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What is zolmiptriptan?
Zolmitriptan orally disintegrating tablets contain 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 molecular formula is CHNO, representing a molecular weight of 287.36. Zolmitriptan is a white to off-white powder that is soluble in methanol and acetone, insoluble in water.
Zolmitriptan orally disintegrating tablets are available as 2.5 mg and 5 mg white uncoated tablets for oral administration. The orally disintegrating tablets contain mannitol, microcrystalline cellulose, crospovidone, aspartame [see ], colloidal silicon dioxide, talc, magnesium stearate and peppermint flavor. The peppermint flavor contains corn starch.
What does zolmiptriptan look like?
What are the available doses of zolmiptriptan?
2.5 mg Orally Disintegrating Tablets:
5 mg Orally Disintegrating Tablets:
What should I talk to my health care provider before I take zolmiptriptan?
Pregnancy: Based on animal data, may cause fetal harm ()
How should I use zolmiptriptan?
Zolmitriptan orally disintegrating tabletsare indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
The recommended starting dose of zolmitriptan is 1.25 mg or 2.5 mg. The 1.25 mg dose can be achieved by manually breaking the functionally-scored 2.5 mg zolmitriptan tablet in half. The maximum recommended single dose of zolmitriptan is 5 mg.
In controlled clinical trials, a greater proportion of patients had headache response following a 2.5 mg or 5 mg dose than following a 1 mg dose. There was little added benefit from the 5 mg dose compared to the 2.5 mg dose, but adverse reactions were more frequent with the 5 mg dose.
If the migraine has not resolved by 2 hours after taking zolmitriptan, or returns after a transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose is 10 mg in any 24-hour period.
The safety of zolmitriptan in the treatment of an average of more than three migraines in a 30-day period has not been established.
What interacts with zolmiptriptan?
Sorry No Records found
What are the warnings of zolmiptriptan?
Sorry No Records found
What are the precautions of zolmiptriptan?
Sorry No Records found
What are the side effects of zolmiptriptan?
Sorry No records found
What should I look out for while using zolmiptriptan?
Zolmitriptan is contraindicated in patients with:
What might happen if I take too much zolmiptriptan?
There is no experience with acute overdose of zolmitriptan. Clinical study subjects who received single 50 mg oral doses of zolmitriptancommonly experienced sedation.
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.
The elimination half-life of zolmitriptan is 3 hours [see ]; therefore, monitor patients after overdose with zolmitriptan for at least 15 hours or until symptoms or signs resolve. It is unknown what effect hemodialysis or peritoneal dialysis has on the plasma concentrations of zolmitriptan.
How should I store and handle zolmiptriptan?
Store at 25º C (77º F); excursions permitted to 15 to 30º C (59 to 86º F) [see USP Controlled Room Temperature].2.5 mg Orally Disintegrating Tablets - 5 mg Orally Disintegrating Tablets - Store zolmitriptan orally disintegrating tablets at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Protect from light and moisture.2.5 mg Orally Disintegrating Tablets - 5 mg Orally Disintegrating Tablets - Store zolmitriptan orally disintegrating tablets at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Protect from light and moisture.2.5 mg Orally Disintegrating Tablets - 5 mg Orally Disintegrating Tablets - Store zolmitriptan orally disintegrating tablets at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Protect from light and moisture.
Chemical StructureNo Image found
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.
Migraines are likely 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 is thought to be due to the agonist effects at the 5-HTreceptors on intracranial blood vessels (including the arteriovenous anastomoses) and sensory nerves of the trigeminal system which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.
Non-Clinical ToxicologyZolmitriptan is contraindicated in patients with:
Theophylline interacts with a wide variety of drugs. The interaction may be pharmacodynamic, i.e., alterations in the therapeutic response to theophylline or another drug or occurrence of adverse effects without a change in serum theophylline concentration. More frequently, however, the interaction is pharmacokinetic, i.e., the rate of theophylline clearance is altered by another drug resulting in increased or decreased serum theophylline concentrations. Theophylline only rarely alters the pharmacokinetics of other drugs.
The drugs listed in have the potential to produce clinically significant pharmacodynamic or pharmacokinetic interactions with theophylline. The information in the “Effect” column of Table II assumes that the interacting drug is being added to a steady-state theophylline regimen. If theophylline is being initiated in a patient who is already taking a drug that inhibits theophylline clearance (e.g., cimetidine, erythromycin), the dose of theophylline required to achieve a therapeutic serum theophylline concentration will be smaller. Conversely, if theophylline is being initiated in a patient who is already taking a drug that enhances theophylline clearance (e.g., rifampin), the dose of theophylline required to achieve a therapeutic serum theophylline concentration will be larger. Discontinuation of a concomitant drug that increases theophylline clearance will result in accumulation of theophylline to potentially toxic levels, unless the theophylline dose is appropriately reduced. Discontinuation of a concomitant drug that inhibits theophylline clearance will result in decreased serum theophylline concentrations, unless the theophylline dose is appropriately increased.
The drugs listed in have either been documented not to interact with theophylline or do not produce a clinically significant interaction (i.e., <15% change in theophylline clearance).
The listing of drugs in and are current as of February 9, 1995. New interactions are continuously being reported for theophylline, especially with new chemical entities. Before addition of a newly available drug in a patient receiving theophylline, the package insert of the new drug and/or the medical literature should be consulted to determine if an interaction between the new drug and theophylline has been reported.
Zolmitriptan 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 zolmitriptan. Some of these reactions occurred in patients without known CAD. 5-HT agonists including zolmitriptan may cause coronary artery vasospasm (Prinzmetal 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 zolmitriptan. Do not administer zolmitriptan if there is evidence of CAD or coronary artery vasospasm . For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first zolmitriptan dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following zolmitriptan administration. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of zolmitriptan.
The following adverse reactions are described elsewhere in other sections of the prescribing information:
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
ProfessionalClonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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