Data from FDA - Curated by Marshall Pearce - Last updated 10 October 2017

Indication(s)

1 INDICATIONS AND USAGE Naratriptan Tablets, USP are indicated for the acute treatment of migraine 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 Tablets, USP is administered to treat any subsequent attacks. •Naratriptan Tablets, USP is not indicated for the prevention of migraine attacks. •Safety and effectiveness of Naratriptan Tablets, USP have not been established for cluster headache. Naratriptan Tablets, USP are a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults. (1) Limitations of Use: •Use only if a clear diagnosis of migraine has been established. (1) •Not indicated for the prophylactic therapy of migraine attacks. (1) •Not indicated for the treatment of cluster headache. (1)

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Advisory information

contraindications
4 CONTRAINDICATIONS Naratriptan Tablets, USP is contraindicated in patients with: •Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina [see Warnings and Precautions (5.1)] •Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.2)] •History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because such patients are at a higher risk of stroke [see Warnings and Precautions (5.4)] •Peripheral vascular disease [see Warnings and Precautions (5.5)] •Ischemic bowel disease [see Warnings and Precautions (5.5)] •Uncontrolled hypertension [see Warnings and Precautions (5.8)] •Recent use (i.e., within 24 hours) of another 5-HT1 agonist, ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide) [see Drug Interactions (7.1, 7.2)] •Hypersensitivity to Naratriptan Tablets, USP (angioedema and anaphylaxis seen) [see Warnings and Precautions (5.9)] •Severe renal or hepatic impairment [see Use in Specific Populations (8.6, 8.7), Clinical Pharmacology (12.3)] •History of coronary artery disease or coronary artery vasospasm (4) •Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders (4) •History of stroke, transient ischemic attack, or hemiplegic or basilar migraine (4) •Peripheral vascular disease (4) •Ischemic bowel disease (4) •Uncontrolled hypertension (4) •Recent (within 24 hours) use of another 5-HT1 agonist (e.g., another triptan) or an ergotamine-containing medication (4) •Hypersensitivity to Naratriptan Tablets, USP (angioedema and anaphylaxis seen) (4) •Severe renal or hepatic impairment (4)
Adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the prescribing information: •Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see Warnings and Precautions (5.1)] •Arrhythmias [see Warnings and Precautions (5.2)] •Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3)] •Cerebrovascular events [see Warnings and Precautions (5.4)] •Other vasospasm reactions [see Warnings and Precautions (5.5)] •Medication overuse headache [see Warnings and Precautions (5.6)] •Serotonin syndrome [see Warnings and Precautions (5.7)] •Increase in blood pressure [see Warnings and Precautions (5.8)] •Hypersensitivity reactions [see Contraindications (4), Warnings and Precautions (5.9)] Most common adverse reactions (≥2% and >placebo) were paresthesias, nausea, dizziness, drowsiness, malaise/fatigue, and throat/neck symptoms. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a long-term open-label trial where patients were allowed to treat multiple migraine attacks for up to 1 year, 15 patients (3.6%) discontinued treatment due to adverse reactions. In controlled clinical trials, the most common adverse reactions were paresthesias, dizziness, drowsiness, malaise/fatigue, and throat/neck symptoms, which occurred at a rate of 2% and at least 2 times placebo rate. Table 1 lists the adverse reactions that occurred in 5 placebo-controlled clinical trials of approximately 1,752 exposures to placebo and Naratriptan Tablets, USP in adult patients with migraine. Only reactions that occurred at a frequency of 2% or more in groups treated with Naratriptan Tablets, USP 2.5 mg and that occurred at a frequency greater than the placebo group in the 5 pooled trials are included in Table 1. The incidence of adverse reactions in controlled clinical trials was not affected by age or weight of the patients, duration of headache prior to treatment, presence of aura, use of prophylactic medications, or tobacco use. There were insufficient data to assess the impact of race on the incidence of adverse reactions. Table 1

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION •Recommended dose: 1 mg or 2.5 mg. (2.1) •May repeat dose after 4 hours if needed; not to exceed 5 mg in any 24-hour period. (2.1) •Mild or moderate renal or hepatic impairment: recommended starting dose is 1 mg not to exceed 2.5 mg in any 24-hour period. (2.2, 2.3) 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 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 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)].
Use in special populations
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. (8.1) 8.1 Pregnancy Pregnancy Category C: There are no adequate and well-controlled trials in pregnant women. Naratriptan Tablets, USP should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In reproductive toxicity studies in rats and rabbits, oral administration of naratriptan was associated with developmental toxicity (embryolethality, fetal abnormalities, pup mortality, offspring growth retardation) at doses producing maternal plasma drug exposures as low as 11 and 2.5 times, respectively, the exposure in humans receiving the maximum recommended daily dose (MRDD) of 5 mg. When naratriptan was administered to pregnant rats during the period of organogenesis at doses of 10, 60, or 340 mg/kg/day, there was a dose-related increase in embryonic death; incidences of fetal structural variations (incomplete/irregular ossification of skull bones, sternebrae, ribs) were increased at all doses. The maternal plasma exposures (AUC) at these doses were approximately 11, 70, and 470 times the exposure in humans at the MRDD. The high dose was maternally toxic, as evidenced by decreased maternal body weight gain during gestation. A no-effect dose for developmental toxicity in rats exposed during organogenesis was not established. When naratriptan was administered orally (1, 5, or 30 mg/kg/day) to pregnant Dutch rabbits throughout organogenesis, the incidence of a specific fetal skeletal malformation (fused sternebrae) was increased at the high dose, and increased incidences of embryonic death and fetal variations (major blood vessel variations, supernumerary ribs, incomplete skeletal ossification) were observed at all doses (4, 20, and 120 times, respectively, the MRDD on a body surface area basis). Maternal toxicity (decreased body weight gain) was evident at the high dose in this study. In a similar study in New Zealand White rabbits (1, 5, or 30 mg/kg/day throughout organogenesis), decreased fetal weights and increased incidences of fetal skeletal variations were observed at all doses (maternal exposures equivalent to 2.5, 19, and 140 times exposure in humans receiving the MRDD), while maternal body weight gain was reduced at 5 mg/kg or greater. A no-effect dose for developmental toxicity in rabbits exposed during organogenesis was not established. When female rats were treated orally with naratriptan (10, 60, or 340 mg/kg/day) during late gestation and lactation, offspring behavioral impairment (tremors) and decreased offspring viability and growth were observed at doses of 60 mg/kg or greater, while maternal toxicity occurred only at the highest dose. Maternal exposures at the no-effect dose for developmental effects in this study were approximately 11 times the exposure in humans receiving the MRDD. 8.3 Nursing Mothers Naratriptan is excreted in rat milk. It is not known whether naratriptan is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Naratriptan Tablets, USP, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. Therefore, Naratriptan Tablets, USP is not recommended for use in patients younger than 18 years of age. One controlled clinical trial evaluated Naratriptan Tablets, USP (0.25 to 2.5 mg) in 300 adolescent migraineurs aged 12 to 17 years who received at least 1 dose of Naratriptan Tablets, USP for an acute migraine. In this study, 54% of the patients were female and 89% were Caucasian. There were no statistically significant differences between any of the treatment groups. The headache response rates at 4 hours (n) were 65% (n = 74), 67% (n = 78), and 64% (n = 70) for placebo, 1-mg, and 2.5-mg groups, respectively. This trial did not establish the efficacy of Naratriptan Tablets, USP compared with placebo in the treatment of migraine in adolescents. Adverse reactions observed in this clinical trial were similar in nature to those reported in clinical trials in adults. 8.5 Geriatric Use Clinical trials of Naratriptan Tablets, USP did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Naratriptan is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in elderly patients who have reduced renal function. In addition, elderly patients are more likely to have decreased hepatic function, they are at higher risk for CAD, and blood pressure increases may be more pronounced in the elderly. A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving Naratriptan Tablets, USP [see Warnings and Precautions (5.1)]. 8.6 Renal Impairment The use of Naratriptan Tablets, USP is contraindicated in patients with severe renal impairment (creatinine clearance: <15 mL/min) because of decreased clearance of the drug. In patients with mild to moderate renal impairment, the recommended starting dose is 1 mg, and the maximum daily dose should not exceed 2.5 mg over a 24-hour period [see Dosage and Administration (2.2), Clinical Pharmacology (12.3)]. 8.7 Hepatic Impairment The use of Naratriptan Tablets, USP is contraindicated in patients with severe hepatic impairment (Child-Pugh grade C) because of decreased clearance. In patients with mild or moderate hepatic impairment (Child-Pugh grade A or B), the recommended starting dose is 1 mg, and the maximum daily dose should not exceed 2.5 mg over a 24-hour period [see Dosage and Administration (2.3), Clinical Pharmacology (12.3)].
Pregnancy and lactation
8.3 Nursing Mothers Naratriptan is excreted in rat milk. It is not known whether naratriptan is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Naratriptan Tablets, USP, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Interactions

7 DRUG INTERACTIONS 7.1 Ergot-Containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and Naratriptan Tablets, USP within 24 hours of each other is contraindicated. 7.2 Other 5-HT1 Agonists Concomitant use of other 5-HT1B/1D agonists (including triptans) within 24 hours of treatment with Naratriptan Tablets, USP is contraindicated because the risk of vasospastic reactions may be additive. 7.3 Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome Cases of serotonin syndrome have been reported during co-administration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7)].

More information

Category Value
Authorisation number ANDA091326
Agency product number 10X8X4P12Z
Orphan designation No
Product NDC 0574-0215,0574-0214
Date Last Revised 26-06-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 311918
Marketing authorisation holder Paddock Laboratories, LLC