Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3212
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
ZOMIG (Spray, Metered)
|
| dailymed-instance:dosage |
Administer one dose of ZOMIG Nasal Spray 5 mg for the treatment of acute migraine. If the headache returns the dose may be repeated after 2 hours. The maximum daily dose should not exceed 10 mg in any 24-hour period. In controlled clinical trials, single doses of 5 mg of zolmitriptan nasal spray were administered into one nostril and were effective for the treatment of acute migraines in adults. Individuals may vary in response to ZOMIG Nasal Spray. The pharmacokinetics of a 5 mg nasal spray dose is similar to the 5 mg oral formulations. Doses lower than 5 mg can only be achieved through the use of an oral formulation. The choice of dose, and route of administration should therefore be made on an individual basis. The effectiveness of a second dose has not been established in placebo-controlled trials. The safety of treating an average of more than four headaches in a 30 day period has not been established.<br/>Hepatic Impairment:: Patients with moderate to severe hepatic impairment have decreased clearance of zolmitriptan and significant elevation in blood pressure was observed in some patients. Use of a lower dose of an alternate formulation with blood pressure monitoring is recommended .
|
| dailymed-instance:descripti... |
ZOMIG' (zolmitriptan) Nasal Spray contains zolmitriptan, which is a selective 5-hydroxytryptamine(5-HT) receptor agonist. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure: The empirical formula is CHNO, representing a molecular weight of 287.36. Zolmitriptan is a white to almost white powder that is readily soluble in water. ZOMIG Nasal Spray is supplied as a clear to pale yellow solution of zolmitriptan, buffered to a pH 5.0. Each ZOMIG Nasal Spray contains 5 mg of zolmitriptan in a 100-��L unit dose aqueous buffered solution containing citric acid, anhydrous, USP, disodium phosphate dodecahydrate USP and purified water USP. ZOMIG Nasal Spray is hypertonic. The osmolarity of ZOMIG Nasal Spray 5 mg is 420 to 470 mOsmol.
|
| dailymed-instance:clinicalP... |
Mechanism of Action:: Zolmitriptan binds with high affinity to human recombinant 5-HTand 5-HTreceptors. Zolmitriptan exhibits modest affinity for 5-HTreceptors, but has no significant affinity (as measured by radioligand binding assays) or pharmacological activity at 5-HT, 5-HT, 5-HT, alpha-, alpha- or beta-adrenergic; H, H, histaminic; muscarinic; dopamine, or dopaminereceptors. The N-desmethyl metabolite also has high affinity for 5-HTand modest affinity for 5-HTreceptors. Current theories proposed to explain the etiology of migraine headache suggest that symptoms are due to local cranial vasodilatation and/or to the release of sensory neuropeptides (vasoactive intestinal peptide, substance P and calcitonin gene-related peptide) through nerve endings in the trigeminal system. The therapeutic activity of zolmitriptan for the treatment of migraine headache can most likely be attributed to the agonist effects at the 5-HTreceptors on intracranial blood vessels (including the arterio-venous anastomoses) and sensory nerves of the trigeminal system which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.<br/>Clinical Pharmacokinetics and Bioavailability:<br/>Absorption:: Zolmitriptan nasal spray is rapidly absorbed via the nasopharynx as detected in a Photon Emission Tomography (PET) study usingC 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 day) nasal dosing. Plasma concentrations of zolmitriptan are sustained for 4 to 6 hours after dosing. Zolmitriptan displays linear kinetics after multiple doses of 2.5 mg, 5 mg, or 10 mg. The mean relative bioavailability of the nasal spray formulation is 102%, compared to the oral tablet. Zolmitriptan and its active metabolite display dose proportionality after single or multiple dosing. Dose proportional increases in zolmitriptan and N-desmethyl metabolite Cand AUC were observed for 2.5 and 5 mg nasal spray doses. The pharmacokinetics for elimination of zolmitriptan and its active N-desmethyl metabolite are similar 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. Food has no significant effect on the bioavailability of zolmitriptan.<br/>Distribution:: Plasma protein binding of zolmitriptan is 25% over the concentration range of 10-1000 ng/mL. The mean (��SD) apparent volume of distribution for zolmitriptan nasal spray formulation is 8.4��3.3 L/kg.<br/>Metabolism:: Zolmitriptan is converted to an active N-desmethyl metabolite such that the metabolite concentrations are about two-thirds that of zolmitriptan. Because the 5HTpotency of the metabolite is 2 to 6 times that of the parent compound, the metabolite may contribute a substantial portion of the overall effect after zolmitriptan administration.<br/>Excretion:: The mean elimination half-life for zolmitriptan and its active N-desmethyl metabolite following nasal spray administration are approximately 3 hours, which is similar to the half-life values seen after oral tablet administration. The half-life values were similar for zolmitriptan and the N-desmethyl metabolite after single (1 day) and multiple (4 day) nasal dosing. Mean total plasma clearance is 25.9 mL/min/kg, of which one-sixth is renal clearance. The renal clearance is greater than the glomerular filtration rate suggesting renal tubular secretion.<br/>Special Populations:<br/>Drug Interactions:: All drug interaction studies were performed in healthy volunteers using a single 10 mg dose of zolmitriptan and a single dose of the other drug except where otherwise noted. Eight drug interaction studies have been performed with zolmitriptan tablets and one study (xylometazoline) was performed with nasal spray.<br/>Xylometazoline:: An in vivo drug interaction study with ZOMIG Nasal Spray indicated that 1 spray (100��L dose) of xylometazoline (0.1% w/v), a decongestant, administered 30 minutes prior to a 5 mg nasal dose of zolmitriptan did not alter the pharmacokinetics of zolmitriptan.<br/>Fluoxetine:: The pharmacokinetics of zolmitriptan, as well as its effect on blood pressure, were unaffected by 4 weeks of pretreatment with oral fluoxetine (20 mg/day).<br/>MAO Inhibitors:: Following one week of administration of 150 mg bid moclobemide, a specific MAO-A inhibitor, there was an increase of about 25% in both Cand AUC for zolmitriptan and a 3-fold increase in the Cand AUC of the active N-desmethyl metabolite of zolmitriptan . Selegiline, a selective MAO-B inhibitor, at a dose of 10 mg/day for 1 week, had no effect on the pharmacokinetics of zolmitriptan and its metabolite.<br/>Propranolol:: Cand AUC of zolmitriptan increased 1.5-fold after one week of dosing with propranolol (160 mg/day). Cand AUC of the N-desmethyl metabolite were reduced by 30% and 15%, respectively. There were no interactive effects on blood pressure or pulse rate following administration of propranolol with zolmitriptan.<br/>Acetaminophen:: A single 1 g dose of acetaminophen does not alter the pharmacokinetics of zolmitriptan and its N-desmethyl metabolite. However, zolmitriptan delayed the Tof acetaminophen by one hour.<br/>Metoclopramide:: A single 10 mg dose of metoclopramide had no effect on the pharmacokinetics of zolmitriptan or its metabolites.<br/>Oral Contraceptives:: Retrospective analysis of pharmacokinetic data across studies indicated that mean plasma concentrations of zolmitriptan were generally higher in females taking oral contraceptives compared to those not taking oral contraceptives. Mean Cand AUC of zolmitriptan were found to be higher by 30% and 50%, respectively, and Twas delayed by one-half hour in females taking oral contraceptives. The effect of zolmitriptan on the pharmacokinetics of oral contraceptives has not been studied.<br/>Cimetidine:: Following the administration of cimetidine, the half���life and AUC of a 5 mg dose of zolmitriptan and its active metabolite were approximately doubled .<br/>Clinical Studies: The efficacy of ZOMIG Nasal Spray 5 mg in the acute treatment of migraine headache with or without aura was demonstrated in a randomized, outpatient, double-blind, placebo-controlled trial. Patients were instructed to treat a moderate to severe headache. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed 15, 30, 45 minutes and 1, 2, and 4 hours after dosing. Pain free response rates and associated symptoms such as nausea, photophobia, and phonophobia were also assessed. A dose of escape medication was allowed 4 to 24 hours after the initial treatment for persistent and recurrent headache. Of the 1372 patients treated in the study, 83% were female and 99% were Caucasian, with a mean age of 40.6 years (range 18 to 65 years). The two hour headache response rates in patients treated with ZOMIG Nasal Spray were statistically significant among patients receiving ZOMIG Nasal Spray compared to placebo. There was a greater percentage of patients with a headache response at 2 hours in the higher dose groups. The headache response efficacy endpoints of the controlled clinical study, analyzed from the first attack data, are shown in Table 1. The estimated probability of achieving an initial headache response by 4 hours following treatment with ZOMIG Nasal Spray is depicted in Figure 1. Note: Figure 1 shows the Kaplan-Meier plot of the probability over time of obtaining headache response (moderate or severe headache improving to mild or no pain) following treatment with zolmitriptan nasal spray. The averages displayed are based on a placebo controlled, outpatient trial providing evidence of efficacy. Patients not achieving headache response or taking additional treatment prior to 4 hours were censored to 4 hours. 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 to placebo. Four to 24 hours following the initial dose of study treatment, patients were allowed to use additional treatment for pain relief in the form of a second dose of study treatment or other medication. The estimated probability of patients taking a second dose or other medication for migraine over the 24 hours following the initial dose of study treatment is summarized in Figure 2. *This Kaplan-Meier plot is based on data obtained from the placebo controlled clinical trial. Patients not using additional treatments were censored at 24 hours. The plot includes both patients who had headache response at 2 hours and those who had no response to the initial dose. It should be noted that the protocol did not allow remedication within 4 hours post dose. The efficacy of ZOMIG was unaffected by presence of aura; presence of headache upon awakening, relationship to menses; gender, age or weight of the patient; or presence of pretreatment nausea. The efficacy of ZOMIG Nasal Spray 5 mg was further supported by an interim analysis of another similarly designed trial. The 2 hour headache response rates for the first 210 subjects in that study for ZOMIG 5 mg and placebo were 70% and 47%, respectively (N=108 and 102, respectively, p=0.0006).
|
| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
ZOMIG should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal's variant angina, or other significant underlying cardiovascular disease . ZOMIG should not be given to patients with cerebrovascular syndromes including (but not limited to) stroke of any type as well as transient ischemic attacks. Because ZOMIG may increase blood pressure, it should not be given to patients with uncontrolled hypertension . ZOMIG should not be used within 24 hours of treatment with another 5-HTagonist, or an ergotamine-containing or ergot-type medication like dihydroergotamine or methysergide. ZOMIG should not be administered to patients with hemiplegic or basilar migraine. Concurrent administration of MAO-A inhibitors or use of zolmitriptan within 2 weeks of discontinuation of MAO-A inhibitor therapy is contraindicated . ZOMIG is contraindicated in patients who are hypersensitive to zolmitriptan or any of its inactive ingredients.
|
| dailymed-instance:supply |
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 5 mg of zolmitriptan in a 100-��L unit dose aqueous buffered solution containing citric acid, anhydrous, USP, disodium phosphate dodecahydrate USP and purified water USP. 5 mg ZOMIG Nasal Spray is supplied in boxes of 6 single use nasal spray units. (NDC 0310-0208-60). Each ZOMIG Nasal Spray single dose unit spray supplies 5 mg of zolmitriptan. The ZOMIG Nasal Spray unit must be discarded after use.<br/>Storage:: Store at controlled room temperature, 20-25��C (68-77��F) [see USP].
|
| dailymed-instance:genericDr... | |
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:overdosag... |
There is no experience with clinical overdose. Volunteers receiving single 50 mg oral doses of zolmitriptan commonly experienced sedation. The elimination half-life of ZOMIG is 3 hours and therefore monitoring of patients after overdose with ZOMIG should continue for at least 15 hours or while symptoms or signs persist. 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.
|
| dailymed-instance:genericMe... |
Zolmitriptan
|
| dailymed-instance:fullName |
ZOMIG (Spray, Metered)
|
| dailymed-instance:adverseRe... |
Serious cardiac events, including myocardial infarction, have occurred following the use of ZOMIG Tablets. These events are extremely rare and most have been reported in patients with risk factors predictive of CAD. Events reported, in association with drugs of this class, have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation .<br/>Incidence in Controlled Clinical Trials:: Among 464 patients treating single attacks with zolmitriptan nasal spray in a blinded placebo controlled trial, there was a low withdrawal rate related to adverse events: 5 mg (1.3%), and placebo (0.4%). 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 most common adverse events in clinical trials for ZOMIG Nasal Spray were: unusual taste, paresthesia, hyperesthesia, and dizziness. Table 2 lists the adverse events that occurred in���2% of the 236 patients in the 5 mg dose group of the controlled clinical trial. Adverse clinical events occurring in���1% and<2% of patients in all attacks of the controlled clinical trial were pain abdominal, pressure throat, vomiting, headache, tightness chest, dysphagia, insomnia, palpitation and reaction aggravation. ZOMIG is generally well tolerated. Across all doses, most adverse reactions were mild and transient and did not lead to long-lasting effects. The incidence of adverse events in controlled clinical trials was not affected by gender, weight, or age of the patients (18-39 vs. 40-65 years of age), or presence of aura. There were insufficient data to assess the impact of race on the incidence of adverse events.<br/>Other Events:: In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented. Because the reports include events observed in open and uncontrolled studies, the role of ZOMIG in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events,etc., limit the value of the quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used ZOMIG Nasal Spray and reported an event divided by the total number of patients exposed to ZOMIG Nasal Spray (n=3059). All reported events 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. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: infrequent adverse events are those occurring in 1/100 to 1/1,000 patients and rare adverse events are those occurring in fewer than 1/1,000 patients.<br/>Body:: Infrequent was allergic reaction, back pain, chills, cyst, flu syndrome, infection, jaw pain, pressure other, jaw tightening, edema of the face, abnormal laboratory test, neck pain, neoplasm, and neck tightness, chest heaviness, chest pain, and chest pressure. Rare were cellulitis, fever, jaw pressure, and neck heaviness.<br/>Cardiovascular:: Infrequent were arrhythmias, hypertension, syncope, thrombophlebitis, and tachycardia. Rare were angina pectoris, bradycardia, atrial fibrillation, myocardial infarct, vasodilation, and vascular disorder.<br/>Digestive:: Infrequent were diarrhea, dyspepsia, tongue edema, gastrointestinal disorder, increased saliva, and thirst. Rare were increased appetite, colitis, constipation, eructation, gastritis, gastrointestinal carcinoma, gingivitis, hepatic neoplasia, intestinal obstruction, jaundice, sialadenitis, and stomatitis.<br/>Endocrine System:: Rare were hyperthyroidism and thyroid edema.<br/>Hemic:: Infrequent was cyanosis. Rare were ecchymosis, lymphadenopathy and leukopenia.<br/>Metabolic Nutritional:: Rare were increased weight, dehydration, and peripheral edema.<br/>Musculoskeletal:: Infrequent were arthralgia, joint disorder, and myalgia. Rare were bone pain, osteoporosis, tenosynovitis and twitching.<br/>Nervous System:: Infrequent were agitation, amnesia, anxiety, ataxia, abnormal coordination, confusion, depersonalization, depression, hypertonia, insomnia, nervousness, speech disorder, abnormal thinking, tremor, vertigo, and circumoral paresthesia. Rare were apathy, convulsions, abnormal dreams, euphoria, hypertonia, irritability tardive dyskinesia, manic reaction, neuropathy, and psychosis.<br/>Respiratory:: Infrequent were bronchitis, increased cough, dyspnea, epistaxis, laryngeal edema, pharyngitis, rhinitis, sinusitis, throat discomfort, and voice alteration. Rare was hiccup, hyperventilation, laryngitis, pneumonia, increased sputum, and yawning.<br/>Skin:: Infrequent was pruritus, rash, skin disorder, and sweating. Rare were eczema, erythema, erythema multiform, hair disorder, and neoplasm.<br/>Special Senses:: Infrequent were amblyopia, disorder of lacrimation, ear pain, eye pain, parosmia and tinnitus. Rare were conjunctivitis, dry eye, photophobia, and visual field defect.<br/>Urogenital:: Infrequent was polyuria and menorrhagia. Rare were breast carcinoma, dysmenorrhea, metrorrhagia, breast neoplasm, unintended pregnancy, suspicious PAP smear, uterine disorder, enlarged uterine fibroids, fibrocytic breast, vaginitis, urogenital neoplasm, cystitis, urinary tract infection, kidney pain, pyelonephritis, urinary frequency, urine impaired, and urinary tract disorder. The adverse experience profile seen with ZOMIG Nasal Spray is similar to that seen with ZOMIG tablets and ZOMIG-ZMT tablets except for the occurrence of local adverse effects from the nasal spray (see ZOMIG Tablet Prescribing Information).<br/>Postmarketing Experience with ZOMIG Tablets:: The following section enumerates potentially important adverse events that have occurred in clinical practice and which have been reported spontaneously to various surveillance systems. The events enumerated represent reports arising from both domestic and non-domestic use of oral zolmitriptan. The events enumerated include all except those already listed in the ADVERSE REACTIONS section above or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of eventsand the role of zolmitriptan in their causation cannot be reliably determined.<br/>Cardiovascular:: Coronary artery vasospasm, transient myocardial ischemia, angina pectoris, and myocardial infarction.<br/>Digestive:: Very rare gastrointestinal ischemic events including splenic infarction, ischemic colitis and gastrointestinal infarction or necrosis have been reported; these may present as bloody diarrhea or abdominal pain.<br/>Neurological:: As with other acute migraine treatments including other 5HTagonists, there have been rare reports of headache.<br/>General:: As with other 5-HTagonists, there have been very rare reports of anaphylaxis or anaphylactoid reactions in patients receiving ZOMIG. There have been rare reports of hypersensitivity reactions, including angioedema. Serotonin syndrome has also been reported during the postmarketing period .
|
| dailymed-instance:warning |
ZOMIG should only be used where a clear diagnosis of migraine has been established.<br/>Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events:: ZOMIG should not be given to patients with documented ischemic or vasospastic coronary artery disease . It is strongly recommended that zolmitriptan not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors (eg, hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, or male over 40 years of age) unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease. The sensitivity of cardiac diagnostic procedures to detect cardiovascular disease or predisposition to coronary artery vasospasm is modest, at best. If, during the cardiovascular evaluation, the patient's medical history, electrocardiographic or other investigations reveal findings indicative of, or consistent with, coronary artery vasospasm or myocardial ischemia, zolmitriptan should notbe administered . For patients with risk factors predictive of CAD, who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of zolmitriptan take place in the setting of a physician's office or similar medically staffed and equipped facility unless the patient has previously received zolmitriptan. Because cardiac ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining on the first occasion of use an electrocardiogram (ECG) during the interval immediately following ZOMIG, in these patients with risk factors. It is recommended that patients who are intermittent long-term users of ZOMIG and who have or acquire risk factors predictive of CAD, as described above, undergo periodic interval cardiovascular evaluation as they continue to use ZOMIG. The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease will be inadvertently exposed to zolmitriptan.<br/>Cardiac Events and Fatalities:: Serious adverse cardiac events, including acute myocardial infarction, have been reported within a few hours following administration of zolmitriptan. Life-threatening disturbances of cardiac rhythm, and death have been reported within a few hours following the administration of other 5-HTagonists. Considering the extent of use of 5-HTagonists in patients with migraine, the incidence of these events is extremely low. ZOMIG can cause coronary vasospasm; at least one of these events occurred in a patient with no cardiac disease history and with documented absence of coronary artery disease. Because of the close proximity of the events to ZOMIG use, a causal relationship cannot be excluded. In the cases where there has been known underlying coronary artery disease, the relationship is uncertain. Patients with symptomatic Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders should not receive ZOMIG.<br/>Premarketing experience with zolmitriptan:: Among the more than 2500 patients with migraine who participated in premarketing controlled clinical trials of ZOMIG Tablets, no deaths or serious cardiac events were reported. In a premarketing controlled clinical trial of ZOMIG Nasal Spray, more than 1,300 patients participated and there were no deaths or serious cardiac events to report.<br/>Postmarketing experience with zolmitriptan:: Serious cardiovascular events have been reported in association with the use of ZOMIG Tablets, and in very rare cases, these events have occurred in the absence of known cardiovascular disease. The uncontrolled nature of postmarketing surveillance, however, makes it impossible to determine definitively theproportion of the reported cases that were actually caused by zolmitriptan or to reliably assess causation in individual cases.<br/>Cerebrovascular Events and Fatalities with 5-HTagonists:: Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with 5-HTagonists; and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not. It should be noted that patients with migraine may be at increased risk of certain cerebrovascular events (eg, stroke, hemorrhage, transient ischemic attack).<br/>Serotonin Syndrome:: The development of a potentially life-threatening serotonin syndrome may occur with triptans, including ZOMIG treatment, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). If concomitant treatment with ZOMIG and an SSRI (e.g., fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram) or SNRI (e.g., venlafaxine, duloxetine) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations,coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). .<br/>Other Vasospasm-Related Events:: 5-HTagonists may cause vasospastic reactions other than coronary artery vasospasm such as peripheral and gastrointestinal vascular ischemia. As with other serotonin 5HTagonists, very rare gastrointestinal ischemic events including ischemic colitis and gastrointestinal infarction or necrosis have been reported with ZOMIG Tablets; these may present as bloody diarrhea or abdominal pain.<br/>Increase in Blood Pressure:: As with other 5-HTagonists, significant elevations in systemic blood pressure have been reported on rare occasions with ZOMIG Tablet use, in patients with and without a history of hypertension; very rarely these increases in blood pressure have been associated with significant clinical events. Zolmitriptan is contraindicated in patients with uncontrolled hypertension. In volunteers, an increase of 1 and 5 mm Hg in the systolic and diastolic blood pressure, respectively, was seen at 5 mg. In the headache trials, vital signs were measured only in the small inpatient study and no effect on blood pressure was seen. In a study of patients with moderate to severe liver disease, 7 of 27 experienced 20 to 80 mm Hg elevations in systolic and/or diastolic blood pressure after a dose of 10 mg of zolmitriptan . An 18% increase in mean pulmonary artery pressure was seen following dosing with another 5-HTagonist in a study evaluating subjects undergoing cardiac catheterization.<br/>Local Adverse Reactions:: Among 922 patients using the zolmitriptan nasal spray to treat 2311 attacks in the controlled clinical study who were exposed, across all doses (0.5 to 5 mg), approximately 3% noted local irritation or soreness at the site of administration. Adverse events of any kind, perceived in the nasopharynx (which may include systemic effects of triptans) were severe in about 1% of patients and approximately 60% resolved in 1 hour. 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. All nasopharyngeal adverse events with an incidence of���2% of patients in any zolmitriptan nasal spray dose groups are included in ADVERSE REACTIONS Table 2.
|
| dailymed-instance:indicatio... |
ZOMIG Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults. ZOMIG is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine . Safety and effectiveness of ZOMIG have not been established for cluster headache, which is present in an older, predominantly male population.
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
ZOMIG
|