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Brand Name :
Systane Ultra, Systane Gel Drops, Systane Lubricant Eye Drops, Systane Preservative-Free
Synonyms :
polyethylene glycol 400/propylene glycol ophthalmic
Class :
Ophthalmic Lubricants
Brand Name :
Systane Ultra, Systane Gel Drops, Systane Lubricant Eye Drops, Systane Preservative-Free
Synonyms :
polyethylene glycol 400/propylene glycol ophthalmic
Class :
Ophthalmic Lubricants
Dosage forms and strengths
propylene glycol/polyethylene glycol 400
ophthalmic drops
0.3%/0.4%
Administer 1-2 drops as needed to the affected eye(s)
Safety and efficacy are not established
Refer adult dosing
Actions and Spectrum
Action:
Lubrication: The drug is primarily used as a lubricant for the eyes. It helps alleviate dryness, irritation, and discomfort caused by various factors, such as environmental conditions, prolonged computer use, contact lens wear, or certain medical conditions.
Moisturization: The solution’s lubricating properties help to provide long-lasting moisture to the ocular surface. This is beneficial for individuals with chronic dry eye syndrome or those who experience dryness due to insufficient tear production.
Spectrum:
Dry Eye Syndrome: The drug is commonly used for the treatment of dry eye syndrome, which is characterized by inadequate tear production or poor tear quality. The lubricating and moisturizing properties of the solution help alleviate the symptoms associated with this condition, such as stinging, burning, grittiness, or a foreign body sensation in the eyes.
Environmental Factors: Exposure to dry or windy environments, air conditioning, heating, or high altitude can cause temporary eye dryness and discomfort. The ophthalmic solution can provide relief by lubricating and hydrating the ocular surface.
Frequency not defined
Irritation
Black Box Warning:
None
Contraindication/Caution:
Hypersensitivity: If you have a known hypersensitivity or allergy to polyethylene glycol 400, propylene glycol, or any other ingredient in the product, you should not use it.
Severe eye infections: It is not recommended to use this medication if you have an active and severe eye infection. Treating the underlying infection should be the priority before using any lubricating eye drops.
Contact lens use: If you wear contact lenses, you should remove them before applying polyethylene glycol 400/propylene glycol ophthalmic. Contact lenses should be reinserted at least 15 minutes after applying the eye drops.
Eye surgery: If you have had recent eye surgery or are scheduled for eye surgery, it is best to consult with your ophthalmologist before using this medication.
Children and infants: The safety and effectiveness of this medication in children and infants have not been established. It is important to consult with a healthcare professional before using it in pediatric populations.
Pregnancy warnings:
Pregnancy category: N/A
Lactation: Excreted into human milk is unknown
Pregnancy Categories:
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.
Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Pharmacology:
polyethylene glycol 400 and propylene glycol are commonly used in ophthalmic formulations as lubricants and excipients. They are usually combined in ophthalmic solutions or ointments to improve the lubrication and moistening of the ocular surface.
Pharmacodynamics:
Lubrication: polyethylene glycol 400 and propylene glycol are hydrophilic substances that help lubricate the ocular surface. They provide a protective layer over the cornea and conjunctiva, reducing friction between the eyelid and the eye. This lubrication helps to alleviate discomfort caused by dryness or irritation.
Moisture retention: The drug humectant properties, which means they have the ability to attract and retain moisture. When applied to the eye, the solution helps to maintain an appropriate level of moisture on the ocular surface. This can be especially beneficial in individuals with insufficient tear production or in dry environments.
Pharmacokinetics:
Absorption: When applied topically as eye drops, both polyethylene glycol 400 and propylene glycol can be absorbed through the cornea into the intraocular tissues. They have relatively low molecular weights, which facilitates their absorption.
Distribution: Once absorbed, these compounds can distribute throughout the intraocular tissues and potentially reach the systemic circulation. However, the extent of distribution depends on various factors, including the concentration of the compound, its lipophilicity, and the barriers it encounters within the eye.
Metabolism: polyethylene glycol 400 and propylene glycol are not extensively metabolized in the body. They are typically considered to undergo minimal or no metabolism. Therefore, they are unlikely to undergo significant biotransformation in the eye or systemic circulation.
Excretion and Elimination
Both compounds are primarily eliminated from the body unchanged, mainly through renal excretion. They are considered to be rapidly eliminated due to their low molecular weights and water solubility.
Administration:
Hold the dropper bottle above the eye, without touching it, and squeeze the prescribed number of drops into the pocket formed by the lower eyelid. Be careful not to touch your eye, eyelashes, or any other surface with the dropper tip. After instilling the drops, close your eye gently and blink a few times to distribute the solution across the surface of the eye.
Patient information leaflet
Generic Name: polyethylene glycol 400/propylene glycol ophthalmic
Why do we use polyethylene glycol 400/propylene glycol ophthalmic?
Lubricating Eye Drops: The drug are often used as lubricating agents in eye drops to relieve dryness and discomfort caused by insufficient tear production or environmental factors.
Drug Solubilization: These glycols can act as solubilizing agents to enhance the solubility of certain drugs in ophthalmic formulations. This helps in improving drug delivery and bioavailability.
Ocular Drug Delivery: The drug are used in ophthalmic formulations as vehicles or carriers to deliver active pharmaceutical ingredients (APIs) to the eye. They help in improving the stability, penetration, and absorption of drugs.
Ophthalmic Ointments: These glycols can be used in the formulation of ophthalmic ointments to provide lubrication and improve drug release and penetration into the ocular tissues.
Contact Lens Solutions: The drug are found in some contact lens solutions to enhance lens comfort and provide lubrication during wear.
Diagnostic Aids: In some instances, these glycols can be used as components in diagnostic aids such as ocular stains or solutions used in ophthalmic procedures.
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