Usage
This combination medication is primarily used topically for the relief of musculoskeletal pain associated with conditions such as:
- Sprains
- Strains
- Osteoarthritis
- Rheumatoid arthritis
- Back pain
Pharmacological Classification: This is a combination product with multiple classifications:
- Diclofenac: Nonsteroidal anti-inflammatory drug (NSAID)
- Lidocaine: Local anesthetic
- Menthol & Methyl Salicylate: Counterirritants
- Tramadol: Opioid analgesic
- Linseed Oil: Anti-inflammatory agent
- Benzyl Alcohol: Preservative, local anesthetic
Mechanism of Action: This combination targets pain through multiple pathways. Diclofenac inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis, thus decreasing inflammation and pain. Lidocaine blocks sodium channels, inhibiting nerve impulse transmission and providing local anesthesia. Menthol and methyl salicylate act as counterirritants, creating cooling and warming sensations that distract from pain. Tramadol binds to mu-opioid receptors in the central nervous system, altering pain perception. Linseed oil, rich in alpha-linolenic acid, further contributes to anti-inflammatory effects. Benzyl alcohol acts as a preservative and also has weak local anesthetic properties.
Alternate Names
This combination, lacking a specific International Nonproprietary Name (INN), is typically referenced by its constituent drugs. Marketing varies by manufacturer, leading to different brand names, such as “Dolig Gel,” “Imore Gel,” and “Synofia Gel.” Some manufacturers might use variations on these names.
How It Works
Pharmacodynamics: The combined effects of the ingredients produce analgesia and reduce inflammation at the application site. Diclofenac reduces prostaglandin synthesis; lidocaine provides local anesthetic action; menthol and methyl salicylate create counterirritant effects; and tramadol acts on opioid receptors for pain relief. Linseed oil adds to the anti-inflammatory action, while benzyl alcohol primarily acts as a preservative with minor local anesthetic effects.
Pharmacokinetics: The ingredients are absorbed through the skin to varying degrees. Diclofenac and methyl salicylate are absorbed systemically to a small extent. Tramadol has limited systemic absorption when applied topically. Lidocaine, menthol, and linseed oil have minimal systemic absorption. Metabolism and elimination pathways differ for each component, with diclofenac and tramadol being metabolized primarily in the liver and excreted renally. Methyl salicylate is metabolized to salicylic acid and excreted renally. Lidocaine is metabolized in the liver.
Dosage
Standard Dosage
Adults:
Apply a thin layer to the affected area 3-4 times daily. The amount will depend on the size of the area. Do not exceed the recommended dose or duration.
Children:
This combination is generally not recommended for use in children under 14 years of age. Some sources suggest contraindication for children under 2, while others suggest caution for children between 2 and 12. Pediatric use requires careful consideration and should be directed by a physician.
Special Cases:
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Elderly Patients: Use with caution. Due to potential age-related decrease in hepatic and renal function, consider dose reduction and monitor closely.
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Patients with Renal Impairment: Use with caution. Dose adjustment may be required based on creatinine clearance. Tramadol, diclofenac, and methyl salicylate are renally cleared.
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Patients with Hepatic Dysfunction: Use with caution. Diclofenac and tramadol are metabolized in the liver. Dose adjustment may be necessary.
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Patients with Comorbid Conditions: Exercise particular caution in patients with asthma, cardiovascular disease, or a history of gastrointestinal bleeding. This combination can exacerbate these conditions.
Clinical Use Cases The provided sources focus on pain relief from musculoskeletal conditions. There is no data supporting its use in clinical settings like intubation, surgical procedures, mechanical ventilation, or emergency situations.
Dosage Adjustments
Adjustments must be made based on individual patient factors like renal or hepatic function, age, and concurrent medications. Patient response should also guide any dosage modifications.
Side Effects
Common Side Effects:
- Application site reactions (itching, redness, burning sensation, dryness)
Rare but Serious Side Effects:
- Allergic reactions (rash, hives, angioedema, difficulty breathing)
- Seizures (with tramadol overuse)
- Serotonin syndrome (with tramadol and other serotonergic drugs)
- Respiratory depression (with tramadol overdose)
Long-Term Effects:
- Skin thinning or discoloration (with prolonged topical corticosteroid use, if present in some formulations)
- Tramadol dependence (with chronic use)
Adverse Drug Reactions (ADR):
Any serious or unexpected reaction needs immediate reporting to a healthcare professional.
Contraindications
- Hypersensitivity to any component
- Third-trimester pregnancy
- Severe hepatic or renal impairment
- Respiratory depression
- Acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic drugs
- Concomitant use of MAO inhibitors
- Asthma, urticaria, or acute rhinitis precipitated by aspirin or other NSAIDs
- Patients with renal impairment
- Hypersensitivity
Drug Interactions
- Diclofenac: Anticoagulants (warfarin), lithium, methotrexate, other NSAIDs, aspirin
- Lidocaine: Antiarrhythmic drugs, certain antidepressants
- Tramadol: Other opioids, antidepressants (SSRIs, SNRIs, TCAs), MAO inhibitors, alcohol, sedatives, CYP2D6 inhibitors or inducers
- Methyl Salicylate: Anticoagulants (warfarin)
- Menthol: Warfarin (oral) may decrease effectiveness.
Pregnancy and Breastfeeding
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Pregnancy: Contraindicated in the third trimester. Use with caution during the first and second trimesters only if the benefits outweigh the risks. May cause harm to the fetus and complications with labor/delivery.
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Breastfeeding: Consult a physician before use. Tramadol is present in breastmilk in small amounts. Diclofenac and ibuprofen are often preferred for breastfeeding mothers. Other components have limited data regarding breast milk excretion. Exercise caution.
Drug Profile Summary
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Mechanism of Action: Multimodal: NSAID (diclofenac and methyl salicylate), local anesthetic (lidocaine), counterirritant (menthol and methyl salicylate), opioid analgesic (tramadol), anti-inflammatory (linseed oil).
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Side Effects: Itching, redness, burning at application site; rarely, allergic reactions, seizures (tramadol), serotonin syndrome, respiratory depression.
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Contraindications: Hypersensitivity, third-trimester pregnancy, severe hepatic/renal impairment, respiratory depression, concomitant MAOI use.
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Drug Interactions: See Drug Interactions section.
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Pregnancy & Breastfeeding: Consult a physician. Contraindicated in third-trimester pregnancy. Caution advised during breastfeeding.
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Dosage: Adults: Apply thinly 3-4 times/day to affected area. Not generally recommended for children under 14. Dosage adjustments necessary for renal/hepatic impairment, elderly.
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Monitoring Parameters: Assess pain levels, monitor application site for reactions, observe for systemic effects (especially with tramadol – drowsiness, respiratory depression).
Popular Combinations
This combination itself is already a mix of several active ingredients. Additional combinations are generally not recommended unless specifically directed by a physician. Concomitant use of oral pain medications, especially NSAIDs or opioids, should be carefully considered due to interaction risks.
Precautions
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General: Pre-screen for allergies, hepatic/renal impairment, drug interactions. Avoid application to broken skin, eyes, or mucous membranes.
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Pregnant Women: Avoid in the third trimester. Consult a physician for first and second trimester use, carefully weighing risk/benefit.
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Breastfeeding Mothers: Consult a physician due to the risk of infant exposure.
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Children & Elderly: Use with caution. Not generally recommended for children under 14. Dose adjustments necessary for elderly patients.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for this combination?
A: Adults: Apply a thin layer to the affected area 3-4 times daily. Not generally recommended for children under 14. Dose adjustments necessary for hepatic/renal impairment and the elderly.
Q2: Can this combination be used during pregnancy?
A: Contraindicated during the third trimester. Use with caution during the first two trimesters only if benefits clearly outweigh risks.
Q3: Can this be used while breastfeeding?
A: Consult a physician before use during breastfeeding due to potential infant exposure through breast milk.
Q4: What are the common side effects?
A: Common side effects are localized to the application site and include itching, redness, and a burning sensation.
Q5: What are the serious side effects?
A: Serious side effects include allergic reactions, seizures (with tramadol overuse), serotonin syndrome (with tramadol and other serotonergic drugs), and respiratory depression (with tramadol overdose).
Q6: What are the contraindications for this medicine?
A: Contraindications include hypersensitivity to any component, third-trimester pregnancy, severe hepatic or renal impairment, respiratory depression, concomitant use of MAO inhibitors, and history of aspirin or NSAID induced asthma, urticaria, or rhinitis.
Q7: What drug interactions should I be aware of?
A: Several drug interactions exist. Consult a detailed drug interaction reference and exercise caution when prescribing to patients on other medications. Pay close attention to interactions with anticoagulants, other NSAIDs, antidepressants, opioids, and certain antiarrhythmics.
Q8: How long can this combination be used?
A: Use should be limited to the shortest duration necessary. Extended use should be carefully evaluated by a physician. Long-term use carries the risk of skin changes and tramadol dependence.
Q9: Can I apply a heating pad after application?
A: Applying external heat after application is generally not recommended as it can exacerbate skin irritation and increase absorption, leading to potential systemic effects.
Q10: Can this be used on open wounds?
A: This medication is intended for intact skin only. It should not be applied to open wounds, broken skin, or mucous membranes.
