Usage
This combination of Alcohol, Diclofenac diethylamine, and Methyl salicylate is primarily prescribed for topical relief of pain and inflammation associated with musculoskeletal and joint disorders such as:
- Muscle strains and sprains
- Backache
- Arthritis (including osteoarthritis and rheumatoid arthritis, but not for systemic treatment)
- Bruises
- Joint pain
- Tendonitis
- Bursitis
Pharmacological Classification:
- Topical non-steroidal anti-inflammatory drug (NSAID) and analgesic.
- Counterirritant (Methyl Salicylate and Menthol).
Mechanism of Action:
Diclofenac, a non-steroidal anti-inflammatory drug (NSAID), works by inhibiting cyclooxygenase (COX) enzymes. These enzymes are involved in producing prostaglandins, which are chemical messengers responsible for pain and inflammation. Methyl salicylate, also an NSAID and a counterirritant, works similarly. Menthol acts as a counterirritant, causing a cooling sensation that can help distract from deeper pain. Alcohol acts as a penetration enhancer, facilitating the absorption of diclofenac and methyl salicylate through the skin.
Alternate Names
The combination does not have a universally recognized International Nonproprietary Name (INN). It is often referred to by its component ingredients.
Brand Names: Numerous brand names exist depending on the region and manufacturer’s formulation. Some common brand name examples (these may vary regionally) include:
- Volini
- Diclogesic Plus
- Moov
- Iodex
How It Works
Pharmacodynamics:
Diclofenac and methyl salicylate both inhibit COX-1 and COX-2 enzymes, thereby reducing the production of prostaglandins, substances responsible for pain and inflammation. Menthol activates TRPM8 receptors, which are cold-sensitive receptors, leading to a sensation of cooling and providing analgesic effects.
Pharmacokinetics:
The combination is applied topically, and the active ingredients are absorbed through the skin. Absorption is enhanced by the presence of alcohol. Diclofenac is metabolized primarily in the liver, and metabolites are excreted mainly in the urine. Methyl salicylate is also metabolized in the liver and excreted in urine. Menthol is metabolized in the liver, and its metabolites are excreted in urine and bile. Elimination pathways are primarily hepatic/renal.
Dosage
Standard Dosage
Adults:
Apply a thin layer of the medication to the affected area 3-4 times daily or as directed by a physician. Gently massage the gel/cream into the skin until absorbed. Do not exceed the recommended dose.
Children:
Use in children below 12 years of age is generally not recommended unless specifically advised by a physician. Dosing will be weight/age dependent. Follow the physician’s prescription carefully.
Special Cases:
-
Elderly Patients: Use with caution. Monitor for adverse effects.
-
Patients with Renal Impairment: Use with caution. Dose adjustment may be required.
-
Patients with Hepatic Dysfunction: Use with caution. Dose adjustment may be required.
-
Patients with Comorbid Conditions: Exercise caution in patients with a history of gastrointestinal bleeding, peptic ulcers, asthma, or cardiovascular disease.
Clinical Use Cases
The combination is not indicated for clinical use cases like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Its use is primarily for topical pain relief.
Dosage Adjustments
Dosage adjustments may be needed for patients with renal or hepatic impairment. Consult with a physician for individualized guidance.
Side Effects
Common Side Effects:
- Local skin irritation (burning, stinging, itching, redness, dryness)
- Contact dermatitis
- Rash
Rare but Serious Side Effects:
- Allergic reactions (difficulty breathing, swelling of face, lips, tongue, or throat)
- Gastrointestinal bleeding (rare with topical use)
- Increased risk of cardiovascular events (rare with topical use, mainly a concern with systemic NSAIDs)
- Kidney problems (rare with topical use, mainly a concern with systemic NSAIDs)
Long-Term Effects:
Prolonged use can potentially lead to skin thinning or other skin changes.
Adverse Drug Reactions (ADR):
See “Rare but Serious Side Effects.”
Contraindications
- Hypersensitivity to any of the components
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
- Third trimester of pregnancy
- Open wounds or broken skin
Drug Interactions
- Oral NSAIDs (Increased risk of gastrointestinal and systemic side effects)
- Anticoagulants (Increased risk of bleeding)
- Certain medications (e.g., methotrexate, lithium) - consult with a physician
Pregnancy and Breastfeeding
Consult a physician before use during pregnancy or breastfeeding. Use is generally avoided during the third trimester. It is not known if topical diclofenac passes into breast milk.
Drug Profile Summary
-
Mechanism of Action: Inhibits COX enzymes, reducing prostaglandin synthesis. Provides a cooling sensation via TRPM8 receptors activation (menthol).
-
Side Effects: Local skin reactions. Rare: allergic reactions, GI bleeding, cardiovascular events.
-
Contraindications: Hypersensitivity, aspirin-induced asthma, 3rd-trimester pregnancy, open wounds.
-
Drug Interactions: Oral NSAIDs, anticoagulants, consult a physician for others.
-
Pregnancy & Breastfeeding: Consult a physician before use. Avoid in the third trimester.
-
Dosage: Apply topically 3-4 times daily to affected area.
-
Monitoring Parameters: Local skin reactions. If used systemically long-term, monitor for GI, cardiovascular, and renal adverse effects (though these are unlikely from topical use).
Popular Combinations
This combination is itself a popular combination for topical pain relief. Other counterirritants like capsaicin may be included in some formulations.
Precautions
- Avoid contact with eyes and mucous membranes.
- Wash hands thoroughly after application.
- Do not use on broken or damaged skin.
- Avoid prolonged sun exposure.
- Consult a doctor before using if pregnant, breastfeeding, or have other medical conditions.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Alcohol + Diclofenac diethylamine + Methyl Salicylate?
A: Apply a thin layer to the affected area 3-4 times daily or as directed by a physician.
Q2: Can I use this combination if I am pregnant?
A: Consult a physician before use during pregnancy, especially during the third trimester.
Q3: Can this be used on open wounds?
A: No, do not apply this combination to broken skin or open wounds.
Q4: Can I use this with other pain relievers like ibuprofen?
A: Consult a physician before using this combination with oral NSAIDs like ibuprofen due to the increased risk of adverse effects.
Q5: What should I do if I experience severe skin irritation?
A: Discontinue use and consult with a physician.
Q6: Can children use this combination?
A: Use in children below 12 is generally not recommended unless prescribed by a doctor.
Q7: Can I drink alcohol while using this medication?
A: Moderate alcohol consumption is unlikely to interact significantly with topical application, but excessive alcohol use while using any NSAID, even topically, is not advisable. Always follow national guidelines and consult with your physician.
Q8: How long can I use this medication?
A: Do not use for more than 7 days unless directed by a physician.
Q9: What if I accidentally ingest the medication?
A: Seek immediate medical attention or contact a poison control center.