Naratriptan

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FDA Labeling Changes

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Uses

Naratriptan Tablets USP are indicated for the acute treatment of migraine attacks with or without aura in adults.

Limitations of Use:

•: Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with Naratriptan Tablets USP, reconsider the diagnosis of migraine before naratriptan is administered to treat any subsequent attacks.
•: Naratriptan Tablets USP are not indicated for the prevention of migraine attacks.
•: Safety and effectiveness of Naratriptan Tablets USP have not been established for cluster headache.

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History

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Other Information

Naratriptan Tablets USP contain naratriptan as the hydrochloride, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:

The molecular formula is C17H25N3O2S•HCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablet for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.

Sources

Naratriptan Manufacturers

Roxane Laboratories, Inc.

Naratriptan | Roxane Laboratories, Inc.

2.1 Dosing Information
The recommended dose of naratriptan is 1 mg or 2.5 mg.

If the migraine returns or if the patient has only partial response, the dose may be repeated once after 4 hours, for a maximum dose of 5 mg in a 24-hour period.

The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established.
2.2 Dosage and Adjustment in Patients With Renal Impairment
Naratriptan is contraindicated in patients with severe renal impairment (creatinine clearance: <15 mL/min) because of decreased clearance of the drug [see Contraindications (4), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

In patients with mild to moderate renal impairment, the maximum daily dose should not exceed 2.5 mg over a 24-hour period and a 1 mg starting dose is recommended [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.3 Dosage Adjustment in Patients With Hepatic Impairment
Naratriptan is contraindicated in patients with severe hepatic impairment (Child-Pugh grade C) because of decreased clearance [see Contraindications (4), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

In patients with mild to moderate hepatic impairment (Child-Pugh grade A or B), the maximum daily dose should not exceed 2.5 mg over a 24-hour period and a 1 mg starting dose is recommended [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

No Recall
Mylan Pharmaceuticals Inc.

Naratriptan | Efficient Laboratories Inc

Directions

Shake well before use

Do not exceed 6 doses in any 24 hour period or as directed by a doctor

Age                                                                             Dose

Adults and Children 12 years and over                       10 mL (2 tsps.) every 4 hours

Children 6 to under 12 years of age                            5 mL (1 tsp.) every 4 hours

Children under 6 years of age                                     Do not use

No Recall
Orchidpharma Inc

Naratriptan | Orchidpharma Inc

2.1 Dosing Information
The recommended dose of naratriptan tablets is 1 mg or 2.5 mg.

If the migraine returns or if the patient has only partial response, the dose may be repeated once after 4 hours, for a maximum dose of 5 mg in a 24 hour period.

The safety of treating an average of more than 4 migraine attacks in a 30 day period has not been established.
2.2 Dosage Adjustment in Patients With Renal Impairment
Naratriptan tablets are contraindicated in patients with severe renal impairment (creatinine clearance: <15 mL/min) because of decreased clearance of the drug [see Contraindications (4), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

In patients with mild to moderate renal impairment, the maximum daily dose should not exceed 2.5 mg over a 24‑hour period and a 1 mg starting dose is recommended [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.3 Dosage Adjustment in Patients With Hepatic Impairment
Naratriptan tablets are contraindicated in patients with severe hepatic impairment (Child-Pugh grade C) because of decreased clearance [see Contraindications (4), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

In patients with mild or moderate hepatic impairment (Child-Pugh grade A or B), the maximum daily dose should not exceed 2.5 mg over a 24 hour period and a 1 mg starting dose is recommended [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

No Recall
Sun Pharmaceutical Industries Limited

Naratriptan | Sun Pharmaceutical Industries Limited

2.1 Dosing Information
The recommended dose of naratriptan tablets are 1 mg or 2.5 mg.

If the migraine returns or if the patient has only partial response, the dose may be repeated once after 4 hours, for a maximum dose of 5 mg in a 24-hour period. The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established.
2.2 Dosage Adjustment in Patients With Renal Impairment
Naratriptan tablets are contraindicated in patients with severe renal impairment (creatinine clearance: <15 mL/min) because of decreased clearance of the drug [see Contraindications (4), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

In patients with mild to moderate renal impairment, the maximum daily dose should not exceed 2.5 mg over a 24-hour period and a 1 mg starting dose is recommended [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.3 Dosage Adjustment in Patients With Hepatic Impairment
Naratriptan tablets are contraindicated in patients with severe hepatic impairment (Child-Pugh grade C) because of decreased clearance [see Contraindications (4), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

In patients with mild or moderate hepatic impairment (Child-Pugh grade A or B), the maximum daily dose should not exceed 2.5 mg over a 24-hour period and a 1 mg starting dose is recommended [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

No Recall
Teva Pharmaceuticals Usa Inc

Naratriptan | Meda Pharmaceuticals Inc.

2.1 Dosage in Adults
Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of Edluar should not exceed 10 mg once daily immediately before bedtime.

The recommended initial doses for women and men are different because zolpidem clearance is lower in women.
2.2 Special Populations
Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of Edluar in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); Use in Specific Populations (8.5)].
2.3 Use with CNS Depressants
Dosage adjustment may be necessary when Edluar is combined with other CNS-depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.4 Administration
The effect of Edluar may be slowed by ingestion with or immediately after a meal.

Edluar sublingual tablet should be placed under the tongue, where it will disintegrate. The tablet should not be swallowed and the tablet should not be taken with water.

No Recall
Heritage Pharmaceuticals Inc.

Naratriptan | Heritage Pharmaceuticals Inc.

2.1 Dosing Information
The recommended dose of naratriptan tablets, USP is 1 mg or 2.5 mg.

If the migraine returns or if the patient has only partial response, the dose may be repeated once after 4 hours, for a maximum dose of 5 mg in a 24-hour period.

The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established.
2.2 Dosage Adjustment in Patients With Renal Impairment
Naratriptan tablets, USP is contraindicated in patients with severe renal impairment (creatinine clearance: <15 mL/min) because of decreased clearance of the drug [see Contraindications (4), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

In patients with mild to moderate renal impairment, the maximum daily dose should not exceed 2.5 mg over a 24-hour period and a 1-mg starting dose is recommended [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.3 Dosage Adjustment in Patients With Hepatic Impairment
Naratriptan tablets, USP are contraindicated in patients with severe hepatic impairment (Child-Pugh grade C) because of decreased clearance [see Contraindications (4), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

In patients with mild or moderate hepatic impairment (Child-Pugh grade A or B), the maximum daily dose should not exceed 2.5 mg over a 24-hour period and a 1-mg starting dose is recommended [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

No Recall
Sandoz Inc

Naratriptan | Sandoz Inc

2.1 Dosing Information
The recommended dose of naratriptan tablets are 1 mg or 2.5 mg.

If the migraine returns or if the patient has only partial response, the dose may be repeated once after 4 hours, for a maximum dose of 5 mg in a 24-hour period.

The safety of treating an average of more than 4 migraine attacks in a 30‑day period has not been established.
2.2 Dosage Adjustment in Patients With Renal Impairment
Naratriptan tablets are contraindicated in patients with severe renal impairment (creatinine clearance: <15 mL/min) because of decreased clearance of the drug [see CONTRAINDICATIONS (4), USE IN SPECIFIC POPULATIONS (8.6), CLINICAL PHARMACOLOGY (12.3)].

In patients with mild to moderate renal impairment, the maximum daily dose should not exceed 2.5 mg over a 24‑hour period and a 1 mg starting dose is recommended [see USE IN SPECIFIC POPULATIONS (8.6), CLINICAL PHARMACOLOGY (12.3)].
2.3 Dosage Adjustment in Patients With Hepatic Impairment
Naratriptan tablets are contraindicated in patients with severe hepatic impairment (Child-Pugh grade C) because of decreased clearance [see CONTRAINDICATIONS (4), USE IN SPECIFIC POPULATIONS (8.7), CLINICAL PHARMACOLOGY (12.3)].

In patients with mild or moderate hepatic impairment (Child-Pugh grade A or B), the maximum daily dose should not exceed 2.5 mg over a 24-hour period and a 1-mg starting dose is recommended[see USE IN SPECIFIC POPULATIONS (8.7), CLINICAL PHARMACOLOGY (12.3)].

No Recall