Usage
- This topical medication is prescribed for the relief of pain and inflammation associated with musculoskeletal and joint disorders such as acute musculoskeletal pain (backache, arthritis, strains, sprains), osteoarthritis, rheumatoid arthritis, and low back pain.
- Pharmacological Classification: Topical analgesic; Non-steroidal anti-inflammatory drug (NSAID).
- Mechanism of Action: Aceclofenac and Methyl Salicylate inhibit cyclooxygenase (COX) enzymes, reducing the production of prostaglandins, which mediate pain and inflammation. Linoleic acid further contributes to the anti-inflammatory action. Menthol acts as a counterirritant, providing a cooling sensation that helps to relieve pain while also enhancing drug penetration. Benzyl Alcohol acts as a preservative.
Alternate Names
- Aceclofenac + Linseed Oil + Menthol + Methyl Salicylate
- Brand names: Kvik Plus Gel, Stednac Gel.
How It Works
- Pharmacodynamics: Aceclofenac and Methyl Salicylate work by inhibiting COX-1 and COX-2 enzymes, thereby reducing prostaglandin synthesis. This leads to a decrease in pain and inflammation. Linoleic acid, an omega-3 fatty acid, also possesses anti-inflammatory properties. Menthol produces a cooling sensation by activating TRPM8 receptors, which can mask pain perception. Methyl salicylate acts as a counterirritant, producing a warming sensation that distracts from the underlying pain.
- Pharmacokinetics: The gel is applied topically, and the active ingredients are absorbed through the skin. Systemic absorption of methyl salicylate can occur, especially with prolonged use or application to large areas. Aceclofenac is metabolized primarily in the liver. Methyl salicylate is metabolized to salicylic acid, which is then excreted in the urine. The other components’ metabolic pathways are not extensively studied.
- Mode of Action: The combination targets multiple pathways involved in pain and inflammation. COX enzyme inhibition reduces prostaglandin production, while menthol and methyl salicylate modulate pain perception through their effects on temperature receptors.
- Elimination Pathways: Aceclofenac and its metabolites are primarily excreted via the renal route. Methyl salicylate is metabolized to salicylic acid and its metabolites and is primarily excreted in the urine.
Dosage
Standard Dosage
Adults: Apply a thin layer to the affected area 3-4 times daily, or as directed by a physician. Do not rub vigorously.
Children: Not recommended for children under 12 years of age. Safety and efficacy have not been established.
Special Cases:
- Elderly Patients: Use with caution. Start with the lowest recommended dose and monitor for adverse effects.
- Patients with Renal Impairment: Use with caution, as systemic absorption of methyl salicylate can occur. Monitor renal function.
- Patients with Hepatic Dysfunction: Use with caution and monitor liver function.
- Patients with Comorbid Conditions: Use cautiously in patients with asthma, nasal polyps, bleeding disorders, gastrointestinal ulcers, or cardiovascular disease.
Clinical Use Cases
This medication is for topical use only and not indicated for systemic administration. It’s not applicable for Intubation, Surgical Procedures, Mechanical Ventilation, Intensive Care Unit (ICU) Use, or Emergency Situations.
Dosage Adjustments
Dose adjustments may be needed based on individual patient response and tolerability. For elderly patients and those with renal or hepatic dysfunction, start with the lowest dose and titrate as needed while monitoring for adverse effects.
Side Effects
Common Side Effects
- Application site reactions: itching, irritation, redness, burning sensation, dryness.
Rare but Serious Side Effects
- Blistering/swelling at the application site, increased/unusual pain at the application site.
- Allergic reactions (e.g., rash, hives, difficulty breathing, swelling of the face, lips, tongue, or throat).
- Salicylate intoxication (with methyl salicylate overuse).
Long-Term Effects
- Skin thinning or discoloration with prolonged use.
- Potential for systemic effects with prolonged use over large areas.
Adverse Drug Reactions (ADR)
- Severe allergic reactions, salicylate toxicity.
Contraindications
- Hypersensitivity to any of the ingredients (aceclofenac, benzyl alcohol, linoleic acid, menthol, methyl salicylate).
- Patients with aspirin-sensitive asthma or history of allergic reaction to other NSAIDs.
- Patients with active peptic ulcers or gastrointestinal bleeding.
Drug Interactions
- Other topical products applied to the same area.
- Oral NSAIDs: May increase risk of systemic adverse effects.
- Anticoagulants (e.g., warfarin): May increase bleeding risk.
- Consult a physician for comprehensive drug interaction screening, including CYP450 interactions.
Pregnancy and Breastfeeding
- Pregnancy: Consult with a physician. Limited human data are available. Animal studies have shown some risk of fetal harm. Use only if the potential benefit outweighs the risk.
- Breastfeeding: Consult with a physician before use. It is unknown if the drug is excreted in breast milk.
Drug Profile Summary
- Mechanism of Action: Inhibits COX enzymes, reduces prostaglandin synthesis; menthol and methyl salicylate provide counterirritant effects.
- Side Effects: Local skin reactions (itching, redness, burning). Rarely, allergic reactions or salicylate toxicity.
- Contraindications: Hypersensitivity, aspirin-sensitive asthma, active peptic ulcers, gastrointestinal bleeding.
- Drug Interactions: Oral NSAIDs, anticoagulants.
- Pregnancy & Breastfeeding: Consult a physician before use.
- Dosage: Adults: Apply thinly 3-4 times/day. Children: Not recommended under 12 years.
- Monitoring Parameters: Monitor for local skin reactions and, with prolonged/extensive use, for systemic side effects.
Popular Combinations
No specific popular combinations of this exact formulation are described. However, topical NSAIDs and counterirritants are often combined for synergistic analgesic and anti-inflammatory effects.
Precautions
- General Precautions: Apply to intact skin only. Avoid contact with eyes, mucous membranes, and open wounds. Do not use with occlusive dressings.
- Specific Populations: Consult a physician during pregnancy and breastfeeding. Use cautiously in children over 12, the elderly, and those with asthma, bleeding disorders, or peptic ulcers.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Aceclofenac + Benzyl Alcohol + Linoleic Acid + Menthol + Methyl Salicylate?
A: Adults: Apply a thin layer to the affected area 3-4 times daily. Not recommended for children under 12.
Q2: Can I use this gel on open wounds?
A: No, avoid applying the gel to open wounds, broken skin, or infected areas. Apply only to intact skin.
Q3: I am pregnant. Can I use this gel?
A: Consult your physician before use during pregnancy. There are limited human data, and animal studies suggest some risk.
Q4: I am breastfeeding. Can I use this medication?
A: Consult your physician before use while breastfeeding, as its safety profile during lactation is not well-established.
Q5: Can I use a heating pad after applying the gel?
A: No, it’s generally not recommended to use heat with this gel, as it can increase absorption and the risk of side effects. Consult your physician.
Q6: What should I do if I accidentally get the gel in my eyes?
A: Immediately rinse your eyes thoroughly with plenty of cool water and seek medical advice if irritation persists.
Q7: Can I take oral NSAIDs while using this gel?
A: Consult your physician before combining this gel with oral NSAIDs, as it may increase the risk of systemic side effects.
Q8: How long can I use this gel?
A: Use as directed by your physician. If symptoms persist beyond the recommended duration, consult your physician.
Q9: What are the signs of an allergic reaction to this gel?
A: Signs of an allergic reaction include rash, hives, itching, swelling (especially of the face, tongue, or throat), and difficulty breathing. Seek immediate medical attention if you experience these symptoms.
