Zolmiptriptan
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Zolmitriptan orally disintegrating tabletsare indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
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- Only use zolmitriptan orally disintegrating tablets if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan orally disintegrating tablets treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan orally disintegrating tablets are administered to treat any subsequent attacks.
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- Zolmitriptan orally disintegrating tablets are not indicated for the prevention of migraine attacks.
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- Safety and effectiveness of zolmitriptan orally disintegrating tablets have not been established for cluster headache.
History
There is currently no drug history available for this drug.
Other Information
Zolmitriptan orally disintegrating tablets contain zolmitriptan, which is a selective 5-hydroxytryptamine1B/1D (5-HT1B/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 molecular formula is C16H21N3O2, 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 Warnings and Precautions (5.9)], colloidal silicon dioxide, talc, magnesium stearate and peppermint flavor. The peppermint flavor contains corn starch.
Sources
Zolmiptriptan Manufacturers
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Glenmark Generics Inc.,usa
![Zolmiptriptan (Zolmitriptan) Tablet, Orally Disintegrating [Glenmark Generics Inc.,usa]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Zolmiptriptan | Glenmark Generics Inc.,usa
2.1 Dosing InformationThe 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.
2.2 Administration of Zolmitriptan Orally Disintegrating TabletsInstruct patients not to break zolmitriptan orally disintegrating tablets because they are not functionally-scored. Administration with liquid is not necessary.
Orally disintegrating tablets are packaged in a blister pack. Instruct patients not to remove the tablet from the blister until just prior to dosing. Subsequently, instruct patients to peel the blister pack open, and to place the orally disintegrating tablet on the tongue, where it will dissolve and it will be swallowed with the saliva.
2.3 Dosing in Patients with Hepatic ImpairmentThe recommended dose of zolmitriptan in patients with moderate to severe hepatic impairment is 1.25 mg (one-half of one 2.5 mg zolmitriptan tablet) because of increased zolmitriptan blood levels in these patients and elevation of blood pressure in some of these patients. Limit the total daily dose in patients with severe hepatic impairment to no more than 5 mg per day.
The use of zolmitriptan orally disintegrating tablets is not recommended in patients with moderate or severe hepatic impairment because these orally disintegrating tablets should not be broken in half [see Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
2.4Dosing in Patients Taking CimetidineIf zolmitriptan is co-administered with cimetidine, limit the maximum single dose of zolmitriptan to 2.5 mg, not to exceed 5 mg in any 24-hour period [see Drug Interactions (7.5), Clinical Pharmacology (12.3)].
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