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(CAS: 13924-17-8)

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Manufacturer: Medpointe

Zolmitriptan Nasal Spray contains zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) 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 C 16 H 21 N 3 O 2 , 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-μL unit dose aqueous buffered solution containing citric acid, anhydrous, USP, disodium phosphate dodecahydrate USP and purified water USP.

What is zolmitriptan.

? Zolmitriptan is a headache medicine. It is believed to work by causing vasoconstriction (narrowing) of blood vessels (arteries and veins) around the brain. Zolmitriptan also reduces the release of substances in the body that contribute to headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.
? Zolmitriptan is used to treat vascular headaches such as migraines. Zolmitriptan will not prevent migraines. It will only treat a migraine that is already occurring.
? Zolmitriptan may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of zolmitriptan?
? If you experience any of the following serious side effects, stop taking zolmitriptan and seek emergency medical attention or contact your doctor immediately:
, an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
, severe or prolonged chest pain or an irregular heartbeat;
, chest, neck, or jaw pain, tightness, or heaviness;
, sudden or severe stomach pain;
, problems seeing; or
, unusual weakness or numbness.
? Other, less serious side effects may be more likely to occur. Continue to take zolmitriptan and talk to your doctor if you experience
, dry mouth;
, unusual taste in the mouth;
, nausea;
, muscle tiredness or weakness;
, tightness, heaviness, or pressure on a body part (other than the chest, neck, or jaw);
, drowsiness or dizziness; or
, tingling, tightness, warmth, or heaviness in a body part.
? Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect zolmitriptan?
? Do not take zolmitriptan if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil) within the last 14 days. The combination could cause seizures, nausea, vomiting, sweating, flushing, and dizziness.
? Do not take zolmitriptan if you have taken any of the following medicines within the previous 24 hours:
, an ergot-based medication such as methysergide (Sansert), ergotamine (Ergostat, Medihaler Ergotamine), dihydroergotamine mesylate (D.H.E., Migranal Nasal Spray), an ergotamine combination product (Cafergot, Ercaf, Wigraine, Cafatine, Cafatine-PB, Cafetrate), and others; or
, almotriptan (Axert), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), or sumatriptan (Imitrex).
? Taking zolmitriptan within 24 hours of any of the medicines listed above may be dangerous.
? Before taking zolmitriptan, tell your doctor if you are taking a selective serotonin reuptake inhibitor (SSRI) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft). You may not be able to take zolmitriptan, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed.
? Before taking zolmitriptan, talk to your doctor if you are taking cimetidine (Tagamet, Tagamet HB). You may require a dosage adjustment or special monitoring during treatment.
? Drugs other than those listed here may also interact with zolmitriptan. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

ZOMIG Nasal Spray is hypertonic. The osmolarity of ZOMIG Nasal Spray 5 mg is 420 to 470 mOsmol.

ZOMIG should not be given to patients with documented ischemic or vasospastic coronary artery disease (see CONTRAINDICATIONS ). 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 not be administered (see CONTRAINDICATIONS ). 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.

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-HT 1 agonists. Considering the extent of use of 5-HT 1 agonists 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.

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 premarketing controlled clinical trial of ZOMIG Nasal Spray, more than 1300 patients participated and there were no deaths or serious cardiac events to report.

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 the proportion of the reported cases that were actually caused by zolmitriptan or to reliably assess causation in individual cases.

Cerebrovascular Events and Fatalities with 5-HT 1 agonists: Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with 5-HT 1 agonists; 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).

Other Vasospasm-Related Events: 5-HT 1 agonists may cause vasospastic reactions other than coronary artery vasospasm such as peripheral and gastrointestinal vascular ischemia. As with other serotonin 5HT 1 agonists, 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.

Increase in Blood Pressure: As with other 5-HT 1 agonists, 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 (see CONTRAINDICATIONS ).

An 18% increase in mean pulmonary artery pressure was seen following dosing with another 5-HT 1 agonist in a study evaluating subjects undergoing cardiac catheterization.

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.