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Pronunciation |
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(NAR
a trip
tan) |
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U.S. Brand
Names |
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Amerge® |
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Generic
Available |
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No |
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Synonyms |
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Naratriptan Hydrochloride |
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Pharmacological Index |
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Serotonin 5-HT1D Receptor Agonist |
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Use |
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Treatment of acute migraine headache with or without
aura |
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Pregnancy Risk
Factor |
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C |
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Contraindications |
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Hypersensitivity to naratriptan or any component; cerebrovascular, peripheral
vascular disease (ischemic bowel disease), ischemic heart disease (angina
pectoris, history of myocardial infarction, or proven silent ischemia); or in
patients with symptoms consistent with ischemic heart disease, coronary artery
vasospasm, or Prinzmetal's variant angina; uncontrolled hypertension or patients
who have received within 24 hours another 5-HT agonist (sumatriptan,
zolmitriptan) or ergotamine-containing product; patients with known risk factors
associated with coronary artery disease; patients with severe hepatic or renal
disease (Clcr <15 mL/minute); do not administer naratriptan to
patients with hemiplegic or basilar migraine |
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Warnings/Precautions |
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Use only if there is a clear diagnosis of migraine. Patients who are at risk
of CAD but have had a satisfactory cardiovascular evaluation may receive
naratriptan but with extreme caution (ie, in a physician's office where there
are adequate precautions in place to protect the patient). Blood pressure may
increase with the administration of naratriptan. Monitor closely, especially
with the first administration of the drug. If the patient does not respond to
the first dose, re-evaluate the diagnosis of migraine before trying a second
dose. |
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Adverse
Reactions |
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1% to 10%:
Central nervous system: Dizziness, drowsiness, malaise/fatigue
Gastrointestinal: Nausea, vomiting
Neuromuscular & skeletal: Paresthesias
Miscellaneous: Pain or pressure in throat or neck
<1% (Limited to important or life-threatening symptoms): Coronary artery
vasospasm, transient myocardial ischemia, myocardial infarction, ventricular
tachycardia, ventricular fibrillation, palpitations, hypertension, EKG changes
(PR prolongation, QTc prolongation, premature ventricular
contractions, atrial flutter, or atrial fibrillation) hypotension, heart
murmurs, bradycardia, hyperlipidemia, hypercholesterolemia, hypothyroidism,
hyperglycemia, glycosuria, ketonuria, eye hemorrhage, abnormal liver function
tests, abnormal bilirubin tests, convulsions, allergic reaction, panic,
hallucinations |
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Drug
Interactions |
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Decreased effect: Smoking increases the clearance of naratriptan
Increased effect/toxicity: Ergot-containing drugs (dihydroergotamine or
methysergide) may cause vasospastic reactions when taken with naratriptan. Avoid
concomitant use with ergots; separate dose of naratriptan and ergots by at least
24 hours. Oral contraceptives taken with naratriptan reduced the clearance of
naratriptan ~30% which may contribute to adverse effects. Selective serotonin
reuptake inhibitors (SSRIs) (eg, fluoxetine, fluvoxamine, paroxetine,
sertraline) may cause lack of coordination, hyper-reflexia, or weakness and
should be avoided when taking naratriptan. |
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Mechanism of
Action |
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The therapeutic effect for migraine is due to serotonin agonist
activity |
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Pharmacodynamics/Kinetics |
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Onset of effect: 30 minutes
Protein binding, plasma: 28% to 31%
Metabolism: Liver, cytochrome P-450 isoenzymes
Bioavailability: 70%
Time to peak: 2-3 hours
Elimination: Urine |
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Usual Dosage |
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Adults: Oral: 1-2.5 mg at the onset of headache; it is recommended to use the
lowest possible dose to minimize adverse effects. If headache returns or does
not fully resolve, the dose may be repeated after 4 hours; do not exceed 5 mg in
24 hours.
Elderly: Not recommended for use in the elderly
Dosing in renal impairment:
Clcr: 18-39 mL/minute: Initial: 1 mg; do not exceed 2.5 mg in 24
hours
Clcr: <15 mL/minute: Do not use
Dosing in hepatic impairment: Contraindicated in patients with severe
liver failure; maximum dose: 2.5 mg in 24 hours for patients with mild or
moderate liver failure; recommended starting dose: 1 mg |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Patient
Information |
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This drug is to be used to reduce your migraine, not to prevent or reduce the
number of attacks. If headache returns or is not fully resolved, the dose may be
repeated after 4 hours. If you have no relief with first dose, do not take a
second dose without consulting prescriber. Do not exceed 5 mg in 24 hours.
Do not take within 24 hours of any other migraine medication without first
consulting prescriber. You may experience some dizziness, fatigue, or
drowsiness; use caution when driving or engaging in tasks that require alertness
until response to drug is known. Frequent mouth care and sucking on lozenges may
relieve dry mouth. Report immediately any chest pain, heart throbbing, tightness
in throat, skin rash or hives, hallucinations, anxiety, or panic.
Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend
to be pregnant. Breast-feeding is not recommended. |
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Dosage Forms |
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Tablet: 1 mg, 2.5 mg |
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