Class: Topical mucositis agent
- Mouthwash (kit for compounding) diphenhydramine hydrochloride 525 mg, hydrocortisone 60 mg, nystatin 0.6 g, First-Mouthwash Suspension II 236 mL
- Mouthwash (kit for compounding) diphenhydramine hydrochloride 200 mg, lidocaine hydrochloride 1.6 g, nystatin 1.6 g, First-Mouthwash Suspension II 236 mL
- Mouthwash (kit for compounding) diphenhydramine hydrochloride 450 mg, hydrocortisone 60 mg, nystatin 1.2 g, tetracycline hydrochloride 1.5 g, First-Mouthwash Suspension II 234 mL
- Mouthwash (kit for compounding) diphenhydramine hydrochloride 200 mg, lidocaine hydrochloride 1.6 g, First-Mouthwash Suspension 236 mL
Diphenhydramine and lidocaine provide local analgesia. Hydrocortisone suppresses inflammatory responses. Nystatin is an antifungal that binds to the cell membrane, changing the permeability and allowing the leakage of intracellular components. Tetracycline is an antibiotic that inhibits bacterial protein synthesis. The antacid (magnesium hydroxide/aluminum hydroxide) component is thought to “coat” the oral mucosa.
Indications and Usage
Palliation of generalized oral mucositis.
Hypersensitivity to any component of the product or to local anesthetics of the amide type. Oral diphenhydramine is contraindicated in newborns or premature infants and breast-feeding women. Hydrocortisone is contraindicated in systemic fungal infections.
Dosage and AdministrationOral mucositis
Oral (topical) Dosage depends on the prescribed formulation. For diphenhydramine/lidocaine 2%/antacid (1:1:1), the dosage is 15 mL swished in the mouth for 30 sec, then spit out. May be used every 2 to 3 h. “Magic mouthwash” has also been prescribed to be given every 4, 6, or 8 h.Children
Oral (topical) No well-established pediatric dosage guidelines are available. The max recommended topical dosage of lidocaine 2% viscous is 3 mg/kg/dose at intervals of at least 2 h.
- First-BXN Mouthwash , First-Duke's Mouthwash , First-Mary's Mouthwash , First-Mouthwash BLM are compounding kits. “Magic mouthwash” has numerous formulations; verify formulation with prescribing health care provider. One common formulation is diphenhydramine (12.5 mg per 5 mL), an antacid, and lidocaine 2% viscous solution mixed in equal proportions (1:1:1).
- Shake the suspension well before dispensing and prior to each use.
For First-BXN Mouthwash , First-Duke's Mouthwash , First-Mary's Mouthwash , and First-Mouthwash BLM , store at room temperature, not to exceed 25°C (77°F), prior to compounding. Store final compounded formulation between 2° and 8°C (36° and 46°F). The compounded product is stable for at least 15 days when stored in the refrigerator. Keep container tightly closed. Protect from light and freezing.
For the extemporaneous compounded product, store at room temperature. Protect from light. No stability information is available for this preparation. When a manufactured final doseform product is used as a source of active ingredient, it may be appropriate to assign an expiration date of up to 25% of the manufacturer's remaining date, or 6 mo, whichever method gives the shortest expiry.
Drug InteractionsAntacids, dairy products, food, iron salts
May decrease oral absorption of tetracycline.Anticoagulants (eg, warfarin)
The action of oral anticoagulants may be increased by tetracycline.Contraceptives, hormonal
Tetracycline may reduce the effect of oral contraceptives.
Drowsiness, dizziness, headache.
Burning sensation, unpleasant taste.
Abdominal pain or discomfort, constipation, dry mouth, diarrhea, nausea, vomiting.
Hypersensitivity reactions, including anaphylaxis.
Category B (diphenhydramine, lidocaine); category C (hydrocortisone, nystatin); Category D (tetracycline). Avoid tetracycline during pregnancy.
Oral diphenhydramine is contraindicated in breast-feeding. Corticosteroids, lidocaine, and tetracycline appear in breast milk.
Avoid tetracycline in children younger than 8 y because abnormal bone formation and discoloration of teeth may occur.
Use with caution in patients with known drug sensitivities.
Dosage reduction of tetracycline may be needed in these patients.
Prolonged use of hydrocortisone may lead to hypothalamic-pituitary adrenal axis–suppression.
Excessive dosage, or short intervals between doses, can result in high plasma levels and serious adverse effects. Instruct patients to strictly adhere to the recommended administration and dosage guidelines.
Lidocaine is a local anesthetic that can impair the gag reflex. This increases the risk of aspiration when eating. Numbness may cause patients to bite their tongues or the inside of their mouths. It may also cause decreased heat sensation. Caution patients to avoid eating for at least 1 h after the administration of viscous lidocaine.
Do not use outdated tetracycline because degradation products are highly nephrotoxic.
Prolonged use of antibiotics may result in bacterial or fungal overgrowth.
Use lidocaine with extreme caution if the mucosa in the area of application has been traumatized because there is the potential for rapid systemic absorption.
Blurred vision, bradycardia, CNS excitation or depression, drowsiness, hypotension, nausea, seizures, tinnitus, vomiting.
- Advise patients to shake the suspension well before each use.
- Advise patients that lidocaine is a local anesthetic that can impair the gag reflex. This increases the risk of aspiration when eating. Instruct patients to be careful when eating; the numbness this drug produces may cause them to bite their tongues or the inside of their mouths. It may also cause decreased heat sensation. Caution patients to avoid eating for at least 1 h after the administration of viscous lidocaine.
Copyright © 2009 Wolters Kluwer Health.