return to: Therapeutic Agents for Oral Mucosal Disease Treatment Strategies
Therapeutic Agents and Treatment Strategies for the Management of Selected Oral Mucosal Diseases
September 2018
Cindy Marek, PharmD &
Faculty, Dept. of Oral Pathology, Radiology & Medicine
The University of Iowa College of Dentistry
see footnote key at bottom of page below (e.g.3)
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RX: Valacyclovir 1 g tablets (Valtrexâ, g) Disp: 4 tablets Sig: 2 tablets at onset of symptoms, then 2 tablets 12 hours after first dose § Drug of choice -probably most efficacious therapy to date § Price of 4 tablets $20
RX: Famciclovir 500 mg tablets Disp: 3 tablets Sig: Take 3 tablets (1500 mg) at onset of prodome § Symptom duration decreased by 1.7 days when taken within an hour of onset of prodome § Price of 3 tablets $30, not available in all pharmacies |
§ A prodrug of acyclovir which is 3 times more bioavailable than acyclovir, may use in patients > 12 years of age § WARNING: Use with caution in renal disease, has not been studied in pre-pubescent children § Headache &/or nausea are dose related side effects (15%)
§ Best taken within 48 hours of symptom onset § Can cause headaches, dizziness, GI upset § Efficacy & safety haven’t been established in patients under 18 years of age, adjust dosage in renal impairment § 2nd line therapy after valacyclovir § FDA pregnancy category: B |
Topical Treatment of Herpes Labialis (Immunocompetent patients)
Ointments and Creams
§ Topicals are MUCH less efficacious than oral (systemic) therapy, prohibitively expensive and not recommended but included here for completeness.
§ Topical creams and ointments are not appropriate for intraoral use
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OTC: Docosanol 10% cream (Abrevaâ) 2 gm tube Directions: Apply 5 times daily at onset of symptoms until lesions heal |
§ Recurrent HSV labialis studies (2) demonstrate mean duration of lesions & pain ↓ by ½ to 1 day § ??? Efficacy compared to other topicals § Cost: $21/2 g tube |
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RX: Penciclovir 1% cream (Denavirâ)
Disp: 5 gm tube Sig: Apply every 2 hrs (9 times/day) during waking hours for 4 days beginning at the onset of symptoms |
§ 1997 study demonstrate↓ mean duration of lesions & pain ↓ by 1 day. § More efficacious than acyclovir ointment § Cost: >$895/5 g tube |
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RX: Acyclovir 5% cream or ointment (Zoviraxâ,g) Disp: 5 gram tube cream (Zoviraxâ) 5 gram tube ointment Sig: Apply thin film every 3 hrs (six times daily) at the onset of symptoms and continue for 7 days |
§ Little benefit, duration of Sx. decreased by ½ day § 5 g tube of Zoviraxâcream $805, 5 g tube 5 g tube generic ointment $300 § Recurrent HSV labialis shows no clinical benefit, but some ↓ in viral shedding § Is NOT effective in prevention of recurrent herpes labialis |
Oral buccal tablet
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RX: Acyclovir 50 mg buccal tablet (Sitavigâ) Disp: 2 Sig: Apply tablet to the upper gum region (canine fossa) within 1 hr after onset of prodromal symptoms.
§ Single application per episode
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§ Study: mean duration of herpes labialis episodes were decreased by ½ day compared to placebo ($315/2 tablets) § Patients experienced 35% aborted episodes § Place on canine fossa and hold in place with slight pressure on the upper lip for 30 sec. to ensure adhesion. § Apply to ipsilateral to symptoms § Contraindication: allergy to casein (milk protein) |
Systemic Agents for Primary & Recurrent HSV Gingiviostomatitis (Immunocompetent Patients)
§ Acute herpetic gingivostomatitis can occur on both movable and attached oral mucosa. Recurrent infections in healthy patients are usually limited to attached gingival and hard palate
§ It is important to note that the duration of treatment for a primary case of HSV gingivostomatitis vs a recurrent case is different. Recurrent cases require shorter durations of treatment!!!
§ Short term therapy is indicated for patients who get recurrent herpetic after prolonged sun exposure, dental treatment, etc. Therapy must be initiated before exposure to any triggers. Start the day before trigger exposure and continue for a full course of treatment as listed below.
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RX: Valacyclovir 500 mg or 1 g (Valtrexâ, g) caplet Primary HSV Gingivostomatitis : Sig: 1 gram BID x 7-10 days Recurrent HSV Gingivostomatitis: Sig: 500mg BID x 3 days Or 1 g once daily x 5 days
RX: Famciclovir 250 mg or 500 mg tablets Primary Gingivostomatitis HSV: Sig: 250 mg TID x 7-10 days Recurrent Gingivostomatitis HSV: Sig: 1000 mg BID x 1 day Or 125 mg BID x 5 days |
§ WARNING: Use with caution in renal & hepatic disease § Approved for 12 years of age and older, limited data in children 2-<12 years of age. Pediatric consult needed for children age 2-6 § Headache & nausea are dose related side effects (15%)
§ Can cause headaches, dizziness, GI upset § Best taken within 48 hours of symptom onset § Efficacy & safety haven’t been established in patients under 18 years of age |
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RX: Acyclovir 400 mg (Zoviraxâ, g) tablet Primary HSV Gingivostomatitis: Sig: 400 mg 3 times daily for 7-10 days Recurrent HSV Gingivostomatitis: Sig: 400 mg 3 times daily for 5 days Or 800mg 3 times daily for 2 days |
§ Only effective if initiated very early in recurrence § WARNING: Use with caution in renal impairment, dehydration § FDA pregnancy category B § Pediatric consult needed for children ages 2-6. § Primary gingivostomatitis in children: Acyclovir 20mg/kg PO QID (max of 400 mg per dose) for seven days based on limited data – low level of evidence |
Prophylaxis for Recurrent HSV Infections (Immunocompetent Patients)
Prophylaxis for recurrent herpes labialis (RHL) and gingivostomatitis using oral antivirals:
- Long term prophylaxis is indicated if patients have at least six or more herpetic outbreaks per year. Reassess need every 6 – 12 months.
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RX: Valacyclovir 500 mg (Valtrexâ, generic) Disp: 30 caplets Sig: Take 500 mg daily
RX: Famciclovir 500 mg (Famvirâ, generic) Disp: 30 tablets Sig: Take 500 mg BID |
§ Doesn’t appear to have large advantage over acyclovir, but regimen is easier § Regimen for patients with >9 episodes/year is 1 gram QD
§ No evidence that famciclovir prevents RHL § Use valacyclovir |
Footnote Key:
1. These medications are all contraindicated in microbial diseases. If given to patients with microbial diseases, microbial proliferation is usually enhanced and systemic dissemination is possible. Candidosis is a common side effect.
2. Systemic steroids are contraindicated or must be used with caution in a number of systemic conditions. Consultation with the patient's physician is recommended before prescribing. Tapering of prednisone is not necessary with 5-7 day burst therapy. Tapering of prednisone is not necessary with alternate day therapy (QOD) if the dosage does not exceed 20 mg QOD. In order to reduce the possibility of adrenocortical suppression, it is important that prednisone be taken in harmony with diurnal adrenocortical steroid levels. In order to accomplish this, prednisone should be taken 1-1/2 hours after normal arising time. Alternate day AM (QOD) dosage also reduces the possibility of adrenocortical suppression.
3. Whenever topical mouth rinses or ointments are prescribed, the manner in which the medication is used is very important. The patient should be advised that the medications are effective on contact and that they should avoid anything by mouth (NPO) for 1/2-1 hour after using them to prolong medication contact time.
4. Baseline hematology laboratory studies to include platelets are necessary to monitor possible bone marrow suppression.
5. Hepatotoxicity has been reported. OPRM Faculty
* Denotes prescription items that must be extemporaneously compounded by a pharmacist. Usually a specialty "compounding pharmacy" is a better choice as they have more experience and knowledge regarding product formulation.
Extemporaneously Compounding Medications for Intraoral Conditions
- Few products available in the U.S - ?? limited product demand
- Problems:
- Difficulty with insurance payments, XIX & Medicare will not reimburse for the full cost
- Expensive – Dental Pharmacy can mail Rxs to patients living in Iowa – at significantly less cost to patient patients and the products are formulated correctly for improved efficacy
- “I can do that” - generalized lack of knowledge – many pharmacies incorrectly compound intraoral products causing mucosal irritation, reduced efficacy
- Make sure products are not flavored or sweetened (especially with sucrose) unless necessary!