Oasis Tears Plus

Description

Oasis TEARS PLUS 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. The product is specifically formulated to alleviate symptoms associated with dry eye conditions.

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 provides lubrication to alleviate 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:

• If the solution changes color or becomes cloudy, as this may indicate degradation or contamination.

• In individuals with known sensitivity to any ingredient in this product, due to the risk of 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, as this may indicate degradation or contamination. Additionally, individuals with known sensitivities to any ingredient in this formulation should refrain from use to prevent adverse reactions.

To maintain the integrity of the product and avoid contamination, it is imperative that the tip of the container does not come into contact with any surfaces during application. Once opened, the product must be discarded and should not be reused to ensure safety and efficacy.

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.

It is essential 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 using this product should be aware of several important safety considerations. The product is intended for external use only. It should not be used if the solution changes color or becomes cloudy, or if the patient is sensitive to any ingredient in the formulation.

During use, it is crucial to avoid contamination by not touching the tip of the container to any surface. Once opened, the product should be discarded and not reused to ensure safety and efficacy.

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, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this medication 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 Oasis Tears Plus (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

Elderly patients do not have specific geriatric use considerations, dosage adjustments, safety concerns, or special precautions associated with the use of Oasis Tears Plus Preservative-Free Lubricant Eye Drops. As such, healthcare providers may administer this product to geriatric patients without the need for modifications or additional monitoring related to age. However, standard clinical judgment should always be applied when treating elderly patients, taking into account their overall health status and any concurrent medications.

Pregnancy

There is no specific information available regarding the use of Oasis Tears Plus Preservative-Free Lubricant Eye Drops during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this product in women of childbearing potential. It is advisable to consult with a healthcare provider for individualized recommendations.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific 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 lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and optimal therapeutic outcomes.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage 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. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

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 compound in these areas.

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 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 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. It is also crucial to inform patients that 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 optimal protection. It must be stored at or below 77°F (25°C) and above 32°F (0°C) to maintain its integrity. Care should be taken to protect the product from light and freezing conditions to ensure its efficacy and safety.

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

View product document (PDF)