Oasis Tears

Description

Oasis TEARS® is a lubricant eye drop formulation designed to provide viscoadaptive relief for individuals experiencing dry eyes. The product is presented in a 10 mL (0.3 fl. oz.) container, ensuring convenient application and dosage.

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 aids in relieving 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 in the following situations:

The solution should not be used if it has changed color or become cloudy, as this may indicate degradation or contamination. Additionally, 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. The product should not be utilized if the solution exhibits any changes in color or becomes cloudy. Additionally, individuals with known sensitivities to any ingredient in this formulation should refrain from use.

In the event of experiencing eye pain, alterations in vision, persistent redness or irritation of the eye, or if the condition worsens or persists beyond 72 hours, it is imperative to discontinue use and consult a healthcare professional.

This product must be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for use if the solution changes color or becomes cloudy, or if the patient is sensitive to any ingredient in the product.

During the use of this product, it is important to avoid contamination by not touching the tip of the container to any surface, and to replace the cap after each use.

Patients are advised to discontinue use and consult a doctor 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.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, medical help should be sought immediately, or the patient should contact a Poison Control Center.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of OASIS TEARS Lubricant Eye Drops during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, healthcare professionals should consider the lack of data when prescribing this product to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be informed of the absence of established safety data in this population.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established, and further research may be necessary to determine the safety profile in this population.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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

Postmarketing experience has included the collection of voluntary reports and data from surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events or side effects associated with the use of the product. For inquiries or to report an adverse event, individuals may contact the designated phone numbers: (800) 631-7180 or (909) 305-5400, or visit the website at www.oasistears.com.

Patient Counseling

Healthcare providers should advise patients to keep the 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 of its ingredients.

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 the 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. Finally, remind patients to replace the cap securely after each use to maintain the product's integrity.

Storage and Handling

The product is supplied in packaging that ensures protection from light and freezing conditions. It is essential to store the product at or below 77°F (25°C) to maintain its integrity and efficacy. Care should be taken to avoid exposure to extreme temperatures and light during storage.

Additional Clinical Information

The medication is administered via the ophthalmic route, with a recommended dosage of 1 or 2 drops instilled in the affected eye(s) as needed. There are no additional details available regarding laboratory tests, abuse information, 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)