Drug Catalog - Product Detail
ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS USP 2.5MG 6CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 64980-0256-16 | RISING PHARMACEUTICALS | 6 | 2.5MG | NA |
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Description
11 DESCRIPTION Zolmitriptan orally disintegrating tablets, USP contain zolmitriptan, which is a selective 5-hydroxytryptamine1B/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 off-white crystalline powder that is freely soluble in N,N-dimethyl formamide, dimethyl sulfoxide and practically insoluble in water. Zolmitriptan orally disintegrating tablets are available as 2.5 mg and 5 mg white to off-white uncoated tablets. The orally disintegrating tablets contain mannitol, microcrystalline cellulose, crospovidone, aspartame [ see Warnings and Precautions (5.9) ], sodium stearyl fumarate, colloidal silicon dioxide, magnesium stearate, orange flavor, modified food starch and triacetin. Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 2.5 mg Orally Disintegrating Tablets - White to off-white, round, flat faced bevelled edge tablets debossed with '359' on one side and 'L' on other side. NDC 64980-256-16 Carton of 1 blister of 6 tablets 5 mg Orally Disintegrating Tablets - White to off-white, round, flat faced bevelled edge tablets debossed with '360' on one side and 'L' on other side. NDC 64980-257-13 Carton of 1 blister of 3 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.
Indications & Usage
1 INDICATIONS AND USAGE Zolmitriptan is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Only use zolmitriptan if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan is administered to treat any subsequent attacks. Zolmitriptan is not indicated for the prevention of migraine attacks. Safety and effectiveness of zolmitriptan have not been established for cluster headache. Zolmitriptan is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults ( 1 ) Limitations of Use : Use only after a clear diagnosis of migraine has been established ( 1 ) Not indicated for the prophylactic therapy of migraine ( 1 ) Not indicated for the treatment of cluster headache ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Recommended starting dose: 1.25 mg or 2.5 mg ( 2.1 ) Maximum single dose: 5 mg ( 2.1 ) May repeat dose after 2 hours if needed; not to exceed 10 mg in any 24 hour period ( 2.1 ) Do not break zolmitriptan orally disintegrating tablets ( 2.2 ) Moderate or Severe Hepatic Impairment: 1.25 mg recommended ( 2.3 , 8.6 ) 2.1 Dosing Information The recommended starting dose of zolmitriptan tablet 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 tablet in half. The maximum recommended single dose of zolmitriptan tablet 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 Tablets Instruct 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 Impairment The recommended dose of zolmitriptan tablet 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) , Clinical Pharmacology (12.3) ]. 2.4 Dosing in Patients taking Cimetidine If 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) ].