Almotriptan patient counseling information

Almotriptan

AXERT® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Almotriptan
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief:  Pratik Bahekar, MBBS [2]

## Patient Counseling Information

[edit | edit source]

### Patient Information Leaflet

[edit | edit source]

Inform patients that Patient Information labeling is available as a separate leaflet. Advise the patient to read this information and assist them in understanding its contents. Provide the patient the opportunity to discuss the contents of the Patient Information and answer any questions they may have. The complete text of the Patient Information is attached to the package insert.

### Risk of Myocardial Ischemia and/or Infarction, Other Adverse Cardiac Events, Other Vasospasm-Related Events, and Cerebrovascular Events

[edit | edit source]

Inform patients that Almotriptan (almotriptan malate) may cause serious cardiovascular side effects such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, or slurring of speech, and should ask for medical advice when observing any indicative signs or symptoms. Apprise the patient of the importance of this follow-up [seeWarnings and Precautions (5.1), (5.2), (5.3), and (5.4)].

### Serotonin Syndrome

[edit | edit source]

Caution patients about the risk of serotonin syndrome with the use of Almotriptan or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see Warnings and Precautions (5.5)].

### Pregnancy

[edit | edit source]

Advise patients to notify their physician if they become pregnant during treatment or intend to become pregnant [see Use in Specific Populations (8.1)].

### Nursing Mothers

[edit | edit source]

Advise patients to notify their physician if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.3)].

### Drug Interactions

[edit | edit source]

Advise patients to talk with their physician or pharmacist before taking any new medicines, including prescription and non-prescription drugs and supplements [seeContraindications (4.5) and (4.6) and Drug-Drug Interactions (7)].

### Ability to Operate Machinery or Vehicles

[edit | edit source]

Counsel patients that Almotriptan may cause dizziness, somnolence, visual disturbances, and other CNS symptoms that can interfere with driving or operating machinery. Accordingly, advise the patient not to drive, operate complex machinery, or engage in other hazardous activities until they have gained sufficient experience with Almotriptan to gauge whether it affects their mental or visual performance adversely.

### Hypersensitivity

[edit | edit source]

Inform patients to tell their physician if they develop a rash, itching, or breathing difficulties after taking Almotriptan [see Warnings and Precautions (5.7)].

FDA-Approved Patient Labeling

See attached.

Product of Spain

Almotriptan Tablets are manufactured by: Janssen-Ortho, LLC Gurabo, Puerto Rico 00778

(JPI logo)

Almotriptan Tablets are manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560

Licensed from: Almirall, S.A. U.S. Patent No. 5,565,447

© Janssen Pharmaceuticals, Inc. 2009

Revised September 2011 7560705

PATIENT LABELING

Almotriptan (AX-ert) (almotriptan malate) TABLETS

Please read this information before you start taking Almotriptan (almotriptan malate) Tablets. Also, read this leaflet each time you renew your prescription just in case anything has changed. Remember, this leaflet does not take the place of careful discussions with your doctor. You and your doctor should discuss Almotriptan when you start taking your medication and at regular checkups.

What is Almotriptan and what is it used for?

Almotriptan is a medication used to treat migraine attacks in adults and adolescents age 12 to 17 years. Almotriptan is a member of a class of drugs called selective serotonin receptor agonists.

Use Almotriptan only for a migraine attack. Do not use Almotriptan to treat headaches that might be caused by other conditions. Tell your doctor about your symptoms. Your doctor will decide if you have migraine.

There is more information about migraine at the end of this leaflet.

Who should not take Almotriptan?1

Do not take Almotriptan if you:

have ever had heart disease. have uncontrolled high blood pressure. have hemiplegic or basilar migraine. If you are not sure, ask your doctor. have taken another serotonin receptor agonist (e.g., another triptan) in the last 24 hours. These include naratriptan (AMERGE®), rizatriptan (MAXALT®), sumatriptan (IMITREX®, TREXIMET®), or zolmitriptan (ZOMIG®). have taken ergotamine-type medicines in the last 24 hours. These include ergotamine (BELLERGAL-S®, CAFERGOT®, ERGOMAR®, WIGRAINE®), dihydroergotamine (D.H.E. 45®), or methysergide (SANSERT®). had an allergic reaction to Almotriptan or any of its ingredients. The active ingredient is almotriptan malate. Ask your doctor or pharmacist about inactive ingredients.

Tell your doctor if you take:

monoamine oxidase (MAO) inhibitors, such as phenelzine sulfate (NARDIL®) or tranylcypromine sulfate (PARNATE®) for depression or another condition, or if it has been less than two weeks since you stopped taking an MAO inhibitor. ketoconazole (NIZORAL®), itraconazole (SPORANOX®), ritonavir (NORVIR®), or erythromycin (EMYCIN®), or if it has been less than one week since you stopped taking one of these drugs. selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), two types of drugs for depression or other disorders. Common SSRIs are CELEXA® (citalopram HBr), LEXAPRO® (escitalopram oxalate), PAXIL® (paroxetine), PROZAC®/SARAFEM® (fluoxetine), SYMBYAX® (olanzapine/fluoxetine), ZOLOFT® (sertraline), and fluvoxamine. Common SNRIs are CYMBALTA® (duloxetine) and EFFEXOR® (venlafaxine).

These medicines may affect how Almotriptan works, or Almotriptan may affect how these medicines work.

To help your doctor decide if Almotriptan is right for you or if you need to be checked while taking Almotriptan, tell your doctor about any:

past or present medical problems. past or present high blood pressure, chest pain, shortness of breath, or heart disease. liver or kidney problems. risk factors for heart disease, such as:

* high blood pressure

* diabetes

* high cholesterol

* overweight

* smoking

* family members with heart disease

* you are past menopause

* you are a male over 40 years old.

Allergic reactions to sulfonamides, also known as sulfa drugs (ask your doctor if you are not sure what sulfonamide drugs are). medicines you take or plan to take, including prescription and non-prescription medicines and herbal supplements. Be sure to include medicines you normally take for a migraine.

Talk to your doctor about using Almotriptan if you are pregnant, planning to become pregnant, or breastfeeding.

How should I take Almotriptan?

When you have a migraine headache, take your medicine as directed by your doctor. If your headache comes back after your first dose, you may take a second dose 2 hours or more after the first dose. If your pain continues after the first dose, do not take a second dose without first checking with your doctor. Do not take more than two Almotriptan Tablets in a 24-hour period. If you take too much medicine, contact your doctor, hospital emergency department, or poison control center right away.

What should I avoid while taking Almotriptan?

Check with your doctor before you take any new medicines, including prescription and non-prescription medicines and supplements. There are some medicines that you should not take during the period 24 hours before and 24 hours after taking Almotriptan. Some of them are listed in the section "Who should not take AXERT?"

What are the possible side effects of Almotriptan?

The side effects are usually mild and do not last long. The following is not a complete list of side effects. Ask your doctor to tell you about the other side effects.

The most common side effects in adults are:

* Nausea
* Sleepiness
* Tingling or burning feeling (paresthesia)
* Headache
* Dry mouth

The most common side effects in adolescents are:

* Dizziness
* Sleepiness
* Nausea
* Headache
* Tingling or burning feeling (paresthesia)
* Vomiting

If you experience sleepiness, you should evaluate your ability to perform complex tasks, such as driving or operating heavy machinery.

Tell your doctor about any other symptoms that you develop while taking Almotriptan. If the symptoms continue or worsen, get medical help right away. Also, tell your doctor if you develop a rash or itching after taking Almotriptan. You may be allergic to the medicine.

In very rare cases, patients taking this class of medicines experience serious heart problems, stroke, or increased blood pressure. Extremely rarely, patients have died. Therefore, tell your doctor right away if you feel tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw after taking Almotriptan. Do not take Almotriptan again until your doctor has checked you.

Some people may have a reaction called serotonin syndrome, which can be life-threatening, when they use Almotriptan. In particular, this reaction may occur when they use Almotriptantogether with certain types of antidepressants known as SSRIs or SNRIs. Symptoms may include mental changes (hallucinations, agitation, or coma), fast heartbeat, changes in blood pressure, high body temperature or sweating, tight muscles, trouble walking, nausea, vomiting, or diarrhea. Call your doctor immediately if you have any of these symptoms after taking Almotriptan.

This is not a complete list of side effects. Talk to your doctor if you develop any symptoms that concern you.

What to do in case of an overdose?

Call your doctor or poison control center or go to the ER.

What is a migraine and how does it differ from other headaches?

A migraine is an intense, throbbing, typically one-sided headache. It often includes nausea, vomiting, sensitivity to light, and sensitivity to sound. The pain and symptoms from a migraine headache may be worse than the pain and symptoms of a common headache.

Some people have visual symptoms before the headache, such as flashing lights or wavy lines, called an aura.

Migraine attacks typically last for hours or, rarely, for more than a day. They can return often. The strength and frequency of migraine attacks may vary.

Based on your symptoms, your doctor will decide whether you have a migraine.

Migraine headaches tend to occur in members of the same family. Both men and women get migraines, but it is more common in women.

What may trigger a migraine attack?

Certain things may trigger migraine attacks in some people. Some of these triggers are:

certain foods or drinks, such as cheese, chocolate, citrus fruit (oranges, grapefruit, lemons, limes, and others), caffeine, and alcohol. stress. a change in behavior, such as too much or too little sleep, missing a meal, or a change in diet. hormone changes in women, such as during monthly menstrual periods.

You may be able to prevent migraine attacks or make them come less often if you understand what triggers your attacks. Keeping a headache diary may help you identify and monitor the possible triggers that cause your migraine. Once you identify the triggers, you and your doctor can change your lifestyle to avoid those triggers.

How does Almotriptan work during a migraine attack?

Treatment with Almotriptan:

reduces swelling of blood vessels surrounding the brain. This swelling is associated with the headache pain of a migraine attack. blocks the release of substances from nerve endings that cause more pain and other symptoms of migraine. interrupts the sending of specific pain signals to your brain.

It is thought that each of these actions contributes to relief of your symptoms by Almotriptan.

How should I store Almotriptan?

Keep your medicine in a safe place where children cannot reach it. It may be harmful to children. Store your medicine away from heat, light, or moisture at a controlled room temperature. If your medicine has expired, throw it away as instructed. If your doctor decides to stop your treatment, do not keep any leftover medicine unless your doctor tells you to do so. Throw away your medicine as instructed. Be sure that discarded tablets are out of the reach of children.

General advice about prescription medicines

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Almotriptan for a condition for which it was not prescribed. Do not give Almotriptan to other people even if they have the same symptoms you have. People may be harmed if they take medicines that have not been prescribed for them.

This leaflet provides a summary of information about Almotriptan. If you have any questions or concerns about either Almotriptan or migraines, talk to your doctor. In addition, talk to your pharmacist or other healthcare provider.

Product of Spain

Almotriptan Tablets are manufactured by: Janssen-Ortho, LLC Gurabo, Puerto Rico 00778

Almotriptan Tablets are manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560

Licensed from: Almirall, S.A. U.S.Patent No. 5,565,447

© Janssen Pharmaceuticals, Inc. 2009

Revised September 2011

7560705

## References

[edit | edit source]