Silktears

Description

This product is packaged in a total of 30 vials, with each vial containing 6 pouches. Each pouch includes 5 sterile dispensers, with each dispenser holding 0.01 fluid ounces (0.35 mL).

Uses and Indications

This drug is indicated for the temporary relief of burning and irritation due to 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 to 2 drops of the medication in the affected eye(s) as needed. It is important to ensure that the dropper does not come into contact with the eye or any other surface to maintain sterility. The frequency of administration should be determined based on the clinical response of the patient.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children. In the event of accidental ingestion, seek immediate medical assistance or contact a Poison Control Center.

Warnings and Precautions

This product is intended for external use only. It is imperative that the solution is not utilized if there are any changes in color or if it becomes cloudy, as this may indicate degradation of the product.

When administering this product, it is essential to adhere to the following precautions to ensure safety and efficacy. The tip of the container must not come into contact with any surface to prevent contamination. Additionally, the product is designed for single use; therefore, it should not be reused. Once opened, any remaining solution should be discarded to avoid potential risks.

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, or persistent redness or irritation. These symptoms may indicate a serious condition that requires further evaluation.

It is crucial 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 should be made without delay.

Side Effects

Patients should discontinue use and consult a healthcare professional if they experience any of the following serious adverse reactions: eye pain, changes in vision, or continued redness or irritation. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

It is important for patients to be aware of these potential reactions and to seek prompt medical attention if they occur. Monitoring for these symptoms is essential to ensure the safe use of the product.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs 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 Silktears (glycerin ophthalmic solution). 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 available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of SILKTEARS (glycerin ophthalmic solution) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this medication in women who are pregnant or may become pregnant. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes in these patients.

Lactation

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

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise caregivers to contact a Poison Control Center without delay.

Prompt action is crucial in managing potential overdosage situations to mitigate risks and ensure patient safety.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately. It is important for patients to understand the potential risks associated with improper use and the necessary steps to take in case of an emergency.

Storage and Handling

The product is supplied in a container that must be stored at room temperature. It is essential to protect the product from light exposure to maintain its integrity. Once the container has been opened, the product should be discarded and not reused. Additionally, the container is not intended for reuse, ensuring proper handling and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)