Amerge

Name: Amerge

Brand names

  • Amerge®

US Brand Name

  1. Amerge

Manufacturer

  • Glades Pharmaceuticals, LLC

Side Effects of Amerge

Amerge may cause serious side effects. See “Drug Precautions” section. 

These serious side effects include:

  • changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
  • stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:
    • sudden or severe stomach pain
    • stomach pain after meals
    • weight loss
    • nausea or vomiting
    • constipation or diarrhea
    • bloody diarrhea
    • fever
  • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
    • cramping and pain in your legs or hips
    • feeling of heaviness or tightness in your leg muscles
    • burning or aching pain in your feet or toes while resting
    • numbness, tingling, or weakness in your legs
    • cold feeling or color changes in 1 or both legs or feet
  • shortness of breath or wheezing
  • hives (itchy bumps); swelling of your tongue, mouth, or throat

The most common side effects of Amerge include:

  • dizziness
  • warm, hot, burning feeling to your face (flushing)
  • cold and hot temperature sensations
  • sensitivity to light or vision problems
  • ear, nose, and throat infections
  • feeling weak, drowsy, or tired
  • decrease in saliva

This is not a complete list of Amerge side effects. Ask your doctor or pharmacist for more information.

Amerge Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Amerge there are no specific foods that you must exclude from your diet when receiving Amerge.

 

Amerge Dosage

Take Amerge exactly as prescribed. Follow the directions on your prescription label carefully. 

The maximum recommended daily dose of Amerge is 5 mg.

 

What is Amerge (naratriptan)?

Naratriptan is a headache medicine that narrows blood vessels around the brain. Naratriptan also reduces substances in the body that can trigger headache pain, sensitivity to light and sound, and other migraine symptoms.

Naratriptan is used to treat migraine headaches. Naratriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Naratriptan should not be used to treat a common tension headache, a headache that causes loss of movement on one side of your body, or any headache that seems to be different from your usual migraine headaches. Use this medicine only if your condition has been confirmed by a doctor as migraine headaches.

Naratriptan may also be used for purposes not listed in this medication guide.

Stability

Storage

Oral

Tablets

20–25°C.1 Protect from heat and light.1

Actions

  • Binds with high affinity to 5-HT1B and 5-HT1D.1 11

  • Structurally and pharmacologically related to other selective 5-HT1B/1D receptor agonists (e.g., almotriptan, eletriptan, frovatriptan, rizatriptan, sumatriptan, zolmitriptan).1 2 11

  • Precise mechanism of action not established; may ameliorate migraine through selective constriction of certain intracranial blood vessels, inhibition of neuropeptide release, and reduced transmission in the trigeminal pain pathway.1 2 3

How do I store and/or throw out Amerge?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Adverse Reactions

The following adverse reactions are discussed in more detail in other sections of the prescribing information:

• Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see Warnings and Precautions (5.1)] • Arrhythmias [see Warnings and Precautions (5.2)] • Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3)] • Cerebrovascular events [see Warnings and Precautions (5.4)] • Other vasospasm reactions [see Warnings and Precautions (5.5)] • Medication overuse headache [see Warnings and Precautions (5.6)] • Serotonin syndrome [see Warnings and Precautions (5.7)] • Increase in blood pressure [see Warnings and Precautions (5.8)] • Hypersensitivity reactions [see Contraindications (4), Warnings and Precautions (5.9)]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a long-term open-label trial where patients were allowed to treat multiple migraine attacks for up to 1 year, 15 patients (3.6%) discontinued treatment due to adverse reactions.

In controlled clinical trials, the most common adverse reactions were paresthesias, dizziness, drowsiness, malaise/fatigue, and throat/neck symptoms, which occurred at a rate of 2% and at least 2 times placebo rate.

Table 1 lists the adverse reactions that occurred in 5 placebo-controlled clinical trials of approximately 1,752 exposures to placebo and Amerge in adult patients with migraine. Only reactions that occurred at a frequency of 2% or more in groups treated with Amerge 2.5 mg and that occurred at a frequency greater than the placebo group in the 5 pooled trials are included in Table 1.

Table 1. Adverse Reactions Reported by at Least 2% of Patients Treated with Amerge and at a Frequency Greater than Placebo

Adverse Reaction

Percent of Patients Reporting

Amerge 1 mg

(n = 627)

Amerge 2.5 mg

(n = 627)

Placebo

(n = 498)

Atypical sensation

2

4

1

  Paresthesias (all types)

1

2

<1

Gastrointestinal

6

7

5

  Nausea

4

5

4

Neurological

4

7

3

  Dizziness

1

2

1

  Drowsiness

1

2

<1

  Malaise/fatigue

2

2

1

Pain and pressure sensation

2

4

2

  Throat/neck symptoms

1

2

1

The incidence of adverse reactions in controlled clinical trials was not affected by age or weight of the patients, duration of headache prior to treatment, presence of aura, use of prophylactic medications, or tobacco use. There were insufficient data to assess the impact of race on the incidence of adverse reactions.

Clinical Studies

The efficacy of Amerge in the acute treatment of migraine headaches was evaluated in 3 randomized, double-blind, placebo-controlled trials in adult patients (Trials 1, 2, 3). These trials enrolled adult patients who were predominantly female (86%) and Caucasian (96%) with a mean age of 41 years (range: 18 to 65 years). In all studies, patients were instructed to treat at least 1 moderate to severe headache. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed up to 4 hours after dosing. Associated symptoms such as nausea, vomiting, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24 hours postdose. A second dose of Amerge or other rescue medication to treat migraines was allowed 4 to 24 hours after the initial treatment for recurrent headache.

In all 3 trials, the percentage of patients achieving headache response 4 hours after treatment, the primary outcome measure, was significantly greater among patients receiving Amerge compared with those who received placebo. In all trials, response to 2.5 mg was numerically greater than response to 1 mg and in the largest of the 3 trials, there was a statistically significant greater percentage of patients with headache response at 4 hours in the 2.5-mg group compared with the 1-mg group. The results are summarized in Table 2.

Table 2. Percentage of Adult Patients with Headache Response (Mild or No Headache) 4 Hours following Treatment

Amerge 1 mg

(n = 491)

Amerge 2.5 mg

(n = 493)

Placebo

(n = 395)

Trial 1

Trial 2

Trial 3

50%a

52%a

54%a

60%a

66%ab

65%a

34%

27%

32%

  aP<0.05 compared with placebo.   bP<0.05 compared with 1 mg.

The estimated probability of achieving an initial headache response in adults over the 4 hours following treatment in pooled Trials 1, 2, and 3 is depicted in Figure 1.

Figure 1. Estimated Probability of Achieving Initial Headache Response within 4 Hours in Pooled Trials 1, 2, and 3a

  a The figure shows the probability over time of obtaining headache response (reduction in headache severity from moderate or severe pain to no or mild pain) following treatment with Amerge. In this Kaplan-Meier plot, patients not achieving response within 240 minutes were censored at 240 minutes.

For patients with migraine-associated nausea, photophobia, and phonophobia at baseline, there was a lower incidence of these symptoms 4 hours following administration of 1-mg and 2.5-mg Amerge compared with placebo.

Four to 24 hours following the initial dose of study treatment, patients were allowed to use additional treatment for pain relief in the form of a second dose of study treatment or other rescue medication. The estimated probability of patients taking a second dose or other rescue medication to treat migraine over the 24 hours following the initial dose of study treatment is summarized in Figure 2.

Figure 2. Estimated Probability of Patients Taking a Second Dose of Amerge Tablets or Other Medication to Treat Migraine over the 24 Hours following the Initial Dose of Study Treatment in Pooled Trials 1, 2, and 3a

  a Kaplan-Meier plot based on data obtained in the 3 controlled clinical trials (Trials 1, 2, and 3) providing evidence of efficacy with patients not using additional treatments censored at 24 hours. The plot also includes patients who had no response to the initial dose. Remedication was discouraged prior to 4 hours postdose.

There is no evidence that doses of 5 mg provided a greater effect than 2.5 mg. There was no evidence to suggest that treatment with Amerge was associated with an increase in the severity or frequency of migraine attacks. The efficacy of Amerge was unaffected by presence of aura; gender, age, or weight of the subject; oral contraceptive use; or concomitant use of common migraine prophylactic drugs (e.g., beta-blockers, calcium channel blockers, tricyclic antidepressants). There was insufficient data to assess the impact of race on efficacy.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events

Inform patients that Amerge may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech and should ask for medical advice if any indicative sign or symptoms are observed. Apprise patients of the importance of this follow-up [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5, 5.8)].

Anaphylactic Reactions

Inform patients that anaphylactic reactions have occurred in patients receiving Amerge. Such reactions can be life-threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens [see Contraindications (4), Warnings and Precautions (5.9)].

Concomitant Use with Other Triptans or Ergot Medications

Inform patients that use of Amerge within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated [see Contraindications (4), Drug Interactions (7.1, 7.2)].

Serotonin Syndrome

Caution patients about the risk of serotonin syndrome with the use of Amerge or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7), Drug Interactions (7.3)].

Medication Overuse Headache

Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions (5.6)].

Pregnancy

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

Lactation

Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.2)].

Ability to Perform Complex Tasks

Treatment with Amerge may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of Amerge.

Amerge is a registered trademark of the GSK group of companies. The other brand listed is a trademark of its owner and is not a trademark of the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2016 the GSK group of companies. All rights reserved.

AMG:6PI

Patient Information

Amerge® (a-MERJ)

(naratriptan hydrochloride)

tablets

Read this Patient Information before you start taking Amerge and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is the most important information I should know about Amerge?

Amerge can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death.

Stop taking Amerge and get emergency medical help right away if you have any of the following symptoms of a heart attack:

• discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw • pain or discomfort in your arms, back, neck, jaw, or stomach • shortness of breath with or without chest discomfort • breaking out in a cold sweat • nausea or vomiting • feeling lightheaded

Amerge is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:

• have high blood pressure • have high cholesterol levels • smoke • are overweight • have diabetes • have a family history of heart disease

What is Amerge?

Amerge is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine headaches.

Amerge is not used to prevent or decrease the number of migraine headaches you have.

Amerge is not used to treat other types of headaches such as hemiplegic migraines (that make you unable to move on one side of your body) or basilar migraines (rare form of migraine with aura).

It is not known if Amerge is safe and effective to treat cluster headaches.

It is not known if Amerge is safe and effective in children younger than 18 years of age.

Who should not take Amerge?

Do not take Amerge if you have:

• heart problems or a history of heart problems • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease) • uncontrolled high blood pressure • severe kidney problems • severe liver problems • hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider. • had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation • taken any of the following medicines in the last 24 hours: • almotriptan (AXERT®) • eletriptan (RELPAX®) • frovatriptan (FROVA®) • rizatriptan (MAXALT®, MAXALT-MLT®) • sumatriptan (IMITREX®, SUMAVEL® DosePro®, ALSUMA®) • sumatriptan and naproxen (TREXIMET®) • ergotamines (CAFERGOT®, ERGOMAR®, MIGERGOT®) • dihydroergotamine (D.H.E. 45®, MIGRANAL®)   Ask your healthcare provider if you are not sure if your medicine is listed above. • an allergy to naratriptan or any of the ingredients in Amerge. See the end of this leaflet for a complete list of ingredients in Amerge.

What should I tell my healthcare provider before taking Amerge?

Before you take Amerge, tell your healthcare provider about all of your medical conditions, including if you:

• have high blood pressure • have high cholesterol • have diabetes • smoke • are overweight • have heart problems or family history of heart problems or stroke • have kidney problems • have liver problems • are not using effective birth control • are pregnant or plan to become pregnant • are breastfeeding or plan to breastfeed. It is not known if Amerge passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take Amerge.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Using Amerge with certain other medicines can affect each other, causing serious side effects.

Especially tell your healthcare provider if you take antidepressant medicines called:

• selective serotonin reuptake inhibitors (SSRIs) • serotonin norepinephrine reuptake inhibitors (SNRIs) • tricyclic antidepressants (TCAs) • monoamine oxidase inhibitors (MAOIs)

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take Amerge?

• Certain people should take their first dose of Amerge in their healthcare provider’s office or in another medical setting. Ask your healthcare provider if you should take your first dose in a medical setting. • Take Amerge exactly as your healthcare provider tells you to take it. • Your healthcare provider may change your dose. Do not change your dose without first talking with your healthcare provider. • Take Amerge with water or other liquids. • If you do not get any relief after your first Amerge tablet, do not take a second tablet without first talking with your healthcare provider. • If your headache comes back or you only get some relief from your headache, you can take a second tablet 4 hours after the first tablet. • Do not take more than a total of 5 mg of Amerge in a 24-hour period. • Some people who take too many Amerge tablets may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with Amerge. • If you take too much Amerge, call your healthcare provider or go to the nearest hospital emergency room right away. • You should write down when you have headaches and when you take Amerge so you can talk with your healthcare provider about how Amerge is working for you.

What should I avoid while taking Amerge?

Amerge can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.

What are the possible side effects of Amerge?

Amerge may cause serious side effects. See “What is the most important information I should know about Amerge?”

These serious side effects include:

• changes in color or sensation in your fingers and toes (Raynaud’s syndrome) • stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include: • sudden or severe stomach pain • stomach pain after meals • weight loss • nausea or vomiting • constipation or diarrhea • bloody diarrhea • fever • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include: • cramping and pain in your legs or hips • feeling of heaviness or tightness in your leg muscles • burning or aching pain in your feet or toes while resting • numbness, tingling, or weakness in your legs • cold feeling or color changes in 1 or both legs or feet • medication overuse headaches. Some people who use too many Amerge tablets may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with Amerge. • serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using Amerge, especially if Amerge is used with antidepressant medicines called SSRIs, SNRIs, TCAs, or MAOIs. Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome: • mental changes such as seeing things that are not there (hallucinations), agitation, or coma • fast heartbeat • changes in blood pressure • high body temperature • tight muscles • trouble walking

The most common side effects of Amerge include:

• tingling or numbness in your fingers or toes • dizziness • warm, hot, burning feeling to your face (flushing) • discomfort or stiffness in your neck • feeling weak, drowsy, or tired

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Amerge. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Amerge?

Store Amerge between 68°F and 77°F (20°C and 25°C).

Keep Amerge and all medicines out of the reach of children.

General information about the safe and effective use of Amerge.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use Amerge for a condition for which it was not prescribed. Do not give Amerge to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Amerge. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Amerge that is written for healthcare professionals.

For more information, go to www.gsk.com or call 1-888-825-5249.

What are the ingredients in Amerge?

Active ingredient: naratriptan hydrochloride

Inactive ingredients: croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, triacetin, titanium dioxide

2.5-mg tablets also contain iron oxide yellow and indigo carmine aluminum lake (FD&C Blue No. 2) for coloring.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Amerge and IMITREX are registered trademarks of the GSK group of companies. The other brands listed are trademarks of their respective owners and are not trademarks of the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.

GlaxoSmithKline

Research Triangle Park, NC 27709

©2016 the GSK group of companies. All rights reserved.

December 2016

AMG:6PIL

PRINCIPAL DISPLAY PANEL

NDC 0173-0561-00

Amerge®

(NARATRIPTAN HYDROCHLORIDE)

Tablets

1 mg naratriptan

9 Tablets

Rx only

Each tablet contains 1 mg of naratriptan as the hydrochloride.

Store at controlled room temperature, 20o to 25oC (68o to 77oF) (see USP).

Do not use if blisters are torn, broken, or missing.

1 mg

Made in Canada

©2016 the GSK group of companies

  10000000142935 Rev.9/16

PRINCIPAL DISPLAY PANEL

NDC 0173-0562-00

Amerge®

(NARATRIPTAN HYDROCHLORIDE)

Tablets

2.5 mg naratriptan

9 Tablets

Rx only

Each tablet contains 2.5 mg of naratriptan as the hydrochloride.

Store at controlled room temperature, 20 o to 25 o C (68 o to 77 o F) (see USP).

Do not use if blisters are torn, broken, or missing.

2.5 mg

Made in Canada

  10000000142971 Rev. 8/16
Amerge 
naratriptan hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0561
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NARATRIPTAN HYDROCHLORIDE (NARATRIPTAN) NARATRIPTAN 1 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
HYPROMELLOSES  
LACTOSE, UNSPECIFIED FORM  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
TRIACETIN  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE Score no score
Shape OVAL (D-shaped) Size 13mm
Flavor Imprint Code GX;CE3
Contains     
Packaging
# Item Code Package Description
1 NDC:0173-0561-00 9 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020763 02/26/1998
Amerge 
naratriptan hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0562
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NARATRIPTAN HYDROCHLORIDE (NARATRIPTAN) NARATRIPTAN 2.5 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
HYPROMELLOSES  
LACTOSE, UNSPECIFIED FORM  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
TRIACETIN  
TITANIUM DIOXIDE  
FERRIC OXIDE YELLOW  
FD&C BLUE NO. 2  
INDIGOTINDISULFONATE SODIUM  
Product Characteristics
Color GREEN Score no score
Shape OVAL (D-shaped) Size 13mm
Flavor Imprint Code GX;CE5
Contains     
Packaging
# Item Code Package Description
1 NDC:0173-0562-00 9 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020763 02/26/1998
Labeler - GlaxoSmithKline LLC (167380711)
Revised: 12/2016   GlaxoSmithKline LLC

Dosing & Uses

Dosage Forms & Strengths

tablet

  • 1mg
  • 2.5mg

Migraine

1-2.5 mg PO at onset; may repeat once after 4 hours

Not to exceed 5 mg/day

Renal Impairment

Mild-to-moderate: Not to exceed 2.5 mg/day

Severe (<15 mL/min); Do not administer

Safety and efficacy not established

Not recommended

Patient Handout

Print without Office InfoPrint with Office Info

What happens if i miss a dose (amerge)?

Since naratriptan is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using naratriptan.

After taking a naratriptan tablet, you must wait four (4) hours before taking a second tablet. Do not take more than two (2) naratriptan tablets in 24 hours.

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