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AMERGE- naratriptan hydrochloride tablet, film coated


  1. Patient Information
  2. Amerge Can Cause Serious Side Effects, Including:
  3. Stop Taking Amerge And Get Emergency Medical Help Right Away If You Have Any Of The Following Symptoms Of A Heart Attack:
  4. 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:
  5. What Is Amerge?
  6. Do Not Take Amerge If You Have:
  7. Taken Any Of The Following Medicines In The Last 24 Hours:
  8. Before You Take Amerge, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  9. How Should I Take Amerge?
  10. What Should I Avoid While Taking Amerge?
  11. What Are The Possible Side Effects Of Amerge?
  12. What Are The Ingredients In Amerge?
  13. Revised: 12/2016document Id:

Patient 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[

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.

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, SUMAVELDosePro, 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.

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 ifyou 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.

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

Rxonly

Each tablet contains 1 mg of naratriptan as the hydrochloride.

Store at controlled room temperature, 20oto 25oC (68oto 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
Amerge 1 mg 9 count carton

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, 20oto 25oC (68oto 77oF) (see USP).

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

2.5 mg

Made in Canada

10000000142971 Rev. 8/16
Amerge 2.5 mg 9 count carton
AMERGE
naratriptan hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0173-0561
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NARATRIPTAN HYDROCHLORIDE(UNII: 10X8X4P12Z) (NARATRIPTAN - UNII:QX3KXL1ZA2)NARATRIPTAN1 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TRIACETIN(UNII: XHX3C3X673)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
ColorWHITEScoreno score
ShapeOVAL (D-shaped)Size13mm
FlavorImprint CodeGX;CE3
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0173-0561-009 in 1 BLISTER PACK; Type 0: Not a Combination Product02/26/1998
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02076302/26/1998
AMERGE
naratriptan hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0173-0562
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NARATRIPTAN HYDROCHLORIDE(UNII: 10X8X4P12Z) (NARATRIPTAN - UNII:QX3KXL1ZA2)NARATRIPTAN2.5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(UNII: J2B2A4N98G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TRIACETIN(UNII: XHX3C3X673)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
INDIGOTINDISULFONATE SODIUM(UNII: D3741U8K7L)
Product Characteristics
ColorGREENScoreno score
ShapeOVAL (D-shaped)Size13mm
FlavorImprint CodeGX;CE5
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0173-0562-009 in 1 BLISTER PACK; Type 0: Not a Combination Product02/26/1998
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02076302/26/1998
Labeler -GlaxoSmithKline LLC (167380711)

Revised: 12/2016document Id: 

acad93b6-73a5-4664-a4a0-2294593f8b21Set id: 13f4a8ec-75a3-4c51-b3bc-6244f3c79e95Version: 17Effective Time: 20161205GlaxoSmithKline LLC



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