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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Splash Pure Pf
Generic Name
Propylene Glycol
Active Ingredient
Propylene GlycolCategory
Non-Standardized Chemical Allergen [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 6 mg/mL | EMULSION | OPHTHALMIC | 57619-307 |
Detailed information about Splash Pure Pf
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Splash Pure Pf, you must consult a qualified healthcare professional.
Propylene Glycol is a synthetic organic compound used as a solvent, humectant, and drug vehicle. Classified as a non-standardized chemical allergen, it plays a critical role in drug delivery and metabolic processes.
Because Propylene Glycol is primarily used as a vehicle or as part of a compound, there is no single 'standard dose' for all patients. Instead, dosage is determined by the specific application:
Extreme caution is required in pediatric dosing. The FDA and the World Health Organization (WHO) have established an Acceptable Daily Intake (ADI) of 25 mg per kilogram of body weight.
Patients with kidney disease (reduced GFR) require significant monitoring. Since 25% of Propylene Glycol is cleared unchanged by the kidneys, those with renal failure can accumulate the substance rapidly. If the serum creatinine is elevated, healthcare providers may switch to PG-free formulations of IV drugs to prevent lactic acidosis.
Because the liver metabolizes Propylene Glycol via alcohol dehydrogenase, patients with cirrhosis or liver failure may experience slower clearance. While specific dose-reduction tables do not exist for the excipient itself, clinicians should be aware of the increased risk of CNS depression in these patients.
Older adults often have a natural decline in renal function. Dose adjustments for medications containing Propylene Glycol should be conservative, starting at the lower end of the dosing range to avoid accumulation and associated confusion or metabolic imbalances.
If you are using a topical product and miss a dose, apply it as soon as you remember. If it is almost time for your next application, skip the missed dose. For IV medications administered in a hospital, the clinical staff will manage the schedule. Do not 'double up' on doses to make up for a missed one.
Propylene Glycol overdose is a medical emergency, typically seen in the context of high-dose IV therapy (e.g., long-term sedation in an ICU).
In the event of a suspected overdose, the medication must be discontinued immediately. Hemodialysis is highly effective at removing Propylene Glycol from the bloodstream and may be required in severe cases.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or stop a prescribed medication containing Propylene Glycol without medical guidance.
Most patients tolerate Propylene Glycol well when used in standard amounts. However, the following common side effects may occur, particularly with topical or oral use:
> Warning: Stop taking Propylene Glycol and call your doctor immediately if you experience any of these serious reactions.
Prolonged exposure to high levels of Propylene Glycol, such as in chronic wound care for large-surface-area burns or long-term ICU sedation, can lead to cumulative toxicity. The most significant long-term risk is chronic metabolic acidosis, which can leach minerals from the bones and impair normal cellular function. Additionally, chronic skin exposure in sensitive individuals can lead to 'hardened' dermatitis, where the skin becomes thick, leathery, and permanently discolored.
Currently, there are no universal FDA Black Box Warnings for Propylene Glycol as a standalone substance. However, many medications that use Propylene Glycol as a vehicle (such as IV Diazepam or Phenytoin) carry significant warnings regarding the rate of infusion. For example, the FDA-approved labeling for Phenytoin injection warns that the rate of administration must not exceed 50 mg per minute in adults to avoid severe hypotension and cardiac arrest, risks that are partially attributed to the Propylene Glycol solvent.
Report any unusual symptoms to your healthcare provider. If you suspect you are having a toxic reaction to a medication containing Propylene Glycol, seek emergency care immediately.
Propylene Glycol is ubiquitous in modern medicine, but it is not without risk. Patients must be aware that while it is 'safe' for the general population, individual tolerance varies significantly. If you have a known allergy to other glycols or alcohols, you must inform your doctor. Furthermore, Propylene Glycol toxicity is a 'hidden' danger in hospital settings because its symptoms often mimic the underlying critical illness (e.g., sepsis or multi-organ failure).
No FDA black box warnings for Propylene Glycol. However, clinicians must strictly adhere to the black box warnings of the primary drugs (like Phenytoin) that utilize Propylene Glycol as a solvent, particularly regarding infusion rates and cardiovascular risks.
If you are receiving high doses of medications containing Propylene Glycol (especially IV Lorazepam), your healthcare team will perform the following:
Propylene Glycol can cause drowsiness and dizziness, especially when administered intravenously or in large oral doses. Do not drive or operate heavy machinery until you know how this substance affects you. The sedative effects of the primary drug (like a benzodiazepine) will be significantly more pronounced than the effects of the Propylene Glycol vehicle itself.
Alcohol (ethanol) and Propylene Glycol are both metabolized by the enzyme alcohol dehydrogenase. Consuming alcohol while taking medications containing Propylene Glycol can lead to 'metabolic competition.' This means the body will process the alcohol first, allowing Propylene Glycol levels to rise to potentially toxic levels. Avoid alcohol consumption during treatment.
There is no specific withdrawal syndrome associated with Propylene Glycol itself. However, if you are stopping a medication that contains it, you must follow the tapering schedule for the active drug to avoid rebound symptoms (e.g., seizures if stopping an anti-epileptic).
> Important: Discuss all your medical conditions with your healthcare provider before starting Propylene Glycol-containing products.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, as Propylene Glycol is a common 'hidden' ingredient in many over-the-counter products.
Propylene Glycol must NEVER be used in the following circumstances:
Conditions requiring a careful risk-benefit analysis include:
Patients allergic to Propylene Glycol may also react to:
> Important: Your healthcare provider will evaluate your complete medical history before prescribing or administering products containing Propylene Glycol.
Propylene Glycol is generally classified as FDA Pregnancy Category C. This means that animal reproduction studies have shown an adverse effect on the fetus, or there are no adequate and well-controlled studies in humans. However, the risk is usually associated with very high doses that cause maternal toxicity. In standard pharmaceutical amounts (as an excipient), it is generally considered low-risk. Nevertheless, during the first trimester, it is prudent to minimize exposure to high-dose IV formulations containing this vehicle unless the medical benefit to the mother outweighs the potential risk to the fetus.
Propylene Glycol is known to pass into breast milk, although the amounts absorbed by the nursing infant from maternal use of topical or oral products are likely negligible. The WHO considers it compatible with breastfeeding in standard doses. However, nursing mothers should avoid applying Propylene Glycol-containing creams directly to the nipple area to prevent direct ingestion by the infant, which could cause irritation or sensitization.
As previously noted, Propylene Glycol is of significant concern in the pediatric population. The 'Gasping Syndrome' is a well-documented toxic reaction in neonates, characterized by metabolic acidosis, respiratory distress, and CNS collapse. This occurs because the neonatal liver lacks the mature enzymes required to break down glycols. For children over the age of one, Propylene Glycol is generally safe, but cumulative doses from multiple medications (e.g., a child receiving an IV sedative, an oral antibiotic syrup, and a topical steroid) must be monitored by a pediatric pharmacist.
In elderly patients, the primary concern is the age-related decline in renal clearance. An 80-year-old patient may have half the kidney function of a 20-year-old, even with a 'normal' serum creatinine. This makes the elderly more susceptible to Propylene Glycol accumulation and subsequent confusion or 'pseudo-intoxication.' Clinicians should use the lowest effective dose of PG-containing medications in this population.
For patients with a GFR (Glomerular Filtration Rate) below 30 mL/min, Propylene Glycol should be used with extreme caution. These patients cannot effectively excrete the 25% of the drug that leaves the body unchanged. In the setting of dialysis, Propylene Glycol is removed by the dialysis membrane, but it can also be present in certain dialysate fluids, requiring careful balance.
Patients with Child-Pugh Class B or C cirrhosis have significantly reduced alcohol dehydrogenase activity. This prolongs the half-life of Propylene Glycol, increasing the risk of CNS side effects. Monitoring for altered mental status is critical in these patients when they receive PG-containing medications.
> Important: Special populations require individualized medical assessment to ensure that the use of Propylene Glycol does not lead to unintended toxicity.
Propylene Glycol acts as a multi-functional agent. In its role as a Non-Standardized Chemical Allergen, it interacts with skin proteins to form a hapten-protein complex, which is then recognized by Langerhans cells, triggering a T-cell mediated immune response in sensitized individuals.
In its role as a Nitrogen Binding Agent and Acidifying Activity agent, its metabolism is key. The conversion of Propylene Glycol to L-lactic acid increases the hydrogen ion concentration in the extracellular fluid. This acidification can be utilized therapeutically in specific contexts but is more often a side effect of high-dose administration. The Ammonium Ion Binding Activity is a secondary effect of its influence on the renal tubular environment and its role in specific metabolic pathways where it can influence nitrogenous waste excretion.
The pharmacodynamic effects of Propylene Glycol are dose-dependent. At low concentrations, it is inert. At higher concentrations (serum levels > 18-25 mg/dL), it begins to exert osmotic pressure on cells and CNS depressive effects. The duration of effect is closely tied to its metabolic rate; once the alcohol dehydrogenase enzymes are saturated, the duration of action increases exponentially.
| Parameter | Value |
|---|---|
| Bioavailability | >90% (Oral); Low (Topical on intact skin) |
| Protein Binding | Negligible (0-5%) |
| Half-life | 2 to 5 hours (Adults); 17 hours (Neonates) |
| Tmax | 1 to 2 hours (Oral) |
| Metabolism | Hepatic (Alcohol Dehydrogenase) |
| Excretion | Renal (20-25% unchanged); Fecal (<5%) |
Propylene Glycol is classified as a pharmaceutical aid (solvent/humectant) and a Non-Standardized Chemical Allergen [EPC]. It is related to other polyols such as Glycerin and Polyethylene Glycol but is distinct in its metabolic pathway and toxicity profile.
Common questions about Splash Pure Pf
Propylene Glycol is primarily used as a solvent and vehicle to help dissolve medications that do not dissolve well in water, such as certain sedatives and anti-seizure drugs. It is also a common humectant in skin creams, helping to trap moisture in the skin and improve the absorption of topical steroids. In some clinical settings, it is used in solutions to dissolve kidney stones or as a diagnostic tool for identifying chemical allergies. Because it is versatile and generally safe, it is found in thousands of FDA-approved products ranging from eye drops to intravenous injections. Always check with your pharmacist if you have a known sensitivity to this compound.
The most common side effects are localized skin irritation, redness, or a mild stinging sensation when applied topically. When taken in oral medications, it may occasionally cause mild nausea or a metallic taste. However, most people do not experience any noticeable side effects from the small amounts found in typical doses. In rare cases of high-dose exposure, more serious symptoms like confusion or rapid breathing can occur. If you notice a persistent rash after using a product, you may have developed a contact allergy to the glycol.
It is generally advised to avoid alcohol if you are taking medications that contain high amounts of Propylene Glycol. Both substances are processed by the same liver enzyme, alcohol dehydrogenase, which means they can compete for metabolism. This competition can slow down the clearance of both the alcohol and the Propylene Glycol, potentially leading to increased intoxication or toxic accumulation of the glycol. This is especially important for patients on IV medications or those with liver disease. Always consult your doctor about alcohol consumption while on prescription therapy.
Propylene Glycol is considered relatively safe during pregnancy when used in standard amounts found in foods and topical cosmetics. However, high-dose intravenous exposure should be handled with caution, as it is classified as Pregnancy Category C. This means that while there is no definitive evidence of harm in humans, exhaustive studies are lacking. Your healthcare provider will determine if the benefits of a medication containing Propylene Glycol outweigh any potential risks to the developing fetus. It is always best to disclose your pregnancy status before starting any new medical treatment.
When used as a drug vehicle in an IV, Propylene Glycol works almost immediately to deliver the active medication into the bloodstream. When used in topical creams as a humectant, it begins to hydrate the skin within minutes of application. For its use in dissolving kidney stones, the process is much slower and may take several days of continuous irrigation. As an allergen in patch testing, the reaction typically takes 24 to 48 hours to appear. The 'work' it does is largely dependent on the specific medical goal of the formulation.
Since Propylene Glycol is usually an inactive ingredient or vehicle, stopping it typically means stopping the primary medication it carries. You should never suddenly stop a prescription medication, such as an anti-seizure drug or a sedative, without your doctor's approval, as this can cause dangerous rebound effects. If you are using a topical cream containing Propylene Glycol for dry skin, you can generally stop using it at any time. If you suspect an allergic reaction, you should stop use immediately and contact your healthcare provider. Always follow the specific discontinuation instructions for the active drug in your formulation.
If you miss a dose of a topical product containing Propylene Glycol, apply it as soon as you remember, unless it is nearly time for your next dose. For oral medications, follow the specific instructions for the active ingredient provided by your pharmacist. Do not take extra medicine to make up for a missed dose, as this could increase the risk of side effects. If the Propylene Glycol is being administered in a hospital setting via IV, the nursing staff will manage the dosing schedule for you. If you are unsure, call your doctor or pharmacist for guidance.
There is no clinical evidence to suggest that Propylene Glycol causes weight gain in humans when used in pharmaceutical or cosmetic amounts. It is not a significant source of calories, and it does not affect the hormones that regulate metabolism or appetite. If you are experiencing unexplained weight gain while taking a medication that contains Propylene Glycol, it is likely due to the active ingredient or an underlying medical condition. For example, some steroids or psychiatric medications can cause weight changes. Discuss any concerns about weight with your healthcare provider.
Propylene Glycol is compatible with many medications, but it has serious interactions with Disulfiram (Antabuse) and Metronidazole (Flagyl). These combinations can cause a severe reaction including vomiting and chest pain. It can also interact with other glycols or alcohols that use the same metabolic pathways in the liver. Because it is an excipient in so many drugs, the risk of 'cumulative' exposure is possible if you are taking multiple medications. Always provide your doctor with a complete list of all your medications, including over-the-counter supplements, to ensure safety.
Propylene Glycol is a widely available chemical compound and is not a 'branded' drug itself. It is found in both brand-name and generic versions of thousands of different products. When a doctor prescribes a medication that uses Propylene Glycol as a vehicle, a generic version of that medication is often available. If you have a specific allergy to Propylene Glycol, you may need to seek out 'glycol-free' versions of certain drugs, which are sometimes available through compounding pharmacies. Your pharmacist can help you identify which products contain this ingredient.
Other drugs with the same active ingredient (Propylene Glycol)