Home › NDC Lookup › Ingredients › Zolmitriptan › 69097-0864-84
Zolmitriptan 5 mg Tablet, Film Coated, 3-count — NDC 69097-0864-84 package photo

Zolmitriptan 5 mg Tablet, Film Coated, 3-count

by Cipla USA Inc. · 1 BLISTER PACK in 1 CARTON (69097-864-84) / 3 TABLET, FILM COATED in 1 BLISTER PACK
NDC 69097-0864-84
🏷️ FDA NDC (as labeled) 69097-864-84 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 69097-864-84
Product NDC 69097-864
11-digit billing NDC 69097086484
NCPDP billing unit EA — each (per item)
RxCUI 200193, 200194
UNII 2FS66TH3YW
Application # ANDA204284
SPL Set ID 16e520fe-2f57-400b-8ee5-9a3f89037d6c
Established class (EPC) Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of action Serotonin 1b Receptor Agonists; Serotonin 1d Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-07-20
Route ORAL
Dosage form TABLET, FILM COATED
Substance ZOLMITRIPTAN
GPI-14 67406080000330
GPI class ZOLMitriptan
GCN Seq No 037036
GCN 46132
HICL code 012958
Ingredient (HICL) Zolmitriptan
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3F
Therapeutic class — specific (HIC3) Antimigraine Preparations
AHFS code 28:32.28.00
AHFS class Selective Serotonin Agonists
FDB label name ZOLMITRIPTAN 5 MG TABLET
FDB brand name Zolmitriptan
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 69097-864-84 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 69097-0864-84. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Serotonin-1b and Serotonin-1d Receptor Agonist class.

Pharmacologic class Serotonin-1b and Serotonin-1d Receptor Agonist
Drug family (ATC) Selective serotonin (5HT1) agonists
How it works Serotonin 1b Receptor Agonists, Serotonin 1d Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerCipla USA Inc.
Application holderINVAGEN PHARMACEUTICALS INC
FDA applicationANDA204284 (ANDA)
Labeler code69097
First marketedJul 2016
Product typeHuman Prescription Drug
Portfolio221 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ZOLMITRIPTAN 5 MG TABLET Ingredient Zolmitriptan
📖 What it is MedlinePlus · NLM

Zolmitriptan is used to treat the symptoms of migraine headaches (severe throbbing headaches that sometimes come with nausea and a strong reaction to sound and light). Zolmitriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels around the brain, stopping pain signals from being sent to the brain, which stops the release of certain natural substances that cause pain, nausea, and other symptoms of migraines. Zolmitriptan does not stop migraine attacks from coming or reduce the number of headaches you have.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Zolmitriptan is designed to treat a migraine that's already started, not just dull the pain a little. It works on specific receptors in the brain to help narrow the widened blood v...
  • What exactly does zolmitriptan do — will it stop my migraine or just take the edge off?
  • Yes — if your migraine hasn't fully gone away after 2 hours, or if it comes back after initially getting better, you can take a second dose. You just need to wait at least 2 hours...
  • Can I take it again if my headache comes back a few hours later?
📖 Read our full Zolmitriptan guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Yellow / Pink
ShapeRound
ImprintIG;459
Size9 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $2.76 $8.28 / 3 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zolmitriptan 5 mg 16571-0804-13 Rising 3 tablets $1.418 AB Availability likely —
Zolmitriptan 5 mg 27241-0022-38 Ajanta 3 tablets $1.418 AB Availability likely —
Zolmitriptan 5 mg 62332-0463-03 Alembic 3 tablets $1.418 AB Availability likely —
Zolmitriptan 5 mg 68001-0250-01 BluePoint 3 tablets $1.418 AB Availability likely —
Zolmitriptan 5 mg 68462-0498-33 Glenmark 3 tablets $1.418 AB Availability likely —
Zolmitriptan 5 mg 71626-0102-03 Medstone 1 tablet $1.418 AB Discontinued —
Zolmitriptan 5 mg 65862-0915-64 Aurobindo 3 tablets $1.498 AB FDA listed —
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 mgthis 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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2016
On the market since
Jul 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Zolmitriptan — the program that covers self-administered drugs. 8 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Zolmitriptan. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.41M
Claims incl. refills
10.9K
Beneficiaries
6.4K
Spend / beneficiary
$221.39
Spend / claim
$129.23
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69097-0864-84 You're viewing this 1 BLISTER PACK in 1 CARTON (69097-864-84) / 3 TABLET, FILM COATED in 1 BLISTER PACK 2016-07-20 Active

🧭 About this NDC listing & data coverage

Finished prescription product
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 ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 69097-864-84, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 69097-0864-84, written without dashes as 69097086484. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 69097-0864-84, the first segment (69097) is the labeler code FDA assigned to Cipla USA Inc.; the middle segment (0864) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (84) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Cipla USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cipla USA Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Patient Medication Information
🎯 Indications and Usage 154 words ▾

1 INDICATIONS AND USAGE Zolmitriptan is 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 ) 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 and Administration ~2 min read ▾

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 )

2.1Dosing 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 81 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 2.5 mg functionally-scored ( 3 ) Tablets: 5 mg (not scored) ( 3 ) 2.5 mg Tablets: Yellow, film-coated, round, biconvex tablets debossed with ' I ' on the left side and ' G ' on the right side of functional score on one side and ' 458 ' on the other. 5 mg Tablets: Pink, film-coated, round, biconvex tablets debossed with ' IG ' on one side and ' 459 ' on the other.

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS 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 ) Monoamine oxidase (MAO)-A inhibitor used in past 2 weeks ( 4 ) Known hypersensitivity to zolmitriptan tablets ( 4 ) 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 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) [see Drug Interactions ( 7.2 ),Clinical Pharmacology ( 12.3 ) ] Known hypersensitivity to zolmitriptan tablets (angioedema and anaphylaxis seen) [see Adverse Reactions ( 6.2 ) ]

⚠️ Warnings and Cautions ~2 min read ▾

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 tablets 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 tablets if occurs ( 5.4 ) Gastrointestinal Ischemic Reactions and Peripheral Vasospastic Reactions : Discontinue zolmitriptan tablets if occurs ( 5.5 ) Medication Overuse Headache : Detoxification may be necessary ( 5.6 ) Serotonin Syndrome : Discontinue zolmitriptan tablets if occurs ( 5.7 , 7.4 )

5.1Myocardial Ischemia, Myocardial Infarction, and Prinzmetal Angina Zolmitriptan tablets are 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 tablets. Some of these reactions occurred in patients without known CAD.

5-HT 1 agonists including zolmitriptan tablets 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 tablets. Do not administer zolmitriptan tablets 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 administrating the first zolmitriptan tablets dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following zolmitriptan tablets administration. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of zolmitriptan tablets.

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 tablets if these disturbances occur. Zolmitriptan tablets are 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 tablets 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 tablets 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 tablets are contraindicated in patients with a history of stroke or transient ischemic attack [ see Contraindications ( 4 ) ].

5.5 Other Vasospasm Reactions 5-HT 1 agonists, including zolm…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS 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 Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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 ) ].

Arrthymias [ 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 ) ].

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 * * Only adverse reactions that were at least 2% more frequent in a zolmitriptan tablets group compared to the placebo group are included. 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 - 3% 4% 7% 10% pain/tightness/pressure 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% 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 w…

🔄 Drug Interactions ~1 min read ▾

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 tablets within 24 hours of each other is contraindicated [see Contraindications ( 4 ) ].

7.2MAO-A Inhibitors MAO-A inhibitors increase the systemic exposure of zolmitriptan tablets and its active N-desmethyl metabolite. Therefore, the use of zolmitriptan tablets 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 zolmitriptan tablets 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 tablets are used concomitantly, limit the maximum single dose of zolmitriptan tablets 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 ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm ( 8.1 )

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of ZOLMITRIPTAN Tablets 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.

The estimated rates of major birth defects (2.2%- 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy. Data Animal Data 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.

8.2Lactation Risk Summary There are no data on the presence of zolmitriptan or its metabolites in human milk, the effects on the breastfed infant, or the effects of zolmitriptan and its metabolites on milk production. In rats, oral dosing with zolmitriptan resulted in levels in milk up to 4 times that in maternal plasma. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Zolmitriptan Tablets and any potential adverse effects on the breastfed infant from Zolmitriptan Tablets or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness in pediatric patients have not been established. Therefore, zolmitriptan tablets are 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 tablets compared to placebo in the treatment of migraine in adolescents. Adverse reactions in the adolescent patients treated with zolmitriptan tablets were similar in nature and frequency to those reported in clinical trials in adults treated with zolmitriptan tablets. Zolmitriptan tablets have not been studied in pediatric patients less than 12 years old.

In the postmarketing experience with triptans, including zolmitriptan tablets, there were no additional adverse reactions seen in pediatric patients that were not seen in adults.

8.5Geriatric Use Clinical studies of zolmitriptan tablets 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 bet…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of ZOLMITRIPTAN Tablets 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.

The estimated rates of major birth defects (2.2%- 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy. Data Animal Data 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.

🧒 Pediatric Use 140 words ▾

8.4Pediatric Use The safety and effectiveness in pediatric patients have not been established. Therefore, zolmitriptan tablets are 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 tablets compared to placebo in the treatment of migraine in adolescents. Adverse reactions in the adolescent patients treated with zolmitriptan tablets were similar in nature and frequency to those reported in clinical trials in adults treated with zolmitriptan tablets. Zolmitriptan tablets have not been studied in pediatric patients less than 12 years old.

In the postmarketing experience with triptans, including zolmitriptan tablets, there were no additional adverse reactions seen in pediatric patients that were not seen in adults.

🧓 Geriatric Use 147 words ▾

8.5Geriatric Use Clinical studies of zolmitriptan tablets 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 tablets [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 117 words ▾

10 OVERDOSAGE There is no experience with acute overdose of zolmitriptan tablets. Clinical study subjects who received single 50 mg oral doses of zolmitriptan tablets commonly experienced sedation. There is no specific antidote to zolmitriptan tablets.

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 tablets is 3 hours [see Clinical Pharmacology ( 12.1 ) ]; therefore, monitor patients after overdose with zolmitriptan tablets 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 ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Zolmitriptan binds with high affinity to human recombinant 5HT 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 tablets 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 arterio-venous 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 the 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

7.0L/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 tablets 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. Specific 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 tablet dose. Adjust the zolmitriptan tablet dose in patients with moderate or severe hepatic impairment [see Dosage and Administration ( 2.3 ), Use in Specific Populations ( 8.6 ) ]. Renal Impairment Clearance of zolmitriptan was reduced by 25% in patients with severe renal impairment (Clcr ≥ 5 ≤ 25 mL/min) compared to subjects with normal renal function (Clcr > = 70 mL/min); no significant change in clearance was observed…

🧬 Mechanism of Action 126 words ▾

12.1Mechanism of Action Zolmitriptan binds with high affinity to human recombinant 5HT 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 tablets 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 arterio-venous 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 108 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING 2.5 mg Tablets - Yellow, film-coated, round, biconvex tablets debossed with ' I ' on the left side and ' G ' on the right side of functional score on one side and ' 458 ' on the other: cartons of 6 unit-dose tablets - NDC 69097-863-17 5 mg Tablets - Pink, film-coated, round, biconvex tablets debossed with ' IG ' on one side and ' 459 ' on the other: cartons of 3 unit-dose tablets - NDC 69097-864-84 Store zolmitriptan tablets at controlled room temperature, 20°C to 25°C (68 °F to 77°F) [see USP Controlled Room Temperature].

Protect from light and moisture.

📋 Description 111 words ▾

11 DESCRIPTION Zolmitriptan tablets are selective 5-hydroxytryptamine 1B/1D (5HT 1B/1D ) receptor agonists. Zolmitriptan is chemically designated as (S)-4-[[3-[2-(dimethylamino)ethyl]-1H-indol-5yl]methyl]-2-oxazolidinone and has the following chemical structure: The empirical 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 freely soluble in methanol and dimethylsulfoxide, insoluble in water.

Zolmitriptan tablets are available as 2.5 mg (yellow and functionally-score) and 5 mg (pink, not scored) film coated tablets for oral administration. The film coated tablets contain lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, polyethylene glycol, polysorbate, titanium dioxide, yellow iron oxide, and red iron oxide. Image

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Myocardial Ischemia and/or Infarction, Prinzmetal's Angina, Other Vasospastic Reactions, and Cerebrovascular Events Inform patients that zolmitriptan tablets 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 tablets 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 Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant. Lactation Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.2) ] . Revised: 10/2019

💬 Patient Medication Information ~3 min read ▾

PATIENT INFORMATION Zolmitriptan Tablets ( ZOLE mi TRIP tan) 2.5 mg and 5 mg 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 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 blocks 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 are pregnant or plan to become pregnant.

It is not known if Zolmitriptan tablets will harm your unborn baby. Tell your doctor if you are breast feeding or plan to breast feed. It is not known if Zolmitriptan passes into your breast milk.

Talk to your doctor about the best way to feed your baby while using Zolmitriptan Tablets. How should I take zolmitriptan tablets? Take zolmitriptan exactly as your doctor tells you to take it.…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69097-0863-17 · Cipla 69097-0865-17 · Cipla →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.