Usage
- Polypodium leucotomos extract (PLE) is primarily used as an oral photoprotective agent, offering protection against the harmful effects of ultraviolet (UV) radiation. It’s also being investigated for its potential benefits in various skin conditions like polymorphous light eruption, other photodermatoses, melasma, vitiligo, atopic dermatitis, and actinic keratosis. It has also been suggested for use in other conditions like dementia and certain cancers, but more research is needed. It is marketed as a dietary supplement, not as a drug.
- Pharmacological Classification: Photoprotectant, antioxidant, immunomodulator.
- Mechanism of Action: PLE exhibits antioxidant, anti-inflammatory, and immunomodulatory properties. It protects against UV-induced DNA damage, reduces inflammation, and modulates immune responses, thereby mitigating the skin’s reaction to UV exposure.
Alternate Names
- Phlebodium aureum, Calaguala, Anapsos, Difur, Fernblock.
How It Works
- Pharmacodynamics: PLE exerts its photoprotective effects through multiple mechanisms: scavenging free radicals, inhibiting UV-induced inflammation, reducing erythema, protecting Langerhans cells, and promoting DNA repair.
- Pharmacokinetics: Limited information is available. PLE is administered orally or topically. Absorption, metabolism, and elimination pathways have not been extensively studied. It is thought that some components may undergo hepatic metabolism, especially through the CYP450 pathway.
- Mode of Action: PLE’s polyphenols, including ferulic, caffeic, p-coumaric, vanillic, and chlorogenic acids, act as antioxidants, neutralizing free radicals generated by UV exposure. It also appears to modulate cytokine balance and exhibit anti-angiogenic activity.
- Elimination Pathways: Precise elimination pathways are not fully characterized, but both renal and hepatic routes are likely involved.
Dosage
Standard Dosage
Adults:
- Photoprotection: 240-480 mg orally, once or twice daily. Higher doses (up to 960 mg/day) have been studied for conditions like vitiligo.
- Atopic Dermatitis: Up to 480 mg/day.
- Actinic Keratosis: 960 mg/day initially, followed by 480 mg/day.
Children:
- Limited data exists on pediatric dosing. Some studies have investigated doses up to 480 mg/day for atopic dermatitis. Pediatric use should be under the guidance of a healthcare professional.
Special Cases:
- Elderly Patients: Dosage adjustment may not be necessary.
- Patients with Renal Impairment: No specific guidelines available. Caution is advised.
- Patients with Hepatic Dysfunction: No specific guidelines available. Caution is advised due to the potential for hepatic metabolism.
- Patients with Comorbid Conditions: Dosage adjustments should be considered based on the specific comorbidity.
Clinical Use Cases
- Intubation: No specific dosage recommendations.
- Surgical Procedures: No specific dosage recommendations.
- Mechanical Ventilation: No specific dosage recommendations.
- Intensive Care Unit (ICU) Use: No specific dosage recommendations.
- Emergency Situations: No specific dosage recommendations.
Dosage Adjustments
- Dose modifications should be considered in patients with renal or hepatic dysfunction, and in those with comorbid conditions. Drug interactions, particularly those involving the CYP450 metabolic pathway, should be considered when adjusting dosage.
Side Effects
Common Side Effects
- Generally well-tolerated. Infrequent reports of mild gastrointestinal upset (e.g., nausea, bloating), fatigue, and headache.
Rare but Serious Side Effects
- Allergic reactions (rash, itching, swelling, dizziness, difficulty breathing).
Long-Term Effects
- Limited data available on long-term use.
Adverse Drug Reactions (ADR)
- No serious ADRs have been consistently reported.
Contraindications
- Known hypersensitivity to PLE.
- Pregnancy and breastfeeding (due to insufficient safety data).
Drug Interactions
- May interact with drugs metabolized by the CYP450 pathway.
- Limited clinical data available on other specific drug interactions.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: Not established.
- Fetal Risks: Insufficient data. Avoid use.
- Breastfeeding: Insufficient data. Avoid use.
Drug Profile Summary
- Mechanism of Action: Antioxidant, anti-inflammatory, immunomodulatory, photoprotective.
- Side Effects: Generally well-tolerated; rarely, mild gastrointestinal issues, fatigue, or headache; potential for allergic reactions.
- Contraindications: Hypersensitivity, pregnancy, breastfeeding.
- Drug Interactions: Potential interactions with drugs metabolized by CYP450 enzymes.
- Pregnancy & Breastfeeding: Avoid use due to lack of safety data.
- Dosage: Photoprotection: 240-480 mg orally, 1-2 times/day. Higher doses for specific conditions.
- Monitoring Parameters: Monitor for allergic reactions and gastrointestinal issues.
Popular Combinations
- Often used in conjunction with topical sunscreens and other photoprotective measures.
- Combination with NB-UVB phototherapy has been studied in vitiligo.
Precautions
- General Precautions: Assess for allergies. Caution in patients with renal or hepatic impairment.
- Specific Populations: Avoid use during pregnancy and breastfeeding. Limited pediatric data; use cautiously under medical supervision.
FAQs (Frequently Asked Questions)
A: For photoprotection in adults, 240-480 mg orally, once or twice daily. Higher doses (up to 960 mg/day) have been studied in specific conditions. Pediatric and special population dosing should be determined by a healthcare professional.
Q2: What are the primary uses of PLE?
A: Primarily used as an oral photoprotective agent. Also investigated for various skin conditions like polymorphous light eruption, melasma, vitiligo, atopic dermatitis, and actinic keratosis.
Q3: How does PLE work to protect the skin?
A: PLE exerts antioxidant, anti-inflammatory, and immunomodulatory effects, protecting against UV-induced DNA damage, reducing inflammation, and modulating immune responses.
Q4: Are there any known drug interactions with PLE?
A: PLE may interact with medications metabolized by the CYP450 pathway. Limited clinical data exists regarding other specific drug interactions.
Q5: Can PLE be used during pregnancy or breastfeeding?
A: No. Use should be avoided during pregnancy and breastfeeding due to insufficient safety data.
Q6: What are the common side effects of PLE?
A: PLE is generally well-tolerated. Infrequent reports of mild gastrointestinal upset (nausea, bloating), fatigue, and headache. Allergic reactions can occur.
Q7: Is PLE safe for long-term use?
A: Limited data is available on the long-term use of PLE.
Q8: How should PLE be administered?
A: PLE is available in oral capsule form and topical creams. Oral administration is most common for photoprotection.
Q9: Is PLE effective in treating vitiligo?
A: PLE has shown some promise as an adjunctive therapy for vitiligo, particularly when combined with NB-UVB phototherapy. More research is needed to confirm its efficacy.
