Pronunciation:

soo-ma-TRIP-tan

Brand Names:

• Imitrex

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antimigraine

Pharmacologic—

Serotonin Receptor Agonist, 5-HT1

Uses of This Medicine:

Sumatriptan is used to treat acute migraine headaches in adults. It is not used to prevent migraine headaches and is not used for cluster headaches. Sumatriptan works in the brain to relieve the pain from migraine headaches. It belongs to the group of medicines called triptans.

Many people find that their headaches go away completely after they take sumatriptan. Other people find that their headaches are much less painful, and that they are able to go back to their normal activities even though their headaches are not completely gone. Sumatriptan often relieves other symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.

Sumatriptan is not an ordinary pain reliever. It will not relieve pain other than from migraine headaches. This medicine is usually used for people whose headaches are not relieved by acetaminophen, aspirin, or other pain relievers.

Sumatriptan has caused serious side effects in some people, especially people who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks of using this medicine as well as the benefits that it can have.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

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

Older adults—

Use of sumatriptan is 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.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other 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
• Nialamide
• Phenelzine
• Procarbazine
• Rasagiline
• Rizatriptan
• Safinamide
• 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
• Benzhydrocodone
• Benzphetamine
• Buprenorphine
• Bupropion
• Butorphanol
• Citalopram
• Clomipramine
• Codeine
• Desipramine
• Desvenlafaxine
• Dexfenfluramine
• Dextroamphetamine
• Dextromethorphan
• Dibenzepin
• Dihydrocodeine
• Dolasetron
• Doxepin
• Duloxetine
• Escitalopram
• Fenfluramine
• Fentanyl
• Fluoxetine
• Fluvoxamine
• Gepirone
• Granisetron
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Imipramine
• Lasmiditan
• Levomilnacipran
• Levorphanol
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lorcaserin
• Melitracen
• Meperidine
• Metaxalone
• Methamphetamine
• Milnacipran
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nefazodone
• Nortriptyline
• Ondansetron
• 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

Other interactions—

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) or
• Cerebrovascular disease (eg, stroke, transient ischemic attack), or history of or
• Heart attack, history of or
• Heart or blood vessel problems or
• Hemiplegic migraine (migraine with some paralysis) 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.

• Seizures or epilepsy, history of or
• Stomach or intestinal bleeding—Use with caution. May make these conditions worse.

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

Proper Use of This Medicine:

Do not use this medicine for a headache that is different from your usual migraines. Talk to your doctor about what to do for regular headaches.

To relieve your migraine as soon as possible, use this medicine as soon as the headache pain begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using sumatriptan.

Ask your doctor ahead of time about any other medicine you might take if sumatriptan does not work. After you use the other medicine, check with your doctor as soon as possible. Headaches that are not relieved by sumatriptan are sometimes caused by conditions that need other treatment.

If you feel much better after a dose of sumatriptan, but your headache comes back or gets worse after a while, wait at least 2 hours before taking another dose. However, use this medicine only as directed by your doctor. Do not use more of it, and do not use it more often, than directed. Using too much sumatriptan may increase the chance of side effects. Do not take more than 200 mg in 24 hours.

Swallow the tablet whole with water or other liquids. Do not crush, break, or chew it.

You may take the tablet with or without food.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For migraine headaches:
    • Adults—25, 50, or 100 milligrams (mg) as a single dose. If you get some relief, or if the migraine comes back after being relieved, another dose may be taken 2 hours after the last dose. Do not take more than 200 mg in any 24-hour period.
    • Children—Use and dose must be determined by your doctor.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

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.

Check with your doctor if you used this medicine and it did not work. Also, check with your doctor if your migraine headaches are worse or if they are occurring more often since you started using this medicine.

You should not use this medicine if you have used an MAO inhibitor (MAOI) such as phenelzine (Nardil®) or tranylcypromine (Parnate®) within the past 2 weeks. Do not use this medicine if you have taken other triptan migraine medicines or ergot-type medicines within the past 24 hours. Some examples of triptan medicines are almotriptan (Axert®), eletriptan (Relpax®), naratriptan (Amerge®), or zolmitriptan (Zomig®). Some examples of ergot-type medicines are dihydroergotamine (D.H.E. 45®, Migranal®), ergotamine (Bellergal®, Cafergot®, Ergomar®, Wigraine®), or methysergide (Sansert®).

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, high cholesterol, 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.

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).

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 your 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, 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.

This medicine may cause a 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, wheezing, 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 effects occur, get emergency help at once.

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 not alert.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Abdominal or stomach pain

anxiety

blurred vision

changes in patterns and rhythms of speech

chest pain or tightness

chills

confusion

dizziness

fast, slow, irregular, pounding, or racing heartbeat or pulse

headache

muscle cramps and stiffness

neck, throat, or jaw pain

nightmares

shivering

sweating

swelling of the fingers, hands, feet, or lower legs

tightness in the chest

trouble breathing

Rare

Blindness

chest pain or discomfort

chest tightness or heaviness

flushing or redness of the skin, especially on the face and neck

increased blinking or spasms of the eyelid

itching, pain, redness, or swelling

lightheadedness, dizziness, or fainting

nerve pain

severe numbness, especially on one side of the face or body

severe or continuing stomach pain

trouble speaking or swallowing

twitching

unusual bleeding or bruising

vomiting of blood or material that looks like coffee grounds

weakness of the arms and legs

Incidence not known

Agitation

back, leg, or stomach pains

bleeding gums

changes in vision

muscle twitching

pinpoint red spots on the skin

poor coordination

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

restlessness

skin rash, hives, or itching

unexplained bleeding or bruising

unusually warm skin

weakness in the arm or leg on one side of the body, sudden and severe

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in color vision

change in hearing

difficulty with concentrating

drowsiness

heartburn

increased sensitivity of the eyes to sunlight

joint pain

muscle aching or cramping

muscle stiffness or tightness

swollen joints

trouble sleeping

Rare

Aggressiveness

belching

change in taste

feeling halos around lights

increased sensitivity to pain

loss of appetite

numbness, pain, tingling, or weakness

stomach discomfort or upset

tingling in the hands and feet

tunnel vision

weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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