Amerge (naratriptan HCl)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Naratriptan hydrochloride is a selective agonist of serotonin (5-hydroxytryptamine; 5-HT) type 1B and 1D receptors (''triptan'').
Naratriptan hydrochloride is a selective agonist of serotonin (5-hydroxytryptamine; 5-HT) type 1B and 1D receptors. Naratriptan is structurally and pharmacologically related to other selective 5-HT1B/1D receptor agonists (e.g., almotriptan, eletriptan, frovatriptan, rizatriptan, sumatriptan, zolmitriptan). Because the mechanisms involved in the pathogenesis of migraine are not clearly understood, the precise mechanism of action of 5-HT1 receptor agonists in the management of migraine has yet to be established.
However, current data suggest that 5-HT1 receptor agonists, including naratriptan, may ameliorate migraine through selective constriction of certain intracranial blood vessels, inhibition of neuropeptide release, and reduced transmission in the trigeminal pain pathway.
Naratriptan is well absorbed with an oral bioavailability of approximately 70%. Peak plasma concentrations are attained within 2-3 hours after administration of a 2.5 mg tablet. Absorption is slower during a migraine attack, with peak plasma concentrations attained in 3-4 hours.
Food does not affect the pharmacokinetics of naratriptan. Naratriptan is distributed into milk in animals. Naratriptan is 28-31% bound to plasma proteins.
In vitro, naratriptan is metabolized by a wide range of CYP isoenzymes to inactive metabolites. Naratriptan is eliminated principally in urine, with 50% of an administered dose excreted as unchanged drug and 30% as metabolites. The mean elimination half-life of naratriptan is 6 hours.
USES: This medication is used to treat migraines. It helps to relieve headaches, pain and other symptoms of migraines, including sensitivity to light/sound, nausea, and vomiting. Prompt treatment allows you to get back to your normal routine and may decrease your need for other pain medications.
Naratriptan does not prevent future migraines or reduce how often you may get a headache. Naratriptan belongs to a group of drugs called triptans. It affects a certain natural chemical (serotonin) that constricts blood vessels in the brain.
It may also block other pain pathways in the brain.
Generic name: naratriptan HCl
Pronunciation: (nair-uh-TRIP-tan)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Amerge
Indications
The following indications are listed for Amerge:
- Migraine
Dosing
Available as naratriptan hydrochloride; dosage is expressed in terms of naratriptan.
Naratriptan is available in a tablet formulation for oral administration. Naratriptan may be administered without regard to meals.
Tablets should be stored at 20-25degreesC.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Known or suspected ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, documented silent ischemia), coronary artery vasospasm (e.g., Prinzmetal variant angina), and uncontrolled hypertension.
*Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders.
*Peripheral vascular disease or ischemic bowel disease.
*History of cerebrovascular syndromes (e.g., stroke, transient ischemic attack) or history of hemiplegic or basilar migraine.
*Recent (i.e., 24 hours or less) treatment with another 5-HT1 receptor agonist or an ergotamine-containing or ergot-type drug.
*Known hypersensitivity to naratriptan.
*Severe renal or hepatic impairment.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
The most common adverse effects (>=2% and greater than placebo) with naratriptan include paresthesia, nausea, dizziness, drowsiness, malaise/fatigue, and throat/neck symptoms.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy have not been established in pediatric patients younger than 18 years of age.
Data on the developmental risk associated with use of naratriptan during pregnancy from a prospective pregnancy exposure registry and epidemiological studies are inadequate to draw definitive conclusions regarding the risk of birth defects following naratriptan exposure.
Naratriptan produced developmental toxicity (e.g., embryolethality, fetal abnormalities) when given to pregnant rats and rabbits. The lowest doses that produced evidence of developmental toxicity in animals were associated with plasma exposures 2.5 to 11 times that in humans at the maximum recommended daily dose for rabbits and rats, respectively.
Naratriptan is distributed into milk in rats; it is not known whether naratriptan is distributed into human milk or has any effects on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for naratriptan and any adverse effects on the breastfed infant from the drug or from the underlying maternal condition.
Dose selection for geriatric patients should be cautious, usually initiating on the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
Clinical trials of naratriptan did not include a sufficient number of patients >=65 years of age to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between geriatric and younger patients.
Dose selection for geriatric patients should be cautious, usually initiating on the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
A cardiovascular evaluation is recommended for geriatric patients with cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of coronary artery disease) prior to naratriptan administration.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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