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General MedicationsORALHigh Alert

zolmiptriptan

ZOLMITRIPTAN

Standard Dose
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 orally disintegrating tablets 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 orally disintegrating tablets 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 orally disintegrating tablets, 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 orally disintegrating tablets 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 orally disintegrating tablets 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 ) ] . 2.4 Dosing in Patients taking Cimetidine If zolmitriptan orally disintegrating tablets are co-administered with cimetidine, limit the maximum single dose of zolmitriptan orally disintegrating tablets to 2.5 mg, not to exceed 5 mg in any 24-hour period [see Drug Interactions ( 7.5 ), Clinical Pharmacology ( 12.3 ) ].
Max Dose
See official label
Primary Use
1 INDICATIONS AND USAGE Zolmitriptan orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults.
Summary

Indications and usage 1 INDICATIONS AND USAGE Zolmitriptan orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use • Only use zolmitriptan orally disintegrating tablets if a clear diagnosis of migraine has been established.

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Zolmitriptan orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use • 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. • Zolmitriptan orally disintegrating tablets are not indicated for the prevention of migraine attacks. • Safety and effectiveness of zolmitriptan orally disintegrating tablets have not been established for cluster headache. Zolmitriptan orally disintegrating tablets are 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 orally disintegrating tablets 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 orally disintegrating tablets 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 orally disintegrating tablets, 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 orally disintegrating tablets 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 orally disintegrating tablets 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 ) ] . 2.4 Dosing in Patients taking Cimetidine If zolmitriptan orally disintegrating tablets are co-administered with cimetidine, limit the maximum single dose of zolmitriptan orally disintegrating tablets to 2.5 mg, not to exceed 5 mg in any 24-hour period [see Drug Interactions ( 7.5 ), Clinical Pharmacology ( 12.3 ) ]. Warnings and cautions 5 WARNINGS AND PRECAUTIONS • Myocardial Ischemia/Infarction, and Prinzmetal Angina : Perform cardiac evaluation in patients with multiple cardiovascular risk factors ( 5.1 ) • Arrhythmias : Discontinue zolmitriptan if occurs ( 5.2 ) • Chest/Throat/Neck/Jaw Pain, Tightness, and Pressure : Generally not associated with myocardial ischemia; evaluate for CAD in patients at high risk ( 5.3 ) • Cerebral Hemorrhage, Subarachnoid Hemorrhage, and Stroke : Discontinue zolmitriptan if occurs ( 5.4 ) • Gastrointestinal Ischemic Reactions and Peripheral Vasospastic Reactions : Discontinue zolmitriptan if occurs ( 5.5 ) • Medication Overuse Headache : Detoxification may be necessary ( 5.6 ) • Serotonin Syndrome : Discontinue zolmitriptan if occurs ( 5.7 , 7.4 ) • Patients with P

Monitoring

  • • 5 WARNINGS AND PRECAUTIONS • Myocardial Ischemia/Infarction, and Prinzmetal Angina : Perform cardiac evaluation in patients with multiple cardiovascular risk factors ( 5.1 ) • Arrhythmias : Discontinue zolmitriptan if occurs ( 5.2 ) • Chest/Throat/Neck/Jaw Pain, Tightness, and Pressure : Generally not associated with myocardial ischemia; evaluate for CAD in patients at high risk ( 5.3 ) • Cerebral Hemorrhage, Subarachnoid Hemorrhage, and Stroke : Discontinue zolmitriptan if occurs ( 5.4 ) • Gastrointestinal Ischemic Reactions and Peripheral Vasospastic Reactions : Discontinue zolmitriptan if occurs ( 5.5 ) • Medication Overuse Headache : Detoxification may be necessary ( 5.6 ) • Serotonin Syndrome : Discontinue zolmitriptan if occurs ( 5.7 , 7.4 ) • Patients with Phenylketonuria : Zolmitriptan orally disintegrating tablets contain phenylalanine ( 5.9 ) 5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal Angina 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 1 agonists including zolmitriptan may cause coronary artery vasospasm (Prinzmetal Angina), even in patients without a history of CAD.

Interaction Notes

  • • 7 DRUG INTERACTIONS 7.1 Ergot-containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions.
  • • Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and zolmitriptan within 24 hours of each other is contraindicated [see Contraindications ( 4 ) ].
  • • 7.2 MAO-A Inhibitors MAO-A inhibitors increase the systemic exposure of zolmitriptan and its active N-desmethyl metabolite.
  • • Therefore, the use of zolmitriptan in patients receiving MAO-A inhibitors is contraindicated [see Contraindications ( 4 ), Clinical Pharmacology ( 12.3 ) ] .