ELETRIPTAN HYDROBROMIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ELETRIPTAN HYDROBROMIDE MONOHYDRATE (UNII: 4139X692FA) (ELETRIPTAN - UNII:22QOO9B8KI)

Available from:

Amneal Pharmaceuticals LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Eletriptan hydrobromide tablets are indicated for the acute treatment of migraine with or without aura in adults. L i m itati o n s 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 eletriptan hydrobromide tablets, reconsider the diagnosis of migraine before eletriptan hydrobromide tablets are administered to treat any subsequent attacks. - Eletriptan hydrobromide tablets are not intended for the prevention of migraine attacks. - Safety and effectiveness of eletriptan hydrobromide tablets have not been established for cluster headache. Eletriptan hydrobromide 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, transient ischemic attack (TIA), or history or current evidence of hemiplegic or basilar migraine because these 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-hydroxytryptamine1  (5-HT1 ) agonist, ergotamine-containing medication, or ergot-type medication such as dihydroergotamine (DHE) or methysergide [ see Drug Interactions (7.1)] . - Hypersensitivity to eletriptan hydrobromide (angioedema and anaphylaxis seen) [ see Warnings and Precautions (5.9)]. - Recent use (i.e., within at least 72 hours) of the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, or nelfinavir [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)]. Risk Summary Available human data on the use of eletriptan hydrobromide in pregnant women are not sufficient to draw conclusions about drug-associated risk for major birth defects and miscarriage. In animal studies, oral administration of eletriptan during pregnancy or throughout pregnancy and lactation was associated with developmental toxicity (decreased fetal and pup weights, increased incidences of fetal structural abnormalities, decreased pup viability) at clinically-relevant doses [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Several studies have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. A study using linked data from the Medical Birth Registry of Norway to the Norwegian Prescription Database compared pregnancy outcomes in women who redeemed prescriptions for triptans during pregnancy, as well as a migraine disease comparison group who redeemed prescriptions for triptans before pregnancy only. Of the 189 women who redeemed prescriptions for eletriptan during the first trimester, 4 (2.1%) had infants with major congenital malformations, while for the 174 women who redeemed prescriptions for eletriptan before, but not during, pregnancy, 11 (6.3%) had infants with major congenital malformations. Methodological limitations of this study, including small size of the eletriptan population and infrequent events, do not allow for thorough characterization of risk. Animal Data When pregnant rats were administered eletriptan (0, 10, 30, or 100 mg/kg/day) during the period of organogenesis, fetal weights were decreased and the incidences of vertebral and sternebral variations were increased at 100 mg/kg/day (approximately 12 times the maximum recommended human dose [MRHD] of 80 mg/day on a mg/m2 basis). The 30 and 100 mg/kg/day doses were also maternally toxic, as evidenced by decreased maternal body weight gain during gestation. The no-effect dose for adverse effects on embryofetal development in rats was 30 mg/kg/day, which is approximately 4 times the MRHD on a mg/m2 basis. When eletriptan (0, 5, 10, or 50 mg/kg/day) was orally administered to pregnant rabbits throughout organogenesis, fetal weights were decreased at 50 mg/kg/day. The incidences of fused sternebrae and vena cava deviations were increased at all doses. Maternal toxicity was not evident at any dose. A no-effect dose for adverse effects on embryofetal development in rabbits was not established; the lowest dose tested (5 mg/kg/day) is similar to the MRHD on a mg/m2 basis. Oral administration of eletriptan (0, 5, 15, or 50 mg/kg/day) to female rats throughout pregnancy and lactation resulted in a decrease in offspring viability and body weight at the highest dose tested. The no-effect dose for adverse effects on pre- and postnatal development in rats (15 mg/kg/day) is approximately 2 times the MRHD on a mg/m2 basis. Risk Summary Eletriptan is excreted in human milk. There are no data on the effects of eletriptan on the breastfed infant or the effects of eletriptan on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for eletriptan hydrobromide and any potential adverse effects on the breastfed child from eletriptan hydrobromide or from the underlying maternal condition. Infant exposure can be minimized by avoiding breastfeeding for 24 hours after treatment. Safety and effectiveness in pediatric patients have not been established. The efficacy of eletriptan hydrobromide tablets (40 mg) in patients 11 to 17 was not established in a randomized, placebo-controlled trial of 274 adolescent migraineurs [see Clinical Studies (14)] . Adverse reactions observed were similar in nature to those reported in clinical trials in adults. Post-marketing experience with other triptans includes a limited number of reports that describe pediatric patients who have experienced clinically serious adverse reactions that are similar in nature to those reported rarely in adults. Long-term safety of eletriptan was studied in 76 adolescent patients who received treatment for up to one year.  A similar profile of adverse reactions to that of adults was observed. The long-term safety of eletriptan in pediatric patients has not been established. Blood pressure was increased to a greater extent in elderly subjects than in young subjects.  The pharmacokinetic disposition of eletriptan in the elderly is similar to that seen in younger adults [see Clinical Pharmacology (12.3)] . In clinical trials, there were no apparent differences in efficacy or the incidence of adverse reactions between patients under 65 years of age and those 65 and above. The effect of severe hepatic impairment on eletriptan hydrobromide metabolism has not been evaluated. Eletriptan hydrobromide is not recommended for use in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)] .

Product summary:

Eletriptan hydrobromide tablets, 20 mg are light yellow to yellow colored, round shaped, biconvex, film-coated tablets, debossed with “AN” on one side and “42” on other side. Each tablet contains 20 mg of eletriptan (base) as the hydrobromide salt. They are available as follows: Bottles of 30:                                                              NDC 65162-042-03 Carton of 6 tablets:                                                     NDC 65162-042-80 (Packages of 6 unit doses, 1 card of 6 tablets each) Eletriptan hydrobromide tablets, 40 mg are light orange to dark yellow colored, round shaped, biconvex, film coated tablets, debossed with “AN” on one side and “43” on other side. Each tablet contains 40 mg of eletriptan (base) as the hydrobromide salt. They are available as follows: Bottles of 30:                                                              NDC 65162-043-03 Carton of 6 tablets:                                                     NDC 65162-043-80 (Packages of 6 unit doses, 1 card of 6 tablets each) Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ELETRIPTAN HYDROBROMIDE- ELETRIPTAN HYDROBROMIDE TABLET, FILM COATED
AMNEAL PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ELETRIPTAN
HYDROBROMIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ELETRIPTAN HYDROBROMIDE TABLETS.
ELETRIPTAN HYDROBROMIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
Eletriptan hydrobromide tablets are a serotonin (5-HT
) receptor agonist (triptan) indicated for the
acute treatment of migraine with or without aura in adults (1)
Limitations of Use:
Use only after a clear diagnosis of migraine has been established (1)
Not indicated for the prophylactic therapy of migraine (1)
Not indicated for the treatment of cluster headache (1)
DOSAGE AND ADMINISTRATION
Single dose: 20 mg or 40 mg (2)
Maximum single dose: 40 mg (2)
May repeat dose after 2 hours if needed; not to exceed 80 mg in any
24-hour period (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg and 40 mg (3)
CONTRAINDICATIONS
History of coronary artery disease (CAD) or coronary artery vasospasm
(4)
Wolff-Parkinson-White syndrome or other cardiac accessory conduction
pathway disorders (4)
History of stroke, transient ischemic attack, or history or current
evidence of hemiplegic or basilar
migraine (4)
Peripheral vascular disease (4)
Ischemic bowel disease (4)
Uncontrolled hypertension (4)
Within 24 hours of treatment with another 5-HT agonist, or an
ergotamine-containing medication (4)
Hypersensitivity to eletriptan hydrobromide (angioedema and
anaphylaxis seen) (4)
Within at least 72 hours of treatment with the following potent CYP3A4
inhibitors: ketoconazole,
itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir,
or nelfinavir (4)
WARNINGS AND PRECAUTIONS
Myocardial ischemia/infarction or Prinzmetal’s angina: Perform
cardiac evaluation in patients with
multiple cardiovascular risk factors (5.1)
Arrhythmias: Discontinue eletriptan hydrobromide if occurs (5.2)
Chest/throat/neck/jaw pain,