ZOMIG 2.5 mg/1
zolmitriptan · TABLET, FILM COATED · Amneal Pharmaceuticals LLC
ZOMIG is a tablet, film coated containing zolmitriptan at 2.5 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals LLC.
Key Facts
- Brand Name
- ZOMIG
- Generic Name
- zolmitriptan
- NDC Code (Product)
60846-130- Manufacturer
- Amneal Pharmaceuticals LLC
- Strength
- 2.5 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA207867
- Drug Class
- Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
- Marketing Start
- 01/09/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ZOMIG is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Only use ZOMIG if a clear diagnosis of migraine has been established. If a patient has no response to ZOMIG treatment for the first migraine attack, reconsider the diagnosis of migraine before ZOMIG is administered to treat any subsequent attacks. ZOMIG is not indicated for the prevention of migraine attacks. Safety and effectiveness of ZOMIG have not been established for cluster headache. ZOMIG 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 & 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) Moderate or Severe Hepatic Impairment: 1.25 mg recommended (2.3, 8.6) 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. 2.3 Dosing in Patients with Hepatic Impairment…
Contraindications
4 CONTRAINDICATIONS ZOMIG is contraindicated in patients with: Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), other significant underlying cardiovascular disease, or coronary artery vasospasm including Prinzmetal’s angina [see Warnings and Precautions (5.1)]. Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.2)]. History of stroke, transient ischemic attack (TIA), or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions (5.4)] . Peripheral vascular disease (PVD) [see Warnings and Precautions (5.5)] . Ischemic bowel disease [see Warnings and Precautions (5.5)] . Uncontrolled hypertension [see Warnings and Precautions (5.8)]. Recent use (i.e., within 24 hours) of another 5-HT 1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide) [see Drug Interactions (7.1, 7.3)] . Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent use of a MAO-A inhibitor (that is within 2 weeks)…
Drug 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 ZOMIG 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 ZOMIG in patients receiving MAO-A inhibitors is contraindicated [see Contraindications (4), Clinical Pharmacology (12.3)] . 7.3 5-HT1B/1D agonists Concomitant use of other 5-HT 1B/1D agonists (including triptans) within 24 hours of ZOMIG treatment is contraindicated because the risk of vasospastic reactions may be additive [see Contraindications (4)] . 7.4 Selective Serotonin Reuptake Inhibitors and Serotonin Norepinephrine Reuptake Inhibitors Cases of life-threatening serotonin syndrome have been reported during co-administration of triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see Warnings and Precautions (5.7)] . 7.5…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in other sections of the prescribing information: Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina [see Warnings and Precautions (5.1)] . Arrhythmias [see Warnings and Precautions (5.2)] . Chest and or Throat, Neck and Jaw Pain/Tightness/Pressure [see Warnings and Precautions (5.3)] . Cerebrovascular Events [see Warnings and Precautions (5.4)] . Other Vasospasm Reactions [see Warnings and Precautions (5.5)] . Medication Overuse Headache [see Warnings and Precautions (5.6)] . Serotonin Syndrome [see Warnings and Precautions (5.7)] . Increase in Blood Pressure [see Warnings and Precautions (5.8)] . Most common adverse reactions (≥5% and > placebo) were neck/throat/jaw pain/tightness/pressure, dizziness, paresthesia, asthenia, somnolence, warm/cold sensation, nausea, heaviness sensation, and dry mouth (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Avema Pharma Solutions at 1-877-753-3935 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical …
Frequently Asked Questions
What is ZOMIG used for?
ZOMIG contains zolmitriptan. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is ZOMIG a controlled substance?
ZOMIG is not classified as a controlled substance by the DEA.
What is the generic name for ZOMIG?
The generic name for ZOMIG is zolmitriptan. There are 12 other brand versions of zolmitriptan.
What is the NDC code for ZOMIG 2.5 mg/1?
The NDC (National Drug Code) for ZOMIG 2.5 mg/1 is 60846-130, listed by Amneal Pharmaceuticals LLC.