Prescribing Guidelines for Commonly Used Medications

Chapter

Summary

A wide range of topical and systemic medications are used in the management of oral medicine conditions. The vast majority of these therapies are not FDA approved for the specific conditions discussed in this book and are therefore considered “off-label” indications. This chapter provides very specific prescribing guidelines and considerations to ensure that the included medications are used in an appropriate and effective manner for the management of oral diseases.

Keywords

Food and drug administration Cream Ointment Gel Solutions Candidiasis Fluconazole Clotrimazole Nystatin Fluocinonide Clobetasol propionate Dexamathastone Tacrolimus Prednisone Methylprednisolone Azathioprine Colchicine Dapsone Hydroxychloroquine Mycophenolate mofetil Pentoxyfilline Thalidomide Penicillin Clindamycin Metronidazole Amoxicillin/clavulanic acid Chlorhexidine gluconate Acyclovir Valacyclovir Pilocarpine Cevimeline Fluoride Ibuprofren Ketoprofen Clonazepam Gabapentin Carbamezapine Amitriptyline Nortriptyline Magic mouthwash Morphine 

12.1 Inflammatory Conditions

12.1.1 Topical Immunomodulatory Agents

Please note that the package insert for all topical medications will explicitly state that they are “not for use in the oral cavity.” While most are not FDA approved for this indication, the medications included in this book are widely used in the practice of oral medicine. It may be helpful to inform both the patient and the pharmacy to avoid any confusion or delays in filling the prescription. Gels are preferable to creams or ointments as they are the most hydrophilic and therefore better absorbed by the wet mucosa. The affected area should be dried with gauze prior to application. The topical agent can be directly applied or mixed with equal parts of a mucoadhesive agent such as Orabase (Colgate-Palmolive, New York, NY) for improved soft tissue retention. Patients should be instructed not to eat or drink for 15–20 min afterward. Alternatively, the topical agent can be applied to gauze placed against the affected tissue for 10–15 min. For lesions restricted to the gingiva and alveolar mucosa, a custom fabricated tray can be used to contain the medication and treat the affected tissues in an intensive manner. Trays should be worn for 15–20 min. Solutions are useful for achieving more widespread topical therapy, and should be swished in the mouth for 5 min then spit out.

In general, topical agents should be applied anywhere from one to six times per day. Any condition requiring more frequent dosing for adequate symptom control would likely benefit from initiation of systemic treatment in addition to topical therapy.

Secondary candidiasis related to topical corticosteroid therapy is rare but may occur in patients who are predisposed, such as diabetics. If this develops, patients can be treated with topical or systemic antifungal therapy (see Chap. 7). In most cases, subsequent prophylactic treatment with fluconazole 100 mg once or twice weekly is sufficient to prevent recurrence.
  • Fluocinonide gel 0.05%. Dispense 60 g tube. Dry affected area with gauze and apply with finger. Systemic absorption is generally negligible but has been reported to cause adrenal suppression following prolonged therapy. This is a Class II (high potency) topical corticosteroid.

  • Clobetasol prorpionate gel 0.05%. Instructions are the same as for fluocinonide gel. This is a Class I (very high potency) topical corticosteroid.

  • Dexamethasone solution 0.1 mg/mL. Dispense 500 mL for 1 month supply. Swish with 3–5 mL for 5 min then spit. This is the most commonly used topical corticosteroid for oral inflammatory conditions that is commercially available as a solution. Others, such as prednisolone, may also be considered.

  • Tacrolimus 0.1% ointment. Dispense 60 g tube. Instructions are the same as for topical corticosteroids. Systemic absorption is negligible but has been reported. Topical tacrolimus is only available commercially as an ointment and can be particularly difficult to apply intraorally. Topical tacrolimus has a FDA “black box” warning indicating that its use may be associated with an increased risk of cancer based on animal studies and isolated case reports. This should be discussed with the patient in advance to avoid any confusion or concern when they encounter the warning on the label.

  • Tacrolimus solution 0.1 mg/mL. This prescription must be prepared by a compounding pharmacist. Dispensing and dosing instructions are the same as for dexamethasone solution. Tacrolimus and dexamethasone can be combined in equal parts of 2 mL each into a single rinse for patients using both agents concurrently.

12.1.2 Systemic Immunomodulatory Agents

  • Prednisone 1 mg/kg orally as a single morning dose, for 1–2 weeks, for severe immune-mediated ulcerative conditions. Monitor for secondary candidiasis. Begin topical corticosteroid and/or steroid sparing therapy at the same time. The main side effects with short-term therapy include euphoria, insomnia, increased appetite, uncontrolled blood glucose in diabetics, and elevated blood pressure. For limited courses of up to 2 weeks, there is generally no need to taper the dose. For longer treatment periods, the dose should be tapered by 5–10 mg every 1–2 days; there is no “standard” tapering protocol. Patients requiring long-term therapy, even at low doses (e.g. 10 mg), must be followed carefully by their primary care physician for prevention and management of steroid-related complications, such as osteoporosis, diabetes mellitus, avascular bone necrosis, and adrenal insufficiency.

  • Methylprednisolone 4 mg “dose pack. This is a convenient way to prescribe a short course of corticosteroids for management of acute inflammation, such as intense temporomandibular joint pain. The package comes with 21 tablets and very clear dosing instructions for rapid taper over 6 days. This prescription is generally inadequate for management of severe oral mucosal disease.

  • Azathioprine 0.5–1.0 mg/kg/day. The most common side effects include gastritis, nausea, and vomiting, which can be minimized by taking with food and/or in divided doses. A serious side effect is myelosuppression; therefore, CBC and platelet count should be checked weekly during the first month, twice monthly during the second and third months, and monthly thereafter. Patients with thiopurine S-methyl transferase deficiency have an increased risk of myelotoxicity; however, the utility of screening for this condition is unclear. Liver function tests should be checked every 2 weeks during the first month and monthly thereafter.

  • Colchicine 0.6 mg tablets once or twice daily. Begin once daily and monitor for response for 1–2 weeks before increasing the dose. Common side effects include diarrhea, nausea, and vomiting. CBC should be checked monthly for myelosuppression.

  • Dapsone 50–100 mg once daily. Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, methemoglobin reductase deficiency, or hemoglobin M are at risk for hemolysis. CBC should be monitored weekly for the first month, monthly for the next 6 months, then semiannually. Liver function tests should be drawn at baseline; periodically thereafter if abnormal.

  • Hydroxychloroquine 200–400 mg once daily with food. Common side effects include diarrhea, nausea, vomiting, myopathy, and headache. CBC should be checked periodically during prolonged therapy. Patients with G6PD deficiency are at risk for hemolysis. Patients on long-term therapy are at risk for irreversible retinopathy and should see an ophthalmologist for a baseline exam and every 3 months thereafter.

  • Mycophenolate mofetil 500 mg twice daily (1.0 g total daily dose); can increase to 1,000 mg twice daily (2.0 g total daily dose). Medication should be taken on an empty stomach. CBC should be checked weekly during the first month, twice monthly for the second and third months, then monthly through the first year. Renal, hepatic, cardiac, and pulmonary function as well as electrolyte panel should be evaluated periodically.

  • Pentoxyfilline 400 mg three times daily. Can increase to 800 mg three times daily. Side effects may include nausea, vomiting, dizziness, and headache. Evidence of positive response to medication may take weeks.

  • Thalidomide 50–200 mg once daily, at night at least 1 h after dinner. The minimum effective dose should be used. Common side effects include edema, rash, hypocalcemia, constipation, nausea, leukopenia, sedation, and peripheral neuropathy. Thalidomide must be discontinued if peripheral neuropathy develops. This medication is only available under a special restricted distribution system call the S.T.E.P.S. Program (System for Thalidomide Education and Prescribing Safety) and prescribing doctors and their patients must be registered.

12.2 Infectious Conditions

12.2.1 Antibacterial Agents

  • Penicillin 500 mg four times daily for 7–14 days. Take on an empty stomach 1 h before, or 2 h after meals.

  • Clindamycin 150–300 mg three to four times daily for 7–14 days. This is a good alternative antibiotic for penicillin-allergic patients. The risk of developing secondary pseudomembranous colitis following short-term therapy is now considered to be negligible.

  • Amoxicillin/clavulanic acid 500/125 or 875/125 mg twice daily for 7–14 days. When used long-term for bisphosphonate osteonecrosis and recurrent soft tissue infection, a single daily dose is typically sufficient. This should be taken with meals.

  • Metronidazole 250 mg once or twice daily for 7–14 days. Patients should be instructed not to consume alcohol while taking this medication due to a potential disulfiram-like reaction.

  • Chlorhexidine gluoconate 0.12% mouthwash. Rinse with 5.0 mL twice daily for 30–60 s and spit. This may cause burning in patients with inflammatory mucosal disease. It can also cause dark staining of the teeth that is removable by professional dental cleaning.

12.2.2 Antiviral Agents

  • Acyclovir 400 mg. For primary herpes infection: 400 mg three times daily for 7–10 days. For episodic reactivation: 400 mg three times a day or 800 mg twice daily for 5 days beginning at the earliest indication of reactivation. For suppressive therapy: 400 mg twice daily. The medication is available in suspension form. Side effects are rare and may include abdominal pain and nausea, headache, and rash.

  • Valacyclovir 500 mg. This has better bioavailability than acyclovir and requires less frequent dosing. For primary herpes infection: 1.0 g twice daily for 7–10 days. For episodic outbreak: 1–2 g twice daily for 5 days beginning at the earliest sign or symptom. For suppressive therapy: 500 mg once daily.

12.2.3 Antifungal Agents

  • Nystatin suspension 100,000 U/mL. Swish 5.0 mL for 2–3 min then swallow; four times daily for 1 week. Can be used once daily for prophylaxis.

  • Clotrimazole troches. Let troche dissolve slowly in the mouth 4–5 times daily for 1 week; one troche daily for prophylaxis. This should not be prescribed in patients with significant salivary gland hypofunction as the troches will not dissolve.

  • Nystatin and triamcinolone cream. Apply to the corners of the mouth twice daily until angular cheilitis resolves; resume therapy as needed.

  • Fluconazole 100 mg once daily for 7–14 days depending on extent and severity of candidiasis. For patients on long-term prophylaxis, 100 mg once or twice weekly is generally effective in preventing recurrence. Side effects are rare but may include nausea, vomiting, and increased liver enzyme levels.

12.3 Salivary Gland Hypofunction

12.3.1 Sialogogues

  • Pilocarpine 5 mg three times daily. This can be increased to 10 mg three times daily but side effects are often poorly tolerated. Common side effects include skin flushing, sweating, nausea, and dizziness. This is contraindicated in patients with narrow-angle glaucoma and poorly controlled asthma, and should generally be avoided in patients with chronic obstructive pulmonary disease.

  • Cevimeline 30 mg three times daily. Instructions are the same as for pilocarpine. This is thought to have slightly more specific affinity for the salivary gland muscarinic receptors.

12.3.2 Fluoride

  • Sodium fluoride 1.1% gel, applied with a toothbrush before bed. The patient should be instructed to expectorate but not rinse with water afterwards. Alternatively, this can be applied in a soft custom tray and left in place for at least 15 min or overnight. A prescription is required.

12.4 Pain Conditions

12.4.1 Nonsteroidal Antiinflammatory Agents

  • Ibuprofen 200–400 mg, every 4–6 h, not to exceed 3,200 mg/day. Common side effects include abdominal pain, nausea, diarrhea, vomiting, rash, increased liver function tests, and renal failure. This should be used with caution and with dosing adjustment in patients with impaired renal function.

  • Ketoprofen cream 20%. This prescription must be prepared by a compounding pharmacist. Apply to the skin of the affected area one to four times daily. Side effects from topical therapy are very rare.

12.4.2 Anticonvulsants

  • Clonazepam 0.5–1.0 mg before bed. Patients may note sedation for the first several days but generally develop tolerance to this anticipated side effect. If symptoms recur midday, an additional day­time dose (0.25–0.5 mg) can be considered. Side effects include dizziness, impaired cognition, and sedation. Alcohol should be avoided as clonazepam may potentiate the sedative effects of other CNS depressants as well as prolong metabolism of other drugs that undergo hepatic clearance. Prescribe with caution in patients with a history of substance dependency, as use of benzodiazepines can be habit forming.

  • Clonazepam 1.0 mg tablet topical therapy. Let the tablet dissolve fully in the mouth (without swallowing saliva) over a 5-min period then spit out. Systemic absorption and associated side effects are negligible.

  • Clonazepam solution 0.1 mg/mL. This prescription must be prepared by a compounding pharmacist. Swish with 3–5 mL for 5 min then spit, one to three times daily. Dispense appropriate volume based on dosing frequency.

  • Gabapentin 300 mg: take 300 mg on day 1, 300 mg twice daily on day 2 (600 mg total dose), and 300 mg three times daily on day 3 (900 mg total dose) with maintenance at 900 mg daily thereafter. The total daily dose may be increased up to 1,800 mg in three divided doses if required for symptom control. Common side effects include ataxia, dizziness, sedation, fatigue, myalgia, and peripheral edema. If side effects are noted with the initial 300 mg dose, then decrease to 100 mg on day 1, 200 mg on day 2, and 300 mg on day 3. The dose may then be carefully increased as tolerated.

  • Carbamazepine 100 mg twice daily; can increase by 200 mg/day (divided into two doses), not to exceed a total dose of 1,200 mg/day. The lowest effective dose should be used. Common side effects include confusion, dizziness, sedation, nausea, vomiting, and lightheadedness. Uncommon but serious side effects include bone marrow suppression with pancytopenia and Stevens–Johnson syndrome. CBC, urinalysis, and liver function tests should be ordered at baseline and then periodically during long-term therapy.

12.4.3 Tricyclic Antidepressants

  • Amitriptyline 10–20 mg at night before bed. Consider starting with 5.0 mg by splitting the tablet and slowly increasing dosage. Desired effects may not be noted for 2–3 weeks. Common side effects include xerostomia, constipation, dizziness, sedation, fatigue, and weight gain. Alcohol should be avoided due to potentiation of CNS sedative effects. This should not be used in conjunction with monoamine oxidase (MAO) inhibitors.

  • Nortriptyline 25 mg at night before bed; may drop down to 10 mg if the higher dose is not well tolerated. Side effects are the same as with amitryptyline but may be less pronounced.

12.4.4 Topical Analgesics

  • Two percent viscous lidocaine. Swish with 2–5 mL for 1 min and spit, as needed. Do not swallow. This can be particularly useful just prior to eating.

  • Magic mouthwash, consisting of equal parts lidocaine, diphenhydramine, and bismuth subsalicylate solutions. Swish with 2–5 mL for 1 min and spit, as needed. A small amount can be swallowed for severe posterior oropharyngeal pain, but this should only be recommended in adults.

  • Morphine oral solution 10 mg/5 mL. Swish with 2–5 mL for 5 min and spit, as needed. Do not swallow. This is available in higher a concentration (10 mg/mL) but should be prescribed with caution and is generally used as a salvage therapy to reduce the need for higher doses of systemic analgesics.

Copyright information

© Humana Press, a part of Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.Massachusetts Eye and Ear InfirmaryBostonUSA
  2. 2.Brigham and Women’s HospitalBostonUSA

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