Pronunciation:

zole-mi-TRIP-tan

Brand Names:

• Zomig
• Zomig-ZMT

Dosage Forms:

• Tablet, Disintegrating
• Tablet

Classifications:

Therapeutic—

Antimigraine

Pharmacologic—

Serotonin Receptor Agonist, 5-HT1

Uses of This Medicine:

Zolmitriptan is used to treat acute migraine headaches in adults. 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 take 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 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 should not be used to 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 do.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of zolmitriptan in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of zolmitriptan in the elderly. However, elderly patients are more likely to have high blood pressure and age-related heart problems, which may require caution and an adjustment in the dose for patients receiving zolmitriptan.

Breast-feeding—

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.

Other 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.

• 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
• Halofantrine
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxyamphetamine
• Ibutilide
• Imipramine
• Isradipine
• Lasmiditan
• Levomilnacipran
• Levorphanol
• Lidoflazine
• Lisdexamfetamine
• Lithium
• Lorcainide
• Lorcaserin
• Mefloquine
• Meperidine
• Metaxalone
• Methadone
• Methamphetamine
• Milnacipran
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nefazodone
• Nortriptyline
• Octreotide
• Ondansetron
• Oxycodone
• Oxymorphone
• Palonosetron
• Paroxetine
• Pentamidine
• Pirmenol
• Pixantrone
• Prajmaline
• Probucol
• Procainamide
• Prochlorperazine
• Propafenone
• Protriptyline
• Quinidine
• Reboxetine
• Remifentanil
• Sematilide
• Sertraline
• Sibutramine
• Sotalol
• Spiramycin
• St John's Wort
• Sufentanil
• Tapentadol
• Tedisamil
• Tramadol
• Trazodone
• Trifluoperazine
• Trimipramine
• Venlafaxine
• Vilazodone
• Vortioxetine
• Ziprasidone

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
• 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
• 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 (e.g., ventricular fibrillation, ventricular tachycardia)—Use with caution. May make these conditions worse.

• Liver disease, moderate to severe—Use of oral disintegrating tablet is not recommended in patients with this condition because these tablets should not be broken in half.

• Phenylketonuria (PKU)—The oral disintegrating tablets contains phenylalanine, which can make your condition worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Using too much zolmitriptan may increase the chance of side effects.

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.

Lying down in a quiet, dark room for a while after you use this medicine may help relieve your migraine.

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 2 doses in any 24-hour period.

Keep the oral disintegrating tablet in the blister pack inside the outer foil pouch until you are ready to take the medicine. Make sure your hands are dry and peel open the blister to remove the tablet. Do not break the tablet. Place the tablet on your tongue and let it dissolve. You do not need to drink water to swallow the dissolved tablet.

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.

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 oral dosage forms (oral tablets):
  • For migraine headaches:
    • Adults—At first, 1.25 or 2.5 milligrams (mg) (tablet may be broken in half) as a single dose. If the migraine comes back after being relieved, another dose may be taken if at least 2 hours have passed since the first dose. Do not take more than 5 mg in a single dose, or 10 mg in any 24-hour period.
    • Children—Use is not recommended.
• For oral dosage form (oral disintegrating tablets):
  • For migraine headaches:
    • Adults—2.5 mg placed on top of your tongue. If the migraine comes back after being relieved, another dose may be taken if at least 2 have passed since the first dose. Do not take more than 5 mg in a single dose or 10 mg in any 24-hour period.
    • Children—Use is not recommended.

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.

Keep the medicine in the blister packs. Throw away any unused medicine after it has been taken out of the blister pack.

Precautions While Using This Medicine:

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 take it.

Do not take 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®), and methysergide (Sansert®). Do not take this medicine within 2 weeks after taking an MAO inhibitor, such as phenelzine, tranylcypromine, Nardil®, or Parnate®.

Check with your doctor if you used this medicine and your migraine did not go away, or if 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.

Check with your doctor right away if you have chest discomfort, jaw or neck tightness after taking 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 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 drowsy or dizzy during or after a migraine, or after taking zolmitriptan to relieve a migraine. As long as you are feeling drowsy or dizzy, do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.

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.

Side Effects of This Medicine:

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:

More common

Chest pain (severe)

heaviness, tightness, or pressure in the chest or neck

sensation of burning, warmth, heat, numbness, tightness, or tingling

Less common or rare

Abdominal or stomach pain (severe)

changes in facial skin color

cough or hoarseness

diarrhea

fast or irregular heartbeat

fever or chills

hives, itching, or skin rash

itching

loss of appetite

lower back or side pain

nausea

painful or difficult urination

puffiness or swelling of the eyelids or around the eyes, face, or lips

tightness in the chest

trouble breathing

weakness

Rare

Blurred vision

confusion

difficulty swallowing

dizziness

fainting

frequent strong or increased urge to urinate

headache

increased volume of pale, dilute urine

nervousness

pounding in the ears

severe numbness, especially on one side of the face or body

slow heartbeat

unusual tiredness or weakness

Incidence not known

Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

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

Lack or loss of strength

sleepiness or unusual drowsiness

warm or cold sensation

Less common

Dizziness or lightheadedness

dry mouth

feeling of constant movement of self or surroundings

sensation of spinning

Rare

Anxiety

crying

depersonalization

depression

dysphoria

euphoria

hyperventilation

irritability

loss of memory

paranoia

problems with memory

quick to react or overreact emotionally

rapidly changing moods

redness of the skin

seeing, hearing, or feeling things that are not there

shaking

trouble sleeping

welts

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.