Oasis Tears

Description

Oasis TEARS® is a preservative-free lubricant eye drop formulation designed to provide viscoadaptive relief for dry eyes. Each package contains 30 sterile single-use containers, with each container holding 0.3 mL (0.01 FL. OZ.) of the solution.

Uses and Indications

This drug is indicated for the temporary relief of burning and irritation due to dryness of the eye. It is also indicated for the temporary relief of discomfort resulting from minor irritations of the eye or exposure to environmental factors such as wind or sun. Additionally, this drug serves as a protectant against further irritation and is utilized to relieve dryness of the eye. It functions as a lubricant to prevent further irritation or to alleviate existing dryness.

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 in the following situations:

• The solution should not be used if it changes color or becomes cloudy, as this may indicate degradation or contamination.

• Individuals with known sensitivity to any ingredient in this product should avoid its use to prevent adverse reactions.

Warnings and Precautions

For external use only. This product should not be utilized if the solution has changed color or become cloudy. Additionally, individuals with known sensitivities to any ingredient in this formulation should refrain from use.

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, persistent redness or irritation of the eye, or if the condition worsens or does not improve within 72 hours.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

To ensure safety, this product must be kept out of reach of children to prevent accidental exposure or ingestion.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated in individuals who are sensitive to any ingredient in the formulation. Users are advised to discontinue use and consult a healthcare professional if they experience any of the following serious adverse reactions: eye pain, changes in vision, continued redness or irritation of the eye, or if symptoms worsen or persist for more than 72 hours.

To minimize the risk of contamination, patients should avoid touching the tip of the container to any surface. Once opened, the product should be discarded and not reused. Additionally, it is crucial to keep the 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.

Patients should also be vigilant for any changes in the solution, such as discoloration or cloudiness, as these changes indicate that the product should not be used.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Oasis 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 the Poison Control Center should be contacted without delay.

Geriatric Use

There is no specific information regarding the use of Oasis Tears Preservative-Free Lubricant Eye Drops in geriatric patients. The prescribing information does not indicate any dosage adjustments, safety concerns, or special precautions that are specifically applicable to elderly patients. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and overall health status. Regular monitoring may be advisable to ensure safety and efficacy in this population.

Pregnancy

There is no specific information available regarding the use of Oasis Tears Preservative-Free Lubricant Eye Drops during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is recommended that pregnant patients consult their healthcare provider for personalized guidance regarding the use of this product during pregnancy.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding. However, as with any medication, it is advisable to monitor breastfed infants for any potential adverse effects.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management procedures.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any overdosage incidents to facilitate effective treatment and minimize risks.

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 these contexts.

Postmarketing Experience

Adverse events have been reported voluntarily and through surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events by calling (800) 631-7180 or (909) 305-5400, or by visiting www.oasistears.com.

Patient Counseling

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

Patients should be informed not to use the product if the solution changes color or becomes cloudy, as this may indicate a loss of efficacy or safety. Additionally, it is important to counsel patients to avoid using the product if they are sensitive to any ingredient contained within it.

Healthcare providers should emphasize the importance of discontinuing use and consulting a doctor if patients experience any of the following: eye pain, changes in vision, continued redness or irritation of the eye, or if their condition worsens or persists for more than 72 hours.

When using the product, patients should be instructed to avoid contamination by not touching the tip of the container to any surface. Once the product is opened, it should be discarded and not reused to ensure safety and effectiveness.

Storage and Handling

The product is supplied in packaging that ensures its integrity and efficacy. It must be stored at temperatures not exceeding 77°F (25°C) and not falling below 32°F (0°C). Care should be taken to protect the product from light and freezing conditions to maintain its quality. Proper handling and storage are essential to ensure the product remains effective throughout its shelf life.

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 Oasis Tears, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)