ZOMIG- zolmitriptan spray, metered

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Amneal Pharmaceuticals

INN (International Name):

ZOLMITRIPTAN

구성:

ZOLMITRIPTAN 5 mg

관리 경로:

NASAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

ZOMIG Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use ZOMIG is contraindicated in patients with: 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 embryo-fetal 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. Safety and effectiveness of ZOMIG in pediatric patients under 12 years of age have not been established. The efficacy of ZOMIG nasal spray in the acute treatment of migraine in pediatric patients 12 to 17 years of age was established in a placebo-controlled study with a total of 81 pediatric patients receiving ZOMIG 2.5 mg and 229 pediatric patients receiving ZOMIG 5 mg [see Clinical Studies (14.2)] . In an earlier study with a different design, ZOMIG 5 mg nasal spray was evaluated in the acute treatment of migraine headache in 171 pediatric patients 12 to 17 years of age. In that study, the efficacy of ZOMIG nasal spray was not established. The safety of ZOMIG nasal spray in the acute treatment of migraine in pediatric patients 12 to 17 years of age was established in two placebo-controlled studies with a total of 81 pediatric patients receiving ZOMIG 2.5 mg and 431 pediatric patients receiving ZOMIG 5 mg [see Adverse Reactions (6.1) ] . The safety profile of ZOMIG nasal spray in pediatric patients 12 to 17 years of age is similar to the profile observed in adults [see Adverse Reactions (6.1)] . In the postmarketing experience with triptans, including ZOMIG, there is a limited number of reports that describe pediatric patients who have experienced clinically serious adverse events; those that were reported are similar in nature to those reported rarely 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. Geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of coronary artery disease) should have a cardiovascular evaluation 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)] . The effect of hepatic disease on the pharmacokinetics of zolmitriptan nasal spray has not been evaluated. After oral 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)] . ZOMIG nasal spray is not recommended in patients with moderate to severe hepatic impairment [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)] . Instructions for Use   ZOMIG® (Zo-mig) (zolmitriptan) Nasal Spray   Important: For use in your nose only. Do not spray in your eyes.   Note: There is only 1 dose in the nasal sprayer. Do not try to prime the nasal sprayer or you will lose the dose. Do not press the plunger until you have put the tip into your nostril or you will lose the dose.   Steps for using ZOMIG Nasal Spray   Step 1. Remove the ZOMIG Nasal Spray unit from the single use package it comes in. Do not remove the unit until you are ready to use it. The unit contains only 1 spray.   Step 2. Blow your nose gently to clear your nasal passages before use.   Step 3. Remove the protective cap (See Figure A ).     Step 4. Keeping your head in an upright position, gently close 1 nostril with your index finger and breathe out gently through your mouth. (See Figure B ). Either nostril can be used.     Step 5. With your other hand, hold the container with your thumb supporting the container at the bottom, and your index and middle fingers on each side of the nozzle. (See Figure C ).     Insert the tip of the sprayer device into your open nostril as far as feels comfortable and tilt your head slightly (See Figure D ).   Do not press the plunger yet.   Step 6. Breathe in gently through your nose and at the same time press the plunger firmly with your thumb to release your dose of ZOMIG Nasal Spray (See Figure D ).   The plunger may feel stiff and you may hear a click. Keep your head slightly tilted back and remove the tip from your nose. Breathe gently through your mouth for 5 to 10 seconds. You may feel liquid in your nose or the back of your throat. This is normal.   Step 7. Dispose the ZOMIG Nasal Spray device after completing the full dose or as soon as it becomes outdated or no longer needed. Dispose of properly. Keep out of reach of children. Do not reuse.   This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.   ZOMIG is a registered trademark of the AstraZeneca group of companies.   Other brands mentioned are trademarks of their respective owners and are not trademarks of the AstraZeneca group of companies. The makers of these brands are not affiliated with AstraZeneca or its products.   ©AstraZeneca 2019   Revised: 04/2019   Distributed by: Amneal Specialty, a division of Amneal Pharmaceuticals LLC Bridgewater, NJ 08807

제품 요약:

The ZOMIG Nasal Spray device is a blue-colored plastic device with a gray protection cap, labeled to indicate the nominal dose. Each ZOMIG Nasal Spray device administers a single dose of ZOMIG. ZOMIG Nasal Spray is supplied as a clear to pale yellow solution of zolmitriptan, buffered to a pH 5.0. Each ZOMIG Nasal Spray device contains 2.5 mg or 5 mg of zolmitriptan in a 100 µL unit dose aqueous buffered solution containing citric acid, anhydrous, USP, disodium phosphate dodecahydrate USP and purified water USP. 2.5 mg ZOMIG® Nasal Spray is supplied in boxes of 6 single‑use nasal spray units. (NDC 64896-682-51) 5 mg ZOMIG® Nasal Spray is supplied in boxes of 6 single‑use nasal spray units. (NDC 64896-681-51). Each ZOMIG® Nasal Spray single dose unit spray supplies 2.5 and 5 mg, respectively, of zolmitriptan. The ZOMIG® Nasal Spray unit must be discarded after use. Store at controlled room temperature, 20‑25°C (68‑77°F) [see USP].

승인 상태:

New Drug Application

제품 특성 요약

ZOMIG- ZOLMITRIPTAN SPRAY, METERED
AMNEAL PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOMIG NASAL SPRAY SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR ZOMIG NASAL SPRAY.
ZOMIG (ZOLMITRIPTAN) NASAL SPRAY
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
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LIMITATIONS OF USE:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Nasal Spray: 2.5 mg and 5 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions (≥5% and > placebo) were:
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ZOMIG Nasal Spray is a serotonin (5 HT)
receptor agonist (triptan) indicated for the acute treatment of
migraine
with or without aura in adults and pediatric patients 12 years and
older (1)
1B/1D
Use only after a clear diagnosis of migraine has been established (1)
Not intended for the prophylactic therapy of migraine (1)
Not indicated for the treatment of cluster headache (1)
Not recommended in patients with moderate to severe hepatic impairment
(1)
Recommended starting dose: 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)
History of ischemic heart disease or coronary artery 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-HT1 agonist (e.g., another
triptan) or of an ergot-type medication (4)
MAO-A inhibitor used in past 2 weeks (4)
Hypersensitivity to ZOMIG (4)
Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina:
Perform cardiac evaluation in patients with
multiple cardiovascular risk factors (5.1)
Arrhythmias: Discontinue dosing if occurs (5.2)
Chest/thr