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CYKLX articaine hydrochloride 80 mg/mL Solution/ Drops

by American Genomics, LLC · 2 POUCH in 1 CARTON (87047-7852-2) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE
NDC 87047-7852-02
🏷️ FDA NDC (as labeled) 87047-7852-2 billing pads the package segment with a zero
This package
Contains.4 mL in 1 vial, single-dose Pack sizes2 compare ↓
Also comes in: 10 pouches 87047-7852-01
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 9, 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) 87047-7852-2
Product NDC 87047-7852
11-digit billing NDC 87047785202
RxCUI 2739743, 2739748
UNII QS9014Q792
Application # NDA218643
SPL Set ID 60e89ad4-8b65-4049-82ba-f34d4836eac0
Established class (EPC) Amide Local Anesthetic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-02
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance ARTICAINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 87047-7852-2 — a 5-4-1 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 package segment → 87047-7852-02. 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.

🏭 Manufacturer & labeler

LabelerAmerican Genomics, LLC
Application holderTHEA PHARMA INC
FDA applicationNDA218643 (NDA)
Labeler code87047
First marketedApr 2026
Product typeHuman Prescription Drug
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

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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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.

💲 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 mLPer 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: 10 pouches
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
Cyklx 80 mg/mLthis 87047-7852-02 American 2 pouches — — 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
Aug 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2039
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 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 15, 2025 RLD RS ⏳ ~12.5 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 12403126 — method of use (U-4422)
US 11826347 — method of use (U-4423)
US 11096922 — method of use (U-4423)
Exclusivity NP
2025 2027 2029 2031 2033 2035 2037 2039
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 (3)
PatentTypeUse codeExpires
US 12403126 ↗ Method of use U-4422 Mar 27, 2039
US 11826347 ↗ Method of use U-4423 Mar 27, 2039
US 11096922 ↗ Method of use U-4423 Mar 27, 2039
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductAug 15, 2028
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Mar 2039 — 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
87047-7852-01 10 POUCH in 1 CARTON (87047-7852-1) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE 2026-04-02 Discontinued by firm
87047-7852-02 You're viewing this 2 POUCH in 1 CARTON (87047-7852-2) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE 2026-04-02 Active

Pack size FAQ

What quantity is in NDC 87047-7852-02?
NDC 87047-7852-02 is listed by the FDA — 2 pouch in 1 carton / 5 vial, single-dose in 1 pouch / .4 ml in 1 vial, single-dose.
What NDC number is used to bill for this package of CYKLX articaine hydrochloride 80 mg/mL Solution/ Drops?
Bill NDC 87047-7852-02 — the 11-digit billing format is 87047785202. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — 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 87047-7852-2, 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: 87047-7852-02, written without dashes as 87047785202. 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 87047-7852-02, the first segment (87047) is the labeler code FDA assigned to American Genomics, LLC; the middle segment (7852) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 American Genomics, LLC. 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 1 other package presentation of this same product, including 10 pouches (87047-7852-01). 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?
American Genomics, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 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
🎯 Indications and Usage 49 words ▾

1 INDICATIONS AND USAGE CYKLX is indicated for ocular surface anesthesia prior to ocular procedures and/or intraocular injections in adults and pediatric patients. CYKLX is an amide local anesthetic indicated for ocular surface anesthesia prior to ocular procedures and/or intraocular injections in adults and pediatric patients. ( 1 )

⏱️ Dosage and Administration 39 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dose of CYKLX is 2 drops applied 30 seconds apart to the ocular surface. The recommended dose of CYKLX is 2 drops applied 30 seconds apart to the ocular surface. ( 2 )

💊 Dosage Forms and Strengths 27 words ▾

3 DOSAGE FORMS AND STRENGTHS Ophthalmic Solution: clear and colorless solution containing 8% articaine in single-dose vial. Ophthalmic Solution: 8% articaine in single-dose vial. ( 3 )

⛔ Contraindications 33 words ▾

4 CONTRAINDICATIONS CYKLX is contraindicated in patients with known hypersensitivity to any component of this preparation. CYKLX is contraindicated in patients with a hypersensitivity to any component of this preparation. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS CYKLX is not for injection or intraocular administration ( 5.1 ) Patients should not touch the eye for at least 10 to 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye ( 5.2 ) Corneal Opacification : Prolonged use of topical ocular anesthetics may produce permanent corneal opacification and ulceration with accompanying visual loss. ( 5.3 ) Do not touch the dropper tip to the eye, eyelids, or any other surface as this may contaminate the solution ( 5.4 ) For Administration by Healthcare Provider : CYKLX is not intended for patient self-administration ( 5.5 )

5.1For Topical Ophthalmic Use CYKLX is not for injection or intraocular administration.

5.2Corneal Injury Due to Insensitivity Patients should not touch the eye for at least 10 to 20 minutes after using CYKLX as accidental injuries can occur due to insensitivity of the eye.

5.3Corneal Opacification Prolonged use of topical ocular anesthetics may produce permanent corneal opacification and ulceration with accompanying visual loss.

5.4Risk of Contamination Do not touch the dropper tip to the eye, eyelids, or any other surface as this may contaminate the solution.

5.5For Administration by Healthcare Provider CYKLX is indicated for administration under the direct supervision of a healthcare provider. CYKLX is not intended for patient self-administration.

🤒 Adverse Reactions 109 words ▾

6 ADVERSE REACTIONS The most common adverse reaction was instillation site pain (incidence 24.5%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact American Genomics at 855-242-9559 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 practice. In controlled trials, the most common adverse reaction with CYKLX was instillation site pain reported in 24.5% (70/286) of subjects, compared to 6.9% (14/203) of subjects in the placebo group.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women with CYKLX to inform a drug associated risk. In animal reproduction studies, subcutaneous administration of articaine hydrochloride and epinephrine (1:100,000) to rabbits throughout organogenesis resulted in maternal toxicity, embryofetal death and increased fetal skeletal variations at doses approximately 160 times the maximum recommended human ophthalmic dose (MRHOD) of CYKLX (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown.

However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Human Data No adequate and well-controlled trials of CYKLX have been conducted in pregnant women. Animal Data In embryo-fetal toxicity studies, subcutaneous administration of articaine hydrochloride and epinephrine (1:100,000) to pregnant rabbits throughout organogenesis produced maternal toxicity, including seizures, at doses of 80 mg/kg/day (approximately 160-fold higher than the bilateral maximum recommended human ophthalmic dose [MRHOD] of 9.6 mg, based on body surface area).

Embryofetal death and skeletal malformations were observed at the same dose Articaine hydrochloride and epinephrine were not maternally toxic and did not produce adverse embryofetal effects in rats and rabbits at oral doses up to 40 mg/kg/day (approximately 40- and 80-fold higher than the MRHOD, respectively). In a pre-/ postnatal developmental study in rats, subcutaneous administration of articaine hydrochloride throughout gestation and lactation resulted in severe maternal toxicity, increased the number of stillbirths and adversely affected passive avoidance, a measure of learning, in pups at a dose of 80 mg/kg (approximately 80 times the MRHOD based on body surface area).

A dose of 40 mg/kg (approximately 40 times the MRHOD based on body surface area) did not produce these effects.

8.2Lactation Risk Summary There is no information regarding the presence of CYKLX or its metabolites in human or animal milk, the effects on the breastfed infant, or the effects on milk production to inform risk of CYKLX to an infant during lactation.

8.4Pediatric Use The safety and effectiveness of CYKLX for ocular surface anesthesia prior to ocular procedures and/or intraocular injections have been established in pediatric patients. Use of CYKLX for this indication is supported by evidence from adequate and well-controlled studies in adults with additional safety data from a single active-controlled study in pediatric patients aged birth to 11 years old [see Clinical Studies (14) ] . A similar safety profile was observed between pediatric and adult patients.

8.5Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger adult subjects.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women with CYKLX to inform a drug associated risk. In animal reproduction studies, subcutaneous administration of articaine hydrochloride and epinephrine (1:100,000) to rabbits throughout organogenesis resulted in maternal toxicity, embryofetal death and increased fetal skeletal variations at doses approximately 160 times the maximum recommended human ophthalmic dose (MRHOD) of CYKLX (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown.

However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Human Data No adequate and well-controlled trials of CYKLX have been conducted in pregnant women. Animal Data In embryo-fetal toxicity studies, subcutaneous administration of articaine hydrochloride and epinephrine (1:100,000) to pregnant rabbits throughout organogenesis produced maternal toxicity, including seizures, at doses of 80 mg/kg/day (approximately 160-fold higher than the bilateral maximum recommended human ophthalmic dose [MRHOD] of 9.6 mg, based on body surface area).

Embryofetal death and skeletal malformations were observed at the same dose Articaine hydrochloride and epinephrine were not maternally toxic and did not produce adverse embryofetal effects in rats and rabbits at oral doses up to 40 mg/kg/day (approximately 40- and 80-fold higher than the MRHOD, respectively). In a pre-/ postnatal developmental study in rats, subcutaneous administration of articaine hydrochloride throughout gestation and lactation resulted in severe maternal toxicity, increased the number of stillbirths and adversely affected passive avoidance, a measure of learning, in pups at a dose of 80 mg/kg (approximately 80 times the MRHOD based on body surface area).

A dose of 40 mg/kg (approximately 40 times the MRHOD based on body surface area) did not produce these effects.

🧒 Pediatric Use 78 words ▾

8.4Pediatric Use The safety and effectiveness of CYKLX for ocular surface anesthesia prior to ocular procedures and/or intraocular injections have been established in pediatric patients. Use of CYKLX for this indication is supported by evidence from adequate and well-controlled studies in adults with additional safety data from a single active-controlled study in pediatric patients aged birth to 11 years old [see Clinical Studies (14) ] . A similar safety profile was observed between pediatric and adult patients.

🧓 Geriatric Use 19 words ▾

8.5Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger adult subjects.

🆘 Overdosage 30 words ▾

10 OVERDOSAGE Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Articaine hydrochloride is an amide local anesthetic. Local anesthetics block the generation and conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination, and conduction velocity of the affected nerve fibers.

12.3Pharmacokinetics Following ocular administration of CYKLX (2 drops), the geometric mean (geometric CV%) maximum plasma concentration (C max ) is 5.4 ng/mL and total systemic exposure (AUC) is 5.1 ng*hr/mL. Absorption Articaine median (min, max) time to maximum plasma concentration (T max ) is 0.25 hour (0.25 – 1.03 hour) Distribution Approximately 60 to 80% of articaine HCl is bound to human serum albumin and γ-globulins at 37°C in vitro. Elimination Articaine estimated elimination half-life is 1.5 hours with an apparent clearance of 872 L/hr.

Metabolism Articaine HCl is metabolized by plasma carboxyesterase to its primary metabolite, articainic acid, which is inactive. In vitro studies show that the human liver microsome P450 isoenzyme system metabolizes approximately 5% to 10% of available articaine with nearly quantitative conversion to articainic acid. Excretion Articaine is excreted primarily through urine with 53-57% of the administered dose eliminated in the first 24 hours following submucosal administration.

Articainic acid is the primary metabolite in urine. A minor metabolite, articainic acid glucuronide, is also excreted in urine.

🧬 Mechanism of Action 71 words ▾

12.1Mechanism of Action Articaine hydrochloride is an amide local anesthetic. Local anesthetics block the generation and conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination, and conduction velocity of the affected nerve fibers.

📦 How Supplied / Storage and Handling 98 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING CYKLX 8%, is supplied as an aseptically prepared, sterile, clear and colorless solution for topical ophthalmic use contained in a low-density polyethylene, single-dose vial with a 0.4 mL fill. 5 single-dose vials are packaged into a foil pouch, with 10 foil pouches in a carton. NDC 87047-7852-01: Carton of 10 foil pouches, 50 single-dose vials.

Storage and Handling: Store at 20°C to 25°C (68°F to 77°F), not to exceed the expiration date printed on the carton and pouch. Store unopened single-dose vials in pouch until ready for use. Discard opened vial after use.

📦 Storage and Handling 38 words ▾

Storage and Handling: Store at 20°C to 25°C (68°F to 77°F), not to exceed the expiration date printed on the carton and pouch. Store unopened single-dose vials in pouch until ready for use. Discard opened vial after use.

📋 Description 128 words ▾

11 DESCRIPTION CYKLX (articaine ophthalmic solution) 8% contains articaine, an amide local anesthetic. CYKLX is an aseptically prepared, sterile, clear and colorless solution for topical ophthalmic use with a pH range of 4.5- 5.0. The chemical name of articaine hydrochloride is methyl 4-methyl-3-[2-(propylamino)propionamido]-2-thiophenecarboxylate, monohydrochloride and the molecular formula is C 13 H 20 N 2 O 3 S∙HCl.

The molecular weight of articaine hydrochloride is 320.84 g/mol, or 283.374 g/mol as articaine (free base). Articaine hydrochloride is represented by the following structural formula: Each mL of CYKLX contains 80 mg of articaine (equivalent to 90.2 mg articaine hydrochloride) as the active ingredient. Inactive ingredients: boric acid, edetate disodium dihydrate, glacial acetic acid, mannitol, sodium acetate trihydrate, water for injection.

CYKLX does not contain an antimicrobial preservative. Chemical Structure

💬 Information for Patients 56 words ▾

17 PATIENT COUNSELING INFORMATION Eye Care Precaution Do not touch the dropper tip to the eye, eyelids, or to any other surface as this may contaminate the product. Advise patients to avoid touching the eye for at least 10 to 20 minutes after using CYKLX as accidental injuries can occur due to insensitivity of the eye.

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