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Sumatriptan Succinate and Naproxen Sodium 85 mg; 500 mg Tablet, 9-count — NDC 44183-0850-09 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sumatriptan Succinate and Naproxen Sodium 85 mg; 500 mg Tablet, 9-count — NDC 44183-850-09 (Billing 44183-0850-09)

by Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven · 9 TABLET in 1 BOTTLE

This is a package of 9 tablets of Sumatriptan Succinate and Naproxen Sodium 85 mg; 500 mg Tablet from Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven, marketed since May 2015 and currently FDA-listed; retail pharmacies pay about $31.83 per tablet (NADAC). It is this product's only package size.

NDC 44183-0850-09
🏷️ FDA NDC (as labeled) 44183-850-09 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 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

NDC database record

One package, one record: these facts belong to NDC 44183-850-09 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
44183 labeler · 850 product · 09 package
Package marketed since
Feb 15, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
9 EA per package
Barcode (UPC)
0344183850091
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 44183-850-09
Product NDC 44183-850
11-digit billing NDC 44183085009
NCPDP billing unit EA — each (per item)
RxCUI 849450
UNII J8BDZ68989, 9TN87S3A3C
UPC 0344183850091
Application # NDA021926
SPL Set ID 5762bbe6-bddf-495c-adf8-9096f98a3a9c
Established class (EPC) Anti-Inflammatory Agents; Nonsteroidal Anti-inflammatory Drug; Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of action Cyclooxygenase Inhibitors; Serotonin 1b Receptor Agonists; Serotonin 1d Receptor Agonists
Chemical class Non-Steroidal
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-05-14
Route ORAL
Dosage form TABLET
Substance SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 67992002600320
GPI class SUMAtriptan-Naproxen Sodium
GCN Seq No 063885
GCN 99597
HICL code 035534
Ingredient (HICL) Sumatriptan Succ/Naproxen Sod
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 SUMATRIPTAN-NAPROXEN 85-500 MG
FDB brand name Sumatriptan Succ-Naproxen Sod
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 063885
  • GCN: 99597
  • GPI-14 (Medi-Span): 67992002600320
  • HICL (First Databank): 035534
  • AHFS class code: 28:08.04.04
  • RxCUI (RxNorm): 849450
Why two NDCs? The FDA registers this code as 44183-850-09 — 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 → 44183-0850-09. 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.

Clinical

Label name SUMATRIPTAN-NAPROXEN 85-500 MG Ingredient Sumatriptan Succ/Naproxen Sod

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.

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 eaPer package
Retail pharmacies payNADAC · weekly $31.832 $286.48 / 9 tablets
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 $22.93 $206.38 / 9 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 May 2022 Aug 2022 Nov 2022 $32.541 $21.836
▼ Down 1% over the last 7 months.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
44183-0850-09 You're viewing this Main listing 9 TABLET in 1 BOTTLE 2018-02-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sumatriptan and Naproxen Sodium 85 mg/1; 500 mg 16714-0891-01 NorthStar 9 tablets $10.463 AB Availability likely save 67%
Sumatriptan and Naproxen Sodium 85 mg/1; 500 mg 47335-0410-22 Sun 9 tablets $10.463 AB Availability likely save 67%
Sumatriptan and Naproxen Sodium 85 mg/1; 500 mg 65862-0928-36 Aurobindo 9 tablets $10.463 AB Availability likely save 67%
Sumatriptan Succinate and Naproxen Sodium 85 mg/1; 500 mgthis 44183-0850-09 Currax 9 tablets $31.832 AB FDA listed —
Treximet 85 mg/1; 500 mg 42847-0850-09 Currax 9 tablets $133.918 AB FDA listed +321%
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
2008
First FDA approval
Apr 2008
📍
2026
Currently FDA-listed
18 years listed
🔓
·
Listed protection lapsed
listed protections lapsed 2026
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: The latest listed FDA patent/protection lapsed Apr 2026 — those protections no longer apply, though a generic still needs FDA approval and a manufacturer to market it.
📅 FDA approved Apr 15, 2008 AB TE-rated RLD RS

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 7332183 — method of use (U-867)
US 7332183 — method of use (U-1719)
US 7332183*PED — drug product
US 7332183*PED — drug product
2008 2010 2012 2014 2016 2018 2020 2022 2024 2026
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 (4)
PatentTypeUse codeExpires
US 7332183 ↗ Method of use U-867 Oct 2, 2025
US 7332183 ↗ Method of use U-1719 Oct 2, 2025
US 7332183*PED ↗ Drug product — Apr 2, 2026
US 7332183*PED ↗ Drug product — Apr 2, 2026
Common questions
Is there a generic version of SUMATRIPTAN-NAPROXEN 85-500 MG?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for SUMATRIPTAN-NAPROXEN 85-500 MG. See the alternatives section for substitutable, lower-cost products.
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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerCurrax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven
Application holderAZURITY PHARMACEUTICALS INC
FDA applicationNDA021926 (NDA AUTHORIZED GENERIC)
Labeler code44183
First marketedMay 2015
Product typeHuman Prescription Drug
Portfolio3 products on file

More NDCs from Currax Pharmaceuticals LLC dba Cypress, Hawthorn... labeler code 44183

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. Nonsteroidal 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 ) Sumatriptan and Naproxen Sodium Tablets 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 ) Cardiovascular Thrombotic Events Nonsteroidal 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 and Precautions (5.1) ] . Sumatriptan and Naproxen Sodium Tablets is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) Warnings and Precautions (5.1) ] .

Gastrointestinal Bleeding, Ulceration, and Perforation 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 and Precautions (5.2) ] .

🎯 Indications and Usage 203 words ▾

1 INDICATIONS AND USAGE Sumatriptan and Naproxen Sodium Tablets is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Sumatriptan and Naproxen Sodium Tablets is a combination of sumatriptan, a serotonin (5-HT) 1b/1d receptor agonist (triptan), and naproxen sodium, a non-steroidal anti-inflammatory drug, indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. ( 1 ) Limitations of Use: Use only if a clear diagnosis of migraine headache has been established.

( 1 ) Not indicated for the prophylactic therapy of migraine attacks. ( 1 ) Not indicated for the treatment of cluster headache. ( 1 ) Limitations of Use: Use only if a clear diagnosis of migraine headache has been established.

If a patient has no response to the first migraine attack treated with Sumatriptan and Naproxen Sodium Tablets, reconsider the diagnosis of migraine before Sumatriptan and Naproxen Sodium Tablets is administered to treat any subsequent attacks. Sumatriptan and Naproxen Sodium Tablets is not indicated for the prevention of migraine attacks. Safety and effectiveness of Sumatriptan and Naproxen Sodium Tablets have not been established for cluster headache.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Adults Recommended dosage: 1 tablet of 85/500 mg. ( 2.1 ) Maximum dosage in a 24-hour period: 2 tablets of 85/500 mg; separate doses by at least 2 hours. ( 2.1 ) Pediatric Patients 12 to 17 years of Age Recommended dosage: 1 tablet of 10/60 mg. ( 2.2 ) Maximum dosage in a 24-hour period: 1 tablet of 85/500 mg. Mild to Moderate Hepatic Impairment Recommended dosage: 1 tablet of 10/60 mg. ( 2.3 , 8.7 )

2.1Dosage in Adults The recommended dosage for adults is 1 tablet of Sumatriptan and Naproxen Sodium Tablets 85/500 mg. Sumatriptan and Naproxen Sodium Tablets 85/500 mg contains a dose of sumatriptan higher than the lowest effective dose. The choice of the dose of sumatriptan, and of the use of a fixed combination such as in Sumatriptan and Naproxen Sodium Tablets 85/500 mg should be made on an individual basis, weighing the possible benefit of a higher dose of sumatriptan with the potential for a greater risk of adverse reactions.

The maximum recommended dosage in a 24-hour period is 2 tablets, taken at least 2 hours apart. The safety of treating an average of more than 5 migraine headaches in adults in a 30-day period has not been established. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ] .

2.2Dosage in Pediatric Patients 12 to 17 Years of Age The recommended dosage for pediatric patients 12 to 17 years of age is 1 tablet of Sumatriptan and Naproxen Sodium Tablets 10/60 mg. The maximum recommended dosage in a 24-hour period is 1 tablet of Sumatriptan and Naproxen Sodium Tablets 85/500 mg. The safety of treating an average of more than 2 migraine headaches in pediatric patients in a 30-day period has not been established.

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ] .

2.3Dosing in Patients with Hepatic Impairment Sumatriptan and Naproxen Sodium Tablets is contraindicated in patients with severe hepatic impairment [see Contraindications (4) , Use in Specific Populations (8.7) , Clinical Pharmacology (12.3) ] . In patients with mild to moderate hepatic impairment, the recommended dosage in a 24-hour period is 1 tablet of Sumatriptan and Naproxen Sodium Tablets 10/60 mg [see Use in Specific Populations (8.7) , Clinical Pharmacology (12.3) ] . Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ] .

2.4Administration Information Sumatriptan and Naproxen Sodium Tablets may be administered with or without food. Tablets should not be split, crushed, or chewed.

💊 Dosage Forms and Strengths 64 words ▾

3 DOSAGE FORMS AND STRENGTHS 10 mg sumatriptan/60 mg naproxen sodium, light-blue film-coated tablets, debossed on one side with "TREXIMET" and the other side with "10-60". 85 mg sumatriptan/500 mg naproxen sodium, blue film-coated tablets, debossed on one side with "TREXIMET". Tablets: 85 mg sumatriptan / 500 mg naproxen sodium ( 3 ) 10 mg sumatriptan / 60 mg naproxen sodium ( 3 )

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS Sumatriptan and Naproxen Sodium Tablets is contraindicated in the following patients: Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal's angina [see Warnings and Precautions (5.1) ]. In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ] . Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.3) ] .

History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [s ee Warnings and Precautions (5.5) ]. Peripheral vascular disease [see Warnings and Precautions (5.6) ]. Ischemic bowel disease [see Warnings and Precautions (5.6) ].

Uncontrolled hypertension [see Warnings and Precautions (5.8) ]. Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine 1 (5-HT 1 ) agonist [see Drug Interactions (7) ]. Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see Drug Interactions (7) , Clinical Pharmacology (12.3) ].

History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.13 , 5.14 , 5.18) ] . Known hypersensitivity (e.g., anaphylactic reactions, angioedema, and serious skin reactions) to sumatriptan, naproxen, or any components of Sumatriptan and Naproxen Sodium Tablets [see Warnings and Precautions (5.14) ].

Severe hepatic impairment [see Warnings and Precautions (5.7) , Use in Specific Populations (8.7) , Clinical Pharmacology (12.3) ]. History of coronary artery disease or coronary vasospasm. ( 4 ) In the setting of CABG surgery.

( 4 ) Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders. ( 4 ) History of stroke, transient ischemic attack, or hemiplegic or basilar migraine. ( 4 ) Peripheral vascular disease.

( 4 ) Ischemic bowel disease. ( 4 ) Uncontrolled hypertension. ( 4 ) Recent (within 24 hours) use of another 5-HT 1 agonist (e.g., another triptan) or of ergotamine-containing medication.

( 4 ) Concurrent or recent (past 2 weeks) use of monoamine oxidase-A inhibitor. ( 4 ) History of asthma, urticaria, other allergic type reactions, rhinitis, or nasal polyps syndrome after taking aspirin or other NSAID/analgesic drugs. ( 4 ) Known hypersensitivity to sumatriptan, naproxen, or any components of Sumatriptan and Naproxen Sodium Tablets (angioedema and anaphylaxis seen).

( 4 ) Severe hepatic impairment. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Cardiovascular Thrombotic Events: Perform cardiac evaluation in patients with cardiovascular risk factors. ( 5.1 ) Arrhythmias: Discontinue Sumatriptan and Naproxen Sodium Tablets if occurs. ( 5.3 ) Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk.

( 5.4 ) Cerebrovascular Events: Discontinue Sumatriptan and Naproxen Sodium Tablets if occurs. ( 5.5 ) Other Vasospasm Reactions: Discontinue Sumatriptan and Naproxen Sodium Tablets if non-coronary vasospastic reaction occurs. ( 5.6 ) 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. ( 5.7 ) Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

( 5.8 ) Heart Failure and Edema: Avoid use of Sumatriptan and Naproxen Sodium Tablets in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. ( 5.9 ) Medication Overuse Headache: Detoxification may be necessary. ( 5.10 ) Serotonin Syndrome: Discontinue Sumatriptan and Naproxen Sodium Tablets if occurs.

( 5.11 ) Renal Toxicity and Hyperkalemia: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of Sumatriptan and Naproxen Sodium Tablets in patients with advanced renal disease. ( 5.12 ) Anaphylactic Reactions: Sumatriptan and Naproxen Sodium Tablets should not be given to patients with the aspirin triad.

Seek emergency help if an anaphylactic reaction occurs. ( 5.13 ) Serious Skin Reactions: Discontinue Sumatriptan and Naproxen Sodium Tablets at first sign of rash or other signs of hypersensitivity. ( 5.14 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically.

( 5.15 ) Fetal Toxicity: Limit use of NSAIDs, including Sumatriptan and Naproxen Sodium Tablets 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. ( 5.16 , 8.1 ) Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.

( 5.17 ) Exacerbation of Asthma Related to Aspirin Sensitivity: Sumatriptan and Naproxen Sodium Tablets is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity). ( 5.18 )

5.1Cardiovascular Thrombotic Events The use of Sumatriptan and Naproxen Sodium Tablets is contraindicated in patients with ischemic or vasospastic coronary artery disease (CAD) and in the setting of coronary artery bypass graft (CABG) surgery due to increased risk of serious cardiovascular events with sumatriptan and NSAIDS [see Contraindications (4) ] . Cardiovascular Events with Sumatriptan There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan.

Some of these reactions occurred in patients without known CAD. Sumatriptan and Naproxen Sodium Tablets may cause coronary artery vasospasm (Prinzmetal's angina), even in patients without a history of CAD. Cardiovascular Thrombotic Events with Nonsteroidal Anti-inflammatory Drugs 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. Th… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1) ] GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.2) ] Arrhythmias [see Warnings and Precautions (5.3) ] Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure [see Warnings and Precautions (5.4) ] Cerebrovascular Events [see Warnings and Precautions (5.5) ] Other Vasospasm Reactions [see Warnings and Precautions (5.6) ] Hepatotoxicity [see Warnings and Precautions (5.7) ] Hypertension [see Warnings and Precautions (5.8) ] Heart Failure and Edema [see Warnings and Precautions (5.9) ] Medication Overuse Headache [see Warnings and Precautions (5.10) ] Serotonin Syndrome [see Warnings and Precautions (5.11) ] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.12) ] Anaphylactic Reactions [see Warnings and Precautions (5.13) ] Serious Skin Reactions [see Warnings and Precautions (5.14) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.15) ] Hematological Toxicity [see Warnings and Precautions (5.17) ] Exacerbation Asthma Related to Aspirin Sensitivity [see Warnings and Precautions (5.18) ] Seizures [see Warnings and Precautions (5.19) ] The most common adverse reactions (incidence ≥2%) were: Adults: Dizziness, somnolence, nausea, chest discomfort/chest pain, neck/throat/jaw pain/tightness/pressure, paresthesia, dyspepsia, dry mouth.

( 6.1 ) Pediatrics: Hot flush (i.e., hot flash[es]) and muscle tightness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Currax Pharmaceuticals LLC at 1-800-793-2145 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults The adverse reactions reported below are specific to the clinical trials with Sumatriptan and Naproxen Sodium Tablets 85/500 mg. See also the full prescribing information for naproxen and sumatriptan products.

Table 1 lists adverse reactions that occurred in 2 placebo-controlled clinical trials (Study 1 and 2) in adult patients who received 1 dose of study drug. Only adverse reactions that occurred at a frequency of 2% or more in any group treated with Sumatriptan and Naproxen Sodium Tablets 85/500 mg and that occurred at a frequency greater than the placebo group are included in Table 1. Table 1.

Adverse Reactions in Pooled Placebo-Controlled Trials in Adult Patients with Migraine Adverse Reactions Sumatriptan and Naproxen Sodium Tablets 85/500 mg % (n = 737) Placebo % (n = 752) Sumatriptan 85 mg % (n = 735) Naproxen Sodium 500 mg % (n = 732) Nervous system disorders Dizziness 4 2 2 2 Somnolence 3 2 2 2 Paresthesia 2 <1 2 <1 Gastrointestinal disorders Nausea 3 1 3 <1 Dyspepsia 2 1 2 1 Dry mouth 2 1 2 <1 Pain and other pressure sensations Chest discomfort/chest pain 3 <1 2 1 Neck/throat/jaw pain/tightness/pressure 3 1 3 1 The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the patients.

There were insufficient data to assess the impact of race on the incidence of adverse reactions. Pediatric Patients 12 to 17 Years of Age In a placebo-controlled clinical trial that evaluated pediatric patients 12 to 17 years of age who received 1 dose of Sumatriptan and Naproxen Sodium Tablets 10/60 mg, 30/180 mg, or 85/500 mg, adverse reactions occurred in 13% of patients who received 10/60 mg, 9% of patients who received 30/180 mg, 13% who received 85/500 mg, and 8% who received placebo. No patients who received Sumatriptan and Naproxen Sodium Tablets experienced adverse reactions leading to withdrawal from the trial.

The incidence of adverse reactions in pediatric patients 12 to 17 years of… [Excerpted — this section continues on DailyMed.]

🔄 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 Sumatriptan and Naproxen Sodium Tablets with drugs that interfere with hemostasis. Concomitant use of Sumatriptan and Naproxen Sodium Tablets and analgesic doses of aspirin is not generally recommended. ( 7.1 ) ACE Inhibitors and ARBs: Concomitant use with Sumatriptan and Naproxen Sodium Tablets 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 loop and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.

( 7.1 ) Digoxin: Concomitant use with Sumatriptan and Naproxen Sodium Tablets can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels. ( 7.1 ) Lithium: Increases lithium plasma levels.

( 7.1 ) Methotrexate: Increases methotrexate plasma levels. ( 7.1 )

7.1Clinically Significant Drug Interactions with Sumatriptan and Naproxen Sodium Tablets See Table 3 for clinically significant drug interactions with NSAIDs or Sumatriptan. Table 3. Clinically Significant Drug Interactions with Naproxen or Sumatriptan Ergot-Containing Drugs Clinical Impact: Ergot-containing drugs have been reported to cause prolonged vasospastic reactions.

Intervention: Because these effects may be additive, coadministration of Sumatriptan and Naproxen Sodium Tablets and ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) within 24 hours of each other is contraindicated. Monoamine Oxidase-A Inhibitors Clinical Impact: MAO-A inhibitors increase systemic exposure of orally administered sumatriptan by 7-fold. Intervention: The use of Sumatriptan and Naproxen Sodium Tablets in patients receiving MAO-A inhibitors is contraindicated.

Other 5-HT 1 Agonists Clinical Impact: 5-HT 1 agonist drugs can cause vasospastic effects. Intervention: Because these effects may be additive, coadministration of Sumatriptan and Naproxen Sodium Tablets and other 5 HT 1 agonists (e.g., triptans) within 24 hours of each other is contraindicated. Drugs That Interfere with Hemostasis Clinical Impact: Naproxen and anticoagulants such as warfarin have a synergistic effect on bleeding.

The concomitant use of naproxen 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 Sumatriptan and Naproxen Sodium Tablets 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 (5.17) ] . Aspirin Clinical Impact: A pharmacodynamic (PD) study has demonstrated an interaction in which lower dose naproxen (220mg/day or 220mg twice daily) interfered with the antiplatelet effect of low-dose immediate-release aspirin, with the interaction most marked during the washout period of naproxen [see Clinical Pharmacology (12.2) ] .

There is reason to expect that the interaction would be present with prescription doses of naproxen or with enteric-coated low-dose aspirin; however, the peak interference with aspirin function may be later than observed in the PD study due to the longer washout period. 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… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

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

8.1Pregnancy Risk Summary Use of NSAIDs, including Sumatriptan and Naproxen Sodium Tablets, 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 Sumatriptan and Naproxen Sodium Tablets use between about 20 and 30 weeks of gestation, and avoid Sumatriptan and Naproxen Sodium Tablets 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 Sumatriptan and Naproxen Sodium Tablets, 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.

Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population ( see Human Data ). In animal studies, administration of sumatriptan and naproxen, alone or in combination, during pregnancy resulted in developmental toxicity (increased incidences of fetal malformations, embryofetal and pup mortality, decreased embryofetal growth) at clinically relevant doses ( see Animal 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 naproxen sodium 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. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

The reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Several studies have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including Sumatriptan and Naproxen Sodium Tablets, can cause premature closure of the fetal ductus arteriosus ( see Data ).

Oligohydramnios/Neonatal Renal Impairment: If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If Sumatriptan and Naproxen Sodium Tablets treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue Sumatriptan and Naproxen Sodium Tablets and follow up according to clinical practice ( see Data ).

L… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Use of NSAIDs, including Sumatriptan and Naproxen Sodium Tablets, 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 Sumatriptan and Naproxen Sodium Tablets use between about 20 and 30 weeks of gestation, and avoid Sumatriptan and Naproxen Sodium Tablets 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 Sumatriptan and Naproxen Sodium Tablets, 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.

Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population ( see Human Data ). In animal studies, administration of sumatriptan and naproxen, alone or in combination, during pregnancy resulted in developmental toxicity (increased incidences of fetal malformations, embryofetal and pup mortality, decreased embryofetal growth) at clinically relevant doses ( see Animal 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 naproxen sodium 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. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

The reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Several studies have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including Sumatriptan and Naproxen Sodium Tablets, can cause premature closure of the fetal ductus arteriosus ( see Data ).

Oligohydramnios/Neonatal Renal Impairment: If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If Sumatriptan and Naproxen Sodium Tablets treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue Sumatriptan and Naproxen Sodium Tablets and follow up according to clinical practice ( see Data ).

Labor or Delivery There are no studies on the effects of naproxen tablets during labor or delivery. In animal studies, NSAIDS, including naproxen, inhibit prostaglandin synthesis, cause delayed parturition, a… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 66 words ▾

8.4Pediatric Use Safety and effectiveness of Sumatriptan and Naproxen Sodium Tablets in pediatric patients under 12 years of age have not been established. The safety and efficacy of Sumatriptan and Naproxen Sodium Tablets for the acute treatment of migraine in pediatric patients 12 to 17 years of age was established in a double-blind, placebo-controlled trial [see Adverse Reactions (6.1) and Clinical Studies (14.2) ] .

🧓 Geriatric Use 116 words ▾

8.5Geriatric Use Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. Sumatriptan and Naproxen Sodium Tablets is not recommended for use in elderly patients who have decreased renal function, higher risk for unrecognized CAD, and increases in blood pressure that may be more pronounced in the elderly [see Warnings and Precautions (5.1 , 5.2 , 5.3 , 5.8 , 5.12) and Clinical Pharmacology (12.3) ] . A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving Sumatriptan and Naproxen Sodium Tablets [see Warnings and Precautions (5.1) ] .

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE Patients (N = 670) have received single oral doses of 140 to 300 mg of sumatriptan without significant adverse effects. Volunteers (N = 174) have received single oral doses of 140 to 400 mg without serious adverse events. Overdose of sumatriptan in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation.

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [see Warnings and Precautions (5.1 , 5.2) ] .

Manage patients with symptomatic and supportive care following an NSAID 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).

Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

For additional information about overdosage treatment contact a poison control center (1-800-222-1222).

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Sumatriptan and Naproxen Sodium Tablets contains sumatriptan and naproxen. Sumatriptan binds with high affinity to cloned 5-HT 1B / 1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of neuropeptide release.

Sumatriptan and Naproxen Sodium Tablets has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of Sumatriptan and Naproxen Sodium Tablets, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Naproxen is a potent inhibitor of prostaglandin synthesis in vitro .

Naproxen 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 naproxen is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

12.2Pharmacodynamics In a healthy volunteer study, 10 days of concomitant administration of naproxen 220 mg once-daily with low-dose immediate-release aspirin (81 mg) showed an interaction with the antiplatelet activity of aspirin as measured by % serum thromboxane B 2 inhibition at 24 hours following the day 10 dose [98.7% (aspirin alone) vs 93.1% (naproxen and aspirin)]. The interaction was observed even following discontinuation of naproxen on day 11 (while aspirin dose was continued) but normalized by day 13. In the same study, the interaction was greater when naproxen was administered 30 minutes prior to aspirin [98.7% vs 87.7%] and minimal when aspirin was administered 30 minutes prior to naproxen [98.7% vs 95.4%].

Following administration of naproxen 220 mg twice-daily with low-dose immediate–release aspirin (first naproxen dose given 30 minutes prior to aspirin), the interaction was minimal at 24 h following day 10 dose [98.7% vs 95.7%]. However, the interaction was more prominent after discontinuation of naproxen (washout) on day 11 [98.7% vs 84.3%] and did not normalize completely by day 13 [98.5% vs 90.7%] [see Drug Interactions (7.1) ] . Blood Pressure In a randomized, double-blind, parallel group, active control trial, Sumatriptan and Naproxen Sodium Tablets 85/500 mg administered intermittently over 6 months did not increase blood pressure in a normotensive adult population (n = 122).

However, significant elevation in blood pressure has been reported with 5-HT 1 agonists and NSAIDs in patients with and without a history of hypertension.

12.3Pharmacokinetics Absorption and Bioavailability Sumatriptan, when given as Sumatriptan and Naproxen Sodium Tablets 85/500 mg, has a mean C max similar to that of sumatriptan succinate 100 mg tablets alone. The median T max of sumatriptan, when given as Sumatriptan and Naproxen Sodium Tablets 85/500 mg, was 1 hour (range: 0.3 to 4.0 hours), which is slightly different compared with sumatriptan succinate 100 mg tablets (median T max of 1.5 hours). Naproxen, when given as Sumatriptan and Naproxen Sodium Tablets 85/500 mg, has a C max which is approximately 36% lower than naproxen sodium 550 mg tablets and a median T max of 5 hours (range: 0.3 to 12 hours), which is approximately 4 hours later than from naproxen sodium tablets 550 mg.

AUC values for sumatriptan and for naproxen are similar for Sumatriptan and Naproxen Sodium Tablets 85/500 mg compared with sumatriptan succinate 100 mg tablets or naproxen sodium 550 mg tablets, respectively. In a crossover trial in 16 subjects, the pharmacokinetics of both components administered as Sumatriptan and Naproxen Sodium Tablets 85/500 mg were similar during a migraine attack and during a migraine-free period. Bioavaila… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 170 words ▾

12.1Mechanism of Action Sumatriptan and Naproxen Sodium Tablets contains sumatriptan and naproxen. Sumatriptan binds with high affinity to cloned 5-HT 1B / 1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of neuropeptide release.

Sumatriptan and Naproxen Sodium Tablets has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of Sumatriptan and Naproxen Sodium Tablets, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Naproxen is a potent inhibitor of prostaglandin synthesis in vitro .

Naproxen 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 naproxen is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

📦 How Supplied / Storage and Handling 130 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Sumatriptan and Naproxen Sodium Tablets 85/500 mg contains 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium and is supplied as blue film-coated tablets debossed on one side with TREXIMET in bottles of 9 tablets with desiccant (NDC 44183-850-09). Sumatriptan and Naproxen Sodium Tablets 10/60 mg contains 14 mg of sumatriptan succinate equivalent to 10 mg of sumatriptan and 60 mg of naproxen sodium and is supplied as light-blue film-coated tablets debossed on one side with TREXIMET and the other side with 10-60 in bottles of 9 tablets with desiccant (NDC 44183-860-09).

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Do not repackage; dispense and store in original container with desiccant.

📦 Storage and Handling 25 words ▾

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Do not repackage; dispense and store in original container with desiccant.

📋 Description ~1 min read ▾

11 DESCRIPTION Sumatriptan and Naproxen Sodium Tablets contains sumatriptan (as the succinate), a selective 5-hydroxytryptamine 1 (5-HT 1 ) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of NSAIDs. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: The empirical formula is C 14 H 21 N 3 O 2 S∙C 4 H 6 O 4 , representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline.

Naproxen sodium is chemically designated as (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, and it has the following structure: The empirical formula is C 14 H 13 NaO 3 , representing a molecular weight of 252.23. Naproxen sodium is a white-to-creamy white crystalline solid, freely soluble in water at neutral pH. Each Sumatriptan and Naproxen Sodium Tablets 85/500 mg tablet for oral administration contains 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium.

Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, sodium bicarbonate, talc, titanium dioxide, and triacetin. Each Sumatriptan and Naproxen Sodium Tablets 10/60 mg tablet for oral administration contains 14 mg of sumatriptan succinate equivalent to 10 mg of sumatriptan and 60 mg of naproxen sodium.

Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, talc, and titanium dioxide. Chemical Structure Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with Sumatriptan and Naproxen Sodium Tablets and periodically during the course of ongoing therapy. Cardiovascular Thrombotic Events, Prinzmetal's Angina, Other Vasospasm-Related Events, Arrhythmias and Cerebrovascular Events Advise patients to be alert for the symptoms of cardiovascular thrombotic effects such as myocardial infarction or stroke, which may result in hospitalization and even death.

Although serious cardiovascular events can occur without warning symptoms, patients should be alert for signs and symptoms of chest pain, shortness of breath, weakness, irregular heartbeat, significant rise in blood pressure, weakness and slurring of speech, and should be advised to report any of these symptoms to their health care provider immediately. Apprise patients of the importance of this follow-up [see Warnings and Precautions (5.1 , 5.3 , 5.5 , 5.6 , 5.8) ] . Gastrointestinal Bleeding, Ulceration, and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider.

In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [see Warnings and Precautions (5.2) ] . Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, instruct patients to stop Sumatriptan and Naproxen Sodium Tablets and seek immediate medical therapy [see Warnings and Precautions (5.7) ] .

Anaphylactic Reactions Inform patients that anaphylactic reactions have occurred in patients receiving the components of Sumatriptan and Naproxen Sodium Tablets. Such reactions can be life-threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens.

Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help [see Contraindications (4) , Warnings and Precautions (5.13) ]. Serious Skin Reactions, including DRESS Inform patients that Sumatriptan and Naproxen Sodium Tablets, like other NSAID-containing products, may increase the risk of serious skin side effects such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS, which may result in hospitalizations and even death.

Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching and should ask for medical advice when observing any indicative signs or symptoms. Advise patients to stop taking Sumatriptan and Naproxen Sodium Tablets immediately if they develop any type of rash or fever and contact their healthcare providers as soon as possible [see Warnings and Precautions (5.14 , 5.15) ] . Fetal Toxicity Inform pregnant women to avoid use of Sumatriptan and Naproxen Sodium Tablets and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus.

If treatment with Sumatriptan and Naproxen Sodium Tablets 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 (5.16) , Use in Specific Populations (8.1) ] . Lactation Advise patients to notify their healthcare provider if they are breastfeedin… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 02/2024 MEDICATION GUIDE Sumatriptan and Naproxen Sodium Tablets Read this Medication Guide before you start taking Sumatriptan and Naproxen Sodium Tablets and each time you get a refill.

There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment. What is the most important information I should know about Sumatriptan and Naproxen Sodium Tablets?

Sumatriptan and Naproxen Sodium Tablets may increase your chance of a heart attack or stroke that can lead to death. Sumatriptan and Naproxen Sodium Tablets contain 2 medicines: sumatriptan and naproxen sodium (a nonsteroidal anti-inflammatory drug [NSAID]). This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take Sumatriptan and Naproxen Sodium Tablets right before or after a heart surgery called a "coronary artery bypass graft (CABG)." Avoid taking Sumatriptan and Naproxen Sodium Tablets 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 Sumatriptan and Naproxen Sodium Tablets 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 one side of your body slurred speech Sumatriptan and Naproxen Sodium Tablets 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 smoke have diabetes have high cholesterol levels are overweight have a family history of heart disease Sumatriptan and Naproxen Sodium Tablets can cause ulcers and bleeding in the stomach and intestines at any time during your treatment. Ulcers and bleeding can happen without warning symptoms and may cause death. Your chance of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs the use of medicines called "corticosteroids," "anticoagulants," and antidepressant medicines called "SSRIs" or "SNRIs" more frequent use drinking alcohol having poor health advanced liver disease bleeding problems longer use smoking older age Sumatriptan and Naproxen Sodium Tablets may cause serious allergic reactions or serious skin reactions that can be life-threatening.

Stop taking Sumatriptan and Naproxen Sodium Tablets and get emergency help right away if you develop: sudden wheezing rash problems breathing or swallowing blisters or bleeding of your lips, eye lids, mouth, nose, or genitals swelling of your lips, tongue, throat or body fainting reddening of your skin with blisters or peeling Sumatriptan and Naproxen Sodium Tablets should only be used exactly as prescribed, at the lowest dose possible for your treatment, and for the shortest time needed. Sumatriptan and Naproxen Sodium Tablets already contains an NSAID (naproxen).

Do not use Sumatriptan and Naproxen Sodium Tablets 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 Sumatriptan and Naproxen Sodium Tablets? Sumatriptan and Naproxen Sodium Tablets is a prescription medicine that contains sumatriptan and naproxen sodium (an NSAID).

Sumatriptan and Naproxen Sodium Tablets is used to treat acute migraine head… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption and Bioavailability Sumatriptan, when given as Sumatriptan and Naproxen Sodium Tablets 85/500 mg, has a mean C max similar to that of sumatriptan succinate 100 mg tablets alone. The median T max of sumatriptan, when given as Sumatriptan and Naproxen Sodium Tablets 85/500 mg, was 1 hour (range: 0.3 to 4.0 hours), which is slightly different compared with sumatriptan succinate 100 mg tablets (median T max of 1.5 hours). Naproxen, when given as Sumatriptan and Naproxen Sodium Tablets 85/500 mg, has a C max which is approximately 36% lower than naproxen sodium 550 mg tablets and a median T max of 5 hours (range: 0.3 to 12 hours), which is approximately 4 hours later than from naproxen sodium tablets 550 mg.

AUC values for sumatriptan and for naproxen are similar for Sumatriptan and Naproxen Sodium Tablets 85/500 mg compared with sumatriptan succinate 100 mg tablets or naproxen sodium 550 mg tablets, respectively. In a crossover trial in 16 subjects, the pharmacokinetics of both components administered as Sumatriptan and Naproxen Sodium Tablets 85/500 mg were similar during a migraine attack and during a migraine-free period. Bioavailability of sumatriptan is approximately 15%, primarily due to presystemic (first-pass) metabolism and partly due to incomplete absorption.

Naproxen is absorbed from the gastrointestinal tract with an in vivo bioavailability of 95%. Food had no significant effect on the bioavailability of sumatriptan or naproxen administered as Sumatriptan and Naproxen Sodium Tablets, but slightly delayed the T max of sumatriptan by about 0.6 hour [see Dosage and Administration (2.3) ] . Distribution Plasma protein binding is 14% to 21%.

The effect of sumatriptan on the protein binding of other drugs has not been evaluated. The volume of distribution of sumatriptan is

2.7L/kg. The volume of distribution of naproxen is

0.16L/kg. At therapeutic levels naproxen is greater than 99% albumin bound. At doses of naproxen greater than 500 mg/day, there is a less-than-proportional increase in plasma levels due to an increase in clearance caused by saturation of plasma protein binding at higher doses (average trough C ss = 36.5, 49.2, and 56.4 mg/L with 500-; 1,000-; and 1,500-mg daily doses of naproxen, respectively).

However, the concentration of unbound naproxen continues to increase proportionally to dose. Metabolism In vitro studies with human microsomes suggest that sumatriptan is metabolized by monoamine oxidase (MAO), predominantly the A isoenzyme. No significant effect was seen with an MAO-B inhibitor.

Naproxen is extensively metabolized to 6-0-desmethyl naproxen, and both parent and metabolites do not induce metabolizing enzymes. Elimination The elimination half-life of sumatriptan is approximately 2 hours. Radiolabeled 14 C-sumatriptan administered orally is largely renally excreted (about 60%), with about 40% found in the feces.

Most of a radiolabeled dose of sumatriptan excreted in the urine is the major metabolite indole acetic acid (IAA) or the IAA glucuronide, both of which are inactive. Three percent of the dose can be recovered as unchanged sumatriptan . The clearance of naproxen is 0.13 mL/min/kg.

Approximately 95% of the naproxen from any dose is excreted in the urine, primarily as naproxen (less than 1%), 6-0-desmethyl naproxen (less than 1%), or their conjugates (66% to 92%). The plasma half-life of the naproxen anion in humans is approximately 19 hours. The corresponding half-lives of both metabolites and conjugates of naproxen are shorter than 12 hours, and their rates of excretion have been found to coincide closely with the rate of naproxen disappearance from the plasma.

In patients with renal failure, metabolites may accumulate. Specific Populations Geriatrics The pharmacokinetics of Sumatriptan and Naproxen Sodium Tablets in geriatric patients have not been studied. Elderly patients are more likely to have decreased hepatic function and decreased renal function [see Sp… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~1 min read ▾

12.2Pharmacodynamics In a healthy volunteer study, 10 days of concomitant administration of naproxen 220 mg once-daily with low-dose immediate-release aspirin (81 mg) showed an interaction with the antiplatelet activity of aspirin as measured by % serum thromboxane B 2 inhibition at 24 hours following the day 10 dose [98.7% (aspirin alone) vs 93.1% (naproxen and aspirin)]. The interaction was observed even following discontinuation of naproxen on day 11 (while aspirin dose was continued) but normalized by day 13. In the same study, the interaction was greater when naproxen was administered 30 minutes prior to aspirin [98.7% vs 87.7%] and minimal when aspirin was administered 30 minutes prior to naproxen [98.7% vs 95.4%].

Following administration of naproxen 220 mg twice-daily with low-dose immediate–release aspirin (first naproxen dose given 30 minutes prior to aspirin), the interaction was minimal at 24 h following day 10 dose [98.7% vs 95.7%]. However, the interaction was more prominent after discontinuation of naproxen (washout) on day 11 [98.7% vs 84.3%] and did not normalize completely by day 13 [98.5% vs 90.7%] [see Drug Interactions (7.1) ] . Blood Pressure In a randomized, double-blind, parallel group, active control trial, Sumatriptan and Naproxen Sodium Tablets 85/500 mg administered intermittently over 6 months did not increase blood pressure in a normotensive adult population (n = 122).

However, significant elevation in blood pressure has been reported with 5-HT 1 agonists and NSAIDs in patients with and without a history of hypertension.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Adults The efficacy of Sumatriptan and Naproxen Sodium Tablets in the acute treatment of migraine with or without aura in adults was demonstrated in 2 randomized, double-blind, multicenter, parallel-group trials utilizing placebo and each individual active component of Sumatriptan and Naproxen Sodium Tablets 85/500 mg (sumatriptan and naproxen sodium) as comparison treatments (Study 1 and Study 2). Patients enrolled in these 2 trials were predominately female (87%) and white (88%), with a mean age of 40 years (range: 18 to 65 years).

Patients were instructed to treat a migraine of moderate to severe pain with 1 tablet. No rescue medication was allowed within 2 hours postdose. Patients evaluated their headache pain 2 hours after taking 1 dose of study medication; headache relief was defined as a reduction in headache severity from moderate or severe pain to mild or no pain.

Associated symptoms of nausea, photophobia, and phonophobia were also evaluated. Sustained pain free was defined as a reduction in headache severity from moderate or severe pain to no pain at 2 hours postdose without a return of mild, moderate, or severe pain and no use of rescue medication for 24 hours postdose. The results from Study 1 and 2 are summarized in Table 4.

In both trials, the percentage of patients achieving headache pain relief 2 hours after treatment was significantly greater among patients receiving Sumatriptan and Naproxen Sodium Tablets 85/500 mg (65% and 57%) compared with those who received placebo (28% and 29%). Further, the percentage of patients who remained pain free without use of other medications through 24 hours postdose was significantly greater among patients receiving a single dose of Sumatriptan and Naproxen Sodium Tablets 85/500 mg (25% and 23%) compared with those who received placebo (8% and 7%) or either sumatriptan (16% and 14%) or naproxen sodium (10%) alone.

Table 4. Percentage of Adult Patients with 2-Hour Pain Relief and Sustained Pain Free Following Treatment P values provided only for prespecified comparisons. Sumatriptan and Naproxen Sodium Tablets 85/500 mg Sumatriptan 85 mg Naproxen Sodium 500 mg Placebo 2-Hour Pain Relief Study 1 65% P <0.05 versus placebo and sumatriptan. n = 364 55% n = 361 44% n = 356 28% n = 360 Study 2 57% n = 362 50% n = 362 43% n = 364 29% n = 382 Sustained Pain Free (2-24 Hours) Study 1 25% P <0.01 versus placebo, sumatriptan, and naproxen sodium. n = 364 16% n = 361 10% n = 356 8% n = 360 Study 2 23% n = 362 14% n = 362 10% n = 364 7% n = 382 The percentage of patients achieving initial headache pain relief within 2 hours following treatment with Sumatriptan and Naproxen Sodium Tablets 85/500 mg is shown in Figure 1.

Figure 1. Percentage of Adult Patients with Initial Headache Pain Relief within 2 Hours Compared with placebo, there was a decreased incidence of photophobia, phonophobia, and nausea 2 hours after the administration of Sumatriptan and Naproxen Sodium Tablets 85/500 mg. The estimated probability of taking a rescue medication over the first 24 hours is shown in Figure 2.

Figure 2. Estimated Probability of Adults Taking a Rescue Medication over the 24 Hours following the First Dose Kaplan-Meier plot based on data obtained in the 2 clinical controlled trials providing evidence of efficacy with patients not using additional treatments censored to 24 hours. Plot also includes patients who had no response to the initial dose.

No rescue medication was allowed within 2 hours postdose. Sumatriptan and Naproxen Sodium Tablets 85/500 mg was more effective than placebo regardless of the presence of aura; duration of headache prior to treatment; gender, age, or weight of the subject; or concomitant use of oral contraceptives or common migraine prophylactic drugs (e.g., beta-blockers, anti-epileptic drugs, tricyclic antidepressants). Figure 1 Figure 2

14.2Pediatric Patients 12 to 17 Years of Age The efficacy of Sumatriptan and Naproxen Sodium Tablets in the acut… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis The carcinogenic potential of Sumatriptan and Naproxen Sodium Tablets has not been studied. In carcinogenicity studies in mouse and rat, sumatriptan was administered orally for 78 and 104 weeks, respectively, at doses up to 160 mg/kg/day. The highest doses tested are approximately 5 (mouse) and 9 (rat) times the maximum human daily dose (MHDD) of 170 mg sumatriptan on a mg/m 2 basis (two tablets of Sumatriptan and Naproxen Sodium Tablets 85/500 mg in a 24-hour period).

The carcinogenic potential of naproxen was evaluated in a 2-year oral carcinogenicity study in rats at doses of 8, 16, and 24 mg/kg/day and in another 2-year oral carcinogenicity study in rats at a dose of 8 mg/kg/day. No evidence of tumorigenicity was found in either study. The highest dose tested is less than the MHDD (1000 mg) of naproxen, on a mg/m 2 basis.

Mutagenesis Sumatriptan and naproxen sodium tested alone and in combination were negative in an in vitro bacterial reverse mutation assay, and in an in vivo micronucleus assay in mice. The combination of sumatriptan and naproxen sodium was negative in an in vitro mouse lymphoma tk assay in the presence and absence of metabolic activation. However, in separate in vitro mouse lymphoma tk assays, naproxen sodium alone was reproducibly positive in the presence of metabolic activation.

Naproxen sodium alone and in combination with sumatriptan was positive in an in vitro clastogenicity assay in mammalian cells in the presence and absence of metabolic activation. The clastogenic effect for the combination was reproducible within this assay and was greater than observed with naproxen sodium alone. Sumatriptan alone was negative in these assays.

Chromosomal aberrations were not induced in peripheral blood lymphocytes following 7 days of twice-daily dosing with Sumatriptan and Naproxen Sodium Tablets in human volunteers. In previous studies, sumatriptan alone was negative in in vitro (bacterial reverse mutation [Ames], gene cell mutation in Chinese hamster V79/HGPRT, chromosomal aberration in human lymphocytes) and in vivo (rat micronucleus) assays. Impairment of Fertility The effect of Sumatriptan and Naproxen Sodium Tablets on fertility in animals has not been studied.

When sumatriptan (5, 50, 500 mg/kg/day) was administered orally to male and female rats prior to and throughout the mating period, there was a drug-related decrease in fertility secondary to a decrease in mating in animals treated with doses greater than 5 mg/kg/day (less than the MHDD of 170 mg on a mg/m 2 basis). It is not clear whether this finding was due to an effect on males or females or both.

13.2Animal Toxicology and/or Pharmacology Corneal Opacities Dogs receiving oral sumatriptan developed corneal opacities and defects in the corneal epithelium. Corneal opacities were seen at the lowest dosage tested, 2 mg/kg/day, and were present after 1 month of treatment. Defects in the corneal epithelium were noted in a 60-week study.

Earlier examinations for these toxicities were not conducted and no-effect doses were not established. The lowest dose tested is less than the MHDD (170 mg) of sumatriptan on a mg/m 2 basis.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis The carcinogenic potential of Sumatriptan and Naproxen Sodium Tablets has not been studied. In carcinogenicity studies in mouse and rat, sumatriptan was administered orally for 78 and 104 weeks, respectively, at doses up to 160 mg/kg/day. The highest doses tested are approximately 5 (mouse) and 9 (rat) times the maximum human daily dose (MHDD) of 170 mg sumatriptan on a mg/m 2 basis (two tablets of Sumatriptan and Naproxen Sodium Tablets 85/500 mg in a 24-hour period).

The carcinogenic potential of naproxen was evaluated in a 2-year oral carcinogenicity study in rats at doses of 8, 16, and 24 mg/kg/day and in another 2-year oral carcinogenicity study in rats at a dose of 8 mg/kg/day. No evidence of tumorigenicity was found in either study. The highest dose tested is less than the MHDD (1000 mg) of naproxen, on a mg/m 2 basis.

Mutagenesis Sumatriptan and naproxen sodium tested alone and in combination were negative in an in vitro bacterial reverse mutation assay, and in an in vivo micronucleus assay in mice. The combination of sumatriptan and naproxen sodium was negative in an in vitro mouse lymphoma tk assay in the presence and absence of metabolic activation. However, in separate in vitro mouse lymphoma tk assays, naproxen sodium alone was reproducibly positive in the presence of metabolic activation.

Naproxen sodium alone and in combination with sumatriptan was positive in an in vitro clastogenicity assay in mammalian cells in the presence and absence of metabolic activation. The clastogenic effect for the combination was reproducible within this assay and was greater than observed with naproxen sodium alone. Sumatriptan alone was negative in these assays.

Chromosomal aberrations were not induced in peripheral blood lymphocytes following 7 days of twice-daily dosing with Sumatriptan and Naproxen Sodium Tablets in human volunteers. In previous studies, sumatriptan alone was negative in in vitro (bacterial reverse mutation [Ames], gene cell mutation in Chinese hamster V79/HGPRT, chromosomal aberration in human lymphocytes) and in vivo (rat micronucleus) assays. Impairment of Fertility The effect of Sumatriptan and Naproxen Sodium Tablets on fertility in animals has not been studied.

When sumatriptan (5, 50, 500 mg/kg/day) was administered orally to male and female rats prior to and throughout the mating period, there was a drug-related decrease in fertility secondary to a decrease in mating in animals treated with doses greater than 5 mg/kg/day (less than the MHDD of 170 mg on a mg/m 2 basis). It is not clear whether this finding was due to an effect on males or females or both.

📄 Recent Major Changes 7 words ▾

Warnings and Precautions ( 5.14 ) 11/2024

📄 Package Label / Principal Display Panel 48 words ▾

PRINCIPAL DISPLAY PANEL - 9 Tablet Bottle Label NDC 44183-850-09 Sumatriptan and Naproxen Sodium Tablets 85 mg/500 mg Do not repackage; dispense and store in original container. Dispense the accompanying Medication Guide to each patient. Rx Only 9 TABLETS MACOVEN PRINCIPAL DISPLAY PANEL - 9 Tablet Bottle Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 44183-0106-30 · Currax 44206-0251-05 · CSL →
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.