Zolmitriptan 5 mg Tablet, Film Coated — NDC 71626-102-03 (Billing 71626-0102-03)
This is a package of Zolmitriptan 5 mg Tablet, Film Coated from Medstone Pharma LLC, no longer marketed (first marketed May 2018), no longer in the FDA NDC Directory; retail pharmacies pay about $1.35 per unit (NADAC). It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 037036
- GCN: 46132
- GPI-14 (Medi-Span): 67406080000330
- HICL (First Databank): 012958
- AHFS class code: 28:32.28.00
- RxCUI (RxNorm): 200193
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Serotonin-1b and Serotonin-1d Receptor Agonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It treats migraine attacks, with or without aura, once they've started. It doesn't prevent migraines, and it hasn't been shown to work for cluster headache. Tablets and dissolving...
- Use it at the start of a migraine, as a tablet, a dissolving tablet or a nasal spray. If the migraine hasn't resolved after 2 hours or comes back, you may be able to take a second...
- Common ones are tightness or pressure in the neck, throat or jaw, dizziness, tingling, tiredness, sleepiness, feeling warm or cold, nausea and dry mouth. These are usually mild. Ca...
- Tell me which one you take. SSRIs, SNRIs and tricyclic antidepressants can raise the risk of serotonin syndrome, and MAO inhibitors should not be used with zolmitriptan. Never comb...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Zolmitriptan — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.353 | $4.06 / 3 tablet |
| Medicaid paysCMS SDUD · 12 mo | $4.75 | $14.26 / 3 tablet |
| Medicare drug plans payPart D · Q2 2026 | $2.76 | $8.28 / 3 tablet |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 71626-0102-03 You're viewing this Main listing | 3 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK | 2018-05-30 | — | Discontinued by firm |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Zolmitriptan 5 mg 16571-0804-13 | Rising | 3 tablets | $1.353 | AB | Availability likely | — |
| Zolmitriptan 5 mg 27241-0022-38 | Ajanta | 3 tablets | $1.353 | AB | Availability likely | — |
| Zolmitriptan 5 mg 62332-0463-03 | Alembic | 3 tablets | $1.353 | AB | Availability likely | — |
| Zolmitriptan 5 mg 68001-0250-01 | BluePoint | 3 tablets | $1.353 | AB | Availability likely | — |
| Zolmitriptan 5 mg 68462-0498-33 | Glenmark | 3 tablets | $1.353 | AB | Availability likely | — |
| Zolmitriptan 5 mgthis 71626-0102-03 | Medstone | 1 tablet | $1.353 | AB | Discontinued | — |
| Zolmitriptan 5 mg 65862-0915-64 | Aurobindo | 3 tablets | $1.498 | AB | FDA listed | +11% |
| Zolmitriptan 5 mg 46708-0463-03 | Alembic | 3 tablets | — | AB | FDA listed | — |
| Zomig 5 mg 60846-0133-60 | Amneal | 3 tablets | — | AB | FDA listed | — |
| Zolmitriptan 5 mg 63548-0102-03 | PLD | 3 tablets | — | AB | FDA listed | — |
| Zolmitriptan 5 mg 69097-0864-84 | Cipla | 3 tablets | — | — | FDA listed | — |
| Zolmitriptan 5 mg 72189-0435-03 | Direct_Rx | 3 tablets | — | AB | FDA listed | — |
| Zolmitriptan 5 mg 76420-0337-03 | Asclemed | 3 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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. 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 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. 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 )
2.1Dosing 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. 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 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 tablets in the treatment of an average of more than three migraines in a 30-day period has not been established.
2.3Dosing in Patients with Hepatic Impairment The recommended dose of zolmitriptan 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. 2.4Dosing in Patients taking Cimetidine If zolmitriptan tablets are co-administered with cimetidine, limit the maximum single dose of zolmitriptan tablets to 2.5 mg, not to exceed 5 mg in any 24-hour period [see Drug Interactions ( 7.5 ), Clinical Pharmacology ( 12.3 ) ].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 2.5 mg Tablets – Yellow colored, round, biconvex film-coated tablets debossed with 101 on one side and deep breakline on other side 5 mg Tablets – Pink colored, round, biconvex film-coated tablets debossed with 102 on one side and plain on other side Tablets: 2.5 mg functionally-scored ( 3 ) Tablets: 5 mg (not scored) ( 3 )
⛔ Contraindications ▾
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 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) [see Drug Interactions ( 7.2 ) and Clinical Pharmacology ( 12.3 ) ] Known hypersensitivity to zolmitriptan (angioedema and anaphylaxis seen) [see Adverse Reactions ( 6.2 ) ] History of coronary artery disease (CAD) or coronary vasospasm ( 4 ) Symptomatic Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders ( 4 ) History of stroke, transient ischemic attack, or hemiplegic or basilar migraine ( 4 ) Peripheral vascular disease ( 4 ) Ischemic bowel disease ( 4 ) Uncontrolled hypertension ( 4 ) Recent (within 24 hours) use of another 5-HT 1 agonist (e.g., another triptan), or an ergotamine-containing medication ( 4 ) Monamine oxidase (MAO)-A inhibitor used in past 2 weeks ( 4 ) Known hypersensitivity to zolmitriptan tablets ( 4 )
⚠️ 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 )
5.1Myocardial 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. Perform a cardiovascular evaluation in triptan-naïve patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving zolmitriptan. Do not administer zolmitriptan if there is evidence of CAD or coronary artery vasospasm [ see Contraindications ( 4 ) ].
For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first zolmitriptan dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following zolmitriptan administration. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of zolmitriptan.
5.2Arrhythmias Life-threatening disturbances of cardiac rhythm including ventricular tachycardia and ventricular fibrillation leading to death have been reported within a few hours following the administration of 5-HT 1 agonists. Discontinue zolmitriptan if these disturbances occur. Zolmitriptan is contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [ see Contraindications ( 4 ) ].
5.3Chest, Throat, Neck and Jaw Pain/Tightness/Pressure As with other 5-HT 1 agonists, sensations of tightness, pain, and pressure in the chest, throat, neck, and jaw commonly occur after treatment with zolmitriptan and is usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk. 5-HT 1 agonists including zolmitriptan are contraindicated in patients with CAD or Prinzmetal’s variant angina [ see Contraindications ( 4 ) ] .
5.4Cerebrovascular Events Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT 1 agonists, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT 1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with symptoms atypical for migraine, exclude other potentially serious neurological conditions.
Zolmitriptan is contraindicated in patients with a history of stroke or transient ischemic attack [ see Contraindications ( 4 ) ].
5.5Other Vasospasm Reactions 5-HT 1 agonists, including zolmitriptan, may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and inf… [Excerpted — this section continues on DailyMed.]
🤒 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 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.
6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In a long-term, open-label study where patients were allowed to treat multiple migraine attacks for up to 1 year, 8% (167 out of 2,058) withdrew from the trial because of adverse reaction. The most common adverse reactions (≥ 5% and > placebo) in these trials were neck/throat/jaw pain, dizziness, paresthesia, asthenia, somnolence, warm/cold sensation, nausea, heaviness sensation, and dry mouth.
Table 1 lists the adverse reactions that occurred in ≥2% of the 2,074 patients in any one of the zolmitriptan 1 mg, 2.5 mg, or 5 mg dose groups in the controlled clinical trials of zolmitriptan in patients with migraines (Studies 1, 2, 3, 4, and 5) [see Clinical Studies ( 14 ) ]. Only adverse reactions that were at least 2% more frequent in a zolmitriptan group compared to the placebo group are included. Several of the adverse reactions appear dose related, notably paresthesia, sensation of heaviness or tightness in chest, neck, jaw, and throat, dizziness, somnolence and possibly asthenia and nausea.
Table 1: Adverse Reaction Incidence in Five Pooled Placebo-Controlled Migraine Clinical Trials 1 Placebo (n=401) Zolmitriptan Tablets 1 mg (n=163) Zolmitriptan Tablets 2.5 mg (n=498) Zolmitriptan Tablets 5 mg (n=1012) ATYPICAL SENSATIONS 6% 12% 12% 18% Paresthesia (all types) 2% 5% 7% 9% Warm/cold sensation 4% 6% 5% 7% PAIN AND PRESSURE SENSATIONS 7% 13% 14% 22% Chest-pain/tightness/pressure and/or heaviness 1% 2% 3% 4% Neck/throat/jaw-pain/tightness/pressure 3% 4% 7% 10% Heaviness other than chest or neck 1% 1% 2% 5% Other-pressure/tightness/heaviness 0 2% 2% 2% DIGESTIVE 8% 11% 16% 14% Dry mouth 2% 5% 3% 3% Dyspepsia 1% 3% 2% 1% Dysphagia 0% 0% 0% 2% Nausea 4% 4% 9% 6% NEUROLOGICAL 10% 11% 17% 21% Dizziness 4% 6% 8% 10% Somnolence 3% 5% 6% 8% Vertigo 0% 0% 0% 2% OTHER Asthenia 3% 5% 3% 9% Sweating 1% 0% 2% 3% 1 Only adverse reactions that were at least 2% more frequent in a zolmitriptan group compared to the placebo group are included.
There were no differences in the incidence of adverse reactions in controlled clinical trials in the following subgroups: gender, weight, age, use of prophylactic medications, or presence of aura. There were insufficient data to assess the impact of race on the incidence of adverse reactions. Less Common Adverse Reactions with Zolmitriptan Tablets: In the paragraphs that follow, the frequencies of less commonly reported adverse clinical reactions are presented.
Because the reports include reactions observed in open and uncontrolled studies, the role of zolmitriptan in their causation cannot be reliably determined. Furthermore, variability associated with adverse reacti… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Ergot-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 ) ].
7.2MAO-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 ) and Clinical Pharmacology ( 12.3 ) ] . 7.3 5-HT 1B/1D agonists Concomitant use of other 5-HT 1B/1D agonists (including triptans) within 24 hours of zolmitriptan treatment is contraindicated because the risk of vasospastic reactions may be additive [see Contraindications ( 4 ) ].
7.4Selective 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 ) ].
7.5Cimetidine Following administration of cimetidine, the half-life and blood levels of zolmitriptan and its active N-desmethyl metabolite were approximately doubled [see Clinical Pharmacology ( 12.3 ) ] . If cimetidine and zolmitriptan are used concomitantly, limit the maximum single dose of zolmitriptan to 2.5 mg, not to exceed 5 mg in any 24-hour period [see Dosage and Administration, ( 2.4 ) and Clinical Pharmacology ( 12.3 ) ].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS The following adverse reactions are described elsewhere in other sections of the prescribing information: Myocardial Ischemia, Myocardial Infarction, and Prinzmetal 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 ) ]. Pregnancy: Based on animal data, may cause fetal harm ( 8.1 )
8.1Pregnancy Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women; therefore, zolmitriptan should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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. When zolmitriptan was administered to pregnant rats during the period of organogenesis at oral doses of 100, 400, and 1200 mg/kg/day (plasma exposures (AUCs) ≈280, 1100, and 5000 times the human AUC at the maximum recommended human dose (MRHD) of 10 mg/day), there was a dose-related increase in embryolethality.
A no-effect dose for embryolethality was not established. When zolmitriptan was administered to pregnant rabbits during the period of organogenesis at oral doses of 3, 10, and 30 mg/kg/day (plasma AUCs ≈1, 11, and 42 times the human AUC at the MRHD), there were increases in embryolethality and in fetal malformations and variations. The no-effect dose for adverse effects on embryo-fetal development was associated with a plasma AUC similar to that in humans at the MRHD.
When female rats were given zolmitriptan during gestation, parturition, and lactation at oral doses of 25, 100, and 400 mg/kg/day (plasma AUCs ≈70, 280, and 1100 times that in human at the MRHD), an increased incidence of hydronephrosis was found in the offspring. The no-effect dose was associated with a plasma AUC ≈280 times that in humans at the MRHD.
8.3Nursing Mothers It is not known whether zolmitriptan is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from zolmitriptan, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. In rats, oral dosing with zolmitriptan resulted in levels in milk up to 4 times higher than in plasma.
8.4Pediatric Use The safety and effectiveness in pediatric patients have not been established. Therefore, zolmitriptan is not recommended for use in patients under 18 years of age. One randomized, placebo-controlled clinical trial of zolmitriptan tablets (2.5, 5 and 10 mg) evaluated 696 pediatric patients (aged 12 to 17 years) with migraines.
This study did not demonstrate the efficacy of zolmitriptan compared to placebo in the treatment of migraine in adolescents. Adverse reactions in the adolescent patients treated with zolmitriptan were similar in nature and frequency to those reported in clinical trials in adults treated with zolmitriptan. Zolmitriptan has not been studied in pediatric patients less than 12 years old.
In the postmarketing experience with triptans, including zolmitriptan, there were no additional adverse reactions seen in pediatric patients that were not seen in adults.
8.5Geriatric Use Clinical studies of zolmitriptan did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not id… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women; therefore, zolmitriptan should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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. When zolmitriptan was administered to pregnant rats during the period of organogenesis at oral doses of 100, 400, and 1200 mg/kg/day (plasma exposures (AUCs) ≈280, 1100, and 5000 times the human AUC at the maximum recommended human dose (MRHD) of 10 mg/day), there was a dose-related increase in embryolethality.
A no-effect dose for embryolethality was not established. When zolmitriptan was administered to pregnant rabbits during the period of organogenesis at oral doses of 3, 10, and 30 mg/kg/day (plasma AUCs ≈1, 11, and 42 times the human AUC at the MRHD), there were increases in embryolethality and in fetal malformations and variations. The no-effect dose for adverse effects on embryo-fetal development was associated with a plasma AUC similar to that in humans at the MRHD.
When female rats were given zolmitriptan during gestation, parturition, and lactation at oral doses of 25, 100, and 400 mg/kg/day (plasma AUCs ≈70, 280, and 1100 times that in human at the MRHD), an increased incidence of hydronephrosis was found in the offspring. The no-effect dose was associated with a plasma AUC ≈280 times that in humans at the MRHD.
Pregnancy Inform patients that zolmitriptan should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus [ see Use in Specific Populations (8.1) ].
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness in pediatric patients have not been established. Therefore, zolmitriptan is not recommended for use in patients under 18 years of age. One randomized, placebo-controlled clinical trial of zolmitriptan tablets (2.5, 5 and 10 mg) evaluated 696 pediatric patients (aged 12 to 17 years) with migraines.
This study did not demonstrate the efficacy of zolmitriptan compared to placebo in the treatment of migraine in adolescents. Adverse reactions in the adolescent patients treated with zolmitriptan were similar in nature and frequency to those reported in clinical trials in adults treated with zolmitriptan. Zolmitriptan has not been studied in pediatric patients less than 12 years old.
In the postmarketing experience with triptans, including zolmitriptan, there were no additional adverse reactions seen in pediatric patients that were not seen in adults.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of zolmitriptan did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of coronary artery disease) prior to receiving zolmitriptan [see Warnings and Precautions ( 5.1 ) ]. The pharmacokinetics of zolmitriptan were similar in geriatric patients (aged > 65 years) compared to younger patients [see Clinical Pharmacology ( 12.3 ) ].
🆘 Overdosage ▾
10 OVERDOSAGE There is no experience with acute overdose of zolmitriptan. Clinical study subjects who received single 50 mg oral doses of zolmitriptan commonly experienced sedation. There is no specific antidote to zolmitriptan.
In cases of severe intoxication, intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. The elimination half-life of zolmitriptan is 3 hours [see Clinical Pharmacology ( 12.1 ) ]; therefore, monitor patients after overdose with zolmitriptan for at least 15 hours or until symptoms or signs resolve. It is unknown what effect hemodialysis or peritoneal dialysis has on the plasma concentrations of zolmitriptan.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Zolmitriptan binds with high affinity to human recombinant 5-HT 1D and 5-HT 1B receptors, and moderate affinity for 5-HT 1A receptors. The N-desmethyl metabolite also has high affinity for 5-HT 1B/1D and moderate affinity for 5-HT 1A receptors. Migraines are likely due to local cranial vasodilatation and/or to the release of sensory neuropeptides (vasoactive intestinal peptide, substance P and calcitonin gene-related peptide) through nerve endings in the trigeminal system.
The therapeutic activity of zolmitriptan for the treatment of migraine headache is thought to be due to the agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels (including the arteriovenous anastomoses) and sensory nerves of the trigeminal system which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.
12.3Pharmacokinetics Absorption, Distribution, Metabolism, and Excretion Absorption Zolmitriptan is well absorbed after oral administration for both zolmitriptan tablets and zolmitriptan orally disintegrating tablets. Zolmitriptan displays linear kinetics over the dose range of 2.5 to 50 mg. The AUC and C max of zolmitriptan are similar following administration of zolmitriptan tablets and zolmitriptan orally disintegrating tablets, but the T max is somewhat later with zolmitriptan orally disintegrating tablets, with a median T max of 3 hours for zolmitriptan orally disintegrating tablet compared with 1.5 hours for the zolmitriptan tablet.
The AUC, C max , and T max for the active N-desmethyl metabolite are similar for the two formulations. During a moderate to severe migraine attack, mean AUC 0-4 and C max for zolmitriptan, dosed as a zolmitriptan tablet, were decreased by 40% and 25%, respectively, and mean T max was delayed by one-half hour compared to the same patients during a migraine free period. Food has no significant effect on the bioavailability of zolmitriptan.
No accumulation occurred on multiple dosing. Distribution Mean absolute bioavailability is approximately 40%. The mean apparent volume of distribution is 7 L/kg.
Plasma protein binding of zolmitriptan is 25% over the concentration range of 10 to 1000 ng/mL. Metabolism Zolmitriptan is converted to an active N-desmethyl metabolite; the metabolite concentrations are about two-thirds that of zolmitriptan. Because the 5HT 1B/1D potency of the metabolite is 2 to 6 times that of the parent compound, the metabolite may contribute a substantial portion of the overall effect after zolmitriptan administration.
Excretion Total radioactivity recovered in urine and feces was 65% and 30% of the administered dose, respectively. About 8% of the dose was recovered in the urine as unchanged zolmitriptan. Indole acetic acid metabolite accounted for 31% of the dose, followed by N-oxide (7%) and N-desmethyl (4%) metabolites.
The indole acetic acid and N-oxide metabolites are inactive. Mean total plasma clearance is 31.5 mL/min/kg, of which one-sixth is renal clearance. The renal clearance is greater than the glomerular filtration rate suggesting renal tubular secretion.
Special Populations Hepatic Impairment In patients with severe hepatic impairment, the mean C max , T max , and AUC 0-∞ of zolmitriptan were increased 1.5-fold, 2-fold (2 vs. 4 hours), and 3-fold, respectively, compared to subjects with normal hepatic function. Seven out of 27 patients experienced 20 to 80 mm Hg elevations in systolic and/or diastolic blood pressure after a 10 mg zolmitriptan dose.
Adjust the zolmitriptan dose in patients with moderate or severe hepatic impairment [see Dosage and Administration ( 2.3 ) and Use in Specific Populations ( 8.6 ) ]. Renal Impairment Clearance of zolmitriptan was reduced by 25% in patients with severe renal impairment (Cl cr ≥ 5 ≤ 25 mL/min) compared to subjects with normal renal function (Cl cr ≥ 70 mL/min); no significant change in clearance was observed in patients with moderate renal im… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Zolmitriptan binds with high affinity to human recombinant 5-HT 1D and 5-HT 1B receptors, and moderate affinity for 5-HT 1A receptors. The N-desmethyl metabolite also has high affinity for 5-HT 1B/1D and moderate affinity for 5-HT 1A receptors. Migraines are likely due to local cranial vasodilatation and/or to the release of sensory neuropeptides (vasoactive intestinal peptide, substance P and calcitonin gene-related peptide) through nerve endings in the trigeminal system.
The therapeutic activity of zolmitriptan for the treatment of migraine headache is thought to be due to the agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels (including the arteriovenous anastomoses) and sensory nerves of the trigeminal system which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 2.5 mg Tablets – Yellow colored, round, biconvex film-coated tablets debossed with 101 on one side and deep breakline on other side and are supplied in cartons containing a blister pack of 6 tablets (NDC 63548-0101-6) 5 mg Tablets – Pink colored, round, biconvex film-coated tablets debossed with 102 on one side and plain on other side and are supplied in cartons containing a blister pack of 3 tablets (NDC 63548-0102-3). Store Zolmitriptan tablets at 20° to 25°C (68° to 77°F); [see USP].
Protect from light and moisture.
📋 Description ▾
11 DESCRIPTION Zolmitriptan Tablets contain zolmitriptan, which is a selective 5-hydroxytryptamine 1B/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: Zolmitriptan Structural Formula The molecular formula is C 16 H 21 N 3 O 2 , representing a molecular weight of 287.36. Zolmitriptan is a white to off-white powder that is soluble in methanol and acetone, insoluble in water.
Zolmitriptan tablets are available as 2.5 mg (yellow) and 5 mg (pink) film coated tablets for oral administration. The film coated tablets contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide, titanium dioxide, polyethylene alcohol, polyethylene glycol, talc, yellow iron oxide (2.5 mg tablet), red iron oxide (5 mg tablet). zolmitriptan structural formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA Approved Patient Labeling ( Patient Information ). Myocardial Ischemia and/or Infarction, Prinzmetal’s angina, Other Vasospastic Reactions, and Cerebrovascular Events Inform patients that zolmitriptan may cause serious cardiovascular adverse reactions such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular reactions can occur without warning symptoms, instruct patients to be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and instruct them to ask for medical advice when observing any indicative sign or symptoms.
Instruct patients to seek medical advice if they have symptoms of other vasospastic reactions [see Warnings and Precautions ( 5.1 , 5.2 , 5.4 , 5.5 ) ]. Medication Overuse Headache Inform patients that use of drugs to treat acute migraines for 10 or more days per month may lead to an exacerbation of headache, and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions ( 5.6 ) ]. Serotonin Syndrome Inform patients about the risk of serotonin syndrome with the use of zolmitriptan or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see Warnings and Precautions ( 5.7 ) ].
Pregnancy Inform patients that zolmitriptan should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus [ see Use in Specific Populations (8.1) ]. Nursing Mothers Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [ see Use in Specific Populations ( 8.3 ) ].
🍼 Nursing Mothers ▾
8.3Nursing Mothers It is not known whether zolmitriptan is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from zolmitriptan, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. In rats, oral dosing with zolmitriptan resulted in levels in milk up to 4 times higher than in plasma.
Nursing Mothers Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [ see Use in Specific Populations ( 8.3 ) ].
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption, Distribution, Metabolism, and Excretion Absorption Zolmitriptan is well absorbed after oral administration for both zolmitriptan tablets and zolmitriptan orally disintegrating tablets. Zolmitriptan displays linear kinetics over the dose range of 2.5 to 50 mg. The AUC and C max of zolmitriptan are similar following administration of zolmitriptan tablets and zolmitriptan orally disintegrating tablets, but the T max is somewhat later with zolmitriptan orally disintegrating tablets, with a median T max of 3 hours for zolmitriptan orally disintegrating tablet compared with 1.5 hours for the zolmitriptan tablet.
The AUC, C max , and T max for the active N-desmethyl metabolite are similar for the two formulations. During a moderate to severe migraine attack, mean AUC 0-4 and C max for zolmitriptan, dosed as a zolmitriptan tablet, were decreased by 40% and 25%, respectively, and mean T max was delayed by one-half hour compared to the same patients during a migraine free period. Food has no significant effect on the bioavailability of zolmitriptan.
No accumulation occurred on multiple dosing. Distribution Mean absolute bioavailability is approximately 40%. The mean apparent volume of distribution is 7 L/kg.
Plasma protein binding of zolmitriptan is 25% over the concentration range of 10 to 1000 ng/mL. Metabolism Zolmitriptan is converted to an active N-desmethyl metabolite; the metabolite concentrations are about two-thirds that of zolmitriptan. Because the 5HT 1B/1D potency of the metabolite is 2 to 6 times that of the parent compound, the metabolite may contribute a substantial portion of the overall effect after zolmitriptan administration.
Excretion Total radioactivity recovered in urine and feces was 65% and 30% of the administered dose, respectively. About 8% of the dose was recovered in the urine as unchanged zolmitriptan. Indole acetic acid metabolite accounted for 31% of the dose, followed by N-oxide (7%) and N-desmethyl (4%) metabolites.
The indole acetic acid and N-oxide metabolites are inactive. Mean total plasma clearance is 31.5 mL/min/kg, of which one-sixth is renal clearance. The renal clearance is greater than the glomerular filtration rate suggesting renal tubular secretion.
Special Populations Hepatic Impairment In patients with severe hepatic impairment, the mean C max , T max , and AUC 0-∞ of zolmitriptan were increased 1.5-fold, 2-fold (2 vs. 4 hours), and 3-fold, respectively, compared to subjects with normal hepatic function. Seven out of 27 patients experienced 20 to 80 mm Hg elevations in systolic and/or diastolic blood pressure after a 10 mg zolmitriptan dose.
Adjust the zolmitriptan dose in patients with moderate or severe hepatic impairment [see Dosage and Administration ( 2.3 ) and Use in Specific Populations ( 8.6 ) ]. Renal Impairment Clearance of zolmitriptan was reduced by 25% in patients with severe renal impairment (Cl cr ≥ 5 ≤ 25 mL/min) compared to subjects with normal renal function (Cl cr ≥ 70 mL/min); no significant change in clearance was observed in patients with moderate renal impairment (Cl cr ≥ 26 ≤ 50 mL/min). Age Zolmitriptan pharmacokinetics in healthy elderly non-migraineur volunteers (age 65 to 76 years) was similar to those in younger non-migraineur volunteers (age 18 to 39 years).
Sex Mean plasma concentrations of zolmitriptan were up to 1.5-fold higher in females than males. Race Retrospective analysis of pharmacokinetic data between Japanese and Caucasians revealed no significant differences. Hypertensive Patients No differences in the pharmacokinetics of zolmitriptan or its effects on blood pressure were seen in mild to moderate hypertensive volunteers compared with normotensive controls.
Drug Interaction Studies All drug interaction studies were performed in healthy volunteers using a single 10 mg dose of zolmitriptan and a single dose of the other drug except where otherwise noted. MAO Inhibitors Following one week of administration of moclobemi… [Excerpted — this section continues on DailyMed.]
🔬 Clinical Studies ▾
14 CLINICAL STUDIES Zolmitriptan Tablets The efficacy of zolmitriptan tablets in the acute treatment of migraine headaches was demonstrated in five randomized, double-blind, placebo-controlled studies (Studies 1, 2, 3, 4, and 5), of which two utilized the 1 mg dose, two utilized the 2.5 mg dose and four utilized the 5 mg dose. In Study 1, patients treated their headaches in a clinic setting. In the other studies, patients treated their headaches as outpatients.
In Study 4, patients who had previously used sumatriptan were excluded, whereas in the other studies no such exclusion was applied. Patients enrolled in these 5 studies were predominantly female (82%) and Caucasian (97%) with a mean age of 40 years (range 12 to 65). Patients were instructed to treat a moderate to severe headache.
Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed at 1, 2, and, in most studies, 4 hours after dosing. Associated symptoms such as nausea, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24 hours post-dose.
A second dose of zolmitriptan tablets or other medication was allowed 2 to 24 hours after the initial treatment for persistent and recurrent headache. The frequency and time to use of these additional treatments were also recorded. In all studies, the effect of zolmitriptan was compared to placebo in the treatment of a single migraine attack.
In all five studies, the percentage of patients achieving headache response 2 hours after treatment was significantly greater among patients who received zolmitriptan tablets at all doses (except for the 1 mg dose in the smallest study) compared to those who received placebo. In Studies 1 and 3, there was a statistically significant greater percentage of patients with headache response at 2 hours in the higher dose groups (2.5 and/or 5 mg) compared to the 1 mg dose group. There were no statistically significant differences between the 2.5 and 5 mg dose groups (or of doses up to 20 mg) for the primary end point of headache response at 2 hours in any study.
The results of these controlled clinical studies are summarized in Table 2. Table 2 Percentage of Patients with Headache Response (Reduction in Headache Severity from Moderate or Severe Pain to Mild or No Headache) 2 Hours Following Treatment in Studies 1 through 5 Placebo Zolmitriptan tablets 1 mg Zolmitriptan tablets 2.5 mg Zolmitriptan tablets 5 mg Study 1 a 16% (n=19) 27% (n=22) NA 60%*# (n=20) Study 2 19% (n=88) NA NA 66%* (n=179) Study 3 34% (n=121) 50%* (n=140) 65%*# (n=260) 67%*# (n=245) Study 4 b 44% (n=55) NA NA 59%* (n=491) Study 5 36% (n=92) NA 62%* (n=178) NA n=number of patients randomized *p<0.05 in comparison with placebo. #p<0.05 in comparison with 1 mg. a Study 1 was the only study in which patients treated the headache in a clinic setting. b Study 4 was the only study where patients were excluded who had previously used sumatriptan.
NA - not applicable The estimated probability of achieving an initial headache response by 4 hours following treatment in pooled Studies 2, 3, and 5 is depicted in Figure 1. Figure 1 Estimated Probability of Achieving Initial Headache Response (Reduction in Headache Severity from Moderate or Severe Pain to Mild or No Headache) Within 4 Hours of Treatment in Pooled Studies 2, 3, and 5* Figure 1 * In this Kaplan-Meier plot, the averages displayed are based on pooled data from 3 placebo controlled, outpatient trials. Patients not achieving headache response or taking additional treatment prior to 4 hours were censored at 4 hours.
For patients with migraine associated photophobia, phonophobia, and nausea at baseline, there was a decreased incidence of these symptoms following administration of zolmitriptan tablets as compared with placebo. Two to 24 hours following the initial dose of study treatment, patients were allowed to use additional treatment for pain relief in the form of a secon… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Zolmitriptan was administered to mice and rats at doses up to 400 mg/kg/day. Mice were dosed for 85 weeks (males) and 92 weeks (females); rats were dosed for 101 weeks (males) and 86 weeks (females). There was no evidence of drug-induced tumors in mice at plasma exposures (AUC) up to approximately 700 times that in humans at the maximum recommended human dose (MRHD) of 10 mg/day.
In rats, there was an increase in the incidence of thyroid follicular cell hyperplasia and thyroid follicular cell adenomas in male rats receiving 400 mg/kg/day. No increase in tumors was observed in rats at 100 mg/kg/day, a dose associated with a plasma AUC approximately 700 times that in humans at the MRHD. Mutagenesis Zolmitriptan was positive in an in vitro bacterial reverse mutation (Ames) assay and in an in vitro chromosomal aberration assay in human lymphocytes.
Zolmitriptan was negative in an in vitro mammalian gene cell mutation (CHO/HGPRT) assay and in oral in vivo mouse micronucleus assays in mouse and rat. Impairment of Fertility Studies of male and female rats administered zolmitriptan prior to and during mating and up to implantation showed no impairment of fertility at oral doses up to 400 mg/kg/day. The plasma exposure (AUC) at this dose was approximately 3000 times that in humans at the MRHD.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Zolmitriptan was administered to mice and rats at doses up to 400 mg/kg/day. Mice were dosed for 85 weeks (males) and 92 weeks (females); rats were dosed for 101 weeks (males) and 86 weeks (females). There was no evidence of drug-induced tumors in mice at plasma exposures (AUC) up to approximately 700 times that in humans at the maximum recommended human dose (MRHD) of 10 mg/day.
In rats, there was an increase in the incidence of thyroid follicular cell hyperplasia and thyroid follicular cell adenomas in male rats receiving 400 mg/kg/day. No increase in tumors was observed in rats at 100 mg/kg/day, a dose associated with a plasma AUC approximately 700 times that in humans at the MRHD. Mutagenesis Zolmitriptan was positive in an in vitro bacterial reverse mutation (Ames) assay and in an in vitro chromosomal aberration assay in human lymphocytes.
Zolmitriptan was negative in an in vitro mammalian gene cell mutation (CHO/HGPRT) assay and in oral in vivo mouse micronucleus assays in mouse and rat. Impairment of Fertility Studies of male and female rats administered zolmitriptan prior to and during mating and up to implantation showed no impairment of fertility at oral doses up to 400 mg/kg/day. The plasma exposure (AUC) at this dose was approximately 3000 times that in humans at the MRHD.
📄 Patient Package Insert ▾
Patient Information Zolmitriptan Tablets Please read this information before you start taking zolmitriptan tablets and each time you renew your prescription just in case anything has changed. Remember, this summary does not take the place of discussions with your doctor. You and your doctor should discuss zolmitriptan tablets when you start taking your medication and at regular checkups.
What are zolmitriptan tablets? Zolmitriptan tablets are a prescription medication used to treat migraine headaches in adults. Zolmitriptan tablets are not for other types of headaches.
The safety and efficacy of zolmitriptan tablets in patients under 18 have not been established. What is a Migraine Headache? Migraine is an intense, throbbing headache.
You may have pain on one or both sides of your head. You may have nausea and vomiting, and be sensitive to light and noise. The pain and symptoms of a migraine headache can be worse than a common headache.
Some women get migraines around the time of their menstrual period. Some people have visual symptoms before the headache, such as flashing lights or wavy lines, called an aura. How do zolmitriptan tablets work?
Treatment with zolmitriptan tablets reduces swelling of blood vessels surrounding the brain. This swelling is associated with the headache pain of a migraine attack. Zolmitriptan tablets block the release of substances from nerve endings that cause more pain and other symptoms like nausea, and sensitivity to light and sound.
It is thought that these actions contribute to relief of your symptoms by zolmitriptan tablets. Who should not take zolmitriptan tablets? Do not take zolmitriptan tablets if you: Have heart disease or a history of heart disease Have uncontrolled high blood pressure Have hemiplegic or basilar migraine (if you are not sure about this, ask your doctor) Have or had a stroke or problems with your blood circulation Have serious liver problems Have taken any of the following medicines in the last 24 hours: other “triptans” like almotriptan (AXERT ® ), eletriptan (RELPAX ® ), frovatriptan (FROVA ® ), naratriptan (AMERGE ® ), rizatriptan (MAXALT ® ), sumatriptan (IMITREX ® ), sumatriptan/naproxen (TREXIMET); ergotamines like BELLERGAL-S ® , CAFERGOT ® , ERGOMAR ® , WIGRAINE ® ; dihydroergotamine like D.H.E.
45 ® or MIGRANAL ® ; or methysergide (SANSERT ® ). These medications have side effects similar to zolmitriptan tablets. Have taken monoamine oxidase (MAO) inhibitors such as phenelzine sulfate (NARDIL ® ) or tranylcypromine sulfate (PARNATE ® ) for depression or other conditions within the last 2 weeks.
Are allergic to zolmitriptan tablets or any of its ingredients. The active ingredient is zolmitriptan. The inactive ingredients are listed at the end of this leaflet.
Tell your doctor about all the medicines you take or plan to take, including prescription and non-prescription medicines, supplements, and herbal remedies. Tell your doctor if you are taking selective serotonin reuptake inhibitors (SSRIs)* or serotonin norepinephrine reuptake inhibitors (SNRIs)*, two types of drugs for depression or other disorders. Common SSRIs are CELEXA® (citalopram HBr), LEXAPRO® (escitalopram oxalate), PAXIL® (paroxetine), PROZAC® (fluoxetine), SYMBYAX® (olanzapine/fluoxetine), ZOLOFT® (sertraline), SARAFEM® (fluoxetine) and LUVOX® (fluvoxamine).
Common SNRIs are CYMBALTA® (duloxetine) and EFFEXOR® (venlafaxine). Your doctor will decide if you can take zolmitriptan tablets with your other medicines. Tell your doctor if you know that you have any of the following: risk factors for heart disease like high cholesterol, diabetes, smoking, obesity (overweight), menopause, or a family history of heart disease or stroke.
Tell your doctor if you are pregnant, planning to become pregnant, breast-feeding, planning to breast-feed, or not using effective birth control. How should I take zolmitriptan tablets? Take zolmitriptan tablets exactly as your doctor tells you to take it.
Your doctor will tell… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Recent Major Changes Dosage and Administration ( 2.1 , 2.3 , 2.4 ) 09/2012 Warnings and Precautions ( 5.6 ) 09/2012
📄 Package Label / Principal Display Panel ▾
Package/Label Display Panel MEDSTONE Zolmitriptan Tablets Zolmitriptan 2.5 mg
Package/Label Display Panel MEDSTONE Zolmitriptan Tablets Zolmitriptan 5 mg
Medicaid utilization & spend
Medicare Part D spend CMS · PART D · 2026 (Q1)
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |