CYKLX 80 mg/mL

articaine hydrochloride · SOLUTION/ DROPS · American Genomics, LLC

No Recall History

Plain English

CYKLX is a solution/ drops containing articaine hydrochloride at 80 mg/mL, taken ophthalmic. Manufactured by American Genomics, LLC.

Key Facts

Brand Name: CYKLX
Generic Name: articaine hydrochloride
NDC Code (Product): 87047-7852
Manufacturer: American Genomics, LLC
Strength: 80 mg/mL
Dosage Form: SOLUTION/ DROPS
Route: OPHTHALMIC
Marketing Status
Application #: NDA218643
Marketing Start: 04/02/2026

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea18 reports

anaphylactic reaction16 reports

cough16 reports

eczema16 reports

erythema16 reports

flushing16 reports

hypersensitivity16 reports

pruritus16 reports

tachycardia16 reports

allergic sinusitis15 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 & Administration

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 )

Contraindications

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 )

Adverse Reactions

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 6.1 Clinical 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.

Frequently Asked Questions

What is CYKLX used for?

CYKLX contains articaine hydrochloride. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is CYKLX a controlled substance?

CYKLX is not classified as a controlled substance by the DEA.

What is the generic name for CYKLX?

The generic name for CYKLX is articaine hydrochloride. There are 12 other brand versions of articaine hydrochloride.

What is the NDC code for CYKLX 80 mg/mL?

The NDC (National Drug Code) for CYKLX 80 mg/mL is 87047-7852, listed by American Genomics, LLC.

Product NDC

87047-7852

Package NDC

87047-7852-1

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)