Usage
This topical medication is used to relieve musculoskeletal pain associated with conditions such as sprains, strains, arthritis, bruises, and backaches. It combines the anti-inflammatory action of a nonsteroidal anti-inflammatory drug (NSAID) with the counterirritant effects of camphor, menthol, and methyl salicylate.
Alternate Names
Setolac Gel, Proxym Gel, S-Etodolac + Camphor + Menthol + Methyl Salicylate + Linseed Oil Gel
How It Works
Pharmacodynamics: S-etodolac, a nonsteroidal anti-inflammatory drug (NSAID), inhibits cyclooxygenase (COX) enzymes, primarily COX-2. This leads to a decrease in prostaglandin synthesis, reducing pain and inflammation. Camphor, menthol, and methyl salicylate act as counterirritants, producing sensations of warmth and coolness that distract from the pain. Linseed oil serves as an emollient, softening and soothing the skin, and may enhance the absorption of the active ingredients.
Pharmacokinetics: S-etodolac is absorbed through the skin, reaching therapeutic levels in the affected area. Limited information is available on the percutaneous absorption of the other components. Methyl salicylate is metabolized to salicylic acid. S-etodolac is primarily metabolized in the liver and excreted in the urine. Camphor is highly lipophilic, extensively metabolized, and excreted primarily in the urine. Menthol is absorbed percutaneously, metabolized in the liver, and excreted in urine and bile. Methyl salicylate is hydrolyzed to salicylic acid, and then metabolized by conjugation with glycine or glucuronic acid and eliminated renally.
Dosage
Standard Dosage
Adults:
Apply a thin layer to the affected area 3-4 times daily. Do not apply to broken or irritated skin.
Children:
Use in children under 12 years old is generally not recommended unless directed by a physician. Pediatric dosing should be determined by a physician based on the child’s age, weight, and the specific condition being treated.
Special Cases:
- Elderly Patients: Use with caution. Start with a lower dose if necessary.
- Patients with Renal Impairment: Dosage adjustment may be necessary; consult a physician.
- Patients with Hepatic Dysfunction: Dosage adjustment may be necessary; consult a physician.
- Patients with Comorbid Conditions: Consult a physician.
Clinical Use Cases
This medication is intended for topical use only and is not typically used in clinical settings like intubation, surgical procedures, mechanical ventilation, ICU, or emergency situations.
Dosage Adjustments
Dose adjustments may be necessary for patients with renal or hepatic impairment. A physician should be consulted for specific recommendations.
Side Effects
Common Side Effects:
Skin irritation, redness, itching, burning or stinging sensation.
Rare but Serious Side Effects:
Allergic reactions (rash, hives, difficulty breathing, swelling of the face, lips, tongue, or throat), severe skin irritation (blistering, peeling).
Long-Term Effects:
Long-term use of topical NSAIDs can potentially lead to skin thinning or other local skin reactions. Systemic effects are rare with topical application but might occur with prolonged use, high dosages, or damaged skin.
Adverse Drug Reactions (ADR):
Severe allergic reactions, skin reactions.
Contraindications
Hypersensitivity to any of the components, including S-etodolac, camphor, menthol, methyl salicylate, or linseed oil. History of allergic reaction to aspirin or other NSAIDs. Third trimester of pregnancy. Open wounds or damaged skin.
Drug Interactions
May interact with oral anticoagulants (warfarin), other topical analgesics, or oral NSAIDs. Concomitant use with other salicylates or NSAIDs should be avoided due to increased risk of adverse reactions.
Pregnancy and Breastfeeding
Avoid use during the third trimester. Consult a doctor before use during the first and second trimesters. Consult a doctor before use during breastfeeding.
Drug Profile Summary
- Mechanism of Action: S-etodolac inhibits COX enzymes and prostaglandin synthesis. Camphor, menthol, and methyl salicylate act as counterirritants.
- Side Effects: Skin irritation, redness, allergic reactions.
- Contraindications: Hypersensitivity, third-trimester pregnancy.
- Drug Interactions: Oral anticoagulants, other topical analgesics, oral NSAIDs.
- Pregnancy & Breastfeeding: Consult a doctor before use, especially during the third trimester and while breastfeeding.
- Dosage: Apply a thin layer 3-4 times daily.
- Monitoring Parameters: Observe for local skin reactions or any signs of systemic effects.
Popular Combinations
This formulation itself is a popular combination, and it’s not typically combined with other drugs for topical use.
Precautions
- General Precautions: Avoid contact with eyes, mucous membranes, or broken skin. Wash hands thoroughly after application.
- Specific Populations: Consult physician for use in pregnant women, breastfeeding mothers, and children under 12.
- Lifestyle Considerations: Avoid activities that increase skin temperature immediately after application.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Camphor + Linseed Oil + Menthol + Methyl Salicylate + S-Etodolac?
A: Adults: Apply a thin layer to the affected area 3-4 times per day. Children under 12: Consult a physician.
Q2: Can this gel be used during pregnancy?
A: It should be avoided during the third trimester. Consult a doctor before using it during the first and second trimesters.
Q3: What are the common side effects?
A: Common side effects include mild skin irritation, redness, itching, and a burning or stinging sensation at the application site.
Q4: Are there any drug interactions I should be aware of?
A: It may interact with oral anticoagulants (e.g., warfarin) and other NSAIDs or salicylates (taken orally or applied topically).
Q5: How does this gel work to relieve pain?
A: S-etodolac reduces inflammation by inhibiting COX enzymes. Camphor, menthol, and methyl salicylate provide counterirritant effects, creating distracting sensations of warmth and coolness.
Q6: Can I apply this gel to broken skin?
A: No, it should not be applied to open wounds, cuts, or irritated skin.
Q7: Can I use a heating pad after applying this gel?
A: No, avoid applying heat to the treated area, as this can increase the risk of side effects.
Q8: How long can I use this gel?
A: Consult your physician for the appropriate duration of treatment. Do not use for more than 7 days unless directed by a doctor.
Q9: What should I do if I accidentally get the gel in my eyes?
A: Flush your eyes with plenty of water and seek medical advice if irritation persists.
Q10: Is this gel safe to use if I have kidney or liver problems?
A: Consult your physician before using this gel if you have any kidney or liver conditions, as dosage adjustments may be necessary.
