Hydropure Lubricating Eye Drops

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

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 temporary relief from 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 changes color or becomes cloudy, as this may indicate degradation or contamination. Additionally, do not use if the tamper-evident ring is broken or missing, as this could compromise the integrity and safety of the product.

Warnings and Precautions

External use only. This product is intended solely for topical application and should not be ingested.

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 a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if they experience any of the following: 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 cases of ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

No specific laboratory tests are recommended for monitoring the use of this product.

Side Effects

Patients should be aware that the product is intended for external use only.

In the event of experiencing eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, patients are advised to discontinue use and consult a doctor. These symptoms may indicate serious adverse reactions that require medical attention.

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 Hydropure Lubricating Eye Drops (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 is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any potential pregnancy with their healthcare provider.

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 contraindications. However, as with any medication, it is advisable to monitor breastfed infants for any potential adverse effects.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in individuals with kidney problems to assess their renal status. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects associated with impaired renal function.

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 adhere to 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 excessive dosing. Symptoms of overdosage 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 implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and intervention strategies.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective treatment and follow-up care.

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 available in the provided data.

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 product if the solution changes color or becomes cloudy, or if the tamper-evident ring is broken or missing. It is important for healthcare providers to emphasize the significance of these conditions to ensure patient safety.

Additionally, patients should be counseled to stop using the product 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 their condition worsens or persists for more than 72 hours.

When using the product, healthcare providers should instruct patients not to touch the tip of the container to any surface to avoid contamination. Patients should also be reminded to replace the cap after each use to maintain the integrity of the medication.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) to maintain its integrity. It is essential to protect the product from light exposure to prevent degradation. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the medication is ophthalmic. 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 Hydropure Lubricating Eye Drops, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)