Zolmitriptan
Generic Name: zolmitriptan
Brand Names:
Zolmitriptan
11 DESCRIPTION Zolmitriptan tablets, USP contain zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Zolmitriptan is chemically designated as (4S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure: The molecular formula is C 16 H 21 N 3 O 2 , representing a molecular weight of 287.36 g/mol. Zolmitriptan is a white to off-white powder that is soluble in methanol and acetone, insoluble in water.
Overview
11 DESCRIPTION Zolmitriptan tablets, USP contain zolmitriptan, which is a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Zolmitriptan is chemically designated as (4S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5-yl]methyl]-2-oxazolidinone and has the following chemical structure: The molecular formula is C 16 H 21 N 3 O 2 , representing a molecular weight of 287.36 g/mol. Zolmitriptan is a white to off-white powder that is soluble in methanol and acetone, insoluble in water.
Uses
1 INDICATIONS AND USAGE Zolmitriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use • Only use zolmitriptan tablets if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan tablets treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan tablets are administered to treat any subsequent attacks. • Zolmitriptan tablets are not indicated for the prevention of migraine attacks. • Safety and effectiveness of zolmitriptan tablets have not been established for cluster headache.
Dosage
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 ) • Moderate or Severe Hepatic Impairment: 1.25 mg recommended ( 2.3 , 8.6 ) 2.1 Dosing Information The recommended starting dose of zolmitriptan 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 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.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in other sections of the prescribing information: • Myocardial Ischemia, Myocardial Infarction, and Prinzmetal Angina [ seeWarnings and Precautions ( 5.1 ) ]. • Arrhythmias [ see Warnings and Precautions ( 5.2 ) ]. • Chest and or Throat, Neck and Jaw Pain/Tightness/Pressure [ seeWarnings and Precautions ( 5.3 ) ]. • Cerebrovascular Events [ see Warnings and Precautions ( 5.4 ) ]. • Other Vasospasm Reactions [ seeWarnings and Precautions ( 5.5 ) ]. • Medication Overuse Headache [ seeWarnings and Precautions ( 5.6 ) ]. • Serotonin Syndrome [ seeWarnings and Precautions ( 5.7 ) ]. • Increase in Blood Pressure [ see Warnings and Precautions ( 5.8 ) ].
Interactions
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 [ seeContraindications ( 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 [ seeContraindications ( 4 ), Clinical Pharmacology ( 12.3 ) ] .
Warnings
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 ) 5.1 Myocardial Ischemia, Myocardial Infarc... 4 CONTRAINDICATIONS Zolmitriptan tablets are contraindicated in patients with: • Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), other significant underlying cardiovascular disease, or c oronary artery vasospasm including Prinzmetal’s angina [see Warnings and Precautions ( 5.1 ) ] • Wolff-Parkinson-White syndrome or arrhythmias a...
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of zolmitriptan in pregnant women. In reproductive toxicity studies in rats and rabbits, oral administration of zolmitriptan to pregnant animals resulted in embryolethality and fetal abnormalities (malformations and variations) at clinically relevant exposures (see Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Zolmitriptan tablet, USP 2.5 mg Tablets – Yellow colored, round, biconvex film-coated tablets debossed with “497” on one side and functionally-scored on the other side and are supplied in Cartons (NDC 69462-497-76) containing one blister pack of 6 unit-dose tablets (NDC 68462-497-40).
Frequently Asked Questions
What is Zolmitriptan used for?▼
1 INDICATIONS AND USAGE Zolmitriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use • Only use zolmitriptan tablets if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan tablets treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan tablets are administered to treat any subsequent attacks. • Zolmitriptan tablets are not indicated for the prevention of migraine attacks. • Safety and effectiveness of zolmitriptan tablets have not been established for cluster headache.
What are the side effects of Zolmitriptan?▼
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in other sections of the prescribing information: • Myocardial Ischemia, Myocardial Infarction, and Prinzmetal Angina [ seeWarnings and Precautions ( 5.1 ) ]. • Arrhythmias [ see Warnings and Precautions ( 5.2 ) ]. • Chest and or Throat, Neck and Jaw Pain/Tightness/Pressure [ seeWarnings and Precautions ( 5.3 ) ]. • Cerebrovascular Events [ see Warnings and Precautions ( 5.4 ) ]. • Other Vasospasm Reactions [ seeWarnings and Precautions ( 5.5 ) ]. • Medication Overuse Headache [ seeWarnings and Precautions ( 5.6 ) ]. • Serotonin Syndrome [ seeWarnings and Precautions ( 5.7 ) ]. • Increase in Blood Pressure [ see Warnings and Precautions ( 5.8 ) ].
Can I take Zolmitriptan during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of zolmitriptan in pregnant women. In reproductive toxicity studies in rats and rabbits, oral administration of zolmitriptan to pregnant animals resulted in embryolethality and fetal abnormalities (malformations and variations) at clinically relevant exposures (see Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
What are the important warnings for Zolmitriptan?▼
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 ) 5.1 Myocardial Ischemia, Myocardial Infarc... 4 CONTRAINDICATIONS Zolmitriptan tablets are contraindicated in patients with: • Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), other significant underlying cardiovascular disease, or c oronary artery vasospasm including Prinzmetal’s angina [see Warnings and Precautions ( 5.1 ) ] • Wolff-Parkinson-White syndrome or arrhythmias a...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.