Naratriptan (Naratriptan)

Trade Name : Naratriptan

West-Ward Pharmaceuticals Corp.

TABLET

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 (Naratriptan) which is also known as Naratriptan and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 1 mg/1 per ml. Read more

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Naratriptan is indicated for the acute treatment of migraine attacks with or without aura in adults.
Limitations of Use:
Naratriptan 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 to off-white round, biconvex tablet debossed with u201c54u201d on one side and u201c227u201d on the other side.
2.5 mg white to off-white round, biconvex tablet debossed with u201c54 351u201d on one side and plain on the other side.
Tablets: 1 mg and 2.5 mg (, )

Naratriptan 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 to 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 naratriptan in adult patients with migraine. Only reactions that occurred at a frequency of 2% or more in groups treated with naratriptan 2.5 mg and that occurred at a frequency greater than the placebo group in the 5 pooled trials are included in Table 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.
Most common adverse reactions (u22652% and >placebo) were paresthesias, nausea, dizziness, drowsiness, malaise/fatigue, and throat/neck symptoms. ()
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 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 6 hours , and therefore monitoring of patients after overdose with naratriptan should continue for at least 24 hours 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.

Naratriptan tablets USP contains naratriptan hydrochloride USP, a selective 5-HTreceptor 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 USP is a white to pale yellow crystalline powder that is readily soluble in watern
Each naratriptan tablet for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride USP, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose (anhydrous), magnesium stearate, and microcrystalline cellulose.

No data

Carcinogenesis
In carcinogenicity studies, mice and rats were given naratriptan by oral gavage for 104 weeks. There was no evidence of an increase in tumors related to naratriptan administration in mice receiving up to 200 mg/kg/day. That dose was associated with a plasma (AUC) exposure that was 110 times the exposure in humans receiving the MRDD of 5 mg. Two rat studies were conducted, one using a standard diet and the other a nitrite-supplemented diet (naratriptan can be nitrosated to form a mutagenic product that has been detected in the stomachs of rats fed a high nitrite diet). Doses of 5, 20, and 90 mg/kg were associated with AUC exposures that in the standard-diet study were 7, 40, and 236 times, respectively, and in the nitrite-supplemented-diet 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-supplemented diet 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 gene mutation (Ames and mouse lymphoma ) assays. Naratriptan was also negative in the human lymphocyte assay and the mouse micronucleus assay. Naratriptan can be nitrosated 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 340 mg/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 170 mg/kg/day or greater and an increase in pre-implantation loss at 60 mg/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 340 mg/kg/day) for 6 months, 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 60 mg/kg was approximately 85 times that in humans at the MRDD.

The efficacy of naratriptan 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 naratriptan 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 naratriptan 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.
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 : Estimated Probability of Achieving Initial Headache Response Within 4 Hours 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 4 hours following administration of 1-mg and 2.5-mg naratriptan 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 : Estimated Probability of Patients Taking a Second Dose of Naratriptan Tablets or Other Medication to Treat Migraine Over the 24 Hours Following the Initial Dose of Study Treatment in Pooled Trials 1, 2, and 3n
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 naratriptan was associated with an increase in the severity or frequency of migraine attacks. The efficacy of naratriptan 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.

Naratriptan Tablets USP
1 mg tablets are supplied as white to off-white round, biconvex tablets debossed with u201c54u201d on one side and u201c227u201d on the other side.
NDC 0054-0278-03: Bottle of 9 Tablets
NDC 0054-0278-25: Bottle of 100 Tablets
2.5 mg tablets are supplied as white to off-white round, biconvex tablets debossed with u201c54 351u201d on one side and plain on the other side.
NDC 0054-0279-03: Bottle of 9 Tablets
NDC 0054-0279-25: Bottle of 100 Tablets
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]

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 naratriptan 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 n .
Anaphylactic Reactions
Inform patients that anaphylactic reactions have occurred in patients receiving naratriptan. 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 n .
Concomitant Use with Other Triptans or Ergot Medications
Inform patients that use of naratriptan within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated n .
Serotonin Syndrome
Caution patients about the risk of serotonin syndrome with the use of naratriptan or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors n n
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) n .
Pregnancy
Advise patients to notify their healthcare provider if they become pregnant during treatment or intend to become pregnant n .
Lactation
Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed n .
Ability to Perform Complex Tasks
Treatment with naratriptan may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of naratriptan.
Distr. by: n
Pharmaceuticals Corp.
Eatontown, NJ 07724
10005230/05
Revised February 2017

Naratriptan Tablets USP
(naru201d a tripu2019 tan)
Rx Only
Read this Patient Information before you start taking naratriptan tablets 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 naratriptan?
Naratriptan can cause serious side effects, including:
Heart attack and other heart problems. Heart problems may lead to death.
Stop taking naratriptan and get emergency medical help right away if you have any of the following symptoms of a heart attack:
Naratriptan 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 naratriptan?
Naratriptan is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine headaches.
Naratriptan is not used to prevent or decrease the number of migraine headaches you have.
Naratriptan 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 naratriptan is safe and effective to treat cluster headaches.
It is not known if naratriptan is safe and effective in children under 18 years of age.
Who should not take naratriptan?
Do not take naratriptan if you have:
Ask your healthcare provider if you are not sure if your medicine is listed above.
What should I tell my healthcare provider before taking naratriptan?
Before you take naratriptan, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take,
Using naratriptan 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 naratriptan?
What should I avoid while taking naratriptan?
Naratriptan 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 naratriptan?
Naratriptan may cause serious side effects.
These serious side effects include:
The most common side effects of naratriptan 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 naratriptan. 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 naratriptan?
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
Keep naratriptan and all medicines out of the reach of children.
General information about the safe and effective use of naratriptan.
Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use naratriptan for a condition for which it was not prescribed. Do not give naratriptan 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 naratriptan. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about naratriptan that is written for healthcare professionals.
For more information call 1-800-962-8364.
What are the ingredients in naratriptan?
Active ingredient: naratriptan hydrochloride USP
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose (anhydrous), magnesium stearate and microcrystalline cellulose.
This Patient Information has been approved by the U.S. Food and Drug Administration.
The brands listed are registered trademarks of their respective owners.
Distr. by: n
Pharmaceuticals Corp.
Eatontown, NJ 07724
10005230/05
Revised February 2017

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Naratriptan (Naratriptan)

Trade Name : Naratriptan

TABLET

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Naratriptan (Naratriptan)

Trade Name : Naratriptan

TABLET

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)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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Can’t find what you’re looking for?

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