Medication info
Naratriptan Orally Disintegrating Tablet 2.5 mg (Naratriptan Hydrochloride)

Naratriptan Orally Disintegrating Tablet 2.5 mg (Naratriptan Hydrochloride)

Prescription medicationOrally disintegrating Tablet
Ingredient · strength
Naratriptan Hydrochloride›2.78mg / 1 tablet
Manufacturer / importer
Daewoong Bio Co., Ltd.
Appearance
White or pale yellow round orally disintegrating tablet
Packaging
6 tablets/PVC[(Alu-Alu)]
Approval status
Active

MFDS item code 202500294 · Approved 2025.02.12 · Insurance code 694004510

Summary

Main use
Rapid relief of migraine, with or without aura
Who uses it
Adults · Children
Adult dosage
This drug should not be used regularly for preventive purposes. It is preferable to administer it as monotherapy, without concomitant use of other migraine medications. This drug 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 must not exceed 5.0 mg in 24 hours. If migraine recurs after a single 2.5 mg dose of this drug, a further 2.5 mg dose may be taken after an interval of at least 4 hours. Patients who do not respond after taking this drug should not take another dose for the same attack unless there is a therapeutic benefit, but may take it for subsequent attacks. Elderly patients (66 years and older): The safety and efficacy of naratriptan in patients aged 66 years and older have not been established; therefore, its 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 in 24 hours must 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 in 24 hours must 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, naratriptan is not recommended for patients under 18 years of age. Children (under 12 years): Clinical data on the use of naratriptan in children under 12 years of age are insufficient; therefore, naratriptan is not recommended.

Ingredients

Manufacturer
Daewoong Bio Co., Ltd.

Efficacy & effects

Rapid relief of migraine, with or without aura

  • Aura
  • migraine
View approved original text

This medication helps provide rapid relief from migraine with or without aura. It quickly reduces headache symptoms caused by migraine to allow for daily activities, and is effective in alleviating pain. Additionally, it allows for early management of migraine symptoms with its fast action after administration. This medication is used for the treatment of migraine.

Dosage and Administration

Adult dosage

This drug should not be used regularly for preventive purposes. It is preferable to administer it as monotherapy, without concomitant use of other migraine medications. This drug 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 must not exceed 5.0 mg in 24 hours. If migraine recurs after a single 2.5 mg dose of this drug, a further 2.5 mg dose may be taken after an interval of at least 4 hours. Patients who do not respond after taking this drug should not take another dose for the same attack unless there is a therapeutic benefit, but may take it for subsequent attacks. Elderly patients (66 years and older): The safety and efficacy of naratriptan in patients aged 66 years and older have not been established; therefore, its 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 in 24 hours must 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 in 24 hours must 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, naratriptan is not recommended for patients under 18 years of age. Children (under 12 years): Clinical data on the use of naratriptan in children under 12 years of age are insufficient; therefore, naratriptan is not recommended.

Precautions

This medication contains the artificial sweetener aspartame, so it should not be used by patients with a specific genetic disorder known as phenylketonuria. The daily intake of aspartame should be limited to below the WHO recommended amounts, and adults should be careful not to exceed 2.4 grams per day. Patients who are allergic to this medication or have heart disease, cerebrovascular disease, uncontrolled hypertension, or severe renal or liver impairment should not take it. Patients with other specific types of migraine or heart-related diseases should also avoid using this medication. Patients allergic to sulfonamide components should use this medication with caution. Be aware that side effects such as headache, dizziness, drowsiness, and fatigue may occur during treatment, and if severe symptoms arise, one should immediately consult a healthcare professional. This medication should only be used in cases of a confirmed diagnosis of migraine, and care should be taken not to exceed the prescribed dosage. Caution should be exercised during tasks requiring concentration such as driving or operating machinery, as drowsiness may occur. For patients at risk of heart disease, the cardiac condition must be checked before administration. If taken together with other specific medications, the risk of side effects may increase, so it is important to inform about any medications currently being taken. Women who are pregnant or may become pregnant should carefully consider the risks to the fetus versus the therapeutic benefits when taking this medication. Women who are breastfeeding should take caution, as this medication can be excreted in breast milk. In case of overdose, one should immediately visit a medical institution for appropriate treatment and monitoring. This medication should be kept out of the reach of children and care should be taken not to transfer it to other containers.

Side effects

Pain, visual impairment, nausea, vomiting, pressure sensation, bradycardia, tachycardia, palpitations, fatigue, lethargy, dizziness, drowsiness, pain, numbness, hot sensation, skin hypersensitivity, anaphylaxis, coronary artery spasm, transient ischemic changes on electrocardiogram, angina, myocardial infarction, peripheral vascular ischemia, ischemic colitis

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is best to store the medication at room temperature between 1 and 30 degrees Celsius. By doing so, the medication's effectiveness can be maintained and used safely.

Appearance and packaging

Appearance

White or pale yellow round orally disintegrating tablet

Package unit

6 tablets/PVC[(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.