Cetrimide + Choline Salicylate + Clotrimazole + Tannic Acid

Usage

• This combination medication is primarily prescribed for the treatment of oral thrush (oral candidiasis) and other oral infections. It is also used for nappy rash in babies. It provides temporary relief from the pain and discomfort associated with mouth ulcers, cold sores, and irritation from orthodontic devices and dental procedures. It can also help relieve symptoms of gum problems like gingivitis and periodontitis, ease discomfort from dental appliances, and promote better oral hygiene by reducing gum inflammation and irritation.

• Pharmacological Classification: Antiseptic, analgesic, anti-inflammatory, antifungal, and astringent.

• Mechanism of Action: Cetrimide acts as an antiseptic. Choline salicylate, a non-steroidal anti-inflammatory drug (NSAID), delivers analgesic and anti-inflammatory effects by inhibiting prostaglandin synthesis. Clotrimazole exerts antifungal action. Tannic acid functions as an astringent, forming a protective layer on mucous membranes and promoting healing while also exhibiting antibacterial and antiviral properties.

Alternate Names

• Clenorush Gel, Clenora Gel

• Brand names vary by manufacturer.

How It Works

• Pharmacodynamics: Cetrimide disrupts bacterial cell membranes. Choline salicylate reduces pain and inflammation. Clotrimazole alters fungal cell wall permeability, leading to cell death. Tannic acid forms a protective layer over mucous membranes, reduces inflammation, and aids healing.

• Pharmacokinetics: Choline salicylate is absorbed systematically after oral administration. The absorption and metabolism of the other components when applied topically in the mouth are less well-defined. All components, or their metabolites, are primarily excreted through the kidneys.

• Mode of Action: Cetrimide: Disrupts bacterial cell membranes, preventing their growth. Choline Salicylate: Inhibits prostaglandin synthesis, reducing pain and inflammation. Clotrimazole: Alters fungal cell wall permeability, leading to cell death. Tannic Acid: Forms a protective layer over mucous membranes, reducing inflammation and promoting healing. It also exhibits antibacterial and antiviral effects.

• Receptor Binding/Enzyme Inhibition: Choline salicylate inhibits cyclooxygenase (COX) enzymes, thus reducing prostaglandin synthesis.

• Elimination Pathways: Primarily renal excretion.

Dosage

Standard Dosage

Adults:

• Apply a pea-sized amount of gel to the affected area three to four times a day.

Children:

• Not recommended for children under 4 months of age. Topical oral salicylate gels are no longer indicated for people younger than 16 years for pain associated with infant teething, orthodontic devices, cold sores, or mouth ulcers. Consult a physician for appropriate dosing in older children.

Special Cases:

• Elderly Patients: Use with caution; dose adjustment may be necessary.
• Patients with Renal Impairment: Consult a physician for dose adjustments.
• Patients with Hepatic Dysfunction: Consult a physician for dose adjustments.
• Patients with Comorbid Conditions: Use with caution in patients with asthma, hypertension, peptic ulcer disease, bleeding disorders, or gout.

Clinical Use Cases

The primary use is for oral and skin application. Dosing for clinical settings like intubation, surgical procedures, mechanical ventilation, or ICU use is not specifically addressed in the provided sources.

Dosage Adjustments

Consult a physician for dosage adjustments based on individual patient factors, including renal/hepatic dysfunction, metabolic disorders, and other relevant comorbid conditions.

Side Effects

Common Side Effects

• Application site reactions (burning, stinging, numbness).
• Altered taste sensation.
• Dry mouth
• Metallic taste.
• Skin irritation, itching, redness, or rash.
• Nausea, vomiting, or diarrhea.
• Headache
• Stomach pain
• Unpleasant taste in the mouth.

Rare but Serious Side Effects

• Allergic reactions (rash, itching, swelling, difficulty breathing).
• Reye’s syndrome (in children under 16 using salicylates) is a rare but potentially fatal condition affecting the brain and liver

Long-Term Effects

• Not typically associated with long-term systemic effects when used topically as directed, but chronic overuse could potentially lead to local irritation or sensitization.

Adverse Drug Reactions (ADR)

• Angioedema (swelling of face, lips, tongue, throat).
• Bronchospasm.

Contraindications

• Known hypersensitivity to any of the components (cetrimide, choline salicylate, clotrimazole, tannic acid).
• Active peptic ulcer disease.
• Bleeding disorders.
• Severe liver or kidney impairment.
• Porphyria.
• Children under 4 months of age. Topical oral salicylate gels are contraindicated in those younger than 16 years for teething pain.

Drug Interactions

• May interact with other topical oral medications (e.g., antifungals, anesthetics, corticosteroids). It’s crucial to inform your doctor about all medications and supplements you are taking.
• Alcohol interaction is unknown
• Consult a doctor before using any herbal supplements

Pregnancy and Breastfeeding

• Safety during pregnancy and breastfeeding has not been fully established. Consult a physician before use. Salicylates are excreted in breast milk and can potentially affect the infant.

Drug Profile Summary

• Mechanism of Action: See above.
• Side Effects: See above.
• Contraindications: See above.
• Drug Interactions: See above.
• Pregnancy & Breastfeeding: Consult a physician.
• Dosage: See above.
• Monitoring Parameters: Observe for local irritation or signs of allergic reaction.

Popular Combinations

• Often used as a standalone topical preparation. Combination with other oral medications should be done under medical supervision.

Precautions

• General Precautions: Pre-screening for allergies and relevant medical conditions is advised.
• Specific Populations: See “Special Cases” under Dosage.
• Lifestyle Considerations: Avoid spicy, acidic foods that might exacerbate oral irritation. Maintain good oral hygiene. Manage stress.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Cetrimide + Choline Salicylate + Clotrimazole + Tannic Acid?

A: See the detailed dosage section above.

Q2: Can I use this combination if I’m pregnant or breastfeeding?

A: Consult your doctor before using this medication if you are pregnant, breastfeeding, or planning to become pregnant.

Q3: What should I do if I accidentally swallow the gel?

A: Rinse your mouth thoroughly with water and contact a physician or poison control center if you experience any adverse effects. Topical use is intended, so swallowing should be avoided.

Q4: How long does it take for this medication to work?

A: The onset of action can vary depending on the severity of the infection and individual response. You should start to notice improvement within a few days. Consult a doctor if symptoms persist or worsen.

Q5: Can I use this combination for other types of infections?

A: This medicine is intended for oral thrush and certain other oral infections or skin irritations. Consult a physician before using it for other conditions.

Q6: Are there any dietary restrictions while using this medication?

A: Avoid spicy and acidic foods, which can irritate mouth ulcers or inflamed areas in the mouth.

Q7: What are the signs of an allergic reaction to this medication?

A: Watch for signs like rash, itching, swelling (especially of the face, lips, tongue, or throat), and difficulty breathing. Seek immediate medical attention if you experience any of these symptoms.

Q8: Can I use this medication along with other oral medications?

A: Inform your doctor about all medications, including over-the-counter drugs and supplements, that you are taking. Some medications may interact.

Q9: Can I use this product if I have diabetes?

A: Use cautiously in patients with diabetes. Consult your physician.

Q10: Are there any long-term side effects I should be aware of?

A: Not typically associated with long-term systemic side effects when used topically as directed.