Zolmitriptan nasal

You should not use this medicine if you have blood circulation problems, coronary heart disease, angina, Wolff-Parkinson-White syndrome, a lack of blood supply to the heart, uncontrolled high blood pressure, ischemic bowel disease, a history of heart attack, or if you have ever had a stroke (including a TIA or "mini-stroke"). Do not use zolmitriptan nasal if your headache seems to be different from your usual migraines.

Do not use zolmitriptan nasal if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Do not use zolmitriptan nasal within 24 hours before or after using another migraine headache medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• feeling of pain or tightness in your jaw, neck, or throat;

• sudden and severe stomach pain and bloody diarrhea;

• bowel problems, weight loss, fever, stomach pain after meals;

• cramps or pain in your legs or hips;

• numbness, tingling, burning pain, coldness, and a pale or blue-colored appearance in your fingers or toes;

• irregular heartbeats;

• heart attack symptoms--chest pain or pressure, pain spreading to your shoulder, nausea, sweating;

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; or

• high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Common side effects may include:

• unusual or unpleasant taste in your mouth;

• numbness;

• dizziness; or

• skin being more sensitive than usual.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Migraine:

Oral:
-Initial dose: 1.25 or 2.5 mg orally once (may break the scored 2.5 mg tablet in half to obtain 1.25 mg dose); may repeat in 2 hours if migraine has not resolved or returns after a transient improvement
-Maintenance Dose: Adjust dose based on individual response
Maximum single dose: 5 mg
Maximum daily dose: 10 mg in a 24-hour period

Orally Disintegrating Tablets:
-Initial dose: 2.5 mg orally once; may repeat in 2 hours if migraine has not resolved or returns after a transient improvement
-Maintenance Dose: Adjust dose based on individual response
Maximum single dose: 5 mg
Maximum daily dose: 10 mg in a 24-hour period

Nasal Spray:
-Initial dose: 2.5 mg intranasally once; may repeat in 2 hours if migraine has not resolved or returns after a transient improvement
-Maintenance Dose: Adjust dose based on individual response
Maximum single dose: 5 mg
Maximum daily dose: 10 mg in a 24-hour period

Comments:
-This drug should only be used after a clear diagnosis of migraine has been established; if a patient has no response for the first migraine attack, reconsider the diagnosis of migraine before treating any subsequent attacks.
-Do not break the oral disintegrating tablet, they are not scored.
-In trials, the majority of patients had headache response following a 2.5 mg or 5 mg dose compared with a 1 mg dose; little added benefit was observed with the 5 mg dose compared to the 2.5 mg dose, but adverse events were more frequent.
-The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

Use: For the acute treatment of migraine with or without aura.

Usual Pediatric Dose for Migraine:

Age 12 years and older:

Nasal Spray:
-Initial dose: 2.5 mg intranasally once; may repeat in 2 hours if migraine has not resolved or returns after a transient improvement
-Maintenance Dose: Adjust dose based on individual response
Maximum single dose: 5 mg
Maximum daily dose: 10 mg in a 24-hour period

Comments:
-This drug should only be used after a clear diagnosis of migraine has been established; if a patient has no response to this drug for the first migraine attack, reconsider the diagnosis of migraine before treating any subsequent attacks.
-The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

Use: For the acute treatment of migraine with or without aura.

Using zolmitriptan while you are using certain other medicines can cause high levels of serotonin to build up in your body, a condition called "serotonin syndrome," which can be fatal. Tell your doctor if you also use:

• medicine to treat depression;

• medicine to treat a psychiatric disorder;

• a narcotic (opioid) medication; or

• medicine to prevent nausea and vomiting.

This list is not complete. Other drugs may interact with zolmitriptan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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 zolmitriptan 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 zolmitriptan if you have taken a MAO-A inhibitor (eg, Nardil®, Parnate®) in the past 14 days.

zolmitriptan 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 zolmitriptan.

Check with your doctor if you have used zolmitriptan and your migraine got worse or started occurring more often.

zolmitriptan 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.

zolmitriptan may cause problems if you have heart disease. If your doctor thinks you might have a problem with zolmitriptan, 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 zolmitriptan. Also, tell your doctor if you have sudden or severe abdominal or stomach pain or bloody diarrhea after using zolmitriptan.

Check with your doctor right away if you have blurred vision, difficulty with reading, or any other change in vision while you are using zolmitriptan. 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.

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:

• 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

• 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

• 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:

• Bad, unusual, or unpleasant (after) taste
• change in taste

• 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

• 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

• 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.

Unusual taste, dry mouth, discomfort in the nose, tingling/numbness, nausea, weakness, drowsiness, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: blue fingers/toes/nails, cold hands/feet.

Zolmitriptan can commonly cause chest/jaw/neck tightness, pain, or pressure that is usually not serious. However, theseside effects are like symptoms of a heart attack, which may include chest/jaw/left arm pain, shortness of breath, or unusual sweating. Get medical help right away if these or other seriousfast/irregular heartbeat, fainting, severe stomach/abdominal pain, bloody diarrhea, signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion).

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.