Usage
This topical medication is primarily used for the management of scars resulting from various causes, including surgical scars, burns, stretch marks, acne scars, scars from breast amputations, and other traumatic skin injuries. It acts as an anti-inflammatory, antibacterial, and counter-irritant. It promotes wound healing, improves skin texture and appearance, and relieves pain and inflammation associated with skin injuries. It can also be used for the treatment of burns and bruises/hematomas. Its pharmacological classification is dermatological agent.
The mechanism of action involves a synergistic effect of the three components:
- Extractum Cepae-Cepalin (onion extract): Inhibits Prostaglandin F2-alpha (PGF2-α) synthesis, reducing inflammation and hypertrophic scarring. It also has antioxidant and antimicrobial properties.
- Heparin: Acts as an anti-inflammatory and anticoagulant, promoting blood flow to the injured site, aiding in the retention of moisture in the scar tissue and facilitating healing.
- Allantoin: Acts as a keratolytic agent, removing dead skin cells and softening the skin. It promotes cell proliferation and stimulates tissue regeneration, thus quickening wound healing.
Alternate Names
Some alternate names and brand names include Thromboscar Gel, Scanil Gel, Contractubex, and Scarlite Gel.
How It Works
Pharmacodynamics: The combined effects of the three ingredients contribute to scar reduction and improved wound healing. Extractum Cepae-Cepalin reduces inflammation and scar tissue formation, heparin improves blood flow and hydration, and allantoin promotes cell regeneration and softens the skin.
Pharmacokinetics: This medication is applied topically, and systemic absorption is minimal. Therefore, detailed pharmacokinetic data (absorption, distribution, metabolism, and excretion) are not typically relevant for topical application.
Mode of Action: Extractum Cepae-Cepalin inhibits PGF2-α, a key mediator in inflammation and scar formation. Heparin, as an anticoagulant, inhibits thrombin formation, reducing inflammation and improving blood flow. Allantoin promotes cell proliferation, tissue regeneration, and keratolysis. No specific receptor binding, enzyme inhibition, or neurotransmitter modulation beyond these mechanisms are detailed in the provided sources.
Dosage
Standard Dosage
Adults: Apply a thin layer to the clean and dry affected area 1-2 times daily, or as directed by the physician. Gently massage until absorbed.
Children: Use in children under 1 year of age is not recommended. For children over 1 year, consult a pediatrician for appropriate dosage and application guidelines.
Special Cases:
- Elderly Patients: No specific dose adjustments are typically necessary; however, consider skin fragility and the potential for irritation.
- Patients with Renal Impairment: No specific dose adjustments are needed for topical application, as systemic absorption is minimal.
- Patients with Hepatic Dysfunction: No specific dose adjustments are necessary for topical application, as systemic absorption is minimal.
- Patients with Comorbid Conditions: Caution is advised for patients with bleeding disorders or those taking anticoagulants. Consult a physician for personalized advice.
Clinical Use Cases
The provided sources primarily focus on scar management and wound healing. Dosage recommendations for specific clinical settings, like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations, are not available. It is not typically used in these scenarios.
Dosage Adjustments
No specific dosage modifications based on patient factors are detailed in the sources. For any concurrent medications, underlying skin conditions, or specific concerns, physician consultation is recommended.
Side Effects
Common Side Effects:
- Itching
- Redness (erythema)
- Tingling sensation
- Mild burning sensation upon application
- Skin irritation
Rare but Serious Side Effects:
- Allergic reactions (e.g., rash, hives, difficulty breathing)
- Severe skin irritation or inflammation
Long-Term Effects: No specific long-term side effects from prolonged topical use are documented.
Adverse Drug Reactions (ADR): Clinically significant ADRs would primarily involve severe allergic reactions or skin reactions requiring discontinuation of the medication and appropriate management.
Contraindications
- Hypersensitivity to any of the ingredients (allantoin, heparin sodium, extractum cepae-cepalin, or parabens)
- Open or unhealed wounds
- Application to mucous membranes (eyes, nose, mouth, genitals)
- Infants under 1 year of age
Drug Interactions
Limited information is available on specific drug interactions. However, caution is advised when used concurrently with other topical medications, especially those containing anti-inflammatory agents or antibiotics. Concomitant use of light therapy, sun lamps, or harsh irritants should be avoided.
Pregnancy and Breastfeeding
- Pregnancy: Consult a physician before use. Animal studies suggest potential fetal risk, though human data are limited. Use only if the benefits outweigh the risks.
- Breastfeeding: Consult a physician before use. Limited data are available on breast milk excretion and potential effects on the infant.
Drug Profile Summary
- Mechanism of Action: Anti-inflammatory, antibacterial, keratolytic, wound healing
- Side Effects: Itching, redness, tingling, irritation
- Contraindications: Hypersensitivity, open wounds, mucous membranes, infants
- Drug Interactions: Limited data; caution with other topical agents
- Pregnancy & Breastfeeding: Consult a physician
- Dosage: Apply a thin layer 1-2 times daily
- Monitoring Parameters: Observe for skin irritation or allergic reactions
Popular Combinations
Not applicable. This is a fixed combination product.
Precautions
- General Precautions: Pre-screening for allergies, metabolic disorders, or organ dysfunction is generally not required for topical use due to minimal systemic absorption.
- Specific Populations: See Pregnancy and Breastfeeding sections. Exercise caution in children and the elderly due to potential skin sensitivity.
- Lifestyle Considerations: No specific lifestyle restrictions are typically associated with this topical medication. However, avoid concomitant use with other topical medications, light therapy, or harsh irritants.
FAQs (Frequently Asked Questions)
A: Apply a thin layer to the clean and dry affected area 1-2 times daily or as directed by the physician.
Q2: Can this gel be used on open wounds?
A: No, it is contraindicated for open or unhealed wounds.
Q3: What are the common side effects?
A: Common side effects include itching, redness, tingling, and mild irritation.
Q4: Can pregnant or breastfeeding women use this medication?
A: Consult a physician before use during pregnancy or breastfeeding. While limited human data suggests low risk, animal studies indicate potential fetal risk, and the effects on nursing infants are not well established.
Q5: Are there any drug interactions I should be aware of?
A: Limited data on drug interactions exist. Caution is advised when using other topical medications concurrently, especially anti-inflammatory agents or antibiotics.
Q6: How long does it take to see results?
A: Scar improvement is a gradual process. Consult your physician for expectations regarding your specific scar type and condition. Continued use as prescribed is essential for optimal results.
Q7: Can I use this gel with light therapy or sun lamps?
A: No, concomitant use with light therapy, sun lamps, or harsh irritants should be avoided.
Q8: What should I do if I experience severe skin irritation?
A: Discontinue use and consult your physician immediately.
Q9: Can this gel be used on children?
A: It is not recommended for children under 1 year old. For older children, consult a pediatrician.
Q10: How should I store this medication?
A: Store at room temperature (20-25°C) away from direct sunlight and heat, and out of reach of children.
