Naratriptan Hydrochloride (Amerge)

Trade Name : AMERGE

GlaxoSmithKline LLC

TABLET, FILM COATED

Strength 1 mg/1

NARATRIPTAN HYDROCHLORIDE Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Naratriptan Hydrochloride (Amerge) which is also known as AMERGE and Manufactured by GlaxoSmithKline LLC. It is available in strength of 1 mg/1 per ml. Read more

Naratriptan Hydrochloride (Amerge) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

AMERGE is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
AMERGE is a serotonin (5-HT) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults. ()
Limitations of Use

No data

2.2n- 2.3

1-mg white tablets, D-shaped, film-coated, and debossed with u201cGX CE3u201d
2.5-mg green tablets, D-shaped, film-coated, and debossed with u201cGX CE5u201d
Tablets: 1 mg and 2.5 mg (, )

AMERGE is contraindicated in patients with:

No data

The following adverse reactions are discussed in more detail in other sections of the prescribing information:
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 1u00a0year, 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.
Tableu00a01 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 2.5u00a0mg and that occurred at a frequency greater than the placebo group in the 5 pooled trials are included in Tableu00a01.
Table 1. Adverse Reactions Reported by at Least 2% of Patients Treated with AMERGE and at a Frequency Greater than Placebo
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.
Most common adverse reactions (u22652 % and > placebo) were paresthesias, nausea, dizziness, drowsiness, malaise/fatigue, and throat/neck symptoms. ()
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or n

No data

Pregnancy: Based on animal data, may cause fetal harm. ()

Adverse reactions observed after overdoses of up to 25 mg included increases in blood pressure resulting in lightheadedness, neck tension, tiredness, and loss of coordination. Also, ischemic ECG changes likely due to coronary artery vasospasm have been reported.
The elimination half-life of naratriptan is about 6u00a0hours ; therefore monitoring of patients after overdose with AMERGE should continue for at least 24u00a0hours or while symptoms or signs persist. There is no specific antidote to naratriptan. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of naratriptan.

AMERGE contains naratriptan hydrochloride, a selective 5-HT receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:
The empirical formula is CHNOSu2022HCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water.
Each AMERGE tablet for oral administration contains 1.11 or 2.78u00a0mg of naratriptan hydrochloride, equivalent to 1 or 2.5u00a0mg of naratriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium; hypromellose; lactose; magnesium stearate; microcrystalline cellulose; triacetin; and titanium dioxide, iron oxide yellow (2.5-mg tablet only), and indigo carmine aluminum lake (FD&C Blue No.u00a02) (2.5-mg tablet only) for coloring.

No data

Carcinogenesis
In carcinogenicity studies, mice and rats were given naratriptan by oral gavage for 104u00a0weeks. There was no evidence of an increase in tumors related to naratriptan administration in mice receiving up to 200u00a0mg/kg/day. That dose was associated with a plasma (AUC) exposure that was 110 times the exposure in humans receiving the MRDD of 5u00a0mg. Two rat studies were conducted, one using a standard diet and the other a nitrite-supplemented diet (naratriptan can be nitrosated in vitro to form a mutagenic product that has been detected in the stomachs of rats fed a high-nitrite diet). Doses of 5, 20, and 90u00a0mg/kg were associated with AUC exposures that in the standard-diet study were 7, 40, and 236 times, respectively, and in the nitrite-supplementedu2013diet study were 7, 29, and 180 times, respectively, the exposure in humans at the MRDD. In both studies, there was an increase in the incidence of thyroid follicular hyperplasia in high-dose males and females and in thyroid follicular adenomas in high-dose males. In the standard-diet study only, there was also an increase in the incidence of benign c-cell adenomas in the thyroid of high-dose males and females. The exposures achieved at the no-effect dose for thyroid tumors were 40 (standard diet) and 29 (nitrite-supplemented diet) times the exposure achieved in humans at the MRDD. In the nitrite-supplementedu2013diet study only, the incidence of benign lymphocytic thymoma was increased in all treated groups of females. It was not determined if the nitrosated product is systemically absorbed. However, no changes were seen in the stomachs of rats in that study.
Mutagenesis
Naratriptan was not mutagenic when tested in in vitro gene mutation (Ames and mouse lymphoma ) assays. Naratriptan was also negative in the in vitro human lymphocyte assay and the in vivo mouse micronucleus assay. Naratriptan can be nitrosated in vitro to form a mutagenic product (WHO nitrosation assay) that has been detected in the stomachs of rats fed a nitrite-supplemented diet.
Impairment of Fertility
In a reproductive toxicity study in which male and female rats were administered naratriptan orally prior to and throughout the mating period (10, 60, 170, or 340u00a0mg/kg/day; plasma exposures [AUC] approximately 11, 70, 230, and 470 times, respectively, the human exposure at the MRDD), there was a drug-related decrease in the number of females exhibiting normal estrous cycles at doses of 170u00a0mg/kg/day or greater and an increase in pre-implantation loss at 60u00a0mg/kg/day or greater. In high-dose males, testicular/epididymal atrophy accompanied by spermatozoa depletion reduced mating success and may have contributed to the observed pre-implantation loss. The exposures achieved at the no-effect doses for pre-implantation loss, anestrus, and testicular effects were approximately 11, 70, and 230 times, respectively, the exposures in humans at the MRDD.
In a study in which rats were dosed orally with naratriptan (10, 60, or 340u00a0mg/kg/day) for 6u00a0months, changes in the female reproductive tract including atrophic or cystic ovaries and anestrus were seen at the high dose. The exposure at the no-effect dose of 60u00a0mg/kg was approximately 85u00a0times that in humans at the MRDD.

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 4u00a0hours after dosing. Associated symptoms such as nausea, vomiting, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24u00a0hours postdose. A second dose of AMERGE or other rescue medication to treat migraines was allowed 4 to 24u00a0hours after the initial treatment for recurrent headache.
In all 3 trials, the percentage of patients achieving headache response 4u00a0hours after treatment, the primary outcome measure, was significantly greater among patients receiving AMERGE compared with those who received placebo. In all trials, response to 2.5u00a0mg was numerically greater than response to 1u00a0mg and in the largest of the 3 trials, there was a statistically significant greater percentage of patients with headache response at 4u00a0hours 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) 4u00a0Hours following Treatment
The estimated probability of achieving an initial headache response in adults over the 4u00a0hours following treatment in pooled Trials 1, 2, and 3 is depicted in Figureu00a01.
Figure 1. Estimated Probability of Achieving Initial Headache Response within 4u00a0Hours in Pooled Trials 1, 2, and 3n
For patients with migraine-associated nausea, photophobia, and phonophobia at baseline, there was a lower incidence of these symptoms 4u00a0hours following administration of 1-mg and 2.5-mg AMERGE compared with placebo.
Four to 24u00a0hours 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 24u00a0hours following the initial dose of study treatment is summarized in Figureu00a02.
Figure 2. Estimated Probability of Patients Taking a Second Dose of AMERGE Tablets or Other Medication to Treat Migraine over the 24u00a0Hours following the Initial Dose of Study Treatment in Pooled Trials 1, 2, and 3n
There is no evidence that doses of 5u00a0mg provided a greater effect than 2.5u00a0mg. 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.

AMERGE tablets containing 1u00a0mg and 2.5u00a0mg of naratriptan (base) as the hydrochloride salt.
AMERGE tablets, 1u00a0mg, are white, D-shaped, film-coated tablets debossed with u201cGX CE3u201d on one side in blister packs of 9u00a0tablets (NDC 0173-0561-00).
AMERGE tablets, 2.5u00a0mg, are green, D-shaped, film-coated tablets debossed with u201cGX CE5u201d on one side in blister packs of 9u00a0tablets (NDC 0173-0562-00).
Store at controlled room temperature, 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP].

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Risk of Myocardial Ischemia and/or Infarction, Prinzmetalu2019s 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 .
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 .
Concomitant Use with Other Triptans or Ergot Medications
Inform patients that use of AMERGE within 24u00a0hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated .
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 .
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) .
Pregnancy
Advise patients to notify their healthcare provider if they become pregnant during treatment or intend to become pregnant .
Lactation
Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed .
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
u00a92016 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:
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:
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:
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:
Tell your healthcare provider about all the medicines you take,
Using AMERGE with certain other medicines can affect each other, causing serious side effects.
Especially tell your healthcare provider if
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?
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.
These serious side effects include:
The most common side effects of AMERGE include:
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 68u00b0F and 77u00b0F (20u00b0C and 25u00b0C).
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.u00a02) 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
u00a92016 the GSK group of companies. All rights reserved.
December 2016
AMG:6PIL

PRINCIPAL DISPLAY PANEL
NDC 0173-0561-00
Amergen
(NARATRIPTAN HYDROCHLORIDE)
Tablets
1 mg naratriptan
9 Tablets
R only
Each tablet contains 1 mg of naratriptan as the hydrochloride.
Store at controlled room temperature, 20 to 25C (68 to 77F) (see USP).
Do not use if blisters are torn, broken, or missing.
1 mg
Made in Canada
u00a92016 the GSK group of companies

PRINCIPAL DISPLAY PANEL
NDC 0173-0562-00
Amergen
(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 to 25 C (68 to 77 F) (see USP).
Do not use if blisters are torn, broken, or missing.
2.5 mg
Made in Canada

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Naratriptan Hydrochloride (Amerge)

Trade Name : AMERGE

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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About GNH

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Naratriptan Hydrochloride (Amerge)

Trade Name : AMERGE

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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Browse from other international pharmaceuticals

General

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Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

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