Usage
This combination medication is primarily prescribed for the topical treatment of mouth ulcers (aphthous ulcers) and other minor oral lesions, such as stomatitis (inflammation of the mouth) and glossitis (inflammation of the tongue). It can also provide relief from discomfort caused by orthodontic appliances or dental procedures. It is not suitable for treating infected or weeping skin lesions.
It falls under the following pharmacological classifications:
- Antiseptic: Cetrimide kills bacteria and fungi.
- Local anesthetic: Lidocaine numbs the affected area.
- Analgesic: Choline salicylate and lidocaine relieve pain.
- Anti-inflammatory: Choline salicylate reduces inflammation.
- Astringent: Tannic acid shrinks and protects the ulcer.
This combination medication works by targeting different aspects of mouth ulcer treatment. Cetrimide acts as an antiseptic, preventing infection. Choline salicylate, a non-steroidal anti-inflammatory drug (NSAID), reduces pain and inflammation by blocking prostaglandin synthesis. Lidocaine provides local anesthetic action by blocking nerve impulses. Tannic acid acts as an astringent, forming a protective layer over the ulcer to promote healing, and may also have some antibacterial and antiviral effects.
Alternate Names
This combination doesn’t have a universally recognized non-proprietary name. It’s often referred to as “T-32 Gum Paint” or simply by the combination of its ingredients. Brand names include BI-Folate Mouth Ulcer Gel, Clenora Gel, Gumrest Gum Paint, and Oracin Gel.
How It Works
Pharmacodynamics: The combined effects of the ingredients contribute to pain relief, reduction of inflammation, and promotion of healing. Choline salicylate, an NSAID, inhibits prostaglandin synthesis, thereby reducing pain and inflammation. Lidocaine blocks nerve impulses, leading to local anesthesia. Tannic acid acts as an astringent and forms a protective barrier, promoting healing and reducing irritation. Cetrimide’s antiseptic action prevents secondary infections.
Pharmacokinetics: As this medication is applied topically, systemic absorption is minimal. Choline salicylate is absorbed to some extent through the oral mucosa. Lidocaine is absorbed slowly after topical application but its systemic effects are generally limited. Tannic acid and cetrimide are not significantly absorbed. Metabolism and elimination pathways for the small amounts absorbed are hepatic (liver) and renal (kidney) respectively.
Dosage
Standard Dosage
Adults: Apply a small quantity of the gel/paint directly to the affected area 3-4 times daily. Do not swallow the medication.
Children: Use in children under 16 is generally not recommended unless specifically prescribed by a doctor. Pediatric dosage guidelines must be determined on a case-by-case basis by a physician.
Special Cases:
-
Elderly Patients: Use with caution. Monitor for adverse effects.
-
Patients with Renal Impairment: Caution is advised; dosage adjustments may be necessary.
-
Patients with Hepatic Dysfunction: Caution is advised; dosage adjustments may be necessary.
-
Patients with Comorbid Conditions: Evaluate individual conditions and adjust dosage as needed. Pre-existing peptic ulcer disease or gastrointestinal bleeding is a contraindication.
Side Effects
Common Side Effects
- Temporary burning or stinging sensation at the application site
- Numbness in the mouth
- Altered taste sensation (metallic taste)
- Dry mouth
Rare but Serious Side Effects
- Allergic reactions (rash, itching, swelling)
Long-Term Effects
No specific long-term adverse effects have been reported with topical use. However, prolonged use of topical salicylates, particularly over large areas, could potentially lead to salicylate toxicity, although this is rare.
Contraindications
- Hypersensitivity to any of the ingredients
- Active peptic ulcer disease
- Gastrointestinal bleeding
- Severe liver or kidney impairment
- Bleeding disorders or low platelet count
- Porphyria (a group of disorders that affect certain enzymes)
- Pregnancy (contraindicated)
- Breastfeeding (consult a doctor)
- Children under 16 (generally not recommended)
Drug Interactions
- NSAIDs (ibuprofen, naproxen): Increased risk of gastrointestinal bleeding
- Anticoagulants (warfarin, heparin): Increased risk of bleeding
- Medications metabolized by CYP enzymes: Potential for altered metabolism
Pregnancy and Breastfeeding
This medication is contraindicated during pregnancy. It should not be used during breastfeeding unless specifically advised by a doctor.
Drug Profile Summary
- Mechanism of Action: Antiseptic, local anesthetic, analgesic, anti-inflammatory, and astringent
- Side Effects: Burning/stinging, numbness, altered taste, dry mouth, allergic reactions
- Contraindications: Hypersensitivity, peptic ulcer, GI bleeding, severe liver/kidney disease, bleeding disorders, porphyria, pregnancy
- Drug Interactions: NSAIDs, anticoagulants, CYP enzyme substrates
- Pregnancy & Breastfeeding: Contraindicated in pregnancy, use with caution during breastfeeding
- Dosage: Apply to affected area 3-4 times daily
- Monitoring Parameters: Observe for allergic reactions or signs of salicylate toxicity.
Popular Combinations
This medication is not typically used in combination with other drugs for the same condition.
Precautions
- Use with caution in elderly patients and those with renal or hepatic impairment.
- Avoid contact with eyes. Rinse immediately with water if contact occurs.
- Avoid swallowing the medication.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Cetrimide + Choline Salicylate + Lidocaine + Tannic Acid?
A: Apply a small amount to the affected area 3-4 times a day. Do not swallow.
Q2: Can this combination be used in children?
A: It is generally not recommended for children under 16 unless prescribed by a doctor.
Q3: What should I do if I accidentally swallow the gel?
A: Rinse your mouth thoroughly with water and contact a doctor or poison control center if you have any concerns.
Q4: Can I use this medication if I am pregnant or breastfeeding?
A: It’s contraindicated during pregnancy. Consult a doctor before using if breastfeeding.
Q5: How long does it take for mouth ulcers to heal with this medication?
A: Mouth ulcers typically heal within 7-10 days, even without treatment. This medication helps to relieve pain and discomfort during the healing process.
Q6: Are there any dietary restrictions while using this medication?
A: Avoid consuming spicy, acidic, or hot foods that may irritate the ulcer.
Q7: Can I use this combination for other oral conditions like gingivitis?
A: While it may provide some temporary relief for gingivitis symptoms, it is not a primary treatment. Consult a dentist for proper diagnosis and treatment.
Q8: What should I do if my mouth ulcer doesn’t heal after a week of using this medication?
A: Consult your doctor or dentist. They may suggest alternative treatments or investigate other causes for the ulcer.
Q9: Can I brush my teeth after applying this gel?
A: It is advisable to wait at least 30 minutes after application before brushing your teeth. This allows the medication to form a protective layer over the ulcer.