ZOMIG- zolmitriptan tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

ZOLMITRIPTAN (UNII: 2FS66TH3YW) (ZOLMITRIPTAN - UNII:2FS66TH3YW)

Disponible depuis:

Amneal Pharmaceuticals LLC

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

ZOMIG is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use - Only use ZOMIG if a clear diagnosis of migraine has been established. If a patient has no response to ZOMIG treatment for the first migraine attack, reconsider the diagnosis of migraine before ZOMIG is administered to treat any subsequent attacks. - ZOMIG is not indicated for the prevention of migraine attacks. - Safety and effectiveness of ZOMIG have not been established for cluster headache. ZOMIG is contraindicated in patients with: - Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), other significant underlying cardiovascular disease, 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 of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions (5.4)] . - Peripheral vascular disease (PVD) [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, or ergot-type medication (such as dihydroergotamine or methysergide) [see Drug Interactions (7.1, 7.3)] . - Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent use of a MAO-A inhibitor (that is within 2 weeks) [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)] . - Known hypersensitivity to ZOMIG (angioedema and anaphylaxis seen) [see Adverse Reactions (6.2)] . Risk Summary There are no adequate data on the developmental risk associated with the use of ZOMIG in pregnant women. In reproductive toxicity studies in rats and rabbits, oral administration of zolmitriptan to pregnant animals resulted in embryolethality and fetal abnormalities (malformations and variations) at clinically relevant exposures (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 estimated rates of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy. Data Animal Data When zolmitriptan was administered to pregnant rats during the period of organogenesis at oral doses of 100, 400, and 1200 mg/kg/day (plasma exposures (AUCs) ≈280, 1100, and 5000 times the human AUC at the maximum recommended human dose (MRHD) of 10 mg/day), there was a dose-related increase in embryolethality. A no-effect dose for embryolethality was not established. When zolmitriptan was administered to pregnant rabbits during the period of organogenesis at oral doses of 3, 10, and 30 mg/kg/day (plasma AUCs ≈1, 11, and 42 times the human AUC at the MRHD), there were increases in embryolethality and in fetal malformations and variations. The no-effect dose for adverse effects on embryofetal development was associated with a plasma AUC similar to that in humans at the MRHD. When female rats were given zolmitriptan during gestation, parturition, and lactation at oral doses of 25, 100, and 400 mg/kg/day (plasma AUCs ≈70, 280, and 1100 times that in human at the MRHD), an increased incidence of hydronephrosis was found in the offspring. The no-effect dose was associated with a plasma AUC ≈280 times that in humans at the MRHD. Risk Summary There are no data on the presence of zolmitriptan or its metabolites in human milk, the effects on the breastfed infant, or the effects of zolmitriptan and its metabolites on milk production. In rats, oral dosing with zolmitriptan resulted in levels in milk up to 4 times that in maternal plasma. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZOMIG and any potential adverse effects on the breastfed infant from ZOMIG or from the underlying maternal condition. The safety and effectiveness in pediatric patients have not been established. Therefore, ZOMIG is not recommended for use in patients under 18 years of age. One randomized, placebo-controlled clinical trial of ZOMIG tablets (2.5, 5 and 10 mg) evaluated 696 pediatric patients (aged 12 to 17 years) with migraines. This study did not demonstrate the efficacy of ZOMIG compared to placebo in the treatment of migraine in adolescents. Adverse reactions in the adolescent patients treated with ZOMIG were similar in nature and frequency to those reported in clinical trials in adults treated with ZOMIG. ZOMIG has not been studied in pediatric patients less than 12 years old. In the postmarketing experience with triptans, including ZOMIG, there were no additional adverse reactions seen in pediatric patients that were not seen in adults. Clinical studies of ZOMIG did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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. A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of coronary artery disease) prior to receiving ZOMIG [see Warnings and Precautions (5.1)] . The pharmacokinetics of zolmitriptan were similar in geriatric patients (aged > 65 years) compared to younger patients [see Clinical Pharmacology (12.3)] . After oral ZOMIG administration, zolmitriptan blood levels were increased in patients with moderate to severe hepatic impairment, and significant elevation in blood pressure was observed in some of these patients [see Warnings and Precautions (5.8)] . Therefore, adjust the ZOMIG dose and administer with caution in patients with moderate or severe hepatic impairment [see Dosage and Administration (2.3) and Clinical Pharmacology (12)] .

Descriptif du produit:

2.5 mg Tablets – Yellow colored, round, biconvex film-coated tablets, debossed with 101 on one side and deep breakline on other side and are supplied in carton of 6 (1 x 6) unit-dose tablets (NDC 60846-130-30). 5 mg Tablets – Pink colored, round, biconvex film-coated tablets, debossed with 102 on one side and plain on the other side and are supplied in carton of 3 (1 x 3) unit-dose tablets (NDC 60846-133-60). Store ZOMIG Tablets between 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from light and moisture.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ZOMIG- ZOLMITRIPTAN TABLET, FILM COATED
AMNEAL PHARMACEUTICALS LLC
REFERENCE LABEL SET ID: 101D7DD3-3970-4025-B6CA-79D28020F99D
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZOM
IG SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOMIG.
ZOMIG (ZOLMITRIPTAN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL:1997
INDICATIONS AND USAGE
ZOMIG is a serotonin (5-HT)
receptor agonist (triptan) indicated for the acute treatment of
migraine
with or without aura in adults (1) (1)
Limitations of Use: (1)
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
Recommended starting dose: 1.25 mg or 2.5 mg (2.1)
Maximum single dose: 5 mg (2.1)
May repeat dose after 2 hours if needed; not to exceed 10 mg in any
24-hour period (2.1)
Moderate or Severe Hepatic Impairment: 1.25 mg recommended (2.3, 8.6)
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg functionally-scored (3)
Tablets: 5 mg (not scored) (3)
CONTRAINDICATIONS
History of coronary artery disease (CAD) or coronary vasospasm (4)
Symptomatic 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-HT agonist (e.g., another
triptan), or an ergotamine-
containing medication (4)
Monoamine oxidase (MAO)-A inhibitor used in past 2 weeks (4)
Known hypersensitivity to ZOMIG or zolmitriptan orally disintegrating
tablets (4)
WARNINGS AND PRECAUTIONS
_Myocardial Ischemia/Infarction, and Prinzmetal’sAngina_: Perform
cardiac evaluation in patients with
multiple cardiovascular risk factors (5.1)
_Arrhythmias_: Discontinue ZOMIG if occurs (5.2)
_Chest/Throat/Neck/Jaw Pain, Tightness, and Pressure_: Generally not
associa