• Phenelzine
• Procarbazine
• Rasagiline
• Rizatriptan
• Selegiline
• Tranylcypromine
• Zolmitriptan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Benzphetamine
• Buprenorphine
• Butorphanol
• Citalopram
• Clomipramine
• Codeine
• Dasabuvir
• Desipramine
• Desvenlafaxine
• Dexfenfluramine
• Dextroamphetamine
• Dibenzepin
• Dihydrocodeine
• Dolasetron
• Doxepin
• Duloxetine
• Escitalopram
• Fentanyl
• Fluoxetine
• Fluvoxamine
• Granisetron
• Hydrocodone
• Hydromorphone
• Imipramine
• Levomilnacipran
• Levorphanol
• Lisdexamfetamine
• Lofepramine
• Lorcaserin
• Melitracen
• Meperidine
• Methamphetamine
• Milnacipran
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nefazodone
• Nortriptyline
• Opipramol
• Oxycodone
• Oxymorphone
• Palonosetron
• Paroxetine
• Pentazocine
• Protriptyline
• Reboxetine
• Remifentanil
• Sertraline
• Sibutramine
• St John's Wort
• Sufentanil
• Tapentadol
• Tianeptine
• Tramadol
• Trazodone
• Trimipramine
• Venlafaxine
• Vilazodone
• Vortioxetine
• Ziprasidone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (chest pain) or
• Arrhythmia (heart rhythm problem) or
• Basilar migraine (migraine with vision and hearing problems), history of or
• Heart attack, history of or
• Heart or blood vessel problems or
• Hemiplegic migraine (migraine with some paralysis), history of or
• Hypertension (high blood pressure), uncontrolled or
• Ischemic bowel disease (bowels have low blood supply) or
• Liver disease, severe or
• Peripheral vascular disease (clogged arteries) or
• Stroke, history of or
• Transient ischemic attack (TIA), history of or
• Wolff-Parkinson-White Syndrome (heart rhythm problem)—Should not be used in patients with these conditions.

• Bleeding problems or
• Blurred vision or
• CNS disorders or
• Kidney disease or
• Liver disease or
• Seizures or epilepsy, history of or
• Stomach or intestinal bleeding—Use with caution. May make these conditions worse.

• Coronary artery disease, family history of or
• Diabetes or
• Hypercholesterolemia (high cholesterol in the blood) or
• Hypertension (high blood pressure), controlled or
• Obesity or
• Raynaud's syndrome—Use with caution. May be at increased risk for certain side effects.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

Do not use this medicine if you have taken other triptan or ergot-type migraine medicines within the past 24 hours. Some examples of triptan medicines are almotriptan (Axert®), eletriptan (Relpax®), frovatriptan (Frova®), naratriptan (Amerge®), rizatriptan (Maxalt®), sumatriptan/naproxen (Treximet®), or zolmitriptan, (Zomig®). Some examples of ergot-type medicines are dihydroergotamine (D.H.E. 45®, Migranal®), ergotamine (Bellergal®, Cafergot®, Ergomar®, Wigraine®), or methysergide (Sansert®). Also, do not use this medicine if you have taken a MAO-A inhibitor (eg, Nardil®, Parnate®) in the past 14 days.

This medicine may cause serious type of allergic reaction called anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.

Check with your doctor if you have used this medicine and your migraine got worse or started occurring more often.

This medicine may cause problems if you have heart disease. If your doctor thinks you might have a problem with this medicine, he or she may want you to take your first dose in the doctor’s office or clinic.

This medicine may increase your risk of having abnormal heart rhythm, heart attack, angina, or stroke. This is more likely to occur if you or a family member already has heart disease, if you have diabetes, high blood pressure, or if you smoke. Call your doctor right away if you have any symptoms of a heart problem, such as chest pain or discomfort, an uneven heartbeat, nausea or vomiting, pain or discomfort in the shoulders, arms, jaw, back, or neck, shortness of breath, or sweating. Call your doctor right away if you have any symptoms of a stroke, such as confusion, difficulty with speaking, double vision, headaches, an inability to move the arms, legs, or facial muscles, an inability to speak, or slow speech.

Check with your doctor right away if you have chest discomfort, jaw or neck tightness after using this medicine. Also, tell your doctor if you have sudden or severe abdominal or stomach pain or bloody diarrhea after using this medicine.

Using sumatriptan alone or in combination with other migraine medicines for 10 or more days per month may lead to worsening of headache. You may keep a headache diary to record the headache frequency and drug use.

Make sure your doctor knows about all the other medicines you are using. Sumatriptan may cause a serious condition called serotonin syndrome when taken with some medicines. This especially includes medicines used to treat depression, such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, olanzapine, paroxetine, sertraline, venlafaxine, Celexa®, Cymbalta®, Effexor®, Lexapro®, Luvox®, Paxil®, Prozac®, Sarafem®, Symbyax®, or Zoloft®. Check with your doctor right away if you have agitation, confusion, diarrhea, excitement while talking that is not normal, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, trembling or shaking that you cannot control, or twitching. These could be symptoms of serotonin syndrome.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your eyes may need to be checked by an ophthalmologist (eye doctor).

Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.

Some people feel dizzy or drowsy during or after a migraine, or using sumatriptan to relieve a migraine. As long as you are feeling dizzy or drowsy, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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.

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 (^) 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 (^) 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).

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 (5.1, 5.2, 5.4, 5.5, 5.8)].

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 (4) and Warnings and Precautions (5.9)].

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 (4), Drug Interactions (7.1, 7.3)].

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 (5.7), Drug Interactions (7.4)].

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 (5.6)].

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 (8.1)].

Nursing Mothers: Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.3)].

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.

Imitrex is a registered trademark of the GlaxoSmithKline group of companies.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2013, GlaxoSmithKline group of companies. All rights reserved.

IMT:4PI

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.

Imitrex, AMERGE, and TREXIMET are registered trademarks of the GlaxoSmithKline group of companies. The other brands listed are trademarks of their respective owners and are not trademarks of GlaxoSmithKline. The makers of these brands are not affiliated with and do not endorse GlaxoSmithKline or its products.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2013, GlaxoSmithKline group of companies. All rights reserved.

November 2013

IMT:4PIL

PRINCIPAL DISPLAY PANEL

NDC 0173-0735-00

Imitrex®

(SUMATRIPTAN SUCCINATE)

TABLETS

25 mg

Rx only

Each tablet contains sumatriptan succinate equivalent to 25 mg of sumatriptan.

9 Tablets

Do not use if package is torn or broken or if you receive fewer tablets than your doctor prescribed.

Made in Canada

©2017 the GSK group of companies.

  10000000146158 Rev. 6/17

PRINCIPAL DISPLAY PANEL

NDC 0173-0736-01

Imitrex®

(SUMATRIPTAN SUCCINATE)

TABLETS

50 mg

Rx only

Each tablet contains sumatriptan succinate equivalent to 50 mg of sumatriptan.

9 Tablets

Do not use if package is torn or broken or if you receive fewer tablets than your doctor prescribed.

Made in Canada

©2017 the GSK group of companies.

  10000000146157 Rev. 6/17

PRINCIPAL DISPLAY PANEL

NDC 0173-0737-01

Imitrex®

(SUMATRIPTAN SUCCINATE)

TABLETS

100 mg

Rx only

Each tablet contains sumatriptan succinate equivalent to 100 mg of sumatriptan.

9 Tablets

Do not use if package is torn or broken or if you receive fewer tablets than your doctor prescribed.

Made in Canada

©2017 the GSK group of companies.

  10000000146401 Rev. 6/17

Imitrex  sumatriptan succinate tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0735 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUMATRIPTAN SUCCINATE (SUMATRIPTAN) SUMATRIPTAN 25 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM   ANHYDROUS DIBASIC CALCIUM PHOSPHATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   SODIUM BICARBONATE

Product Characteristics Color WHITE Score no score Shape TRIANGLE (triangular-shaped) Size 9mm Flavor Imprint Code I;25 Contains

Packaging # Item Code Package Description 1 NDC:0173-0735-00 1 CARTON in 1 CARTON 1 1 BLISTER PACK in 1 CARTON 1 9 TABLET, FILM COATED in 1 BLISTER PACK

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020132 12/17/2003

Imitrex  sumatriptan succinate tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0736 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUMATRIPTAN SUCCINATE (SUMATRIPTAN) SUMATRIPTAN 50 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM   ANHYDROUS DIBASIC CALCIUM PHOSPHATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   SODIUM BICARBONATE

Product Characteristics Color WHITE Score no score Shape TRIANGLE (triangular-shaped) Size 11mm Flavor Imprint Code Imitrex;50 Contains

Packaging # Item Code Package Description 1 NDC:0173-0736-01 1 CARTON in 1 CARTON 1 1 BLISTER PACK in 1 CARTON 1 9 TABLET, FILM COATED in 1 BLISTER PACK

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020132 12/17/2003

Imitrex  sumatriptan succinate tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0737 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUMATRIPTAN SUCCINATE (SUMATRIPTAN) SUMATRIPTAN 100 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM   ANHYDROUS DIBASIC CALCIUM PHOSPHATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   SODIUM BICARBONATE   HYPROMELLOSES   TITANIUM DIOXIDE   TRIACETIN

Product Characteristics Color PINK Score no score Shape TRIANGLE (triangular-shaped) Size 11mm Flavor Imprint Code Imitrex;100 Contains

Packaging # Item Code Package Description 1 NDC:0173-0737-01 1 CARTON in 1 CARTON 1 1 BLISTER PACK in 1 CARTON 1 9 TABLET, FILM COATED in 1 BLISTER PACK

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020132 12/19/2003

Labeler - GlaxoSmithKline LLC (167380711)

Revised: 11/2013   GlaxoSmithKline LLC