Usage
Choline salicylate + lidocaine + menthol is a topical combination product primarily used for the relief of pain and inflammation associated with mouth ulcers (aphthous stomatitis), minor mouth irritations, sore gums, denture irritation, and orthodontic appliance-related discomfort. It may also provide relief from teething pain in infants (under strict medical supervision).
Its pharmacological classifications include:
- Choline salicylate: Non-Steroidal Anti-Inflammatory Drug (NSAID)
- Lidocaine: Local anesthetic
- Menthol: Counterirritant
This combination medication works through a multifaceted mechanism: Choline salicylate inhibits cyclooxygenase (COX) enzymes, thus reducing prostaglandin synthesis and diminishing inflammation and pain. Lidocaine blocks voltage-gated sodium channels in nerve fibers, which inhibits nerve impulse transmission and induces a local anesthetic effect. Finally, menthol activates TRPM8 receptors, generating a cooling sensation that provides temporary pain relief through counter-irritation.
Alternate Names
- Choline Salicylate/Lidocaine/Menthol combination gel
- Choline Salicylate/Lignocaine/Menthol combination gel
- Smilogel (Brand name)
- Ora-Fast (Brand name)
How It Works
Pharmacodynamics: Choline salicylate acts as an anti-inflammatory and analgesic agent, lidocaine provides local anesthesia, and menthol acts as a counterirritant.
Pharmacokinetics: These medications are applied topically to the oral mucosa, therefore, there is minimal systemic absorption and limited information is available on their specific pharmacokinetics.
Mode of Action:
- Choline salicylate: Inhibits COX-1 and COX-2 enzymes, decreasing prostaglandin production, leading to reduced pain and inflammation.
- Lidocaine: Blocks sodium channels, preventing nerve impulse propagation and inducing local anesthesia.
- Menthol: Stimulates TRPM8 receptors, producing a cooling sensation and relieving pain through counter-irritation.
Elimination Pathways: Primarily through saliva and swallowed small amounts of medication are minimally systemically absorbed and likely eliminated by hepatic metabolism and renal excretion.
Dosage
Standard Dosage
Adults: Apply a pea-sized amount of gel to the affected area every 3-4 hours, or as directed by a physician. Avoid eating or drinking for at least 30 minutes after application.
Children: For children above three months of age, use under strict medical supervision and consult a doctor for the correct dosage and administration guidelines. For children under 3 months of age, consult a doctor before use. Not recommended for children under 16 unless specifically advised by a doctor due to possible association with Reye’s syndrome.
Special Cases:
- Elderly Patients: Use cautiously and monitor for adverse effects. No specific dose adjustments are typically necessary.
- Patients with Renal Impairment: Use with caution. Monitor renal function.
- Patients with Hepatic Dysfunction: Use with caution. Monitor liver function.
- Patients with Comorbid Conditions: Evaluate individual cases and exercise caution in patients with bleeding disorders or taking blood thinners.
Clinical Use Cases
The primary clinical use is for the symptomatic relief of pain and discomfort associated with mouth ulcers and other minor oral irritations. Dosage remains consistent with the standard recommendations, as needed.
Dosage Adjustments
Dosage adjustments might be necessary in specific populations based on age, liver or kidney function, and other health conditions. Always follow a physician’s guidance for dosage adjustments.
Side Effects
Common Side Effects
- Temporary burning or stinging sensation at the application site
- Temporary numbness
- Mild tingling sensation
- Taste changes
Rare but Serious Side Effects
- Allergic reactions (rash, itching, swelling)
- Methemoglobinemia (rare but serious)
Long-Term Effects
No significant long-term effects are expected with topical use as directed.
Adverse Drug Reactions (ADR)
Significant ADRs are rare but may include severe allergic reactions (anaphylaxis) or salicylate toxicity (with excessive use).
Contraindications
- Hypersensitivity to any of the ingredients (choline salicylate, lidocaine, menthol)
- Patients with aspirin-induced asthma or other NSAID sensitivities
- Active peptic ulceration
- Children under 3 months of age (without medical supervision)
- Children and adolescents under the age of 16 (due to the risk of Reye’s syndrome)
Drug Interactions
- Aspirin and other salicylates: Increased risk of salicylate toxicity
- NSAIDs (ibuprofen, naproxen): Increased risk of side effects
- Anticoagulants (warfarin): May increase the risk of bleeding
- Antidiabetic medications: Potential for interaction; monitor glucose levels
Pregnancy and Breastfeeding
Consult a doctor before use during pregnancy or breastfeeding. Short-term use of recommended doses may be acceptable in some cases, but it’s essential to weigh the benefits against potential risks.
Drug Profile Summary
- Mechanism of Action: Anti-inflammatory, analgesic, local anesthetic, and counterirritant actions.
- Side Effects: Temporary burning, stinging, numbness, taste changes, and rarely allergic reactions.
- Contraindications: Hypersensitivity, aspirin-induced asthma, active peptic ulcers, and children under 16.
- Drug Interactions: Aspirin, NSAIDs, anticoagulants, antidiabetic medications.
- Pregnancy & Breastfeeding: Consult a doctor before use.
- Dosage: Apply pea-sized amount to the affected area every 3-4 hours.
- Monitoring Parameters: Observe for allergic reactions, signs of salicylate toxicity, or methemoglobinemia.
Popular Combinations
This is a combination product. Avoid using it with other topical oral medications unless directed by a physician.
Precautions
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General Precautions: Assess allergies and pre-existing medical conditions before use. Use cautiously in patients with hepatic or renal impairment.
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Specific Populations: See sections on pregnancy, breastfeeding, and children.
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Lifestyle Considerations: Limit alcohol consumption, as it may interact with choline salicylate.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Choline Salicylate + Lidocaine + Menthol?
A: Adults: Apply a pea-sized amount to the affected area every 3-4 hours. Children (over 3 months): Consult a doctor. Children under 16: Not recommended unless specifically advised by a doctor.
Q2: Can this gel be used for teething pain in infants?
A: It can be used for teething pain in infants over three months old, but only under strict medical supervision. Consult a doctor for appropriate usage.
Q3: What should I do if the gel accidentally gets in my eyes?
A: Rinse the eyes immediately with plenty of water and seek medical attention if irritation persists.
Q4: Can I swallow the gel?
A: No, this gel is for topical oral application only. Do not swallow.
Q5: How long can I use this gel?
A: Consult your doctor for the appropriate duration of use. Do not use continuously for extended periods without medical advice.
Q6: Can I use this gel if I am allergic to aspirin?
A: No, do not use this gel if you are allergic to aspirin or other NSAIDs as it contains choline salicylate.
Q7: What are the signs of an allergic reaction to this gel?
A: Signs of an allergic reaction include rash, itching, swelling, and difficulty breathing. Seek immediate medical attention if these occur.
Q8: Can I use this gel if I am pregnant or breastfeeding?
A: Consult your doctor before using this gel if you are pregnant or breastfeeding.
Q9: What are the potential drug interactions I should be aware of?
A: Potential drug interactions include aspirin, NSAIDs, anticoagulants (like warfarin), and some antidiabetic medications.
Q10: What should I do if I experience severe side effects?
A: Discontinue use and immediately consult your doctor or seek emergency medical assistance.
