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Generic Name: sumatriptan (Nasal route)
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antimigraine
Pharmacologic Class: Serotonin Receptor Agonist, 5-HT1
Uses For Sumavel DosePro
Sumatriptan nasal spray 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 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 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 Sumavel DosePro
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of sumatriptan nasal spray in the pediatric population. Safety and efficacy have not been established.
Use of sumatriptan nasal spray 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.
|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.|
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.
- Ergoloid Mesylates
- Methylene Blue
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.
- St John's Wort
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
- Basilar migraine (migraine with vision and hearing problems) or
- Cerebrovascular disease (e.g., 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)—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, 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. The chance of side effects may be increased. Heart or blood vessel disease sometimes do not cause any symptoms, some people do not know that they have these problems. Before deciding whether you should use this medicine, your doctor may need to do some tests to make sure that you do not have any of these conditions.
Proper Use of sumatriptan
This section provides information on the proper use of a number of products that contain sumatriptan. It may not be specific to Sumavel DosePro. Please read with care.
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. Using sumatriptan during the aura probably will not prevent the headache from occurring. However, even if you do not use sumatriptan until your migraine has been present for several hours, the medicine will still work.
Lying down in a quiet, dark room for a while after you use this medicine may help relieve your migraine.
If you are not much better in 1 or 2 hours after using this medicine, do not use any more of this medicine for the same migraine. A migraine that is not relieved by the first dose of sumatriptan probably will not be relieved by a second dose, either. Ask your doctor ahead of time about other medicine to be taken if sumatriptan does not work. After taking 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. However, even if sumatriptan does not relieve one migraine, it may still relieve the next one.
If you feel much better after a dose of sumatriptan, but your headache comes back or gets worse after a while, you may use more sumatriptan. 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.
Your doctor may direct you to take another medicine to help prevent headaches. It is important that you follow your doctor's directions, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve. This can reduce the amount of sumatriptan or pain relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.
Using this medicine for 10 or more days per month may make your headache worse (medication overuse headache). If your headache becomes worse, call your doctor. It is also important that you write down when you have migraine headaches and when you take this medicine.
This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
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 nasal dosage form (nasal solution):
- For migraine headaches:
- Adults—5 milligrams (mg) (1 spray into one nostril) or 10 mg (2 sprays in one nostril or 1 spray in each nostril) or 20 mg (1 spray into one nostril). If pain is not relieved, another spray (5 mg, 10 mg, or 20 mg) should not be used for the same migraine attack. Another spray (5 mg, 10 mg, or 20 mg) may be used for a migraine that occurs at a later time as long as it has been at least 2 hours since the last spray. Do not use more than 40 mg in a 24-hour period (one day).
- Children—Use and dose must be determined by your doctor.
- For migraine headaches:
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 Sumavel DosePro
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.
You should not use this medicine if you have used an MAO inhibitor (MAOI) such as isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®) within the past 2 weeks. Do not use this medicine if you have taken other migraine medicines (e.g., almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan/naproxen, zolmitriptan, Amerge®, Axert™, Frova®, Maxalt®, Relpax®, Treximet®, or Zomig®) or an ergotamine medicine (e.g., dihydroergotamine, methysergide, Cafergot®, D.H.E. 45®, Ergomar®, Migergot®, or Migranal®) within the past 24 hours.
Check with your doctor if you have used this medicine and your migraine did not go away, or if 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 a heart attack, angina, or stroke. This is more likely to occur if you have diabetes, high blood pressure, or high cholesterol, or if you already have a heart disease or a family history of heart disease, if you smoke, if you are male and over 40 years of age, or if you are female and have gone through menopause. 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.
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.
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 side effects occur, get emergency help at once.
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.
Sumavel DosePro 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
- Chest pain (mild)
- difficulty with swallowing
- heaviness, tightness, or pressure in the chest or neck
- pounding heartbeat
- skin rash, hives, itching, or bumps on the skin
- Chest pain (severe)
- changes in skin color on the face
- convulsions (seizures)
- fast or irregular breathing
- puffiness or swelling of the eyelids, area around the eyes, face, or lips
- shortness of breath, troubled breathing, or wheezing
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
- Burning, discharge, pain, or soreness in the nose
- change in taste
- discomfort in the jaw, mouth, tongue, throat, nose, or sinuses
- feeling cold, “strange,” or weak
- feeling of burning, warmth, heat, numbness, tightness, or tingling
- muscle aches, cramps, or stiffness
- nausea or vomiting
- unusual or unpleasant (after) taste
- Feeling of constant movement of self or surroundings
- sensation of spinning
- burning sensation
- discomfort of the nasal cavity and throat
- general feeling of illness or tiredness
- vision changes
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.
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- Drug class: antimigraine agents