June 28, 2016
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Amerge

"COPENHAGEN ” An investigational agent that blocks a key headache-related receptor significantly reduces the number of mean monthly migraine days, new phase 2 data show.

Findings showed that after 52 weeks, 18.5% of patients with migra"...

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Amerge




Side Effects
Interactions

SIDE EFFECTS

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

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.

Read the Amerge (naratriptan) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Ergot-Containing Drugs

Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and AMERGE within 24 hours of each other is contraindicated.

Other 5-HT1 Agonists

Concomitant use of other 5-HT1B/1D agonists (including triptans) within 24 hours of treatment with AMERGE is contraindicated because the risk of vasospastic reactions may be additive.

Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors And Serotonin Syndrome

Cases of serotonin syndrome have been reported during co-administration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [see WARNINGS AND PRECAUTIONS].

Read the Amerge Drug Interactions Center for a complete guide to possible interactions

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/21/2016

Side Effects
Interactions

Amerge - User Reviews

Amerge User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Amerge sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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