Onzetra Xsail (Nasal)
Generic Name: sumatriptan (Nasal route)
Commonly used brand name(s)
In the U.S.
- Onzetra Xsail
Available Dosage Forms:
Therapeutic Class: Antimigraine
Pharmacologic Class: Serotonin Receptor Agonist, 5-HT1
Uses For Onzetra Xsail
Sumatriptan nasal powder and spray are used to treat acute migraine headaches with or without aura 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 Onzetra Xsail
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 powder and spray in the pediatric population. Safety and efficacy have not been established.
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.
|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
- 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.
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 Onzetra Xsail. Please read with care.
Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Using too much sumatriptan may increase the chance of side effects.
This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.
Do not use this medicine for a headache that is different from your usual migraines. 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 take if sumatriptan does not work. After you take 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, you may use one additional dose of sumatriptan 2 hours after the first dose. Do not use more than 3 doses in any 24-hour period.
This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
To use the nasal powder:
- This medicine is given through Xsail™ breath-powered delivery device.
- Remove the disposable nosepiece from its foil pouch, then remove the clear device cap from the reusable delivery device, and click the nosepiece into the device body. Use the nosepiece immediately after removing from the foil pouch.
- Fully press and release the white piercing button on the device body to pierce the capsule inside the nosepiece. Press it only once.
- Insert the nosepiece into the nostril so that it makes a tight seal. The device is then rotated and the mouthpiece inserted between the lips.
- Blow forcefully through the mouthpiece to deliver the medicine into the nasal cavity. Do not press the white button while blowing.
- Press the clear tab to remove the first nosepiece. Throw the used nosepiece in the trash can.
- Repeat the same steps using a second nosepiece into the other nostril to complete the recommended dose.
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 powder):
- For migraine headaches:
- Adults—22 milligrams (mg) (1 nosepiece in each nostril, total of 2 nosepieces) per day. Another dose (22 mg) may be used as long as it has been at least 2 hours since the last spray. Do not use more than 44 mg (4 nosepieces) in a 24-hour period (one day).
- Children—Use and dose must be determined by your doctor.
- For migraine headaches:
- 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). Another spray (5 mg, 10 mg, or 20 mg) may be used 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:
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not store in the refrigerator or freezer.
Precautions While Using Onzetra Xsail
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.
Onzetra Xsail 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
- Changes in skin color on the face
- chest pain (severe)
- convulsions (seizures)
- fast or irregular breathing
- puffiness or swelling of the eyelids, area around the eyes, face, or lips
- troubled breathing
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.
See also: Side effects (in more detail)
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