aceclofenac/methyl salicylate/menthol/linseed oil/capsaicin

Action and Spectrum

Actions and Spectrum: 

aceclofenac/methyl Salicylate/menthol/linseed Oil/capsaicin is a combination medication commonly used topically for pain relief and anti-inflammatory purposes.  

• aceclofenac: It is a nonsteroidal anti-inflammatory drug (NSAID) that helps reduce pain and inflammation. It generally works by inhibiting the production of prostaglandins, which are chemicals that promote inflammation and pain in the body. aceclofenac treats conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. 
• methyl Salicylate: methyl salicylate is a topical analgesic in the salicylate drug class. It relieves pain by producing a cooling sensation on the skin and increasing blood flow to the affected area. It often relieves minor aches and pains associated with conditions like muscle strains, sprains, and arthritis. 
• menthol: menthol is a topical analgesic that produces a cooling sensation when typically applied to the skin. It generally works by activating cold-sensitive receptors in the skin, which can help alleviate pain and discomfort. menthol is commonly used in topical products for muscle and joint pain relief. 
• linseed Oil (Flaxseed Oil): It is often included in topical preparations for its emollient and moisturizing properties. While it doesn’t directly address pain or inflammation, it can helps improve the texture and hydration of the skin, which may benefit conditions like dry or irritated skin. 
• capsaicin: It is an active compound found in chili peppers. It is used topically in some pain relief products because it blocks nerve pain signals. Initially, it may cause a burning sensation, but over time, it can desensitize nerve endings and relieve certain types of pain, such as neuropathic pain. 

Combining these ingredients in a topical formulation is intended to provide pain relief and anti-inflammatory effects. It may manage musculoskeletal conditions like arthritis, muscle strains, and joint pain. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Anxiety 

Apnoea 

Asystole 

Burning 

Colic 

Constipation 

Contact dermatitis 

Convulsions 

Delirium 

Dermatitis 

Diarrhoea 

Diarrhoea 

Dizziness 

Dyspepsia 

Excitement 

Flatulence 

Gastritis 

Irritation 

Nausea 

Nausea 

Pruritis 

Rash 

Skin redness 

Stinging 

Ulcerative stomatitis 

Vertigo 

Vomiting 

Vomiting 

Warm 

Black Box Warning

Black Box Warning: 

None 

Contraindication / Caution

Contraindication/Caution: 

Contraindication 

• Allergy or Hypersensitivity: Individuals allergic to any of the active ingredients in the combination (aceclofenac, methyl Salicylate, menthol, linseed Oil, or capsaicin) should not use this product.  
• Skin Conditions: If you have certain skin conditions, such as eczema or psoriasis, it’s essential to consult with the healthcare professional before using this combination, as it may exacerbate these conditions or cause skin irritation. 
• Pregnancy and Breastfeeding: The safety of this combination during pregnancy and breastfeeding has not been well established.  
• Children and Infants: This combination is generally not recommended for use in children or infants unless specifically prescribed by a healthcare provider. Children may be more sensitive to the active ingredients, and their use should be under close medical supervision. 
• Aspirin or Salicylate Allergy: Individuals with a known allergy to aspirin or salicylates (related to methyl Salicylate) should avoid products containing methyl Salicylate. 
• Severe Liver or Kidney Disease: People with severe liver or kidney disease may need dosage adjustments or should avoid this medication altogether, as these organs may metabolize some ingredients. 
• Certain Medications: There can be potential drug interactions between this combination and other medications you may be taking. Always inform the healthcare provider about all medications, including over-the-counter and herbal supplements, that you are using. 
• Previous Skin Reactions: If you have had previous adverse skin reactions to topical medications, including allergic reactions or irritation, discussing this with your healthcare provider before using this combination is essential. 
• Use on Sensitive Areas: Avoid applying this combination to sensitive areas such as the face, eyes, mucous membranes, or genitalia, as it may cause irritation or discomfort. 

Caution 

• Skin Sensitivity: Some individuals may have sensitive skin or be prone to allergies. Before applying this combination, it’s essential to perform a patch test on the small skin area  
• Avoid Contact with the Eyes and also Mucous Membranes: Avoid getting this drug in your eyes, mouth, nose, or any other mucous membranes, as it can cause irritation and discomfort. If accidental contact occurs, rinse the affected area with plenty of water. 
• Duration of Use: Follow the recommended duration of use specified on the product label or as advised by a healthcare provider. Prolonged use of topical pain relief medications can sometimes lead to skin sensitization or other adverse effects. 
• Wash Hands Thoroughly: After applying the medication, wash your hands thoroughly to avoid accidentally transferring it to your eyes, nose, or mouth. 
• Do Not Bandage Tightly: Do not tightly bandage/wrap the treated area unless directed by a healthcare provider. Tight bandaging can increase the absorption of the active ingredients and may lead to adverse effects. 
• Heat Sources: Avoid using heating pads, hot water bottles, or other heat sources on the treated area immediately after applying this medication, as it can increase the absorption of some active ingredients and potentially cause skin irritation or burns. 
• Avoid Sun Exposure: Some ingredients in this combination, such as menthol and capsaicin, can make the skin more sensitive to sunlight. Protecting the treated area from the direct sunlight and UV exposure is advisable, especially if you are using this medication during the day. 
• Consult a Healthcare Provider: If you are in pregnant, breastfeeding, have underlying medical conditions, or are taking other medications, consult a healthcare provider before using this combination. They can guide you on whether it’s safe and appropriate for your situation. 
• Use as Directed: Always follow the recommended dosage and usage instructions provided on the product label or as your healthcare provider prescribes.  
• Discontinue Use for Severe Irritation: If you experience severe skin irritation, a rash, or any other concerning symptoms after using this medication, discontinue use immediately and seek medical attention. 

Pregnancy / Lactation

Pregnancy consideration:  

US FDA pregnancy category: Not assigned. 

Lactation:   

Excreted into human milk: Not known. 

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 
• <b>Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    
• Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence, these categories of drugs need to be avoided by pregnant women.    
• Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology: 

aceclofenac/methyl Salicylate/menthol/linseed Oil/capsaicin is a topical combination medication with a multifaceted pharmacology. aceclofenac, a nonsteroidal anti-inflammatory drug (NSAID), inhibits prostaglandin synthesis, reducing pain and inflammation. methyl Salicylate acts as a topical analgesic by producing a cooling effect and enhancing blood flow to the application site. menthol provides additional topical analgesia through its cooling action on nerve receptors.

linseed Oil offers emollient and moisturizing properties. capsaicin initially induces a burning sensation but desensitizes nerve endings, modulating pain perception. Together, these components offer a synergistic approach to pain relief by reducing inflammation, altering pain perception, and soothing discomfort, making it suitable for musculoskeletal and inflammatory conditions when applied topically to the affected area. 

Pharmacodynamics: 

Mechanism of action: aceclofenac/methyl Salicylate/menthol/linseed Oil/capsaicin is a topical combination medication for pain relief and anti-inflammatory purposes.  

aceclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that works by typically inhibiting the action of the enzyme cyclooxygenase (COX).  

methyl Salicylate is a topical analgesic that typically produces a cooling sensation when applied to skin. It generally works by dilating blood vessels in the area of application, which increases blood flow and helps to alleviate pain. Additionally, it may have a counterirritant effect, where the cooling sensation temporarily distracts from underlying pain. 

menthol is another topical analgesic that provides a cooling sensation on the skin. It works by activating cold-sensitive receptors known as TRPM8 receptors. These receptors are part of ion channels’ transient receptor potential (TRP) family. Activation of TRPM8 receptors can help alleviate pain and discomfort. 

linseed Oil is often included in topical preparations for its emollient and moisturizing properties. While it does not have a direct pain-relieving or anti-inflammatory mechanism, it can help improve the texture and hydration of the skin, which may be beneficial for conditions associated with dry or irritated skin. 

capsaicin is the active compound typically found in chili peppers. It initially stimulates and then desensitizes nerve endings in the skin. When applied topically, it activates TRPV1 receptors, leading to a burning sensation and the release of substance P. Over time, repeated exposure to capsaicin reduces substance P and desensitization of the nerve endings, providing pain relief, especially for neuropathic pain. 

Pharmacokinetics: 

Absorption 

When applied topically, aceclofenac is absorbed through the skin, but the absorption is generally limited compared to oral administration. 

methyl Salicylate is readily absorbed through the skin, and its absorption is influenced by factors such as skin integrity and the concentration of the compound in the topical product. 

menthol is absorbed through the skin, depending on concentration and skin permeability. 

linseed Oil is applied topically to the skin and is not significantly absorbed systemically. 

capsaicin is absorbed through the skin upon topical application. 

Distribution 

After absorption, aceclofenac can enter the bloodstream to some extent, but it remains primarily localized at the application site. 

After absorption, methyl Salicylate can be distributed systemically but is often localized to the application area. 

After absorption, menthol acts locally to provide a cooling sensation and does not typically exhibit significant systemic distribution. 

linseed Oil remains primarily localized at the site of application. 

capsaicin remains primarily at the site of application, where it initially induces a burning sensation before desensitizing nerve endings. 

Metabolism 

aceclofenac undergoes hepatic metabolism to form its active metabolite, diclofenac. This metabolic process primarily occurs after oral administration and is less relevant when applied topically. 

methyl Salicylate can undergo hydrolysis in the body to release salicylic acid, which can be further metabolized. 

menthol is metabolized in the liver into various metabolites, then excreted. 

linseed Oil is not metabolized to a significant extent when applied topically. 

capsaicin can undergo metabolism in the liver by enzymes such as cytochrome P450. 

Elimination and Excretion 

The elimination of aceclofenac and its metabolites typically involves renal excretion. 

Salicylic acid and its metabolites are primarily excreted through renal clearance. 

Metabolites of menthol are primarily excreted through renal and biliary routes. 

linseed Oil is not subject to significant systemic excretion. 

Metabolites of capsaicin are excreted through various routes, including renal excretion. 

Adminstartion

Administration: 

aceclofenac/methyl Salicylate/menthol/linseed oil/capsaicin is a combination medication typically administered topically, which is applied to the skin.  

Clean the Affected Area: Clean the affected skin with mild soap and water before applying the medication.  

Shake the Container (if applicable): If the medication comes in a lotion, cream, gel, or spray, it’s a good practice to shake the container well before use to ensure an even distribution of the active ingredients. 

Apply a Thin Layer: Apply a thin, uniform layer of the medication to the affected area. You can use your clean fingers or a clean applicator to do this. Avoid using excessive amounts of the medication. 

Massage Gently: After applying the medication, you can gently massage it into the skin. This helps absorb the active ingredients and can enhance its effectiveness. 

Wash Hands: After applying the drug, wash your hands thoroughly to avoid accidentally transferring it to your eyes, nose, or mouth. 

Frequency of Application: Follow the dosing instructions provided on the product label or as the healthcare provider prescribes. Some products may be applied 2-3 times daily, while others may have different dosing schedules. 

Avoid Bandaging Tightly: Unless directed by a healthcare provider, avoid tightly bandaging or wrapping the treated area, as this can increase the absorption of the active ingredients and may lead to adverse effects. 

Heat Sources: Do not use heating pads, hot water bottles, or other heat sources on the treated area immediately after applying this medication, as it can increase the absorption of some active ingredients and potentially cause skin irritation or burns. 

Avoid Sun Exposure: Some ingredients in this combination, such as menthol and capsaicin, can make the skin more sensitive to sunlight. Protect the treated area from the direct sunlight and UV exposure, mainly if you use this medication daily. 

Duration of Use: Use the medication for the prescribed duration or as your healthcare provider recommends. Prolonged use of topical pain relief medications can sometimes lead to skin sensitization or other adverse effects. 

Consult a Healthcare Provider: If you generally any questions or concerns about the application of this medication or if you experience severe skin irritation or adverse reactions, consult a healthcare provider for guidance. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: aceclofenac/methyl salicylate/menthol/linseed oil/capsaicin 

Why do we use aceclofenac/methyl salicylate/menthol/linseed oil/capsaicin? 

aceclofenac/methyl salicylate/menthol/linseed oil/capsaicin is a topical combination medication for its pain-relieving and anti-inflammatory properties. This combination of active ingredients can be used to address various conditions and symptoms, including: 

Muscle and Joint Pain: This combination is commonly used to alleviate pain and also discomfort associated with muscle strains, sprains, and joint pain. It may be applied to the affected area to relieve and reduce inflammation. 

Arthritis: Individuals with osteoarthritis, rheumatoid arthritis, or other forms of arthritis may use this combination to help manage pain and inflammation in the affected joints. 

Back Pain: It can be applied to the lower back or other areas of the spine to relieve pain caused by conditions like lumbar spondylosis or herniated discs. 

Sports Injuries: Athletes and active individuals may use this medication to address pain from sports-related injuries, such as muscle pulls, ligament sprains, or contusions. 

Neuropathic Pain: Some individuals with neuropathic pain conditions, such as diabetic neuropathy or post-herpetic neuralgia, may find relief by applying this combination to the affected areas. 

Localized Pain: It can be used for localized pain relief in specific body areas, such as the shoulders, knees, elbows, or hands. 

Postoperative Pain: In some cases, healthcare providers may recommend using this medication after specific surgical procedures to manage postoperative pain and inflammation. 

Generalized Aches and Pains: People experiencing generalized body aches and pains, often due to overexertion or physical stress, may use this medication for relief. 

Chronic Pain Conditions: This combination may be considered part of the multimodal approach to managing chronic pain conditions, such as fibromyalgia when recommended by a healthcare provider. 

Localized Swelling and Inflammation: Some ingredients’ anti-inflammatory properties can help reduce localized swelling and inflammation associated with various injuries or conditions.