Pharmanaratriptan Oral Disintegrating Tablet 2.5 mg (Naratriptan Hydrochloride)

Adult dosage

This medication should not be used regularly for preventive purposes and is preferably administered as monotherapy, without concomitant use of other migraine treatments. This medication is an orally disintegrating tablet. Place it on the tongue, allow it to dissolve in saliva, and swallow. Do not chew or crush it. 1. 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 medication, a further 2.5 mg dose may be taken after an interval of at least 4 hours. In patients who do not respond to this medication, do not repeat the dose for the same attack unless there is a therapeutic benefit; however, it may be used for subsequent attacks. 3. Elderly patients (66 years and older) The safety and efficacy of naratriptan have not been established in elderly patients aged 66 years and older; therefore, its use is not recommended. Pharmacokinetic data indicate that clearance decreases with age. 4. 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). 5. 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): Single doses of naratriptan 0.25 mg, 1.0 mg, and 2.5 mg have not been 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.

This medication contains the artificial sweetener aspartame, and should not be administered to patients with the genetic disorder phenylketonuria. The daily intake of aspartame should be limited to below the WHO recommended level of 40 mg/kg, and for adults, care should be taken to not exceed a maximum of 2.4 g per day. It should not be used in patients who have had hypersensitivity reactions to this drug or have a history of ischemic heart disease, myocardial infarction, coronary artery spasms, and cerebrovascular accidents. Additionally, it should not be administered to patients with uncontrolled hypertension, severe renal and hepatic impairment, or to patients who have taken similar medications recently. Patients with hypersensitivity to sulfonamide components should take special caution when using this drug. Side effects such as temporary headache, dizziness, drowsiness, nausea may occur when taking this medication, so caution should be exercised with activities that require alertness, such as driving or operating machinery. Used only in patients diagnosed with migraines, and exceeding the prescribed dose should be avoided. In patients with a risk of cardiovascular diseases, heart condition should be confirmed before administration, and pregnant or nursing women should use the medication cautiously after consulting with a physician. Since side effects may occur when combined with other specific medications, it is essential to inform healthcare providers about any medications being taken. In case of overdose, the patient's condition should be monitored for at least 24 hours and necessary treatment should be provided. Keep out of reach of children, and avoid transferring the medication to other containers.

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

This medication may be sensitive to air and moisture, so it must be stored in a sealed container. Room temperature storage between 1 to 30 degrees Celsius is recommended to maintain the drug's efficacy over time.

Appearance

Round oral disintegrating tablet, white or pale yellow in color

Package unit

6 tablets/PPT [(Alu-Alu)]