Medication info
Naratan Oral Disintegrating Tablet 2.5 mg (Naratriptan Hydrochloride)

Naratan Oral Disintegrating Tablet 2.5 mg (Naratriptan Hydrochloride)

Prescription medicationTablet
Ingredient · strength
Naratriptan Hydrochloride›2.78mg / 1 tablet
Manufacturer / importer
Eden Pharma Co., Ltd.
Appearance
White or light yellow round oral disintegrating tablets
Packaging
6 tablets/PTP [Alu-Alu]
Approval status
Active

MFDS item code 202402970 · Approved 2024.12.16 · Insurance code 628902450

Summary

Main use
Rapid relief of migraine with or without aura
Who uses it
Adults · Children
Adult dosage
This medication should not be used routinely for prevention. It is preferable to use it as monotherapy, without concomitant use of other migraine medications. This is an orally disintegrating tablet. Place it on the tongue, allow it to dissolve in saliva, and swallow. Do not chew or crush it. Adults (18 ∼ 65 years): The recommended dose of naratriptan is 2.5 mg as a single dose. The total dose over 24 hours should not exceed 5.0 mg. If migraine recurs after a single 2.5 mg dose of this medication, another 2.5 mg dose may be taken after an interval of at least 4 hours. Patients who do not respond to this medication should not take another dose for the same attack unless there is a therapeutic benefit; however, it may be taken for subsequent attacks. Older adults (66 years and older): The safety and efficacy of naratriptan have not been established in patients 66 years and older; therefore, use is not recommended. Pharmacokinetic data indicate that clearance decreases with age. Patients with renal impairment: Use with caution in patients with renal impairment. The maximum dose over 24 hours should not exceed 2.5 mg. Do not administer to patients with severe renal impairment (creatinine clearance < 10 mL/min). Patients with hepatic impairment: Use with caution in patients with hepatic impairment. The maximum dose over 24 hours should not exceed 2.5 mg. Do not administer to patients with severe hepatic impairment (Child Pugh grade C).
Children's dosage
Adolescents (12 ∼ 17 years): In placebo-controlled trials in adolescents, single doses of naratriptan 0.25 mg, 1.0 mg, and 2.5 mg were not shown to be more effective than placebo. Therefore, use of naratriptan is not recommended in patients younger than 18 years. Children (younger than 12 years): Clinical data on the use of naratriptan in children younger than 12 years are insufficient; therefore, use of naratriptan is not recommended.

Ingredients

Manufacturer
Eden Pharma Co., Ltd.

Efficacy & effects

Rapid relief of migraine with or without aura

  • Aura
  • migraine
View approved original text

This medication helps to rapidly relieve migraines regardless of the presence of aura. It aids in quickly reducing migraine symptoms, minimizing disruption to daily life. Therefore, it is effective for the prompt relief of migraines.

Dosage and Administration

Adult dosage

This medication should not be used routinely for prevention. It is preferable to use it as monotherapy, without concomitant use of other migraine medications. This is an orally disintegrating tablet. Place it on the tongue, allow it to dissolve in saliva, and swallow. Do not chew or crush it. Adults (18 ∼ 65 years): The recommended dose of naratriptan is 2.5 mg as a single dose. The total dose over 24 hours should not exceed 5.0 mg. If migraine recurs after a single 2.5 mg dose of this medication, another 2.5 mg dose may be taken after an interval of at least 4 hours. Patients who do not respond to this medication should not take another dose for the same attack unless there is a therapeutic benefit; however, it may be taken for subsequent attacks. Older adults (66 years and older): The safety and efficacy of naratriptan have not been established in patients 66 years and older; therefore, use is not recommended. Pharmacokinetic data indicate that clearance decreases with age. Patients with renal impairment: Use with caution in patients with renal impairment. The maximum dose over 24 hours should not exceed 2.5 mg. Do not administer to patients with severe renal impairment (creatinine clearance < 10 mL/min). Patients with hepatic impairment: Use with caution in patients with hepatic impairment. The maximum dose over 24 hours should not exceed 2.5 mg. Do not administer to patients with severe hepatic impairment (Child Pugh grade C).

Children's dosage

Adolescents (12 ∼ 17 years): In placebo-controlled trials in adolescents, single doses of naratriptan 0.25 mg, 1.0 mg, and 2.5 mg were not shown to be more effective than placebo. Therefore, use of naratriptan is not recommended in patients younger than 18 years. Children (younger than 12 years): Clinical data on the use of naratriptan in children younger than 12 years are insufficient; therefore, use of naratriptan is not recommended.

Precautions

This medication contains the artificial sweetener aspartame, and should not be used by patients with the genetic disorder phenylketonuria. The daily intake of aspartame should be controlled to be below the WHO recommended amount, and care should be taken not to exceed 2.4 g per day for a 60 kg adult. Patients who have had hypersensitivity reactions to this medication or those with a history of ischemic heart disease, myocardial infarction, certain vascular spasm diseases, or cerebrovascular incidents should not take this medication. Additionally, it should not be administered to patients with severe renal or liver impairment, patients who have taken another 5-HT1 agonist within 24 hours, or patients with neurological paralysis symptoms related to migraines. Caution is advised when using this medication in patients allergic to sulfonamides. Various side effects such as headache, dizziness, drowsiness, fatigue, nausea, and vomiting may occur upon taking this medication, and if symptoms worsen, consultation with a medical professional is advised. Only use if a migraine diagnosis is certain, and care should be taken not to exceed the prescribed dosage. Drowsiness may occur after taking this medication, so caution should be exercised when engaging in activities that require alertness, such as driving or operating machinery. Patients at risk for cardiovascular disease should verify their heart condition before taking this medication, as acute overuse of migraine medications can worsen headaches. Serious side effects like serotonin syndrome may occur when taken in conjunction with certain antidepressants or other migraine treatments, requiring monitoring by a medical professional. Women who are pregnant or may become pregnant should carefully consider the benefits and risks of using this medication, and breastfeeding women should also exercise caution while taking it. In cases of overdose, patients should be observed for at least 24 hours and receive appropriate treatment as necessary. Additionally, keep this medication in a safe place out of reach of children, and avoid transferring it to other containers.

Side effects

  • Pain
  • visual impairment
  • nausea
  • vomiting
  • heaviness
  • bradycardia
  • tachycardia
  • palpitations
  • fatigue
  • lethargy
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  • dizziness
  • drowsiness
  • pain
  • numbness
  • warmth
  • tightness
  • sensation of pressure
  • skin hypersensitivity
  • anaphylaxis
  • coronary artery spasm
  • transient ischemic ECG changes
  • angina pectoris
  • myocardial infarction
  • peripheral vascular ischemia
  • ischemic colitis

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve its effectiveness.

Appearance and packaging

Appearance

White or light yellow round oral disintegrating tablets

Package unit

6 tablets/PTP [Alu-Alu]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.