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rizatriptan benzoate 10 mg Tablet, Orally Disintegrating, 200-count — NDC 33342-0094-46 package photo

rizatriptan benzoate 10 mg Tablet, Orally Disintegrating, 200-count

by Macleods Pharmaceuticals Limited · 200 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-094-46)
NDC 33342-0094-46
🏷️ FDA NDC (as labeled) 33342-094-46 billing pads the product segment with a zero
This package
Contains200-count Pack sizes11 compare ↓
Also priced by: Part D plans $1.01/unit — full pricing hub ↓
Also comes in: 3 tablets 33342-0094-52 3 tablets 33342-0094-72 3 tablets 33342-0094-73 5 tablets 33342-0094-47 6 tablets 33342-0094-41 6 tablets 33342-0094-45 10 tablets 33342-0094-12 12 tablets 33342-0094-04 18 tablets 33342-0094-23 30 tablets 33342-0094-07
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

⚠️
Other active recalls for Rizatriptan Benzoate (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 9, 2025 — CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. (Ascend Laboratories, LLC) · FDA recall D-0534-2025
Class II · Jul 9, 2025 — CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. (Ascend Laboratories, LLC) · FDA recall D-0533-2025
Class II · May 13, 2024 — CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0535-2024
Class II · May 13, 2024 — CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0534-2024
Class II · May 10, 2024 — CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0532-2024
Class II · May 10, 2024 — CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0533-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Past resolved recalls for this product (2)
Class III · Oct 18, 2021 · Terminated — Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples. (MACLEODS PHARMA USA, INC) · FDA recall D-0079-2022
Class III · Oct 18, 2021 · Terminated — Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples. (MACLEODS PHARMA USA, INC) · FDA recall D-0080-2022

🆔 Identity & classification

FDA NDC (as labeled) 33342-094-46
Product NDC 33342-094
11-digit billing NDC 33342009446
RxCUI 312837, 312839
UNII WR978S7QHH
UPC 0333342094452, 0333342094414, 0333342094469, 0333342094520 +2 more
Application # ANDA203146
SPL Set ID 57ed2505-28f1-4292-b3c3-a49bf0f7c683
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 2014-09-23
Route ORAL
Dosage form TABLET, ORALLY DISINTEGRATING
Substance RIZATRIPTAN BENZOATE
GPI-14 67406060107230
GPI class Rizatriptan Benzoate
GCN Seq No 040224
GCN 19594
HICL code 018535
Ingredient (HICL) Rizatriptan Benzoate
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 RIZATRIPTAN 10 MG ODT
FDB brand name Rizatriptan
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 33342-094-46 — 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 → 33342-0094-46. 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

LabelerMacleods Pharmaceuticals Limited
Application holderMACLEODS PHARMACEUTICALS LTD
FDA applicationANDA203146 (ANDA)
Labeler code33342
First marketedSep 2014
Product typeHuman Prescription Drug
Portfolio381 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 RIZATRIPTAN 10 MG ODT Ingredient Rizatriptan Benzoate
📖 What it is MedlinePlus · NLM

Rizatriptan is used to treat migraine headaches (severe, throbbing headaches that sometimes cause nausea and sensitivity to sound and light). Rizatriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels in the brain, stopping pain signals from being sent, which stops the release of certain natural substances that cause pain, nausea, and other symptoms of migraine. Rizatriptan 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
  • Rizatriptan stops a migraine that's already started — it's not a preventive medication. You take it when a migraine hits, and it works by narrowing blood vessels in the brain and q...
  • What exactly does rizatriptan do — will it prevent my migraines?
  • Take it as soon as you recognize a migraine coming on — the earlier the better. You don't have to wait until the pain is severe. If the headache goes away and then comes back, you...
  • When should I take it — right when the headache starts, or should I wait?
📖 Read our full Rizatriptan 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 White
ShapeRound
ImprintL59
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 Z0H242BBR1
    Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
  • UNII UTY7PDF93L
    A plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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 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 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII V95R5KMY2B
    Peppermint is a flavoring agent derived from the peppermint plant. It's added to medicines to improve taste and mask bitter or unpleasant flavors, making them easier to take.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

7 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 $1.01 $201.22 / 200 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
Rizatriptan Benzoate 10 mg 57237-0086-63 Rising 6 tablets $0.510 AB Availability likely —
Rizatriptan Benzoate 10 mg 65862-0626-12 Aurobindo 3 tablets $0.510 — Availability likely —
Rizatriptan Benzoate 10 mg 69452-0157-73 Bionpharma 3 tablets $0.510 AB Availability likely —
rizatriptan benzoate 10 mg 68462-0468-06 Glenmark 1 tablet $0.778 — FDA listed —
Maxalt-Mlt 10 mg 78206-0143-01 Organon 1 tablet $44.222 AB Availability likely —
Rizatriptan Benzoate 10 mg 29300-0269-21 Unichem 3 tablets — — FDA listed —
rizatriptan benzoate 10 mgthis 33342-0094-46 Macleods 200 tablets — AB FDA listed —
Rizatriptan Benzoate 10 mg 43817-0135-04 Panacea 3 tablets — AB FDA listed —
Rizatriptan Benzoate 10 mg 51407-0680-03 Golden 3 tablets — AB FDA listed —
Rizatriptan Benzoate 10 mg 68071-3568-08 NuCare 6 tablets — AB FDA listed —
Rizatriptan Benzoate 10 mg 70518-4362-00 REMEDYREPACK 3 tablets — AB FDA listed —
Rizatriptan Benzoate 10 mg 71205-0398-06 Proficient 6 tablets — — FDA listed —
Rizatriptan Benzoate 10 mg 71205-0557-06 Proficient 6 tablets — AB FDA listed —
Rizatriptan Benzoate 10 mg 71335-1819-01 Bryant 10 tablets — AB FDA listed —
Rizatriptan Benzoate 10 mg 71335-2982-01 Bryant 9 tablets — AB FDA listed —
Rizatriptan Benzoate ODT 10 mg 72189-0341-09 Direct 9 tablets — AB FDA listed —
Rizatriptan Benzoate ODT 10 mg 72189-0609-18 Direct_rx 18 tablets — AB FDA listed —
Rizatriptan Benzoate 10 mg 76420-0909-18 Asclemed 6 tablets — AB FDA listed —
Rizatriptan Benzoate 10 mg 80425-0535-01 Advanced 6 tablets — AB FDA listed —
Rizatriptan benzoate 10 mg 62135-0999-17 Chartwell 18 tablets — — 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

🏛️
2014
On the market since
Sep 2014
📍
2026
Currently FDA-listed
12 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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
6 tablets33342-0094-41 36,924 Rx · $543,210
3 tablets33342-0094-72 14 Rx · $221
30 tablets33342-0094-07 No Medicaid data
10 tablets33342-0094-12 No Medicaid data
6 tablets33342-0094-45 No Medicaid data
200 tablets this page33342-0094-46 No Medicaid data
5 tablets33342-0094-47 No Medicaid data
3 tablets33342-0094-52 No Medicaid data
3 tablets33342-0094-73 No Medicaid data
12 tablets33342-0094-04 No Medicaid data
18 tablets33342-0094-23 No Medicaid data
Drug total (last 4 qtrs): 36,938 Rx · 367,203 units · $543,431 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Rizatriptan (matched by generic name) — the program that covers self-administered drugs. 11 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 Rizatriptan. CMS lists 3 products for this generic; we show the highest-spend one. 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
$3.6M
Claims incl. refills
209.4K
Beneficiaries
122K
Spend / beneficiary
$29.53
Spend / claim
$17.20
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 Per unit Per pack Marketing startStatus
33342-0094-07 30 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-094-07) — — 2014-09-23 Active
33342-0094-12 10 BLISTER PACK in 1 CARTON (33342-094-12) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK — — 2014-09-23 Active
33342-0094-41 3 BLISTER PACK in 1 CARTON (33342-094-41) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK $0.5103 / ea $9.19 2018-06-04 Active
33342-0094-45 2 BLISTER PACK in 1 CARTON (33342-094-45) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK $0.7782 / ea $9.34 2018-12-19 Active
33342-0094-46 You're viewing this 200 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-094-46) — — 2014-09-23 Active
33342-0094-47 4 POUCH in 1 CARTON (33342-094-47) / 1 BLISTER PACK in 1 POUCH / 5 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK — — 2014-09-23 Active
33342-0094-52 1 BLISTER PACK in 1 CARTON (33342-094-52) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK $0.5103 / ea $1.53 2017-02-13 Active
33342-0094-72 6 BLISTER PACK in 1 CARTON (33342-094-72) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK $0.7782 / ea $14.01 2017-02-13 Active
33342-0094-73 3 BLISTER PACK in 1 CARTON (33342-094-73) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK $0.7782 / ea $7.00 2017-02-13 Active
33342-0094-04 12 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-094-04) — — 2023-02-27 Active
33342-0094-23 18 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-094-23) — — 2023-02-27 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 33342-0094-46?
NDC 33342-0094-46 is a 200-count package — 200 tablet, orally disintegrating in 1 container.
What is the difference between NDC 33342-0094-46 and NDC 33342-0094-52?
Both are rizatriptan benzoate 10 mg Tablet, Orally Disintegrating — the drug itself is identical. NDC 33342-0094-46 is the 200-count package, while NDC 33342-0094-52 is the 3 tablets package.
What NDC number is used to bill for this package of rizatriptan benzoate 10 mg Tablet, Orally Disintegrating?
Bill NDC 33342-0094-46 — the 11-digit billing format is 33342009446. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 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 ✓ 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) — 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 33342-094-46, 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: 33342-0094-46, written without dashes as 33342009446. 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 33342-0094-46, the first segment (33342) is the labeler code FDA assigned to Macleods Pharmaceuticals Limited; the middle segment (0094) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (46) 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 Macleods Pharmaceuticals Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 10 other package presentations of this same product, including 3 tablets (33342-0094-52), 3 tablets (33342-0094-72), 3 tablets (33342-0094-73). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Macleods Pharmaceuticals Limited 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.
🚨 Boxed Warning 🎯 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
🚨 Boxed Warning 2 words ▾

BOXED WARNING

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS & USAGE Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use • Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. • Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications ( 4 )]. • Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks. • Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache.

Rizatriptan benzoate is a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age ( 1 ) Limitations of Use: • Use only after 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 min read ▾

2 DOSAGE & ADMINISTRATION Adults: 5 or 10 mg single dose; separate repeat doses by at least two hours; maximum dose in a 24-hour period: 30 mg ( 2.1 ) Pediatric patients 6 to 17 years: 5 mg single dose in patients less than 40 kg (88 lb); 10 mg single dose in patients 40 kg (88lb) or more ( 2.2 ) Adjust dose if co-administered with propranolol ( 2.4 )

2.1Dosing Information in Adults The recommended starting dose of rizatriptan benzoate orally disintegrating tablets is either 5 mg or 10 mg for the acute treatment of migraines in adults. The 10-mg dose may provide a greater effect than the 5-mg dose, but may have a greater risk of adverse reactions [see Clinical Studies ( 14.1 )]. Redosing in Adults Although the effectiveness of a second dose or subsequent doses has not been established in placebo-controlled trials, if the migraine headache returns, a second dose may be administered 2 hours after the first dose.

The maximum daily dose should not exceed 30 mg in any 24-hour period. The safety of treating, on average, more than four headaches in a 30-day period has not been established.

2.2Dosing Information in Pediatric Patients (Age 6 to 17 Years) Dosing in pediatric patients is based on the patient's body weight. The recommended dose of rizatriptan benzoate orally disintegrating tablets is 5 mg in patients weighing less than 40 kg (88 lb), and 10 mg in patients weighing 40 kg (88 lb) or more. The efficacy and safety of treatment with more than one dose of rizatriptan benzoate orally disintegrating tablets within 24 hours in pediatric patients 6 to 17 years of age have not been established.

2.3Administration of Rizatriptan Benzoate Orally Disintegrating Tablets For rizatriptan benzoate orally disintegrating tablets, administration with liquid is not necessary. Orally disintegrating tablets are packaged in a blister within a carton and patients should not remove the blister from the carton until just prior to dosing. The blister pack should then be peeled open with dry hands and the orally disintegrating tablet placed on the tongue, where it will dissolve and be swallowed with the saliva.

2.4Dosage Adjustment for Patients on Propranolol Adult Patients In adult patients taking propranolol, only the 5-mg dose of rizatriptan benzoate orally disintegrating tablets is recommended, up to a maximum of 3 doses in any 24-hour period (15 mg) [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )]. Pediatric Patients For pediatric patients weighing 40 kg (88 lb) or more, taking propranolol, only a single 5-mg dose of rizatriptan benzoate orally disintegrating tablets is recommended (maximum dose of 5 mg in a 24-hour period).

Rizatriptan benzoate orally disintegrating tablets should not be prescribed to propranolol-treated pediatric patients who weigh less than 40 kg (88 lb) [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )].

💊 Dosage Forms and Strengths 74 words ▾

3 DOSAGE FORMS AND STRENGTHS Rizatriptan Benzoate Orally Disintegrating Tablets, USP • The 5 mg tablets are white to off-white, round shaped uncoated tablets debossed with 'L58' on one side and plain on other side. • The 10 mg tablets are white to off-white, round shaped uncoated tablets debossed with 'L 59' on one side and plain on other side. • Rizatriptan Benzoate Orally Disintegrating Tablets: 5 mg and 10 mg ( 3 )

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS Rizatriptan benzoate orally disintegrating tablets are contraindicated in patients with: • Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease [see Warnings and Precautions ( 5.1 )]. • Coronary artery vasospasm including Prinzmetal's angina [see Warnings and Precautions ( 5.1 )]. • History of stroke or transient ischemic attack (TIA) [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 ( 7.2 and 7.3 )]. • Hemiplegic or basilar migraine [ see Indications and Usage ( 1 ) ]. • Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor [see Drug Interactions ( 7.5 ) and Clinical Pharmacology ( 12.3 )]. •Hypersensitivity to rizatriptan or any of the excipients (angioedema and anaphylaxis seen) [see Adverse Reactions ( 6.2 )]. • History of ischemic heart disease or coronary artery vasospasm ( 4 ) • History of stroke or transient ischemic attack ( 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 of an ergotamine-containing medication ( 4 ) • Hemiplegic or basilar migraine ( 4 ) • MAO-A inhibitor used in the past 2 weeks ( 4 ) • Hypersensitivity to rizatriptan or any of the excipients ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Myocardial ischemia, myocardial infarction, and Prinzmetal's angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors ( 5.1 ) • Arrhythmias: Discontinue dosing if occurs ( 5.2 ) • Chest/throat/neck/jaw pain, tightness, pressure, or heaviness; Generally not associated with myocardial ischemia; Evaluate patients at high risk ( 5.3 ) • Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue dosing if occurs ( 5.4 ) • Gastrointestinal ischemic events, peripheral vasospastic reactions: Discontinue dosing if occurs ( 5.5 ) • Medication overuse headache: Detoxification may be necessary ( 5.6 ) • Serotonin syndrome: Discontinue dosing if occurs ( 5.7 )

5.1Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina Rizatriptan benzoate should not be given to patients with ischemic or vasospastic coronary artery disease. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of rizatriptan benzoate. Some of these reactions occurred in patients without known coronary artery disease (CAD).

5-HT 1 agonists, including rizatriptan benzoate may cause coronary artery vasospasm (Prinzmetal's Angina), even in patients without a history of CAD. Triptan-naïve patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) should have a cardiovascular evaluation prior to receiving rizatriptan benzoate. If there is evidence of CAD or coronary artery vasospasm, rizatriptan benzoate should not be administered [see Contraindications ( 4 )] .

For patients who have a negative cardiovascular evaluation, consideration should be given to administration of the first rizatriptan benzoate dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following rizatriptan benzoate administration. Periodic cardiovascular evaluation should be considered in intermittent long-term users of rizatriptan benzoate who have cardiovascular risk factors.

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 rizatriptan benzoate if these disturbances occur.

5.3Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure As with other 5-HT 1 agonists, sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck and jaw commonly occur after treatment with rizatriptan benzoate and are usually non-cardiac in origin. However, if a cardiac origin is suspected, patients should be evaluated. Patients shown to have CAD and those with Prinzmetal's variant angina should not receive 5-HT 1 agonists.

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. Also, patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, transient ischemic attack).

Discontinue rizatriptan benzoate if a cerebrovascular event occurs. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions. Rizatriptan benzoate should not be administered to patients with a history of stroke or transient ischemic attack [see Contraindications ( 4 )].

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

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: • Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina [see Warnings and Precautions ( 5.1 )]. • Arrhythmias [see Warnings and Precautions ( 5.2 )]. • Chest, Throat, Neck and/or 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 )].

The most common adverse reactions in adults were (incidence ≥ 5% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation and dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 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. Adults Incidence in Controlled Clinical Trials Adverse reactions to rizatriptan benzoate were assessed in controlled clinical trials that included over 3700 adult patients who received single or multiple doses of rizatriptan benzoate tablets.

The most common adverse reactions during treatment with rizatriptan benzoate (≥ 5% in either treatment group and greater than placebo) were asthenia/fatigue, somnolence, pain/pressure sensation and dizziness. These adverse reactions appeared to be dose related. Table 1 lists the adverse reactions (incidence ≥ 2% and greater than placebo) after a single dose of rizatriptan benzoate in adults.

Table 1: Incidence (≥ 2% and Greater than Placebo) of Adverse Reactions After a Single Dose of Rizatriptan Benzoate Tablets or Placebo in Adults Adverse Reactions % of Patients Rizatriptan Benzoate Tablets 5 mg (N=977) Rizatriptan Benzoate Tablets 10 mg (N=1167) Placebo (N=627) Atypical Sensations 4 5 4 Paresthesia 3 4 <2 Pain and other Pressure Sensations 6 9 3 Chest Pain: tightness/pressure and/or heaviness <2 3 1 Neck/throat/jaw: pain/tightness/pressure <2 2 1 Regional Pain: tightness/pressure and/or heaviness <1 2 0 Pain, location unspecified 3 3 <2 Digestive 9 13 8 Dry Mouth 3 3 1 Nausea 4 6 4 Neurological 14 20 11 Dizziness 4 9 5 Headache <2 2 <1 Somnolence 4 8 4 Other Asthenia/fatigue 4 7 2 The frequencies of adverse reactions in clinical trials did not increase when up to three doses were taken within 24 hours.

Adverse reaction frequencies were also unchanged by concomitant use of drugs commonly taken for migraine prophylaxis (including propranolol), oral contraceptives, or analgesics. The incidences of adverse reactions were not affected by age or gender. There were insufficient data to assess the impact of race on the incidence of adverse reactions.

Other Events Observed in Association with the Administration of Rizatriptan Benzoate in Adults In the following section, the frequencies of less commonly reported adverse events are presented that were not reported in other sections of the labeling. Because the reports include events observed in open studies, the role of rizatriptan benzoate in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, limit the value of the quantitative frequency estimates provided.

Event frequencies are calculated as the number of patients who used rizatriptan benzoate and reported an event divided by the total number of patients exposed to rizatriptan benzoate (N=3716). All reported events occurred at an incidence ≥ 1%, or are believed to be reasona…

🔄 Drug Interactions 195 words ▾

7 DRUG INTERACTIONS

7.1Propranolol The dose of rizatriptan benzoate should be adjusted in propranolol-treated patients, as propranolol has been shown to increase the plasma AUC of rizatriptan by 70% [see Dosage and Administration ( 2.4 ) and Clinical Pharmacology ( 12.3 )].

7.2Ergot-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 rizatriptan benzoate within 24 hours is contraindicated [see Contraindications ( 4 )].

7.3Other 5-HT1 Agonists Because their vasospastic effects may be additive, co-administration of rizatriptan benzoate and other 5-HT 1 agonists within 24 hours of each other is contraindicated [see Contraindications ( 4 )] .

7.4SSRIs/SNRIs and Serotonin Syndrome Cases of 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 )].

7.5Monoamine Oxidase Inhibitors Rizatriptan benzoate is contraindicated in patients taking MAO-A inhibitors and non-selective MAO inhibitors. A specific MAO-A inhibitor increased the systemic exposure of rizatriptan and its metabolite [see Contraindications ( 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 ) • Phenylketonurics: Rizatriptan benzoate orally disintegrating tablets contain phenylalanine ( 8.6 )

8.1Pregnancy Risk Summary Available human data on the use of rizatriptan benzoate in pregnant women are not sufficient to draw conclusions about drug-associated risk for major birth defects and miscarriage. In animal studies, developmental toxicity was observed following oral administration of rizatriptan during pregnancy (decreased fetal body weight in rats) or throughout pregnancy and lactation (increased mortality, decreased body weight, and neurobehavioral impairment in rat offspring) at maternal plasma exposures greater than that expected at therapeutic doses in humans [ see Animal Data ].

In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The reported rate of major birth defects among deliveries to women with migraine range from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk In women with migraine, there is an increased risk of adverse perinatal outcomes in the mother, including pre-eclampsia and gestational hypertension.

Data Human Data The Pregnancy Registry for rizatriptan benzoate did not identify any pattern of congenital anomalies or other adverse birth outcomes over the period of 1998 to 2018. However, the lack of identification of any pattern should be viewed with caution, as the number of prospective reports with outcome information was low and did not provide sufficient power to detect an increased risk of individual birth defects associated with the use of rizatriptan benzoate. Additionally, there was significant loss to follow-up in the prospective pregnancy reports, further complicating this assessment of an association between rizatriptan benzoate and any pattern of congenital anomalies or other adverse birth outcomes.

In a study using data from the Swedish Medical Birth Register, live births to women who reported using triptans or ergots during pregnancy were compared with those of women who did not. Of the 157 births with first-trimester exposure to rizatriptan, 7 infants were born with malformations (relative risk 1.01 [95% CI: 0.40 to 2.08]). A study using linked data from the Medical Birth Registry of Norway to the Norwegian Prescription Database compared pregnancy outcomes in women who redeemed prescriptions for triptans during pregnancy, as well as a migraine disease comparison group who redeemed prescriptions for triptans before pregnancy only, compared with a population control group.

Of the 310 women who redeemed prescriptions for rizatriptan during the first trimester, 10 had infants with major congenital malformations (OR 1.03 [95% CI: 0.55 to 1.93]), while for the 271 women who redeemed prescriptions for rizatriptan before, but not during, pregnancy, 12 had infants with major congenital malformations (OR 1.48 [95% CI: 0.83 to 2.64]), each compared with the population comparison group. Animal Data When rizatriptan (0, 2, 10, or 100 mg/kg/day) was administered orally to pregnant rats throughout organogenesis, a decrease in fetal body weight was observed at the highest doses tested.

At the mid dose (10 mg/kg/day), which was a no-effect dose for adverse effects on embryofetal development, plasma exposure (AUC) was approximately 15 times that in humans at the maximum recommended human dose (MRHD) of 30 mg/day. When rizatriptan (0, 5, 10, or 50 mg/kg/day) was administered orally to pregnant rabbits throughout organogenesis, no adverse fetal effects were observed. Plasma exposure (AUC) at the highest dose tested was 115 times that in humans at the MRHD.

Placental transfer of drug to the fetus was demonstrated in both species. Oral…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Available human data on the use of rizatriptan benzoate in pregnant women are not sufficient to draw conclusions about drug-associated risk for major birth defects and miscarriage. In animal studies, developmental toxicity was observed following oral administration of rizatriptan during pregnancy (decreased fetal body weight in rats) or throughout pregnancy and lactation (increased mortality, decreased body weight, and neurobehavioral impairment in rat offspring) at maternal plasma exposures greater than that expected at therapeutic doses in humans [ see Animal Data ].

In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The reported rate of major birth defects among deliveries to women with migraine range from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk In women with migraine, there is an increased risk of adverse perinatal outcomes in the mother, including pre-eclampsia and gestational hypertension.

Data Human Data The Pregnancy Registry for rizatriptan benzoate did not identify any pattern of congenital anomalies or other adverse birth outcomes over the period of 1998 to 2018. However, the lack of identification of any pattern should be viewed with caution, as the number of prospective reports with outcome information was low and did not provide sufficient power to detect an increased risk of individual birth defects associated with the use of rizatriptan benzoate. Additionally, there was significant loss to follow-up in the prospective pregnancy reports, further complicating this assessment of an association between rizatriptan benzoate and any pattern of congenital anomalies or other adverse birth outcomes.

In a study using data from the Swedish Medical Birth Register, live births to women who reported using triptans or ergots during pregnancy were compared with those of women who did not. Of the 157 births with first-trimester exposure to rizatriptan, 7 infants were born with malformations (relative risk 1.01 [95% CI: 0.40 to 2.08]). A study using linked data from the Medical Birth Registry of Norway to the Norwegian Prescription Database compared pregnancy outcomes in women who redeemed prescriptions for triptans during pregnancy, as well as a migraine disease comparison group who redeemed prescriptions for triptans before pregnancy only, compared with a population control group.

Of the 310 women who redeemed prescriptions for rizatriptan during the first trimester, 10 had infants with major congenital malformations (OR 1.03 [95% CI: 0.55 to 1.93]), while for the 271 women who redeemed prescriptions for rizatriptan before, but not during, pregnancy, 12 had infants with major congenital malformations (OR 1.48 [95% CI: 0.83 to 2.64]), each compared with the population comparison group. Animal Data When rizatriptan (0, 2, 10, or 100 mg/kg/day) was administered orally to pregnant rats throughout organogenesis, a decrease in fetal body weight was observed at the highest doses tested.

At the mid dose (10 mg/kg/day), which was a no-effect dose for adverse effects on embryofetal development, plasma exposure (AUC) was approximately 15 times that in humans at the maximum recommended human dose (MRHD) of 30 mg/day. When rizatriptan (0, 5, 10, or 50 mg/kg/day) was administered orally to pregnant rabbits throughout organogenesis, no adverse fetal effects were observed. Plasma exposure (AUC) at the highest dose tested was 115 times that in humans at the MRHD.

Placental transfer of drug to the fetus was demonstrated in both species. Oral administration of rizatriptan (0, 2, 10, or 100 mg/kg/day) to female rats prior to and during mating and continuing throughout gestation and lactation resulted in reduced body weight in offsprin…

🧒 Pediatric Use 99 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients under 6 years of age have not been established. The efficacy and safety of rizatriptan benzoate orally disintegrating tablets in the acute treatment of migraine in patients aged 6 to 17 years was established in an adequate and well-controlled study [see Clinical Studies (14.2)]. The incidence of adverse reactions reported for pediatric patients in the acute clinical trial was similar in patients who received rizatriptan benzoate orally disintegrating tablets to those who received placebo.

The adverse reaction pattern in pediatric patients is expected to be similar to that in adults.

🧓 Geriatric Use 139 words ▾

8.5Geriatric Use Clinical studies of rizatriptan benzoate 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. Although the pharmacokinetics of rizatriptan were similar in elderly (aged ≥ 65 years) and in younger adults (n=17), in general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range.

This reflects the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of coronary artery disease) should have a cardiovascular evaluation prior to receiving rizatriptan benzoate [see Warnings and Precautions ( 5.1 )].

🆘 Overdosage 209 words ▾

10 OVERDOSAGE No overdoses of rizatriptan benzoate were reported during clinical trials in adults. Some adult patients who received 40 mg of rizatriptan benzoate either a single dose or as two doses with a 2-hour interdose interval had dizziness and somnolence. In a clinical pharmacology study in which 12 adult subjects received rizatriptan benzoate, at total cumulative doses of 80 mg (given within four hours), two of the subjects experienced syncope, dizziness, bradycardia including third degree AV block, vomiting, and/or incontinence.

In the long-term, open label study, involving 606 treated pediatric migraineurs 12 to 17 years of age (of which 432 were treated for at least 12 months), 151 patients (25%) took two 10-mg doses of rizatriptan benzoate orally disintegrating tablets within a 24-hour period. Adverse reactions for 3 of these patients included abdominal discomfort, fatigue, and dyspnea. In addition, based on the pharmacology of rizatriptan benzoate, hypertension or myocardial ischemia could occur after overdosage.

Gastrointestinal decontamination, (i.e., gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with rizatriptan benzoate. Clinical and electrocardiographic monitoring should be continued for at least 12 hours, even if clinical symptoms are not observed. The effects of hemo- or peritoneal dialysis on serum concentrations of rizatriptan are unknown.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Rizatriptan binds with high affinity to human cloned 5-HT 1B/1D receptors. Rizatriptan presumably exerts its therapeutic effects in the treatment of migraine headache by binding to 5-HT 1B/1D receptors located on intracranial blood vessels and sensory nerves of the trigeminal system.

12.3Pharmacokinetics Absorption Rizatriptan is completely absorbed following oral administration. The mean oral absolute bioavailability of the rizatriptan benzoate tablet is about 45%, and mean peak plasma concentrations (C max ) are reached in approximately 1 to 1.5 hours (T max ). The presence of a migraine headache did not appear to affect the absorption or pharmacokinetics of rizatriptan.

Food has no significant effect on the bioavailability of rizatriptan but delays the time to reach peak concentration by an hour. In clinical trials, rizatriptan benzoate was administered without regard to food. The bioavailability and C max of rizatriptan were similar following administration of rizatriptan benzoate tablets and rizatriptan benzoate orally disintegrating tablets, but the rate of absorption is somewhat slower with rizatriptan benzoate orally disintegrating tablets, with T max delayed by up to 0.7 hour.

AUC of rizatriptan is approximately 30% higher in females than in males. No accumulation occurred on multiple dosing. Distribution The mean volume of distribution is approximately 140 liters in male subjects and 110 liters in female subjects.

Rizatriptan is minimally bound (14%) to plasma proteins. Metabolism The primary route of rizatriptan metabolism is via oxidative deamination by monoamine oxidase-A (MAO-A) to the indole acetic acid metabolite, which is not active at the 5-HT 1B/1D receptor. N-monodesmethyl-rizatriptan, a metabolite with activity similar to that of parent compound at the 5-HT 1B/1D receptor, is formed to a minor degree.

Plasma concentrations of N-monodesmethyl-rizatriptan are approximately 14% of those of parent compound, and it is eliminated at a similar rate. Other minor metabolites, the N-oxide, the 6-hydroxy compound, and the sulfate conjugate of the 6-hydroxy metabolite are not active at the 5-HT 1B/1D receptor. Elimination The total radioactivity of the administered dose recovered over 120 hours in urine and feces was 82% and 12%, respectively, following a single 10-mg oral administration of 14 C-rizatriptan.

Following oral administration of 14 C-rizatriptan, rizatriptan accounted for about 17% of circulating plasma radioactivity. Approximately 14% of an oral dose is excreted in urine as unchanged rizatriptan while 51% is excreted as indole acetic acid metabolite, indicating substantial first pass metabolism. The plasma half-life of rizatriptan in males and females averages 2 to 3 hours.

Cytochrome P450 Isoforms Rizatriptan is not an inhibitor of the activities of human liver cytochrome P450 isoforms 3A4/5, 1A2, 2C9, 2C19, or 2E1; rizatriptan is a competitive inhibitor (K=1400 nM) of cytochrome P450 2D6, but only at high, clinically irrelevant concentrations. Special Populations Geriatric: Rizatriptan pharmacokinetics in healthy elderly non-migraineur volunteers (age 65 to 77 years) were similar to those in younger non-migraineur volunteers (age 18 to 45 years). Pediatric: The pharmacokinetics of rizatriptan was determined in pediatric migraineurs 6 to 17 years of age.

Exposures following single dose administration of 5 mg rizatriptan benzoate orally disintegrating tablets to pediatric patients weighing 20-39 kg (44-87 lb) or 10 mg rizatriptan benzoate orally disintegrating tablets to pediatric patients weighing ≥40 kg (88 lb) were similar to those observed following single dose administration of 10 mg rizatriptan benzoate orally disintegrating tablets to adults. Gender : The mean AUC 0-∞ and C max of rizatriptan (10 mg orally) were about 30% and 11% higher in females as compared to males, respectively, while T max occurred at approximately the same time.

Hepatic impai…

🧬 Mechanism of Action 45 words ▾

12.1Mechanism of Action Rizatriptan binds with high affinity to human cloned 5-HT 1B/1D receptors. Rizatriptan presumably exerts its therapeutic effects in the treatment of migraine headache by binding to 5-HT 1B/1D receptors located on intracranial blood vessels and sensory nerves of the trigeminal system.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Rizatriptan Benzoate Orally Disintegrating Tablets, USP are available in strengths of 5 mg and 10 mg containing 7.265 mg or 14.53 mg of rizatriptan benzoate, USP equivalent to 5 mg or 10 mg of rizatriptan, respectively. The 5 mg tablets are white to off-white, round shaped uncoated tablets debossed with 'L58' on one side and plain on other side. They are available as follows: NDC 33342-093-48 PVC/PE/PVDC blister card of 10 tablets per triple laminated pouch, 4 Triple laminated pouches per carton (40 tablets total).

NDC 33342-093-04 Container pack of 12 tablets NDC 33342-093-23 Container pack of 18 tablets NDC33342-093-07 Container pack 30 tablets NDC33342-093-46 Container pack of 200 tablets NDC33342-093-12 Unit Dose Blister Package of 100 (10 x 10) tablets NDC33342-093-52 Unit Dose Blister Package of 3 (1 x 3) tablets NDC33342-093-73 Unit Dose Blister Package of 9 (3 x 3) tablets NDC33342-093-72 Unit Dose Blister Package of 18 (6 x 3) tablets NDC33342-093-41 Unit Dose Blister Package of 18 (3 x 6) tablets NDC33342-093-45 Unit Dose Blister Package of 12 (2 x 6) tablets The 10 mg tablets are white to off-white, round shaped uncoated tablets debossed with 'L59' on one side and plain on other side.

They are available as follows: NDC 33342-094-47 PVC/PE/PVDC blister card of 5 tablets per triple laminated pouch, 4 Triple laminated pouches per carton (20 tablets total). NDC33342-094-04 Container pack of 12 tablets NDC33342-094-23 Container pack of 18 tablets NDC33342-094-07 Container pack 30 tablets NDC33342-094-46 Container pack of 200 tablets NDC33342-094-12 Unit Dose Blister Package of 100 (10 x 10) tablets NDC33342-094-52 Unit Dose Blister Package of 3 (1 x 3) tablets NDC33342-094-73 Unit Dose Blister Package of 9 (3 x 3) tablets NDC33342-094-72 Unit Dose Blister Package of 18 (6 x 3) tablets NDC33342-094-41 Unit Dose Blister Package of 18 (3 x 6) tablets NDC33342-094-45 Unit Dose Blister Package of 12 (2 x 6) tablets Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature].

Preserve in well-closed light-resistant containers.

📋 Description 151 words ▾

11 DESCRIPTION Rizatriptan benzoate orally disintegrating tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Rizatriptan benzoate is described chemically as: N,N -dimethyl-5-(1 H -1,2,4-triazol-1-ylmethyl)-1 H -indole-3-ethanamine monobenzoate and its structural formula is: Its molecular formula is C 15 H 19 N 5 •C 7 H 6 O 2 , representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C.

Rizatriptan benzoate orally disintegrating tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each orally disintegrating tablet contains following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, carboxymethyl cellulose calcium, magnesium stearate, mannitol, aspartame, and peppermint flavor. USP Dissolution Test 2. structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Risk of Myocardial Ischemia and/or Infarction, Prinzmetal's Angina, Other Vasospasm-Related Events, and Cerebrovascular Events Inform patients that rizatriptan benzoate may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms.

Patients should be apprised of the importance of this follow-up [see Warnings and Precautions ( 5.1 , 5.2 , 5.4 , 5.5 )] . Serotonin Syndrome Patients should be cautioned about the risk of serotonin syndrome with the use of rizatriptan benzoate 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 ), Drug Interactions ( 7.4 ), and Clinical Pharmacology ( 12.3 )] . Pregnancy Inform patients that rizatriptan benzoate should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations ( 8.1 )] .

Lactation Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations ( 8.2 )] . Ability to Perform Complex Tasks Since migraines or treatment with rizatriptan benzoate may cause somnolence and dizziness, instruct patients to evaluate their ability to perform complex tasks during migraine attacks and after administration of rizatriptan benzoate. Medication Overuse Headache Inform patients that use of acute migraine drugs 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 )] .

Handling of Orally Disintegrating Tablets Packages Instruct patients not to remove the blister from the carton until ready to use the orally disintegrating tablet inside [see Dosage and Administration ( 2.3 )]. Patients with Phenylketonuria Inform phenylketonuric patients that rizatriptan benzoate orally disintegrating tablets contain phenylalanine (a component of aspartame). Each 5-mg orally disintegrating tablet contains 0.84 mg phenylalanine, and each 10-mg orally disintegrating tablet contains 1.68 mg phenylalanine [see Use in Specific Populations ( 8.6 )] .

The brand names mentioned herein are registered trademarks of their respective manufacturers. Manufactured for : Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufactured by : Macleods Pharmaceuticals Ltd.

Baddi, Himachal Pradesh, INDIA Revised: February 2023 .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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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.