Impax Laboratories, Inc.
Manufacturer Details
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Impax Laboratories, Inc. Drugs
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![Zomig (Zolmitriptan) Tablet Zomig Zmt (Zolmitriptan) Tablet, Orally Disintegrating [Impax Laboratories, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=df93b636-103f-4fb5-26b6-50f639e29b1d&name=9f4b598b-6cf3-4341-9387-177cb8509af0-06.jpg)
Zomig
2.1 Dosing Information
The recommended starting dose of ZOMIG 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 ZOMIG 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 ZOMIG, 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 ZOMIG in the treatment of an average of more than three migraines in a 30-day period has not been established.
2.2 Administration of ZOMIG-ZMT Orally Disintegrating Tablets
Instruct patients not to break ZOMIG-ZMT 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 ZOMIG in patients with moderate to severe hepatic impairment is 1.25 mg (one-half of one 2.5 mg ZOMIG 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 ZOMIG-ZMT 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)].
2.4 Dosing in Patients taking Cimetidine
If ZOMIG is co-administered with cimetidine, limit the maximum single dose of ZOMIG 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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Hourglass Illusion Tinted Moisturizer Sand Spf 15
2.1 Dosing Information
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.
2.2 Dosing in Patients with Hepatic Impairment
ZOMIG nasal spray is not recommended in patients with moderate to severe hepatic impairment because of increased zolmitriptan blood levels in these patients and elevation of blood pressure in some of these patients. The recommended dosage of ZOMIG nasal spray in patients with mild hepatic impairment is the same as for patients with normal hepatic function [see Dosage and Administration (2.1),Warnings and Precautions (5.8),Use in Specific Populations (8.6)andClinical Pharmacology (12.3)].
2.3 Dosing in Patients taking Cimetidine
If ZOMIG is co‑administered with cimetidine, limit the maximum single dose of ZOMIG to 2.5 mg, not to exceed 5 mg in any 24‑hour period [see Drug Interactions (7.4)andClinical Pharmacology (12.3)].
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