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Zomig Nasal Spray Prescribing Information

zomig nasal spray prescribing information

Medically reviewed by Drugs. Last updated on Dec 1, 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. The recommended starting dose for Zomig Nasal Spray in adult and pediatric patients 12 years of age and older is 2. As the individual response to Zomig Nasal Spray may vary, the dose should be adjusted on an individual basis.

Zomig Nasal Spray is not recommended in patients with moderate to severe hepatic impairment because of increased zolmitriptan blood levels in these patients and elevation of blood pressure in some of these patients. The recommended dosage of Zomig Nasal Spray in patients with mild hepatic impairment is the same as for patients with normal hepatic function [see Dosage and Administration 2. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of ZOMIG.

Some of these reactions occurred in patients without known CAD. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administrating the first ZOMIG dose in a medically-supervised setting and performing an electrocardiogram ECG immediately following ZOMIG administration.

For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of ZOMIG. However, if a cardiac origin is suspected, patients should be evaluated. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with symptoms atypical for migraine, other potentially serious neurological conditions should be excluded.

ZOMIG should not be administered to patients with a history of stroke or transient ischemic attack [see Contraindications 4 ]. Overuse of acute migraine drugs e. Medication overuse headache may present as migraine-like daily headaches, or as a marked increase in frequency of migraine attacks.

Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms which often includes a transient worsening of headache may be necessary. Serotonin syndrome symptoms may include mental status changes e. The onset of symptoms usually rapidly occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication.

Very rarely these increases in blood pressure have been associated with significant clinical events. The following adverse reactions are discussed in more detail in other sections of labeling:. Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Among patients treating single attacks with Zomig Nasal Spray in a blinded placebo-controlled trial Study 1 , there was a low withdrawal rate related to adverse reactions: None of the withdrawals were due to a serious event.

One patient was withdrawn due to abnormal ECG changes from baseline that were incidentally found 23 days after the last dose of Zomig Nasal Spray. The incidence of adverse reactions in controlled clinical trials was not affected by gender, weight, or age of the patients vs.

There were insufficient data to assess the impact of race on the incidence of adverse reactions. Nasopharyngeal examinations, in a subset of patients participating in two long term trials of up to one-year duration, failed to demonstrate any clinically significant changes with repeated use of Zomig Nasal Spray.

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical reactions are presented. Because the reports include reactions observed in open and uncontrolled studies, the role of ZOMIG in their causation cannot be reliably determined.

Furthermore, variability associated with adverse reaction reporting, the terminology used to describe adverse reactions, etc. All reported reactions are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug.

Reactions are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: Pediatric Patients 12 to 17 Years of Age. 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 studies [see Pediatric Use 8. Other common adverse reactions were nasal discomfort, dizziness, oropharyngeal pain, and nausea.

The adverse reaction profile was similar across gender. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The reactions enumerated include all except those already listed in the Clinical Trials Experience section above or the Warnings and Precautions section. There have been reports of anaphylaxis, anaphylactoid, and hypersensitivity reactions including angioedema in patients receiving ZOMIG.

Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. MAO-A inhibitors increase the systemic exposure of zolmitriptan. Cases of life-threatening serotonin syndrome have been reported during combined use of selective serotonin reuptake inhibitors SSRIs or serotonin norepinephrine reuptake inhibitors SNRIs and triptans [see Warnings and Precautions 5. 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.

The estimated rates of major birth defects 2. Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy. A no-effect dose for embryolethality was not established.

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. 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.

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. In an earlier study with a different design, ZOMIG 5 mg nasal spray was evaluated in the acute treatment of migraine headache in 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. 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. 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. 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. Zomig Nasal Spray is not recommended in patients with moderate to severe hepatic impairment [see Dosage and Administration 2.

There is no experience with acute overdose. There is no specific antidote to zolmitriptan. In cases of severe intoxication, intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system.

It is unknown what effect hemodialysis or peritoneal dialysis has on the plasma concentrations of zolmitriptan. Zolmitriptan is chemically designated as S [[3-[2- dimethylamino ethyl]-1H-indolyl]methyl]oxazolidinone and has the following chemical structure:.

The empirical formula is C 16 H 21 N 3 O 2 , representing a molecular weight of Zolmitriptan is a white to almost white powder that is readily soluble in water. Each Zomig Nasal Spray contains 2. Zomig Nasal Spray is hypertonic. The osmolarity of Zomig Nasal Spray for 2. Zolmitriptan nasal spray is rapidly absorbed via the nasopharynx as detected in a Photon Emission Tomography PET study using 11C zolmitriptan.

Zolmitriptan was detected in plasma by 5 minutes and peak plasma concentration generally was achieved by 3 hours. The time at which maximum plasma concentrations were observed was similar after single 1 day or multiple 4 days nasal dosing.

Plasma concentrations of zolmitriptan are sustained for 4 to 6 hours after dosing. Zolmitriptan and its active N-desmethyl metabolite display linear kinetics after single or multiple doses of Zomig Nasal Spray over the dose range of 0. The pharmacokinetics of the N-desmethyl metabolite are similar to that of zolmitriptan for all nasal spray dosages. The N-desmethyl metabolite is detected in plasma by 15 minutes and peak plasma concentration is generally achieved by 3 hours after administration.

The mean apparent volume of distribution for zolmitriptan nasal spray formulation is 8. Mean total plasma clearance for zolmitriptan nasal spray is The renal clearance is greater than the glomerular filtration rate suggesting renal tubular secretion.

Mean plasma concentrations of orally administered zolmitriptan were up to 1. There are no significant differences in the pharmacokinetics of orally administered zolmitriptan in Japanese and Caucasians.

The effect of renal impairment on the pharmacokinetics of zolmitriptan nasal spray has not been evaluated. In patients with severe hepatic impairment, the mean C max , T max , and AUC of zolmitriptan dosed orally were increased 1. No differences in the pharmacokinetics of oral zolmitriptan or its effects on blood pressure were seen in mild to moderate hypertensive volunteers compared with normotensive controls.

Eight drug interaction studies have been performed with zolmitriptan tablets and one study xylometazoline was performed with nasal spray. C max and AUC of zolmitriptan increased 1. There were no interactive effects on blood pressure or pulse rate following administration of propranolol with zolmitriptan. However, zolmitriptan delayed the Tmax of acetaminophen by one hour. The effect of zolmitriptan on the pharmacokinetics of oral contraceptives has not been studied.

Following the administration of cimetidine, the half-life and AUC of a 5 mg dose of zolmitriptan and its active metabolite were approximately doubled. A dosage adjustment is therefore required [see Drug Interactions 7. Zolmitriptan was positive in an in vitro bacterial reverse mutation Ames assay and in an in vitro chromosomal aberration assay in human lymphocytes.

In Study 1, patients were instructed to treat a moderate to severe headache.

Zomig Nasal Spray Dosage Guide - erectiledysfunctioncure.icu Frequently Asked Questions

Zomig nasal spray prescribing information

All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient. This Web site contains information relating to various medical conditions and treatment. Such information is provided for educational purposes only and is not meant to be a substitute for the advice of a physician or other healthcare professionals.

You should not use this information for diagnosing a health problem or disease. All quotes included in this Web site represent the individual experience of some doctors, some patients, and their caregivers. Individual responses to treatment may vary. This site is intended for residents of the United States only. Any products discussed herein may have different product labeling in different countries. This product information is intended for US healthcare professionals only.

Skip to main content. Do not remove the unit until you are ready to use it. The unit contains only 1 spray Blow your nose gently before use Remove the protective cap. There is only one 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 Block one nostril by pressing firmly on the side of your nose. Either nostril can be used. 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.

The estimated rates of major birth defects 2. Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy.

A no-effect dose for embryolethality was not established. 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. 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.

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.

In an earlier study with a different design, ZOMIG 5 mg nasal spray was evaluated in the acute treatment of migraine headache in 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.

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. 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. 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. Zomig Nasal Spray is not recommended in patients with moderate to severe hepatic impairment [see Dosage and Administration 2.

There is no experience with acute overdose. There is no specific antidote to zolmitriptan. In cases of severe intoxication, intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system.

It is unknown what effect hemodialysis or peritoneal dialysis has on the plasma concentrations of zolmitriptan. Zolmitriptan is chemically designated as S [[3-[2- dimethylamino ethyl]-1H-indolyl]methyl]oxazolidinone and has the following chemical structure:. The empirical formula is C 16 H 21 N 3 O 2 , representing a molecular weight of Zolmitriptan is a white to almost white powder that is readily soluble in water.

Each Zomig Nasal Spray contains 2. Zomig Nasal Spray is hypertonic. The osmolarity of Zomig Nasal Spray for 2. Zolmitriptan nasal spray is rapidly absorbed via the nasopharynx as detected in a Photon Emission Tomography PET study using 11C zolmitriptan.

Zolmitriptan was detected in plasma by 5 minutes and peak plasma concentration generally was achieved by 3 hours. The time at which maximum plasma concentrations were observed was similar after single 1 day or multiple 4 days nasal dosing. Plasma concentrations of zolmitriptan are sustained for 4 to 6 hours after dosing.

Zolmitriptan and its active N-desmethyl metabolite display linear kinetics after single or multiple doses of Zomig Nasal Spray over the dose range of 0. The pharmacokinetics of the N-desmethyl metabolite are similar to that of zolmitriptan for all nasal spray dosages. The N-desmethyl metabolite is detected in plasma by 15 minutes and peak plasma concentration is generally achieved by 3 hours after administration.

The mean apparent volume of distribution for zolmitriptan nasal spray formulation is 8. Mean total plasma clearance for zolmitriptan nasal spray is The renal clearance is greater than the glomerular filtration rate suggesting renal tubular secretion. Mean plasma concentrations of orally administered zolmitriptan were up to 1. There are no significant differences in the pharmacokinetics of orally administered zolmitriptan in Japanese and Caucasians.

The effect of renal impairment on the pharmacokinetics of zolmitriptan nasal spray has not been evaluated. In patients with severe hepatic impairment, the mean C max , T max , and AUC of zolmitriptan dosed orally were increased 1. No differences in the pharmacokinetics of oral zolmitriptan or its effects on blood pressure were seen in mild to moderate hypertensive volunteers compared with normotensive controls.

Eight drug interaction studies have been performed with zolmitriptan tablets and one study xylometazoline was performed with nasal spray. C max and AUC of zolmitriptan increased 1. There were no interactive effects on blood pressure or pulse rate following administration of propranolol with zolmitriptan. However, zolmitriptan delayed the Tmax of acetaminophen by one hour. The effect of zolmitriptan on the pharmacokinetics of oral contraceptives has not been studied.

Following the administration of cimetidine, the half-life and AUC of a 5 mg dose of zolmitriptan and its active metabolite were approximately doubled. A dosage adjustment is therefore required [see Drug Interactions 7.

Zolmitriptan was positive in an in vitro bacterial reverse mutation Ames assay and in an in vitro chromosomal aberration assay in human lymphocytes.

In Study 1, patients were instructed to treat a moderate to severe headache. Pain-free response rates and associated symptoms such as nausea, photophobia, and phonophobia were also assessed. In Study 1, of the patients taking Zomig Nasal Spray 2. The two-hour headache response rates in patients treated with Zomig Nasal Spray were significantly higher among patients receiving Zomig Nasal Spray at all doses, compared with placebo see Table 3.

Estimated probability of achieving an initial headache response after treatment in Study 1. The estimates displayed are based on a placebo-controlled, outpatient trial providing evidence of efficacy.

For patients with migraine associated photophobia, phonophobia, and nausea at baseline, there was a decreased incidence of these symptoms following administration of Zomig Nasal Spray as compared with placebo. Estimated probability of patients taking an escape medication within the 24 hours following the initial dose of study treatment in Study 1.

The efficacy of Zomig Nasal Spray in the acute treatment of migraine headache with or without aura in pediatric patients 12 to 17 years of age was demonstrated in Study 2, a randomized, double-blind, placebo-controlled trial with a single-blind run-in period. Patients had to have an established diagnosis of migraine history indicating the presence of migraine for at least 1 year with or without aura with a typical untreated migraine headache attack lasting 3 hours or more.

If the patient met all conditions for randomization, including a lack of response to the placebo run-in, a subsequent single migraine headache attack was treated with 1 blinded dose of either Zomig Nasal Spray 5 mg, 2. In Study 2, of the patients taking Zomig Nasal Spray 2. Study 2 evaluated the proportion of pediatric patients 12 to 17 years of age who had no headache pain at 2 hours following treatment.

Headache response defined as a reduction in migraine-related headache pain severity from moderate or severe pain to mild or no pain and the absence of nausea, photophobia, and phonophobia at 2 hours post treatment were also assessed. Two to 24 hours following the initial dose of study treatment, patients were allowed to use their usual medication for pain relief.

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 contains 2. Inform patients that ZOMIG may cause serious cardiovascular side effects such as myocardial infarction or stroke, which may result in hospitalization and even death.

Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms [see Warnings and Precautions 5. Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache, and encourage patients to record headache frequency and drug use e.

Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant. Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations 8. The Zomig Nasal Spray device is packaged in a carton and is a blue-colored plastic device with a gray protection cap, labeled to indicate the nominal dose.

Caution patients to not remove the gray protection cap until prior to dosing. The Zomig Nasal Spray device is placed in a nostril and actuated to deliver a single dose. Caution patients to avoid spraying the contents of the device in their eyes. Please read this information before you start taking Zomig Nasal Spray and each time you renew your prescription just in case anything has changed. Remember, this summary does not take the place of discussions with your doctor.

You and your doctor should discuss Zomig Nasal Spray when you start taking your medication and at regular checkups. Zomig Nasal Spray is a prescription medicine used to treat migraine headaches with or without aura in adults and pediatric patients 12 to 17 years of age. What should I tell my doctor before using Zomig Nasal Spray? Before using Zomig Nasal Spray, tell your doctor about all of your medical conditions, including if you: Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

For detailed instructions, see the step-by-step instructions for using Zomig Nasal Spray at the end of this Patient Information. Zomig Nasal Spray can cause dizziness, weakness, or drowsiness. If you have these symptoms do not drive a car, use machinery, or do anything that needs you to be alert. Call your doctor right away if you have any of the following symptoms after using Zomig Nasal Spray:. These are not all the possible side effects of Zomig Nasal Spray.

For more information ask your doctor or pharmacist. General information about the safe and effective use of Zomig Nasal Spray. Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use Zomig Nasal Spray for a condition for which it was not prescribed. Do not give Zomig Nasal Spray to other people, even if they have the same symptoms that you have.

It may harm them. This leaflet summarizes the most important information about Zomig Nasal Spray. If you would like more information, talk to your doctor.

You can ask your pharmacist or doctor for information about Zomig Nasal Spray that is written for health professionals. For use in your nose only. Do not spray in your eyes. 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.

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.

Zomig nasal spray prescribing information

Overuse of acute migraine drugs e. Available for Android and iOS devices. Pain-free response rates and associated symptoms such as nausea, photophobia, and phonophobia were also assessed. If the patient met all conditions for randomization, including a lack of response to the placebo run-in, a subsequent single migraine headache attack was treated with 1 blinded dose of either Zomig Nasal Spray 5 mg, 2. Who should not use Zomig Nasal Spray? There is no specific antidote to zolmitriptan. Either nostril can be used.

Dec 01,  · This leaflet summarizes the most important information about Zomig Nasal Spray. If you would like more information, talk to your doctor. You can ask your pharmacist or doctor for information about Zomig Nasal Spray that is written for health professionals. For more information go to erectiledysfunctioncure.icu or call Jan 11,  · This leaflet summarizes the most important information about ZOMIG Nasal Spray. If you would like more information, talk to your doctor. You can ask your pharmacist or doctor for information about ZOMIG Nasal Spray that is written for health professionals. For more information go to erectiledysfunctioncure.icu or call Dec 21,  · Dosing Information. The recommended starting dose for ZOMIG nasal spray in adult and pediatric patients 12 years of age and older is mg. As the individual response to ZOMIG nasal spray may vary, the dose should be adjusted on an individual basis.

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Zomig nasal spray prescribing information
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