Biotrue Hydration Boost

Description

Bio True® Lubricant Eye Drops, manufactured by BAUSCH + LOMB, are preservative-free and designed to provide hydration and comfort for dry eyes. Each sterile multi-dose bottle contains 0.33 fluid ounces (10 mL) of the solution, which is enhanced with hyaluronic acid (HA), a natural moisturizer, along with antioxidants and electrolytes. The formulation offers instant moisture and comfort, making it suitable for individuals seeking relief from dryness.

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 should instruct patients to remove the tamper-evident ring before taking off the cap of the bottle. The bottle should be tipped at a downward angle or held upside down to facilitate the delivery of the drop to the eye. Patients are to squeeze the bottle gently to instill 1 or 2 drops into the affected eye(s) as needed. After use, it is essential to replace the cap securely to maintain the integrity of the product.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only. The product must not be used if the solution has changed color or become cloudy, or if the tamper-evident ring is broken or missing. To prevent contamination, users should avoid touching the tip of the container to any surface and should ensure that the cap is replaced immediately after use.

Healthcare professionals should advise patients to discontinue use and seek medical attention if they experience any of the following: eye pain, changes in vision, or continued redness or irritation of the eye. Additionally, if the condition worsens or persists for more than 72 hours, medical consultation is recommended.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center without delay.

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 tamper evident ring is broken or missing.

During the use of this product, patients are advised to avoid touching the tip of the container to any surface to prevent contamination and to ensure the cap is replaced after each use.

Patients should discontinue use and consult a healthcare professional if they experience any of the following adverse reactions: eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Biotrue Hydration Boost (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 BIOTRUE HYDRATION BOOST (glycerin solution/drops) in geriatric patients. The prescribing information does not provide details on dosage adjustments, safety concerns, or special precautions that may be necessary for elderly patients.

Healthcare providers should exercise clinical judgment when prescribing this product to geriatric patients, considering the absence of targeted data in this population. Monitoring for any potential adverse effects or unique responses in elderly patients is advisable, given the lack of specific guidance.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy, including safety concerns, dosage modifications, or special precautions. Therefore, healthcare professionals are advised to exercise caution when prescribing this product to pregnant patients. The potential risks and benefits should be carefully weighed, and alternative therapies should be considered when appropriate. Women of childbearing potential should be informed of the lack of data and encouraged to discuss any concerns with their healthcare provider.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Consequently, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the potential risks to breastfed infants are not well characterized. It is advisable to consider the benefits of breastfeeding alongside the potential risks associated with the medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data 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 lack of information 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

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 at a temperature range of 15 to 25 °C (59 to 77 °F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature range to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Biotrue Hydration Boost, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)