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Naratriptan (Oral Route)

US Brand Names

Description

Naratriptan is used to treat acute migraine headaches in adults. It is not used to prevent migraine headaches and is not used for cluster headaches. Naratriptan 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 naratriptan. 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. Naratriptan often relieves symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.

Naratriptan 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.

Naratriptan 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.

This product is available in the following dosage forms:

• Tablet

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

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

Geriatric

Use of naratriptan is not recommended in elderly patients with kidney problems, liver problems, heart and blood vessel disease, or high blood pressure.

Pregnancy

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
• Dihydroergotamine
• Eletriptan
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Frovatriptan
• Linezolid
• Methylergonovine
• Methysergide
• Rizatriptan
• Sumatriptan
• Zolmitriptan

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.

• Amitriptyline
• Citalopram
• Clovoxamine
• Desvenlafaxine
• Duloxetine
• Escitalopram
• Femoxetine
• Fluoxetine
• Fluvoxamine
• Lorcaserin
• Milnacipran
• Nefazodone
• Paroxetine
• Reboxetine
• Sertraline
• Sibutramine
• St John's Wort
• Tapentadol
• Trazodone
• Tryptophan
• Venlafaxine
• Zimeldine

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. 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
• Kidney disease, severe or
• Liver disease, severe or
• Peripheral vascular disease (clogged arteries)—Should not be used in patients with these conditions.

• Coronary artery disease, history of or
• Diabetes or
• Hypercholesterolemia (high cholesterol in the blood) or
• Hypertension (high blood pressure) or
• Obesity or
• Raynaud's syndrome—Use with caution. The chance of side effects may be increased. Heart or blood vessel disease and high blood pressure sometimes do not cause any symptoms, so some people do not know that they have these problems. Before deciding whether you should use naratriptan, your doctor may need to do some tests to make sure that you do not have any of these conditions.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Do not use naratriptan 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, take naratriptan with water or other liquids 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 naratriptan.

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

Ask your doctor ahead of time about any other medicine you may take if naratriptan does not work. After you take the other medicine, check with your doctor as soon as possible. Headaches that are not relieved by naratriptan are sometimes caused by conditions that need other treatment.

If you feel much better after a dose of naratriptan, but your headache comes back or gets worse after a while, you may use more naratriptan. 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 naratriptan may increase the chance of side effects.

If your pain does not does not improve after the first dose of medicine, do not take a second dose. Call your doctor.

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 naratriptan or other pain medicines 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. 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 form (tablets):
  • For migraine headaches:
    • Adults—1 or 2.5 milligrams (mg) taken as a single dose. If the migraine comes back after being relieved, another dose may be taken 4 hours after the last dose. Do not take more than 5 mg in any 24-hour period.
    • Children—Use and dose must be determined by your doctor.

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 take it.

You should 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®), rizatriptan (Maxalt®), sumatriptan (Imitrex®, Treximet®), and zolmitriptan (Zomig®). Some examples of ergot-type medicines are dihydroergotamine (D.H.E. 45®, Migranal®) and ergotamine (Bellergal®, Cafergot®, Ergomar®, or Wigraine®).

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 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 or a family member already has heart disease, if you have diabetes, high blood pressure, high cholesterol, 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.

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.

Make sure your doctor knows about all the other medicines you are using. Naratriptan 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.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and 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.

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 drowsy or dizzy during or after a migraine, or after taking naratriptan 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 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.

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:

• Chest pain (severe)
• Heaviness, tightness, or pressure in the chest, throat, or neck
• Sensation of burning, warmth, heat, numbness, tightness, or tingling

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

• Convulsions (seizures)
• Irregular heartbeat
• Slow heartbeat

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:

• Anxiety
• Bone pain
• Change in taste sensation
• Chills or fever
• Difficulty with sleeping
• Eye problems
• Fainting
• General feeling of discomfort or illness
• Joint pain
• Muscle or joint stiffness, tightness, or rigidity
• Pounding heartbeat
• Stomach discomfort or pain
• Trembling or shaking of the hands or feet
• Unusual tiredness or weakness

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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