Eletriptan Hydrobromide (Relpax)

Trade Name : Relpax

Roerig

TABLET, FILM COATED

Strength 20 mg/1

ELETRIPTAN HYDROBROMIDE Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]

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

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Eletriptan Hydrobromide (Relpax) which is also known as Relpax and Manufactured by Roerig. It is available in strength of 20 mg/1 per ml. Read more

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

Use only after a clear diagnosis of migraine has been established ()
Not indicated for the prophylactic therapy of migraine ()
Not indicated for the treatment of cluster headache ()

The maximum recommended single dose is 40 mg.
In controlled clinical trials, single doses of 20 mg and 40 mg were effective for the acute treatment of migraine in adults. A greater proportion of patients had a response following a 40 mg dose than following a 20 mg dose .
If the migraine has not resolved by 2 hours after taking RELPAX, or returns after transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose should not exceed 80 mg.
The safety of treating an average of more than 3 migraine attacks in a 30-day period has not been established.

Single dose: 20 mg or 40 mg ()
Maximum single dose: 40 mg ()
May repeat dose after 2 hours if needed; not to exceed 80 mg in any 24-hour period ()

20 mg Tablets
40 mg Tablets
Tablets: 20 mg and 40 mg ()

RELPAX is contraindicated in patients with:

History of coronary artery disease (CAD) or coronary artery vasospasm ()
Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders ()
History of stroke, transient ischemic attack, or history or current evidence of hemiplegic or basilar migraine ()
Peripheral vascular disease ()
Ischemic bowel disease ()
Uncontrolled hypertension ()
Within 24 hours of treatment with another 5-HT agonist, or an ergotamine-containing medication ()
Hypersensitivity to RELPAX (angioedema and anaphylaxis seen) ()
Within at least 72 hours of treatment with the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, or nelfinavir ()

RELPAX should only be used where a clear diagnosis of migraine has been established.

Myocardial ischemia/infarction or Prinzmetal's angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors ()
Arrhythmias: Discontinue RELPAX if occurs ()
Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not myocardial ischemia; evaluate high risk patients for CAD ()
Cerebral hemorrhage, subarachnoid hemorrhage, or stroke: Discontinue RELPAX if occurs ()
Gastrointestinal ischemia or infarction events, or peripheral vasospastic reactions: Discontinue RELPAX if occurs ()
Medication overuse headache: Detoxification may be necessary ()
Serotonin syndrome: Discontinue RELPAX if occurs (, )

The following adverse reactions are described elsewhere in other sections of the prescribing information:
Most common adverse reactions (u2265 5% and > placebo) were asthenia, nausea, dizziness, and somnolence. These reactions appear to be dose-related. ()
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No data

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

The elimination half-life of eletriptan is about 4 hours , therefore monitoring of patients after overdose with eletriptan should continue for at least 20 hours or longer while symptoms or signs persist.
There is no specific antidote to eletriptan.
It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentration of eletriptan.

RELPAX (eletriptan hydrobromide) tablets contain eletriptan hydrobromide, which is a selective 5-hydroxytryptamine 1B/1D (5-HT1B/1D) receptor agonist. Eletriptan hydrobromide is chemically designated as (R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide, and it has the following chemical structure:
The empirical formula is CHNOS . HBr, representing a molecular weight of 463.43. Eletriptan hydrobromide is a white to light pale colored powder that is readily soluble in water.
Each RELPAX Tablet for oral administration contains 24.2 or 48.5 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of eletriptan, respectively. Each tablet also contains the inactive ingredients microcrystalline cellulose NF, lactose monohydrate NF, croscarmellose sodium NF, magnesium stearate NF, titanium dioxide USP, hypromellose, triacetin USP and FD&C Yellow No. 6 aluminum lake.

No data

No data

The efficacy of RELPAX in the acute treatment of migraines was evaluated in eight randomized, double-blind placebo-controlled studies. All eight studies used 40 mg. Seven studies evaluated an 80 mg dose and two studies included a 20 mg dose.
In all eight studies, randomized patients treated their headaches as outpatients. Seven studies enrolled adults and one study enrolled adolescents (age 11 to 17). Patients treated in the seven adult studies were predominantly female (85%) and Caucasian (94%) with a mean age of 40 years (range 18 to 78). In all studies, patients were instructed to treat a 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 2 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 post dose. In the adult studies, a second dose of RELPAX or other medication was allowed 2 to 24 hours after the initial treatment for both persistent and recurrent headaches. The incidence and time to use of these additional treatments were also recorded.
In the seven adult studies, the percentage of patients achieving headache response 2 hours after treatment was significantly greater among patients receiving RELPAX at all doses compared to those who received placebo. The two-hour response rates from these controlled clinical studies are summarized in Table 2.
Comparisons of the performance of different drugs based upon results obtained in different clinical trials are never reliable. Because studies are generally conducted at different times, with different samples of patients, by different investigators, employing different criteria and/or different interpretations of the same criteria, under different conditions (dose, dosing regimen, etc.), quantitative estimates of treatment response and the timing of response may be expected to vary considerably from study to study.
The estimated probability of achieving an initial headache response within 2 hours following treatment is depicted in Figure 1.
*Figure 1 shows the Kaplan-Meier plot of probability over time of obtaining headache response (no or mild pain) following treatment with eletriptan. The plot is based on 7 placebo-controlled, outpatient trials in adults providing evidence of efficacy (Studies 1 through 7). Patients not achieving headache response or taking additional treatment prior to 2 hours were censored at 2 hours.
For patients with migraine-associated photophobia, phonophobia, and nausea at baseline, there was a decreased incidence of these symptoms following administration of RELPAX as compared to placebo.
Two 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 medication. The estimated probability of taking a second dose or other medications for migraine over the 24 hours following the initial dose of study treatment is summarized in Figure 2.
*This Kaplan-Meier plot is based on data obtained in 7 placebo-controlled trials in adults (Studies 1 through 7). Patients were instructed to take a second dose of study medication as follows: a) in the event of no response at 2 hours (studies 2 and 4u20137) or at 4 hours (study 3); b) in the event of headache recurrence within 24 hours (studies 2u20137). Patients not using additional treatments were censored at 24 hours. The plot includes both patients who had headache response at 2 hours and those who had no response to the initial dose. It should be noted that the protocols did not allow re-medication within 2 hours post dose.
The efficacy of RELPAX was unaffected by the duration of attack, gender or age of the patient, relationship to menses, or concomitant use of estrogen replacement therapy/oral contraceptives or frequently used migraine prophylactic drugs.
In a single study in adolescents (n=274), there were no statistically significant differences between treatment groups. The headache response rate at 2 hours was 57% for both RELPAX 40 mg Tablets and placebo.

RELPAX Tablets containing 20 mg or 40 mg eletriptan (base) as the hydrobromide salt. RELPAX Tablets are orange, round, convex shaped, film-coated tablets with appropriate debossing.
They are supplied in the following strengths and package configurations:

See n

LAB-0076-21.0

RELPAX (REL - packs)
(eletriptan hydrobromide)
Tablets
Please read this information before you start taking RELPAX and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is the most important information I should know about RELPAX?
RELPAX can cause serious side effects, including:
Heart attack and other heart problems. Heart problems may lead to death.
Stop taking RELPAX and get emergency medical help right away if you have any of the following symptoms of a heart attack:
RELPAX 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:
Serotonin syndrome
Ask your doctor or pharmacist for a list of these medicines if you are not sure.
Call your doctor right away if you have any of the following symptoms of serotonin syndrome:
What is RELPAX?
RELPAX is a prescription medicine used to treat acute migraine headaches with or without aura in adults.
RELPAX is for people who have been diagnosed with migraine headaches.
RELPAX is not used to prevent or decrease the number of migraine headaches you have.
It is not known if RELPAX is safe and effective to treat cluster headaches.
It is not known if RELPAX is safe and effective in children.
Who should not take RELPAX?
Do take RELPAX if you:
What should I tell my doctor before taking RELPAX?
Before you take RELPAX, tell your doctor if you:
Tell your doctor about all the medicines you take
Especially tell your doctor if you
Ask your doctor 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 doctor or pharmacist when you get a new medicine.
How should I take RELPAX?
What should I avoid while taking RELPAX?
RELPAX 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 RELPAX?
RELPAX may cause serious side effects.
These serious side effects include:
The most common side effects of RELPAX include:
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of RELPAX. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
How should I store RELPAX?
u2022 Store RELPAX at room temperature between 68u00b0F to 77u00b0F (20u00b0C to 25u00b0C).
General information about the safe and effective use of RELPAX
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use RELPAX for a condition for which it was not prescribed. Do not give RELPAX to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information summarizes the most important information about RELPAX. If you would like more information about RELPAX, talk with your doctor. You can ask your doctor or pharmacist for information on RELPAX that is written for health professionals.
For more information, call 1-866-4RELPAX (1-866-473-5729) or go to www.RELPAX.com.
What are the ingredients in RELPAX?
Active ingredient: eletriptan hydrobromide
Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, titanium dioxide, hypromellose, triacetin, and FD&C Yellow No. 6 aluminum lake.
All brands are trademarks of their owners.
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
LAB 0077-12.0
November 2013

Relpaxn- 20mgn- Tablet PFIZER INC
LOT: XXXXXXXEXP: YYYY MMM
TO REMOVE TABLET1. SEPARATE ALONG PERFORATION2. PEEL BACK PAPER AT ARROW3. PUSH TABLET THROUGH FOIL
420839903

20mg*NDC 0049-2330-45
RELPAXn (eletriptan HBr)
6 tablets1 card x six 20 mg tabletsRx only

Relpaxn- 40mgn- Tablet PFIZER INC
LOT: XXXXXXXEXP: YYYY MMM
TO REMOVE TABLET1. SEPARATE ALONG PERFORATION2. PEEL BACK PAPER AT ARROW3. PUSH TABLET THROUGH FOIL
420840003

40mg*NDC 0049-2340-45
RELPAXn (eletriptan HBr)
6 tablets1 card x six 40 mg tabletsRx only

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Eletriptan Hydrobromide (Relpax)

Trade Name : Relpax

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

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Eletriptan Hydrobromide (Relpax)

Trade Name : Relpax

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)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

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US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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