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ZOMIG
Overview
What is ZOMIG?
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 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.
ZOMIG Nasal Spray is hypertonic. The osmolarity of ZOMIG Nasal Spray for 2.5 mg is 360 to 420 mOsmol, and for 5 mg is 420 to 470 mOsmol.
What does ZOMIG look like?
What are the available doses of ZOMIG?
Nasal Spray: 2.5 mg and 5 mg (3)
What should I talk to my health care provider before I take ZOMIG?
Pregnancy: Based on animal data, may cause fetal harm.
How should I use ZOMIG?
Limitations of Use:
The recommended starting dose for ZOMIG nasal spray in adult and pediatric patients 12 years of age and older is 2.5 mg. As the individual response to ZOMIG nasal spray may vary, the dose should be adjusted on an individual basis. The maximum recommended single dose of ZOMIG is 5 mg.
If the migraine has not resolved by 2 hours after taking ZOMIG, or returns after a transient improvement, another dose may be administered at least 2 hours after the previous dose.
The maximum daily dose should not exceed 10 mg in any 24‑hour period.
The safety of ZOMIG in the treatment of an average of more than four headaches in a 30‑day period has not been established.
What interacts with ZOMIG?
Sorry No Records found
What are the warnings of ZOMIG?
Sorry No Records found
What are the precautions of ZOMIG?
Sorry No Records found
What are the side effects of ZOMIG?
Sorry No records found
What should I look out for while using ZOMIG?
ZOMIG is contraindicated in patients with:
What might happen if I take too much ZOMIG?
There is no experience with acute overdose. Clinical study subjects 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.
How should I store and handle ZOMIG?
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 5 mg 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].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 5 mg 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].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 5 mg 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].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 5 mg 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].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 5 mg 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].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 5 mg 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].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Zolmitriptan binds with high affinity to human recombinant 5‑HT and 5‑HT receptors, and moderate affinity for 5‑HT receptors. The N‑desmethyl metabolite also has high affinity for 5‑HTand moderate affinity for 5‑HT receptors.
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 ZOMIG for the treatment of migraine headache is thought to be due to the agonist effects at the 5‑HT receptors 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.
Non-Clinical Toxicology
ZOMIG is contraindicated in patients with:Inhibitors of CYP3A4 and CYP2D6
The concomitant use of hydrocodone bitartrate and acetaminophen oral solution and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of hydrocodone from hydrocodone bitartrate and acetaminophen oral solution, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of hydrocodone bitartrate and acetaminophen oral solution and both CYP3A4 and CYP2D6 inhibitors, particularly when an inhibitor is added after a stable dose of hydrocodone bitartrate and acetaminophen oral solution is achieved [see ].
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, hydrocodone plasma concentration will decrease [see ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to hydrocodone bitartrate and acetaminophen oral solution.
If concomitant use is necessary, consider dosage reduction of hydrocodone bitartrate and acetaminophen oral solution until stable drug effects are achieved. Follow patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the hydrocodone bitartrate and acetaminophen oral solution dosage until stable drug effects are achieved. Follow patients for signs or symptoms of opioid withdrawal.
Inducers of CYP3A4
The concomitant use of hydrocodone bitartrate and acetaminophen oral solution and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of hydrocodone [see ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to [see ].
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the hydrocodone plasma concentration will increase [see ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.
If concomitant use is necessary, consider increasing the hydrocodone bitartrate and acetaminophen oral solution dosage until stable drug effects are achieved [see ]. Follow for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider hydrocodone bitartrate and acetaminophen oral solution dosage reduction and monitor for signs of respiratory depression.
Benzodiazepines and Other CNS Depressants
Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants such as benzodiazepines and other sedative hypnotics, anxiolytics, and tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see ].
Serotonergic Drugs
The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome [see ].
If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue hydrocodone bitartrate and acetaminophen oral solution if serotonin syndrome is suspected.
Monoamine Oxidase Inhibitors (MAOIs)
The concomitant use of opioids and MAOIs, such as phenelzine, tranylcypromine, or linezolid, may manifest as serotonin syndrome, or opioid toxicity (e.g., respiratory depression, coma) [see ].
The use of hydrocodone bitartrate and acetaminophen oral solution is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
The concomitant use of opioids with other opioid analgesics, such as butorphanol, nalbuphine, pentazocine, may reduce the analgesic effect of hydrocodone bitartrate and acetaminophen oral solution and/or precipitate withdrawal symptoms.
Advise patient to avoid concomitant use of these drugs.
Muscle Relaxants
Hydrocodone bitartrate and acetaminophen oral solution may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
If concomitant use is warranted, follow patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of hydrocodone bitartrate and acetaminophen oral solution and/or the muscle relaxant as necessary.
Diuretics
Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
If concomitant use is warranted, monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
Anticholinergic Drugs
The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
If concomitant use is warranted, follow patients for signs of urinary retention or reduced gastric motility when hydrocodone bitartrate and acetaminophen oral solution is used concomitantly with anticholinergic drugs.
ZOMIG is contraindicated in patients with ischemic or vasospastic coronary artery disease (CAD). 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. 5-HT agonists including ZOMIG may cause coronary artery vasospasm (Prinzmetal’s Angina), even in patients without a history of CAD.
Perform a cardiovascular evaluation in triptan-naïve patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving ZOMIG. Do not administer ZOMIG if there is evidence of CAD or coronary artery vasospasm []. 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.
The following adverse reactions are discussed in more detail in other sections of labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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