Description
Zolmitriptan nasal spray is used to treat acute migraine headaches in adults and children 12 years of age and older. It is not used to prevent migraine headaches and is not used for cluster headaches. Zolmitriptan 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 zolmitriptan. 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. Zolmitriptan often relieves other symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.
Zolmitriptan 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.
Zolmitriptan 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.
This product is available in the following dosage forms:
- Spray
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
Safety and efficacy of zolmitriptan nasal spray have not been established in pediatric patients younger than 12 years
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of zolmitriptan nasal spray in the elderly. However, elderly patients are more likely to have kidney, liver, or heart disease, which may require caution and an adjustment in the dose for patients receiving zolmitriptan nasal spray.
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
- Cisapride
- Dihydroergotamine
- Eletriptan
- Ergoloid Mesylates
- Ergonovine
- Ergotamine
- Frovatriptan
- Isocarboxazid
- Levomethadyl
- Linezolid
- Mesoridazine
- Methylene Blue
- Methylergonovine
- Methysergide
- Naratriptan
- Phenelzine
- Procarbazine
- Rizatriptan
- Sumatriptan
- Terfenadine
- Thioridazine
- Tranylcypromine
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.
- Acecainide
- Ajmaline
- Alfentanil
- Amiodarone
- Amitriptyline
- Amoxapine
- Amphetamine
- Aprindine
- Azimilide
- Benzhydrocodone
- Benzphetamine
- Bretylium
- Buprenorphine
- Chloroquine
- Citalopram
- Codeine
- Desipramine
- Desvenlafaxine
- Dextroamphetamine
- Dibenzepin
- Dihydrocodeine
- Disopyramide
- Dofetilide
- Dolasetron
- Doxepin
- Dronedarone
- Droperidol
- Duloxetine
- Erythromycin
- Escitalopram
- Fenfluramine
- Fentanyl
- Flecainide
- Fluconazole
- Fluoxetine
- Fluvoxamine
- Foscarnet
- Gemifloxacin
- Gepirone
- Granisetron
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Cimetidine
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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- 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
- Hemiplegic migraine (migraine with some paralysis), history of or
- Hypertension (high blood pressure), uncontrolled or
- Ischemic bowel disease (bowels have low blood supply) 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.
- Coronary artery disease, family history of or
- Diabetes or
- Hypertension (high blood pressure) or
- Obesity or
- Raynaud's syndrome—Use with caution. May be at increased risk for certain side effects.
- Heart rhythm problems (eg, ventricular fibrillation, ventricular tachycardia)—Use with caution. May make these conditions worse.
- Liver disease, moderate or severe—Use is not recommended in patients with this condition.
Proper Use
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 zolmitriptan 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 zolmitriptan for a headache that is different from your usual migraines. Instead, check with your doctor.
To relieve your migraine as soon as possible, use zolmitriptan 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 zolmitriptan.
Ask your doctor ahead of time about any other medicine you might take if zolmitriptan does not work. After you take the other medicine, check with your doctor as soon as possible. Headaches that are not relieved by zolmitriptan are sometimes caused by conditions that need other treatment.
If you feel much better after a dose of zolmitriptan, but your headache comes back or gets worse after a while, you may use one additional dose of zolmitriptan 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. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
To use the nasal spray:
- Do not try to prime the nasal spray or you will lose your dose. The unit contains only 1 spray.
- Gently blow your nose before using the spray.
- Remove the gray protection cap and keep your head in an upright position.
- Close one nostril with your index finger and breathe out gently through your mouth. Either nostril can be used.
- Insert the tip of the nose piece into your nostril and tilt your head slightly. Breathe in gently through your nose and at the same time and slowly release one spray.
- Keep your head slightly tilted back and remove the tip from your nose, and then breathe gently through your mouth for 5 to 10 seconds. You may feel liquid in your nose or the back of your throat. This is normal.
- Throw away the used nasal spray. Do not reuse.
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 nasal dosage form (nasal spray):
- For migraine headaches:
- Adults and children 12 years and older—At first, 2.5 milligrams (mg) (1 spray into one nostril). Another spray (2.5 mg or 5 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.
- The maximum single dose is 5 mg. Do not use more than 10 mg in a 24-hour period (one day).
- For migraine headaches:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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
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 used 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®), or sumatriptan (Imitrex®, Treximet®). 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 allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Check with your doctor if you have used zolmitriptan and your migraine got worse or started occurring more often.
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.
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.
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 right away if you have blurred vision, difficulty with reading, or any other change in vision while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Using zolmitriptan 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. Zolmitriptan may cause a serious condition called serotonin syndrome when taken with some medicines. This includes medicines to treat depression, such as amitriptyline (Elavil®), citalopram (Celexa®), duloxetine (Cymbalta®), escitalopram (Lexapro®), fluoxetine (Prozac®, Sarafem®, Symbyax®), fluvoxamine (Luvox®), olanzapine (Zyprexa®), paroxetine (Paxil®), sertraline (Zoloft®), or venlafaxine (Effexor®). 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.
Some people feel dizzy or drowsy during or after a migraine, or using zolmitriptan 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.
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.
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 or rare
- Blurred vision
- cough
- difficulty with swallowing
- dizziness
- fainting
- fast, slow, pounding, or irregular heartbeat or pulse
- headache
- nervousness
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- shortness of breath
- skin rash, hives, or itching
- tightness in the chest
- unusual tiredness or weakness
Rare
- Arm, back, or jaw pain
- chest pain or discomfort
- chest tightness or heaviness
- nausea
- pain or discomfort in the arms, jaw, back, or neck
- sweating
Incidence not known
- Agitation
- bloody diarrhea
- confusion
- diarrhea
- fever
- overactive reflexes
- pain, pressure, or tightness in the chest, throat, neck, or jaw
- paleness or cold feeling in the fingertips and toes
- poor coordination
- restlessness
- severe stomach pain
- shivering
- talking or acting with excitement you cannot control
- tingling or pain in the fingers or toes when exposed to cold
- trembling or shaking
- twitching
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
- Bad, unusual, or unpleasant (after) taste
- change in taste
Less common
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- discomfort, irritation, or soreness in the nose
- dry mouth
- increased sensitivity to pain
- increased sensitivity to touch
- lack or loss of strength
- sleepiness or unusual drowsiness
Less common or rare
- Continuing ringing or buzzing or other unexplained noise in the ears
- discouragement
- fear
- feeling sad or empty
- frequent urination
- hearing loss
- hyperventilation
- increased volume of pale, dilute urine
- irritability
- lack of appetite
- loss of interest or pleasure
- loss of memory
- problems with memory
- trouble concentrating
- trouble sleeping
Rare
- Burning, dry, or itching eyes
- convulsions
- discharge or excessive tearing
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- swelling or inflammation of the mouth
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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