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SYMBRAVO meloxicam, rizatriptan 20 mg; 10 mg Tablet, 3-count — NDC 81968-0020-03 package photo

SYMBRAVO meloxicam, rizatriptan 20 mg; 10 mg Tablet, 3-count

by Axsome Therapeutics, Inc. · 1 BOTTLE in 1 CARTON (81968-020-03) / 3 TABLET in 1 BOTTLE
NDC 81968-0020-03
🏷️ FDA NDC (as labeled) 81968-020-03 billing pads the product segment with a zero
This package
Contains3-count Pack sizes3 compare ↓
Also comes in: 2 tablets 81968-0020-02 9 tablets 81968-0020-09
Rx only Brand 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) 81968-020-03
Product NDC 81968-020
11-digit billing NDC 81968002003
RxCUI 2711789, 2711795
UNII VG2QF83CGL, WR978S7QHH
UPC 0381968020034, 0381968020096
Application # NDA215431
SPL Set ID dcf1ecd1-08a0-8e47-e053-2a95a90abdc7
Established class (EPC) Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-19
Route ORAL
Dosage form TABLET
Substance MELOXICAM; RIZATRIPTAN BENZOATE
GPI-14 67992002450320
GCN Seq No 087178
GCN 57005
HICL code 050252
Ingredient (HICL) Rizatriptan Benzoate/Meloxicam
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 28:08.04.04
AHFS class Reversible Cox-1/Cox-2 Inhibitors
FDB label name SYMBRAVO 20-10 MG TABLET
FDB brand name Symbravo
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 81968-020-03 — 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 → 81968-0020-03. 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 Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Amides, Oxicams
How it works Cyclooxygenase Inhibitors
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

LabelerAxsome Therapeutics, Inc.
Application holderAXSOME THERAPEUTICS INC
FDA applicationNDA215431 (NDA)
Labeler code81968
First marketedMay 2025
Product typeHuman Prescription Drug
Portfolio7 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 SYMBRAVO 20-10 MG TABLET Ingredient Rizatriptan Benzoate/Meloxicam
📖 What it is MedlinePlus · NLM

Meloxicam and rizatriptan is used to treat the symptoms of migraine headaches. Meloxicam is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the body's production of a substance that causes pain and inflammation. 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 to the brain, and blocking the release of certain natural substances that cause pain, nausea, and other symptoms of migraine. Meloxicam and rizatriptan does n...

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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
ShapeCapsule
ImprintMXRZ;20;10
Size17 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 2PP9364507
    A modified form of beta-cyclodextrin, a natural sugar-like molecule. It helps dissolve and stabilize drugs in liquid medicines and improves how well the body absorbs certain medications.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • 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 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. 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 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.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.

12 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 2 tablets 9 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
Symbravo 20 mg/1; 10 mgthis 81968-0020-03 Axsome 3 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2025
First FDA approval
Jan 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2045
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2045. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 30, 2025 RLD RS ⏳ ~18.5 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 12551489 — method of use (U-1719)
US 12551488 — method of use (U-1719)
US 12544383 — method of use (U-1719)
US 10702535 — method of use (U-4136)
US 10702602 — method of use (U-1719)
US 11013806 — method of use (U-1719)
US 10722583 — method of use (U-1719)
US 12128052 — method of use (U-1719)
US 10987358 — method of use (U-1719)
US 10729696 — method of use (U-1719)
US 10688102 — method of use (U-1719)
US 11865117 — method of use (U-1719)
US 10729697 — method of use (U-1719)
US 11617755 — method of use (U-1719)
US 10729773 — method of use (U-1719)
US 10517950 — method of use (U-1719)
US 11426414 — method of use (U-1719)
US 9821075 — method of use (U-1719)
US 10029010 — method of use (U-4133)
US 10137131 — method of use (U-1719)
US 10195278 — method of use (U-1719)
US 10695429 — method of use (U-1719)
US 10265324 — method of use (U-1719)
US 11369684 — method of use (U-1719)
US 10695430 — method of use (U-1719)
US 10363312 — method of use (U-1719)
US 10688185 — method of use (U-1719)
US 10653777 — method of use (U-1719)
US 10583144 — method of use (U-1719)
US 11331323 — method of use (U-1719)
US 10561664 — method of use (U-1719)
US 10537642 — method of use (U-1719)
US 10369224 — method of use (U-4134)
US 10532101 — method of use (U-1719)
US 11285213 — method of use (U-1719)
US 10426839 — method of use (U-4135)
US 10471014 — method of use (U-1719)
US 11219626 — method of use (U-1719)
US 10471069 — method of use (U-1719)
US 10512692 — method of use (U-1719)
US 11207328 — method of use (U-1719)
US 10512693 — method of use (U-1719)
US 11135295 — method of use (U-1719)
US 11045549 — method of use (U-1719)
US 11020483 — method of use (U-1719)
US 11826370 — method of use (U-1719)
US 10940153 — method of use (U-1719)
US 11602563 — method of use (U-1719)
US 11806354 — method of use (U-1719)
US 11510927 — method of use (U-1719)
US 10933137 — method of use (U-1719)
US 11504429 — method of use (U-1719)
US 11471464 — method of use (U-1719)
US 10933136 — method of use (U-1719)
US 11801250 — method of use (U-1719)
US 10799588 — method of use (U-1719)
US 10780165 — method of use (U-1719)
US 10821181 — method of use (U-1719)
US 11759522 — method of use (U-1719)
US 10758618 — method of use (U-1719)
US 10918722 — method of use (U-1719)
US 11738085 — method of use (U-1719)
US 11013805 — method of use (U-1719)
US 11712441 — method of use (U-1719)
US 10905693 — method of use (U-1719)
US 11628173 — method of use (U-1719)
US 10894053 — method of use (U-1719)
US 11617791 — method of use (U-1719)
US 10821182 — method of use (U-1719)
US 11617756 — method of use (U-1719)
US 11607456 — method of use (U-1719)
US 11571428 — method of use (U-1719)
US 11471465 — method of use (U-1719)
US 10780166 — method of use (U-1719)
US 10758617 — method of use (U-1719)
US 12472257 — method of use (U-4134)
US 12472256 — method of use (U-4356)
US 12485176 — method of use (U-4133)
US 12370196 — method of use (U-1719)
US 10265400 — method of use (U-4509)
US 10265399 — method of use (U-4509)
US 10307484 — method of use (U-4509)
US 10369225 — method of use (U-4356)
US 10456471 — method of use (U-4509)
US 11266657 — method of use (U-1719)
US 11433078 — method of use (U-1719)
US 11433079 — method of use (U-1719)
US 11944683 — method of use (U-1719)
US 12611413 — method of use (U-1719)
US 12005118 — method of use (U-1719)
US 12616752 — method of use (U-4510)
US 10058614 — drug product
US 10463736 — drug product
US 12472258 — drug product
Exclusivity NP
2025 2027 2029 2031 2033 2035 2037 2039 2041 2043 2045
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (94)
PatentTypeUse codeExpires
US 12551489 ↗ Method of use U-1719 May 28, 2040
US 12551488 ↗ Method of use U-1719 May 28, 2040
US 12544383 ↗ Method of use U-1719 Mar 10, 2045
US 10702535 ↗ Method of use U-4136 Apr 11, 2036
US 10702602 ↗ Method of use U-1719 Apr 11, 2036
US 11013806 ↗ Method of use U-1719 Apr 11, 2036
US 10722583 ↗ Method of use U-1719 Apr 11, 2036
US 12128052 ↗ Method of use U-1719 May 28, 2040
US 10987358 ↗ Method of use U-1719 Apr 11, 2036
US 10729696 ↗ Method of use U-1719 Apr 11, 2036
US 10688102 ↗ Method of use U-1719 Apr 11, 2036
US 11865117 ↗ Method of use U-1719 Apr 11, 2036
US 10729697 ↗ Method of use U-1719 Apr 11, 2036
US 11617755 ↗ Method of use U-1719 Apr 11, 2036
US 10729773 ↗ Method of use U-1719 Apr 11, 2036
US 10517950 ↗ Method of use U-1719 Apr 11, 2036
US 11426414 ↗ Method of use U-1719 Apr 11, 2036
US 9821075 ↗ Method of use U-1719 Apr 11, 2036
US 10029010 ↗ Method of use U-4133 Apr 11, 2036
US 10137131 ↗ Method of use U-1719 Apr 11, 2036
US 10195278 ↗ Method of use U-1719 Apr 11, 2036
US 10695429 ↗ Method of use U-1719 Apr 11, 2036
US 10265324 ↗ Method of use U-1719 Apr 11, 2036
US 11369684 ↗ Method of use U-1719 Apr 11, 2036
US 10695430 ↗ Method of use U-1719 Apr 11, 2036
US 10363312 ↗ Method of use U-1719 Apr 11, 2036
US 10688185 ↗ Method of use U-1719 Apr 11, 2036
US 10653777 ↗ Method of use U-1719 Apr 11, 2036
US 10583144 ↗ Method of use U-1719 Apr 11, 2036
US 11331323 ↗ Method of use U-1719 Apr 11, 2036
US 10561664 ↗ Method of use U-1719 Apr 11, 2036
US 10537642 ↗ Method of use U-1719 Apr 11, 2036
US 10369224 ↗ Method of use U-4134 Apr 11, 2036
US 10532101 ↗ Method of use U-1719 Apr 11, 2036
US 11285213 ↗ Method of use U-1719 Apr 11, 2036
US 10426839 ↗ Method of use U-4135 Apr 11, 2036
US 10471014 ↗ Method of use U-1719 Apr 11, 2036
US 11219626 ↗ Method of use U-1719 Apr 11, 2036
US 10471069 ↗ Method of use U-1719 Apr 11, 2036
US 10512692 ↗ Method of use U-1719 Apr 11, 2036
US 11207328 ↗ Method of use U-1719 Apr 11, 2036
US 10512693 ↗ Method of use U-1719 Apr 11, 2036
US 11135295 ↗ Method of use U-1719 Apr 11, 2036
US 11045549 ↗ Method of use U-1719 Apr 11, 2036
US 11020483 ↗ Method of use U-1719 Apr 11, 2036
US 11826370 ↗ Method of use U-1719 Apr 11, 2036
US 10940153 ↗ Method of use U-1719 Apr 11, 2036
US 11602563 ↗ Method of use U-1719 Apr 11, 2036
US 11806354 ↗ Method of use U-1719 Apr 11, 2036
US 11510927 ↗ Method of use U-1719 Apr 11, 2036
US 10933137 ↗ Method of use U-1719 Apr 11, 2036
US 11504429 ↗ Method of use U-1719 Apr 11, 2036
US 11471464 ↗ Method of use U-1719 Apr 11, 2036
US 10933136 ↗ Method of use U-1719 Apr 11, 2036
US 11801250 ↗ Method of use U-1719 Apr 11, 2036
US 10799588 ↗ Method of use U-1719 Apr 11, 2036
US 10780165 ↗ Method of use U-1719 Apr 11, 2036
US 10821181 ↗ Method of use U-1719 Apr 11, 2036
US 11759522 ↗ Method of use U-1719 Apr 11, 2036
US 10758618 ↗ Method of use U-1719 Apr 11, 2036
US 10918722 ↗ Method of use U-1719 Apr 11, 2036
US 11738085 ↗ Method of use U-1719 Apr 11, 2036
US 11013805 ↗ Method of use U-1719 Apr 11, 2036
US 11712441 ↗ Method of use U-1719 Apr 11, 2036
US 10905693 ↗ Method of use U-1719 Apr 11, 2036
US 11628173 ↗ Method of use U-1719 Apr 11, 2036
US 10894053 ↗ Method of use U-1719 Apr 11, 2036
US 11617791 ↗ Method of use U-1719 Apr 11, 2036
US 10821182 ↗ Method of use U-1719 Apr 11, 2036
US 11617756 ↗ Method of use U-1719 Apr 11, 2036
US 11607456 ↗ Method of use U-1719 Apr 11, 2036
US 11571428 ↗ Method of use U-1719 Apr 11, 2036
US 11471465 ↗ Method of use U-1719 Apr 11, 2036
US 10780166 ↗ Method of use U-1719 Apr 11, 2036
US 10758617 ↗ Method of use U-1719 Apr 11, 2036
US 12472257 ↗ Method of use U-4134 May 18, 2038
US 12472256 ↗ Method of use U-4356 May 18, 2038
US 12485176 ↗ Method of use U-4133 Apr 11, 2036
US 12370196 ↗ Method of use U-1719 Dec 29, 2041
US 10265400 ↗ Method of use U-4509 Apr 11, 2036
US 10265399 ↗ Method of use U-4509 Apr 11, 2036
US 10307484 ↗ Method of use U-4509 Apr 11, 2036
US 10369225 ↗ Method of use U-4356 Apr 11, 2036
US 10456471 ↗ Method of use U-4509 Apr 11, 2036
US 11266657 ↗ Method of use U-1719 Apr 11, 2036
US 11433078 ↗ Method of use U-1719 Apr 11, 2036
US 11433079 ↗ Method of use U-1719 Apr 11, 2036
US 11944683 ↗ Method of use U-1719 Apr 11, 2036
US 12611413 ↗ Method of use U-1719 Dec 29, 2041
US 12005118 ↗ Method of use U-1719 Jan 25, 2043
US 12616752 ↗ Method of use U-4510 May 18, 2038
US 10058614 ↗ Drug product — Apr 11, 2036
US 10463736 ↗ Drug product — Apr 11, 2036
US 12472258 ↗ Drug product — May 18, 2038
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductJan 30, 2028
Common questions
Is there a generic version of SYMBRAVO 20-10 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for SYMBRAVO 20-10 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Mar 2045 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.
9 tablets81968-0020-09 3,241 Rx · $3,602,807
2 tablets81968-0020-02 No Medicaid data
3 tablets this page81968-0020-03 No Medicaid data
Drug total (last 4 qtrs): 3,241 Rx · 28,850 units · $3,602,807 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 Symbravo — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Symbravo. 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
$1.18M
Claims incl. refills
954
Beneficiaries
533
Spend / beneficiary
$2,216.88
Spend / claim
$1,238.57
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
81968-0020-02 1 BOTTLE in 1 CARTON (81968-020-02) / 2 TABLET in 1 BOTTLE — — 2025-11-21 Active
81968-0020-03 You're viewing this 1 BOTTLE in 1 CARTON (81968-020-03) / 3 TABLET in 1 BOTTLE — — 2025-05-19 Active
81968-0020-09 9 TABLET in 1 BOTTLE (81968-020-09) $122.70 / ea $1,104.28 2025-05-19 Active

This pack shows little to no recent Medicaid volume — the 9 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 81968-0020-03?
NDC 81968-0020-03 is a 3-count package — 1 bottle in 1 carton / 3 tablet in 1 bottle.
What is the difference between NDC 81968-0020-03 and NDC 81968-0020-02?
Both are SYMBRAVO meloxicam, rizatriptan 20 mg; 10 mg Tablet — the drug itself is identical. NDC 81968-0020-03 is the 3-count package, while NDC 81968-0020-02 is the 2 tablets package.
What NDC number is used to bill for this package of SYMBRAVO meloxicam, rizatriptan 20 mg; 10 mg Tablet?
Bill NDC 81968-0020-03 — the 11-digit billing format is 81968002003. 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 81968-020-03, 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: 81968-0020-03, written without dashes as 81968002003. 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 81968-0020-03, the first segment (81968) is the labeler code FDA assigned to Axsome Therapeutics, Inc.; the middle segment (0020) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Axsome Therapeutics, Inc.. 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 2 other package presentations of this same product, including 2 tablets (81968-0020-02), 9 tablets (81968-0020-09). 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?
Axsome Therapeutics, 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.
🚨 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 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Risk Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings & Precautions (5.1) ] . SYMBRAVO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) , Warnings & Precautions (5.1) ] .

Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings & Precautions (5.2) ] .

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (5.1) .

SYMBRAVO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery ( 4 , 5.1 ). NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms.

Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events ( 5.2 ).

🎯 Indications and Usage 166 words ▾

1 INDICATIONS AND USAGE SYMBRAVO is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use SYMBRAVO 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 SYMBRAVO, the diagnosis of migraine should be reconsidered before SYMBRAVO is administered to treat any subsequent attacks.

SYMBRAVO is not indicated for the preventive treatment of migraine attacks. SYMBRAVO is not indicated for the treatment of cluster headache. SYMBRAVO is a combination of meloxicam (an NSAID) and rizatriptan (a serotonin (5-HT) 1B/1D receptor agonist (triptan)), indicated for the acute treatment of migraine with or without aura in adults ( 1 ).

Limitations of Use SYMBRAVO should only be used where a clear diagnosis of migraine has been established ( 1 ). SYMBRAVO is not indicated for the preventive treatment of migraine ( 1 ). SYMBRAVO is not indicated for the treatment of cluster headache ( 1 ).

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dose of SYMBRAVO is one tablet by mouth as needed ( 2.1 ). The maximum daily dose is 20 mg meloxicam and 10 mg rizatriptan (1 tablet) ( 2.1 ).

2.1Recommended Dose The recommended dose of SYMBRAVO is one tablet (containing 20 mg meloxicam and 10 mg rizatriptan) by mouth, as needed for the acute treatment of migraine. The maximum daily dose should not exceed one tablet. The safety and effectiveness of a second dose for the same migraine attack have not been established.

The safety of treating, on average, more than 7 headaches in a 30-day period has not been established. Use for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ] .

2.2Administration Swallow SYMBRAVO tablets whole. Do not crush, divide, or chew the tablets. SYMBRAVO can be taken with or without food.

2.3Not Substitutable with Other Formulations of Meloxicam and of Rizatriptan SYMBRAVO tablets have not shown equivalent systemic exposures to other formulations of oral meloxicam and of oral rizatriptan. Therefore, SYMBRAVO tablets are not substitutable with other formulations of oral meloxicam or oral rizatriptan products, even if the milligram strengths are the same. Do not substitute SYMBRAVO with similar dose strengths of other meloxicam or rizatriptan products [see Clinical Pharmacology (12.3) ] .

💊 Dosage Forms and Strengths 39 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 20 mg meloxicam and 10 mg rizatriptan, white and modified capsule-shaped, debossed with “MXRZ” on one side and “20/10” on the other. Tablets: 20 mg meloxicam and 10 mg rizatriptan ( 3 )

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS SYMBRAVO is 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 & Precautions (5.1) ] . Coronary artery vasospasm including Prinzmetal’s angina [see Warnings & Precautions (5.1) ] . In the setting of coronary artery bypass graft (CABG) surgery [see Warnings & Precautions (5.1) ] .

History of stroke or transient ischemic attack (TIA) [see Warnings & Precautions (5.4) ] . Hemiplegic or basilar migraine. Peripheral vascular disease (PVD) [see Warnings & Precautions (5.7) ] .

Ischemic bowel disease [see Warnings & Precautions (5.7) ] . Uncontrolled hypertension [see Warnings & Precautions (5.9) ] . Concomitant use of propranolol [see Drug Interactions (7.1) ] Recent use (i.e., within 24 hours) of an ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-HT1 agonist (e.g., another triptan) [see Drug Interactions (7.1) ] .

Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor [see Drug Interactions (7.1) , Clinical Pharmacology (12.3) ] . Known hypersensitivity (e.g., anaphylactic reactions and angioedema seen) to SYMBRAVO, meloxicam, rizatriptan, NSAIDs or any of the excipients in SYMBRAVO [see Warnings & Precautions (5.5) , Adverse Reactions (6.2) ] . History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

Severe, sometimes fatal anaphylactic-like reactions to NSAIDs have been reported in such patients [see Warnings & Precautions (5.16 )] . Moderate to severe renal insufficiency in patients who are at risk for renal failure due to volume depletion or who are on dialysis [see Warnings & Precautions (5.11 )]. Ischemic coronary artery disease or other significant underlying cardiovascular disease ( 4 ) Coronary artery vasospasm ( 4 ) In the setting of CABG surgery ( 4 ) History of stroke or transient ischemic attack ( 4 ) Hemiplegic or basilar migraine ( 4 ) Peripheral vascular disease ( 4 ) Ischemic bowel disease ( 4 ) Uncontrolled hypertension ( 4 ) Concomitant use of propranolol ( 4 ) Recent (within 24 hours) use of an ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), another 5-HT 1 agonist (e.g., another triptan) ( 4 ) Concurrent administration or recent discontinuation (i.e., within the past 2 weeks) of a MAO-A inhibitor ( 4 ) Known hypersensitivity to SYMBRAVO, meloxicam, rizatriptan, NSAIDs, triptans, or any of the excipients in SYMBRAVO ( 4 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4 ) Moderate to severe renal insufficiency in patients who are at risk for renal failure due to volume depletion or who are on dialysis ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Cardiovascular Thrombotic Events, Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors ( 5.1 ). Arrhythmias: Discontinue dosing if arrhythmia occurs ( 5.3 ). Cerebral Hemorrhage, Subarachnoid Hemorrhage, and Stroke: Discontinue dosing if occurs ( 5.4 ).

Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs ( 5.5 ). Chest/Throat/Neck/Jaw Pain, Tightness, Pressure, or Heaviness: Generally not associated with myocardial ischemia; evaluate patients at high risk ( 5.6 ). Gastrointestinal Ischemic Events, Peripheral Vasospastic Reactions: Discontinue dosing if occurs ( 5.7 ).

Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop ( 5.8 ). Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs.

Monitor blood pressure ( 5.9 , 7.1 ). Heart Failure and Edema: Avoid use of SYMBRAVO in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure ( 5.10 ). Renal Toxicity and Hyperkalemia: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia.

Use is not recommended in patients with moderate to severe renal insufficiency; avoid the use in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function ( 4 , 5.11 ). Serious Skin Reactions: Discontinue SYMBRAVO at first appearance of skin rash or other signs of hypersensitivity ( 5.12 ). Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue SYMBRAVO and evaluate clinically ( 5.13 ).

Fetal Toxicity: Limit use of NSAIDs, including SYMBRAVO, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus ( 5.14 , 8.1 ). Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia ( 5.15 , 7.1 ).

Exacerbation of Asthma Related to Aspirin Sensitivity: SYMBRAVO is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) ( 5.16 ). Medication Overuse Headache: Detoxification may be necessary ( 5.17 ).

Serotonin Syndrome: Discontinue dosing if occurs ( 5.18 ).

5.1Cardiovascular Thrombotic Events and Myocardial Infarction Cardiovascular Thrombotic Events with NSAIDS Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.

However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treat…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Cardiovascular Thrombotic Events and Myocardial Infarction [see Warnings and Precautions (5.1) ] GI Bleeding, Ulceration, and Perforation [see Warnings and Precautions (5.2) ] Arrhythmias [see Warnings and Precautions (5.3) ] Cerebrovascular Events [see Warnings and Precautions (5.4) ] Anaphylactic Reactions [see Warnings and Precautions (5.5)] Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure [see Warnings and Precautions (5.6) ] Other Vasospasm Reactions [see Warnings and Precautions (5.7) ] Hepatotoxicity [see Warnings and Precautions (5.8) ] Hypertension/Increase in Blood Pressure [see Warnings and Precautions (5.9) ] Heart Failure and Edema [see Warnings and Precautions (5.10) ] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.11) ] Serious Skin Reactions [see Warnings and Precautions (5.12)] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.13) ] Fetal Toxicity [see Warnings and Precautions (5.14) ] Hematologic Toxicity [see Warnings and Precautions (5.15) ] Exacerbation of Asthma Related to Aspirin Sensitivity [see Warnings and Precautions (5.16 )] Medication Overuse Headache [see Warnings and Precautions (5.17) ] Serotonin Syndrome [see Warnings and Precautions (5.18) ] Most common adverse reactions (≥1% and greater than placebo) are dizziness and somnolence ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact Axsome Therapeutics at 1-800-484-1672 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In two randomized, double-blind, controlled trials in adults with migraine, a total of 581 patients received a single dose of SYMBRAVO after the onset of a migraine attack (Studies 1 and 2) [see Clinical Studies (14) ] .

The most common adverse reactions from these two trials after treatment with SYMBRAVO (incidence ≥1% and greater than placebo) are provided in Table 1. Table 1: Incidence (≥1% and Greater than Placebo) of Adverse Reactions after a Single Dose of SYMBRAVO in Adults (Study 1 and Study 2) SYMBRAVO N=581 a % Rizatriptan 10 mg N=434 b % Meloxicam 20 mg N=433 b % Placebo N=361 a % Somnolence 2 2 2 1 Dizziness 2 2 1 1 a Study 1 and Study 2 pooled b Data from Study 1 only; Study 2 did not include arms with each individual component Long-term safety was assessed in 706 patients dosing intermittently for up to 12 months in an open-label extension trial where patients treated at least 2 migraines per month with SYMBRAVO.

Of these 706 patients, 496 patients were exposed to SYMBRAVO for at least 6 months, and 132 were exposed for at least 12 months, all of whom treated at least 2 migraine attacks per month, on average.

6.2Postmarketing Experience The following adverse reactions have been reported with the individual components of SYMBRAVO, meloxicam and rizatriptan, from postmarketing experience. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Meloxicam Blood and Lymphatic System Disorders: Agranulocytosis Hepatobiliary Disorders: Jaundice; liver failure Psychiatric Disorders: Alterations in mood (such as mood elevation) Renal and Urinary Disorders: Acute urinary retention; interstitial nephritis Reproductive System and Breast Disorders: Infertility female Skin and Subcutaneous Tissue Disorders: Anaphylactic reactions including shock; erythema multiforme; exfoliative dermatitis; Stevens-Johnson syndrome; fixed drug eruption (FDE); toxic epidermal necrolysis [see Warnings and Precautions (5.12)…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Drugs that Interfere with Hemostasis (e.g., warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking SYMBRAVO with drugs that interfere with hemostasis. Concomitant use of SYMBRAVO and analgesic doses of aspirin is not generally recommended ( 7.1 ). ACE Inhibitors, ARBs, or Beta-Blockers: Concomitant use with SYMBRAVO may diminish the antihypertensive effect of these drugs.

Monitor blood pressure ( 7.1 ). ACE Inhibitors and ARBs: Concomitant use with SYMBRAVO in elderly, volume-depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function ( 7.1 ).

Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects ( 7.1 ). Lithium: Monitor for increases in lithium plasma levels ( 7.1 ) Methotrexate: Monitor for increases methotrexate plasma levels.

( 7.1 ).

7.1Drugs Having Clinically Important Interactions with SYMBRAVO See Table 2 for clinically significant drug interactions with SYMBRAVO [see Clinical Pharmacology (12.3) ] . Table 2: Clinically Important Drug Interactions with SYMBRAVO Drugs That Interfere with Hemostasis Clinical Impact Meloxicam and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of meloxicam and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.

Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention Monitor patients with concomitant use of SYMBRAVO with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see Warnings and Precautions (5.15) ] .

Caution should be used when administering SYMBRAVO with warfarin since patients on warfarin may experience changes in International Normalized Ratio (INR) and an increased risk of bleeding complications when a new medication is introduced. Aspirin Clinical Impact Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see Warnings and Precautions (5.2 )].

Intervention Concomitant use of SYMBRAVO and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see Warnings and Precautions (5.15) ] . In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding [see Warnings and Precautions (5.2) ] . Meloxicam in SYMBRAVO is not a substitute for low dose aspirin for cardiovascular protection.

SSRIs/SNRIs and Serotonin Syndrome Clinical Impact Cases of serotonin syndrome have been reported during co-administration of triptans and SSRIs or SNRIs [see Warnings and Precautions (5.18) ]. Intervention SYMBRAVO treatment should be discontinued if serotonin syndrome is suspected. ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta blockers.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failu…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of SYMBRAVO in women who have difficulties conceiving ( 8.3 ).

8.1Pregnancy SYMBRAVO has not been studied in pregnant women. However, there are data pertaining to the use of the individual components, meloxicam and rizatriptan during pregnancy. These data are described below.

Risk Summary 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 reported rate of major birth defects among infants born 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. Meloxicam Use of NSAIDs, including SYMBRAVO, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

Because of these risks, limit dose and duration of SYMBRAVO use between about 20 and 30 weeks of gestation, and avoid SYMBRAVO use at about 30 weeks of gestation and later in pregnancy [see Clinical Considerations, Data] . Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including SYMBRAVO, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment.

Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies, embryofetal death was observed in rats and rabbits treated during the period of organogenesis with meloxicam at oral doses equivalent to 0.5 and 4.9 times, respectively, the maximum recommended human dose (MRHD) of 20 mg of meloxicam, based on body surface area (mg/m 2 ). Increased incidence of septal heart defects was observed in rabbits treated throughout embryogenesis with meloxicam at an oral dose equivalent to 59 times the MRHD of 20 mg of meloxicam on a mg/m 2 basis.

In pre- and post-natal reproduction studies, there was an increased incidence of dystocia, delayed parturition, and decreased offspring survival at 0.06 times the MRHD of 20 mg of meloxicam on a mg/m 2 basis. No teratogenic effects were observed in rats and rabbits treated with meloxicam during organogenesis at an oral dose equivalent to 2 and 20 times, respectively, the MRHD of 20 mg of meloxicam on a mg/m 2 basis [se e Data] . Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization.

In animal studies, administration of prostaglandin synthesis inhibitors, such as meloxicam, resulted in increased pre- and post-implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses.

Rizatriptan Available human data on the use of rizatriptan 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 doses greater than the MRHD of 10 mg rizatriptan on a mg/m 2 basis [see Animal Data] .

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk In women with migraine, t…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy SYMBRAVO has not been studied in pregnant women. However, there are data pertaining to the use of the individual components, meloxicam and rizatriptan during pregnancy. These data are described below.

Risk Summary 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 reported rate of major birth defects among infants born 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. Meloxicam Use of NSAIDs, including SYMBRAVO, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

Because of these risks, limit dose and duration of SYMBRAVO use between about 20 and 30 weeks of gestation, and avoid SYMBRAVO use at about 30 weeks of gestation and later in pregnancy [see Clinical Considerations, Data] . Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including SYMBRAVO, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment.

Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies, embryofetal death was observed in rats and rabbits treated during the period of organogenesis with meloxicam at oral doses equivalent to 0.5 and 4.9 times, respectively, the maximum recommended human dose (MRHD) of 20 mg of meloxicam, based on body surface area (mg/m 2 ). Increased incidence of septal heart defects was observed in rabbits treated throughout embryogenesis with meloxicam at an oral dose equivalent to 59 times the MRHD of 20 mg of meloxicam on a mg/m 2 basis.

In pre- and post-natal reproduction studies, there was an increased incidence of dystocia, delayed parturition, and decreased offspring survival at 0.06 times the MRHD of 20 mg of meloxicam on a mg/m 2 basis. No teratogenic effects were observed in rats and rabbits treated with meloxicam during organogenesis at an oral dose equivalent to 2 and 20 times, respectively, the MRHD of 20 mg of meloxicam on a mg/m 2 basis [se e Data] . Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization.

In animal studies, administration of prostaglandin synthesis inhibitors, such as meloxicam, resulted in increased pre- and post-implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses.

Rizatriptan Available human data on the use of rizatriptan 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 doses greater than the MRHD of 10 mg rizatriptan on a mg/m 2 basis [see Animal Data] .

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. Fetal/Neonatal Adverse Reactions Premature Closure o…

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and effectiveness of SYMBRAVO in pediatric patients have not been established.

🧓 Geriatric Use 124 words ▾

8.5Geriatric Use Clinical studies of SYMBRAVO did not include subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, hepatic, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, treat for the fewest number of days per month, as needed, and monitor patients for adverse effects [see Warnings and Precautions (5.1 , 5.2 , 5.8 , 5.11 )] .

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 SYMBRAVO [see Warnings and Precautions (5.1 , 5.9 )] .

🆘 Overdosage ~2 min read ▾

10 OVERDOSAGE No overdoses of SYMBRAVO were reported during clinical trials in adults. Evaluation and treatment of SYMBRAVO overdose is based on experience with the individual components, meloxicam and rizatriptan. In case of an overdosage, discontinue SYMBRAVO and contact a regional poison control center at 1-800-222-1222.

Overdose of Meloxicam Symptoms following acute meloxicam overdoses have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression and coma have occurred, but were rare [see Warnings and Precautions (5.2 , 5.9 , 5.11 , 5.15 )] .

Manage patients with symptomatic and supportive care following a meloxicam overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage).

Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may be employed but are not likely to be useful due to high protein binding. There is limited experience with meloxicam overdose. In four reported cases of meloxicam overdose, patients took 6- to 11-times the highest available oral dose of meloxicam tablets (15 mg); all recovered.

Cholestyramine is known to accelerate the clearance of meloxicam. Accelerated removal of meloxicam by 4 g doses of cholestyramine given three times a day was demonstrated in a clinical trial. Administration of cholestyramine may be useful following an overdosage.

Overdose of Rizatriptan In a clinical pharmacology study in which 12 adult subjects received rizatriptan 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. Based on the pharmacology of rizatriptan, 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.

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 SYMBRAVO contains meloxicam and rizatriptan. Meloxicam has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of meloxicam, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Meloxicam is a potent inhibitor of prostaglandin synthesis in vitro. Meloxicam concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models.

Prostaglandins are mediators of inflammation. Because meloxicam is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues. 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.

12.2Pharmacodynamics Cardiac Electrophysiology Rizatriptan The effects of rizatriptan on QT prolongation have not been studied; however, arrhythmias have occurred after administration of 5-HT 1 agonists [see Warnings and Precautions (5.3) ] . Blood Pressure Rizatriptan Significant elevation in blood pressure, including hypertensive crisis, has been reported in patients treated with rizatriptan, with and without a history of hypertension [see Warnings and Precautions (5.9) ] .

12.3Pharmacokinetics SYMBRAVO is a combination of rizatriptan and meloxicam. Meloxicam when given as SYMBRAVO has a mean C max of approximately 2,900 ng/mL and a mean AUC 0-24 of approximately 33,000 ng*hr/mL. Rizatriptan when given as SYMBRAVO has a mean C max of 32 ng/mL and a mean AUC 0-24 of 83 ng*hr/mL.

Absorption After oral administration of a single dose of SYMBRAVO under fasted conditions, the median T max for the meloxicam component is 0.88 hours, which is less than oral meloxicam tablets (T max of 4-5 hours). The median T max for the rizatriptan component is 0.75 hours. Effect of Food The exposures of meloxicam and rizatriptan were comparable after administration of SYMBRAVO in the fasted and fed states.Administration of SYMBRAVO after a high-fat, high-calorie meal decreased the exposures of meloxicam by approximately 7% for AUC 0-24 and 27% for C max and increased the AUC 0-24 of rizatriptan by approximately 10% with no significant change in C max .

Food intake delayed the time to maximal plasma concentration for both meloxicam (from 0.88 hours to 5 hours) and rizatriptan (from 0.75 hours to 1.5 hours). Therapeutic concentrations of meloxicam were achieved within 1.5 hours with co-administration of food [see Dosage and Administration (2.2) ] . Distribution Meloxicam The apparent volume of distribution during the terminal elimination phase (Vz) of meloxicam is approximately 10 L.

Meloxicam is approximately 99.4% bound to human plasma proteins (primarily albumin) within the therapeutic dose range. The fraction of protein binding is independent of drug concentration, over the clinically relevant concentration range, but decreases to approximately 99% in patients with renal disease. Meloxicam penetration into human red blood cells, after oral dosing, is less than 10%.

Following a radiolabeled dose, over 90% of the radioactivity detected in the plasma was present as unchanged meloxicam. Rizatriptan The mean volume of distribution of rizatriptan is approximately 140 liters in male subjects and 110 liters in female subjects. Rizatriptan is minimally bound (14%) to plasma proteins.

Elimination Metabolism Meloxicam Meloxicam is extensively metabolized in the liver. Meloxicam metabolites include 5'-carboxy meloxicam (60% of dose), from cytochrome P450 (CYP) mediated metabolism formed by oxidation of an intermediate metabolite, 5'-hydroxymethyl meloxicam, which is also excreted to a lesser extent (9% of dose).…

🧬 Mechanism of Action 144 words ▾

12.1Mechanism of Action SYMBRAVO contains meloxicam and rizatriptan. Meloxicam has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of meloxicam, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Meloxicam is a potent inhibitor of prostaglandin synthesis in vitro. Meloxicam concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models.

Prostaglandins are mediators of inflammation. Because meloxicam is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues. 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 84 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied SYMBRAVO tablets are white, modified capsule-shaped, film-coated and debossed with "MXRZ" on one side and "20/10" on the other. SYMBRAVO is supplied in the following package configuration: Package Configuration Strength NDC Code Bottles of 9 tablets meloxicam 20 mg and rizatriptan 10 mg 81968-020-09

16.2Storage and Handling Store SYMBRAVO in the original bottle at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .

📋 Description ~1 min read ▾

11 DESCRIPTION SYMBRAVO contains meloxicam, a nonsteroidal anti-inflammatory drug (NSAID), and rizatriptan (as rizatriptan benzoate), a selective 5-HT 1B/1D receptor agonist. Meloxicam Meloxicam has the molecular formula C 14 H 13 N 3 O 4 S 2 and is chemically designated as 4-hydroxy-2-methyl-N-(5 methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. It has a molecular weight of 351.4 g/mole.

The structural formula is: Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) = 0.1 in n-octanol/buffer pH 7.4.

Meloxicam has pKa values of 1.1 and 4.2. Rizatriptan Rizatriptan benzoate has the molecular formula C 15 H 19 N 5 · C 7 H 6 O 2 and is chemically designated as N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H indole-3 ethanamine monobenzoate. The molecular weight of the free base rizatriptan is 269.4 g/mole.

The structural formula is: Rizatriptan benzoate 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. Each SYMBRAVO tablet for oral administration contains 20 mg of meloxicam and 10 mg of rizatriptan (equivalent to 14.5 mg of rizatriptan benzoate). Each tablet also contains the excipients colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, partially hydrolyzed polyvinyl alcohol, polyethylene glycol, povidone, pregelatinized starch, sodium bicarbonate, sulfobutyl-ether-ß-cyclodextrin sodium, talc, and titanium dioxide.

Structure Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Cardiovascular Thrombotic Effects Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately [see Warnings and Precautions (5.1) ] . Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-Related Events, and Cerebrovascular Events Inform patients that rizatriptan, a component of SYMBRAVO, 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 , 5.3 , 5.4 , 5.6 , 5.7 )] . Gastrointestinal Bleeding, Ulceration, and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their healthcare provider.

In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for the signs and symptoms of GI bleeding [see Warnings and Precautions (5.2) ] . Anaphylactic Reactions Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [see Contraindications (4) and Warnings and Precautions (5.5 , 5.16) ] .

Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop SYMBRAVO and seek immediate medical therapy [see Warnings and Precautions (5.8) ] . Heart Failure and Edema Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [see Warnings and Precautions (5.10) ] .

Serious Skin Reactions, including DRESS Advise patients to stop SYMBRAVO immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible [see Contraindications (4) , Warnings and Precautions (5.12 , 5.13 )] . Female Fertility Advise females of reproductive potential who desire pregnancy that meloxicam, a component of SYMBRAVO, may be associated with a reversible delay in ovulation [see Use in Specific Populations (8.3) ] . Lactation Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.2 )] .

Fetal Toxicity Inform pregnant women to avoid use of SYMBRAVO and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with SYMBRAVO is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours [see Warnings and Precautions (5.14) , Use in Specific Populations (8.1) ] . Avoid Concomitant Use of NSAIDs Inform patients that the concomitant use of SYMBRAVO with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [see Warnings and Precautions (5.2) , Drug Interactions (7.1) ] .

Alert patients that NSAIDs may be present in “over the counter” medications for treatment of colds, fever, or insomnia. Use of NSAIDs and Low-Dose Aspirin Inform patients not t…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE SYMBRAVO ® (sim-BRAH-voh) (meloxicam-rizatriptan) tablets, for oral use What is the most important information I should know about SYMBRAVO? SYMBRAVO contains 2 medicines: meloxicam (a nonsteroidal anti-inflammatory drug [NSAID]) and rizatriptan (a triptan). NSAIDs, including SYMBRAVO, can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death.

This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take SYMBRAVO right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking SYMBRAVO after a recent heart attack unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Stop taking SYMBRAVO and get emergency help right away if you have any of the following symptoms of a heart attack or stroke: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw, or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded weakness in one part or on side of your body slurred speech SYMBRAVO is not for people with risk factors for heart disease unless a heart exam is done and shows no problem.

You have a higher risk for heart disease if you: have high blood pressure have high cholesterol levels smoke are overweight have diabetes have a family history of diabetes Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach, and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs” or “SNRIs” (antidepressants), or aspirin (an antiplatelet) increasing doses of NSAIDs older age longer use of NSAIDs poor health smoking advanced liver disease drinking alcohol bleeding problems SYMBRAVO may cause serious allergic reactions or serious skin reactions that can be life-threatening.

Stop taking SYMBRAVO and get emergency help right away if you develop: sudden wheezing swelling of your lips, tongue, throat or body rash fainting problems breathing or swallowing reddening of your skin with blisters or peeling blisters or bleeding of your lips, eye lids, mouth, nose, or genitals SYMBRAVO should only be used: exactly as prescribed for the shortest time needed SYMBRAVO already contains an NSAID (meloxicam). Do not use SYMBRAVO with other medicines to lessen pain or fever or with other medicines for colds or sleeping problems without talking to your healthcare provider first, because they may contain an NSAID also.

What is SYMBRAVO? SYMBRAVO is a combination of meloxicam (an NSAID) and rizatriptan (a triptan). SYMBRAVO is used to treat acute migraine headaches with or without aura in adults.

SYMBRAVO is not for the treatment of other types of migraines such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura). SYMBRAVO is not to be used to prevent or decrease the number of migraine headaches you have. It is not known if SYMBRAVO is safe and effective for the treatment of cluster headaches.

It is not known if SYMBRAVO is safe and effective in children. Who should not take SYMBRAVO? Do not take SYMBRAVO if you: have or have had heart problems. right before or after heart bypass surgery. have or have had a stroke or a transient ischemic attack (TIA). have or have had blood vessel problems, including ischemic bowel disease. have or had hemiplegic migraines or basilar migraines. narrowing of blood…

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