Brand Name
US Brand Name
Alsuma
Imitrex
Imitrex Stat Dose Refill
Sumavel DosePro
Zembrace Symtouch
Description
Sumatriptan injection is used to treat acute migraine attacks and cluster headaches in adults. 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 use 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 any kind of pain other than 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 in those who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks of using this medicine as well as its benefits.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
- Kit
Before Using
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 injection in the pediatric population. Use of Imitrex® is not recommended in children. Safety and efficacy have not been established.
Geriatric
Use of sumatriptan injection 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.
Breastfeeding
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.
Drug Interactions
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
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), history of or
- Heart attack, history of or
- Heart or blood vessel disease 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
- Heart rhythm problems (eg, ventricular fibrillation, ventricular tachycardia) or
- Seizures or epilepsy, history of or
- Stomach or bowel 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) or
- Obesity or
- Raynaud's syndrome—Use with caution. May be at increased risk for more serious side effects.
Proper Use
Do not use this medicine for a migraine or cluster headache that is different from your usual headaches. Instead, check with your doctor.
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 use 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 1 hour before using 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 use more than 2 doses in 24 hours.
This medicine is given as a shot under your skin (usually on the stomach, thighs, or upper arms). Sumatriptan injection may sometimes be given at home to patients who do not need to be in a hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.
If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.
This medicine is available in 3 forms. You may use a single dose vial, prefilled syringe, or a prefilled autoinjector.
Do not use the medicine if it is dark colored or cloudy.
After you have finished injecting the medicine, be sure to follow the precautions in the patient directions about safely discarding the empty cartridge and the needle. Always return the empty cartridge and needle to their container before discarding them. Do not throw away the autoinjector unit, because refills are available.
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 injection dosage form:
- For migraine or cluster headaches:
- Adults—
- Alsuma™, Imitrex®, and Sumavel®: 4 or 6-milligram (mg) injected under the skin. If the headache comes back after being relieved, one more dose may be injected after 1 hour. Do not use more than 2 doses of 6-mg, or 3 doses of 4-mg in any 24-hour period.
- Zembrace™ Symtouch™: 3 milligram (mg) injected under the skin. If the headache comes back after being relieved, one more dose may be injected after 1 hour. Do not use more than 4 doses of 3-mg in any 24-hour period.
- Children—Use and dose must be determined by your doctor.
- Adults—
- For migraine or cluster headaches:
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.
Throw away used syringes or autoinjectors in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
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 and to check for unwanted effects.
Check with your doctor if you have used this medicine and have not had good relief. Also, check with your doctor if your migraine or cluster headaches are worse, or if they are occurring more often, than before you started receiving this medicine.
You should not receive this medicine if you are using or 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 used other triptan migraine medicines. 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®).
Check with your doctor if you have used sumatriptan and your migraine got worse or started occurring more often.
The needle shield of the Imitrex® prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before receiving this medicine.
This medicine may increase your risk of having heart rhythm problems, 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, 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 doctor may want you to have your eyes 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 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 used 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.
This medicine may cause serious types of allergic reaction, including anaphylaxis and angioedema. These can be life-threatening and require 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 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 avoid alcoholic beverages, especially during a headache.
This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Side Effects
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
- Blurred vision
- chest pain or discomfort
- chills
- confusion
- difficult or labored breathing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fainting
- fast, pounding, or irregular heartbeat or pulse
- headache
- nervousness
- pounding in the ears
- shakiness in the legs, arms, hands, or feet
- slow heartbeat
- sweating
- tight feeling in the head
- tightness or pressure in the chest
- trembling or shaking of the hands or feet
- unusual tiredness or weakness
Rare
- Black, tarry stools
- blood in the urine
- blood in the vomit
- burning while urinating
- cough
- decreased urination
- depression of the skin
- diarrhea
- dry mouth
- feeling of warmth or heat
- fever
- flushing or redness of the skin, especially on the face and neck
- general feeling of discomfort or illness
- inability to move the eyes
- inability to move the legs or arms
- increase in heart rate
- increased blinking or spasms of the eyelid
- increased sensitivity to pain
- increased sensitivity to touch
- indentation of the skin
- joint pain
- loss of appetite
- muscle aches and pains
- nausea
- pain in the groin or genitals
- paleness of the skin
- paleness or cold feeling in the fingertips and toes
- paralysis of one side of the body
- rapid breathing
- runny nose
- severe or continuing stomach pain
- sharp back pain just below the ribs
- shivering
- sore throat
- sticking out of the tongue
- sunken eyes
- thirst
- tingling in the hands and feet
- tingling or pain in the fingers or toes when exposed to cold
- trouble sleeping
- trouble speaking or swallowing
- uncontrolled twisting movements of the neck, trunk, arms, or legs
- unusual facial expressions
- vomiting
- wrinkled skin
Incidence not known
- Agitation
- back, leg, or stomach pains
- bleeding gums
- blood in the stools
- bluish color of the fingernails, lips, skin, palms, or nail beds
- changes in skin color
- changes in vision
- decreased awareness or responsiveness
- depression
- double vision
- general body swelling
- headache, sudden, severe, and continuing
- high fever
- hives or itching
- hostility
- inability to speak
- irritability
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss of ability to use or understand speech or language
- loss of appetite
- loss of consciousness
- loss of vision
- migraine headache
- muscle twitching
- noisy breathing
- nosebleeds
- overactive reflexes
- pain, tenderness, or swelling of the foot or leg
- pinpoint red spots on the skin
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- rectal bleeding
- redness, soreness, or itching skin
- restlessness
- seizures
- severe or sudden headache
- severe sleepiness
- slurred speech
- sores, ulcers, or white spots on the lips or in the mouth
- sores, welting, or blisters
- stomach pain and tenderness
- swelling of the face, ankles, hands, feet, or lower legs
- swollen glands
- talking or acting with excitement you cannot control
- temporary blindness
- trembling or shaking
- twitching
- unexplained bleeding or bruising
- unusual bleeding or bruising
- unusual drowsiness, dullness, or feeling of sluggishness
- unusually warm skin
- weakness in the arm or leg on one side of the body, sudden and severe
- weight loss
- yellowing of the eyes or skin
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:
More common
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- burning or tingling sensation
- drowsiness
- feeling of constant movement of self or surroundings
- feeling of warmth
- redness of the face, neck, arms, and occasionally, upper chest
- relaxed and calm feeling
- sensation of spinning
- sleepiness
Less common
- Anxiety
- bad, unusual, or unpleasant (after) taste
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in color vision
- change in taste
- difficulty seeing at night
- difficulty with moving
- discomfort in the jaw, nasal cavity, or throat
- false or unusual sense of well-being
- feeling strange
- heartburn
- increased sensitivity of the eyes to sunlight
- joint pain, stiffness, or swelling
- mental confusion
- muscle aching or cramping
- neck pain or stiffness
- red, sore eyes
- stomach discomfort
- swollen joints
- tearing of the eyes
- thirst
- weakness
Rare
- Backache
- belching
- bloated or full feeling
- changes in patterns and rhythms of speech
- cramps
- dry heaves
- excess air or gas in the stomach or bowels
- extreme thirst
- heavy bleeding
- hiccups
- hunger
- increased thirst
- muscle tiredness
- muscle twitching or jerking
- pain
- passing gas
- reduced appetite
- rhythmic movement of muscles
- severe stomach pain with nausea and vomiting
- tenderness of the skin
Incidence not known
- Deafness
- panic
- severe sunburn
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.
CON-XXXXXXXX
