Eyeganics Organic Tears

Description

EYEGANICS Organic TEARS are sterile lubricant eye drops formulated to provide organic relief for dry eyes. Each 0.3 fluid ounce (10 mL) bottle contains preservative-free ingredients, ensuring a gentle application suitable for sensitive eyes. The product is certified USDA Organic, reflecting its adherence to organic standards.

Uses and Indications

This drug is indicated for the temporary relief of burning and irritation due to dryness of the eye. It serves as a protectant against further irritation and is effective in alleviating dryness of the eye.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals are advised to instill 1 or 2 drops of the medication in the affected eye(s) as needed. The frequency of administration should be determined based on the clinical condition of the patient and the response to treatment. It is important to ensure that the drops are administered in a sterile manner to prevent contamination.

Contraindications

Use of this product is contraindicated if the solution changes color or becomes cloudy. This alteration may indicate degradation of the product, which could compromise safety and efficacy.

Warnings and Precautions

For external use only. The solution must not be used if it changes color or becomes cloudy, as this may indicate a loss of efficacy or safety.

Healthcare professionals should advise patients to discontinue use and seek medical attention if they experience any of the following symptoms: eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours. These symptoms may indicate a more serious underlying condition that requires further evaluation.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients should be aware that the product is intended for external use only. It is crucial to discontinue use and consult a healthcare professional if any of the following occur: eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Additionally, patients should not use the product if the solution changes color or becomes cloudy, as this may indicate a compromise in its safety or efficacy.

In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately. Care should be taken to keep the product out of reach of children to prevent any potential harm.

Drug Interactions

No drug interactions have been reported for this medication. Additionally, there are no interactions identified between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Eyeganics Organic Tears (glycerin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information regarding the use of Eyeganics Organic Tears during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients. As with any medication, the potential benefits must be weighed against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on the nursing infant are not well studied; thus, the risks versus benefits should be considered.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Prompt action is crucial in mitigating potential adverse effects associated with overdosage. The symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. It is recommended that healthcare providers follow established protocols for the specific substance to guide the treatment process effectively.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the solution if it changes color or becomes cloudy, as this may indicate a loss of efficacy or safety.

It is important for healthcare providers to counsel patients to stop using the medication and consult a doctor if they experience any of the following: eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Additionally, to prevent contamination, patients should be instructed not to touch the tip of the container to any surface and to replace the cap immediately after use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product within the temperature range of 59° to 86°F (15° to 30°C) to maintain its efficacy and integrity. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be followed to prevent any compromise to the product's quality.

Additional Clinical Information

The route of administration for the medication is ophthalmic, with a recommended dosage of 1 or 2 drops instilled in the affected eye(s) as needed. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Eyeganics Organic Tears, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)