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Over the counter Medications for the Treatment of Herpes Simplex


Over the counter Medications for the Treatment of Herpes Simplex

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									                                                                 Reference Section

                                          Over-the-counter Medications for the Treatment of
                                          Herpes Simplex Virus Infections
                                                                                                                                                        a report by
                                                                                                                                  Eric T Stoopler, DMD

                                                                       Assistant Professor of Oral Medicine, University of Pennsylvania School of Dental Medicine

                                          Oral herpes virus infections are commonly seen by                 time of lesions by inhibiting DNA replication in
                                          medical and dental professionals. Herpes simplex virus            HSV-infected cells.
                                          (HSV) is transmitted via salivary and genital secretions.
                                          Localized and systemic infections may be induced by               Recurrent HSV Infections
                                          the virus. HSV types 1 and 2 are the etiologic agents in
                                          most common intraoral herpes virus infections. They               Following resolution of a primary HSV infection, the
                                          can be distinguished on the basis of the distinct                 virus migrates to the trigeminal nerve ganglion, where
                                          antibodies that are formed against each type of virus;            it is capable of remaining in a latent state. Reactivation
Eric T Stoopler, DMD, is an Assistant
                                          classically, HSV 1 causes a majority of cases of oral and         of the virus may follow exposure to cold or sunlight,
   Professor of Oral Medicine at the      pharyngeal infections, while HSV 2 is implicated in               stress, trauma, or immunosuppression, and cause a
University of Pennsylvania School of      most genital and anal infections.1 Depending on sexual            recurrent infection. Recurrent herpes labialis (RHL) is
 Dental Medicine. He is the Director
    of the Operating Room Dentistry
                                          practices, both types can cause primary or recurrent              the common form of recurrent oral HSV infection that
     Program at the Hospital of the       infections in the oral and/or genital area.                       appears on the vermillion border or skin of the lip and
  University of Pennsylvania and the                                                                        is referred to as a ‘cold sore’ or ‘fever blister’ (see Figure
 Oral Diagnosis and Emergency Care
       Clinics at the School of Dental
                                          Primary HSV Infections                                            1). Although a majority of recurrent herpes infections
  Medicine. Dr Stoopler has authored                                                                        occur on the lips and heavily keratinized mucosa of the
  numerous articles on oral mucosal       The incidence of primary infections with HSV 1                    palate and gingiva, recurrent intraoral herpes (RIH) can
       disease, facial pain, and dental
      treatment of medically complex
                                          increases after six months of age and reaches a peak              occur on any intraoral mucosal surface and is seen most
patients. He is a diplomate of both       between two and three years of age.2 Incidence of                 frequently in immunocompromised patients. Recurrent
           the American Board of Oral     primary HSV 2 infection does not increase until                   HSV (RHSV) lesions in these patients appear as
   Medicine and the American Board
          of Special Care Dentistry. Dr
                                          sexual activity begins. Symptomatic primary HSV                   progressively enlarging ulcers, which may involve large
  Stoopler earned his DMD from the        disease is preceded or accompanied by generalized                 portions of the labial and intraoral mucosa; these lesions
  University of Pennsylvania in 1999      symptoms that may include fever, headache, malaise,               occasionally disseminate, causing generalized infection.3
 and then completed a fellowship in
  Oral Medicine at the University of
                                          nausea, and vomiting. In the oral cavity, generalized
           Pennsylvania Medical Center    acute marginal gingivitis is evident, while vesicles and          The only systemic antiviral medication approved by the
                               in 2002.   ulcers appear on the oral mucosa one to two days after            US Food and Drug Administration (FDA) for treatment
                                          the prodromal symptoms appear. Primary HSV in                     of RHL is valacyclovir. The recommended dose is 2g,
                                          healthy children is usually a self-limiting disease, with         twice a day, for one day. Topical antiviral medications
                                          fever disappearing in three or four days and oral                 available by prescription have been shown to be of
                                          lesions that heal in a week to 10 days. Treatment of              limited benefit for the treatment of RHL. Topical
                                          primary HSV infection is usually palliative. Milder               penciclovir, applied every two hours for four days while
                                          cases can be managed by supportive care only,                     awake, reduces the duration and pain of RHL by one to
                                          including maintenance of fluids, use of acetaminophen             two days.4 Topical acyclovir has been reported to
                                          to reduce fever, and use of topical anesthetics such as           decrease the duration of RHL lesions by 12 hours.5
                                          viscous lidocaine to decrease oral pain.1 If the patient          Some clinicians advocate the use of suppressive doses of
                                          presents to the clinician within 72 hours of onset of             systemic acyclovir to prevent severe, frequent
                                          vesicle eruption, prescription systemic antiviral                 disfiguring recurrences of RHL. Immunosuppressed
                                          medication, such as acyclovir, valacyclovir, and                  patients with HSV infection generally respond well to
                                          famciclovir, may be helpful in shortening the healing             acyclovir administered orally or intravenously.

                                          1. Stoopler ET, “Oral herpetic infections (HSV 1-8)”, Dent Clin North Am (2005);49: pp. 15–29.
                                          2. Greenberg MS,“Ulcerative, vesicular, and bullous lesions”, Greenberg MS, Glick M, (eds.), Burket’s oral medicine: diagnosis
                                             and treatment, 10th edition (2003), Ontario: BC Decker, pp. 50–84.
                                          3. Greenberg MS, et al.,“A comparative study of herpes simplex infections in renal transplant and leukemic patients”, J Infect Dis
                                             (1987);156(2): pp. 280–287.

1                                                                                                                                          US PHARMACY REVIEW 2006
                Over-the-counter Medications for the Treatment of Herpes Simplex Virus Infections

Over-the-counter (OTC) Medications for                     Figure 1: Acute Recurrent Herpes Labialis (RHL)
Tr e a t m e n t o f H S V I n f e c t i o n s             Lesion

OTC medications are those that can be obtained
without a prescription from a licensed healthcare
professional. Although there are numerous OTC
products, they can be generally classified into three

• those that are approved by the FDA for treatment of
  RHSV infections;

• those that are not approved by the FDA for
  treatment of RHSV infections, but are legally
  marketed to provide skin protection and/or relief of
  symptoms, and
                                                           Phenique® Cold-Sore Gel, and ChapStick®
• non-approved, alternative remedies.                      Medicated Lip Balm. Herpecin-L® is an OTC
                                                           product that contains mostly natural ingredients and is
F DA - a p p rove d OT C P ro d u c t s f o r              marketed to treat and relieve cold sores/fever blisters,
Tr e a t m e n t o f R H S V I n f e c t i o n s           relieve dry, chapped lips, and to protect lips from the
                                                           sun.9 Individuals should use these products in
Docosanol (Abreva®) 10% cream is the only FDA-             accordance with the manufacturer’s directions.
approved OTC medication for treatment of recurrent
oral-facial HSV infections. Docosanol is a saturated       Many OTC products that are marketed for relief of
primary alcohol derived from plant extracts that           pain associated with herpetic lesions contain various
inhibits viral entry into cells.6 When docosanol 10%       concentrations of benzocaine. Benzocaine is an ester
cream was applied to recurrent herpetic lesions five       local anesthetic that blocks both the initiation and
times per day in one study, the median time to             conduction of nerve impulses by decreasing the
healing of lesions was one day shorter when                neuronal membrane’s permeability to sodium ions. It is
compared to placebo treatment.6 In addition, patients      commonly used as a topical anesthetic agent for
using docosanol demonstrated a reduction in severity       dentistry and is available in commercial products in
of the lesions and painful symptoms as compared to         concentrations ranging from 2% to 20%. Common
placebo.6,7 The recommended dosing of docosanol is         examples of these products include Anbesol®
five applications per day to the affected area of the      Gel/Liquid, Orabase® Gel, Orajel® Gel/Liquid, and
face or lips at the initial sign of a cold sore or fever   Zilactin®-B Gel. Zilactin®-L Liquid contains lidocaine,
blisters and continues until the lesions are healed.8      an amide-type anesthetic that is commonly used as an
Side effects that have been reported with use of           injectable local anesthetic in both medicine and
docosanol are headaches, rash, and pruritus.7 It is        dentistry. Individuals should use these products in
recommended that docosanol should not be used in           accordance with the manufacturer’s directions.
patients under 12 years of age and those with
hypersensitivity reactions.                                OTC antibiotic ointments have been advocated for use
                                                           by some clinicians to aid in treatment of herpetic
N o n - F DA - a p p rove d OT C P ro d u c t s f o r      lesions. Although these products are not virucidal, they
Tr e a t m e n t o f R H S V I n f e c t i o n s           can help prevent bacterial colonization and secondary
                                                           infection of herpetic lesions. Some common examples
There are several OTC products that are legally            of these products include Polysporin® (a combination
marketed for skin protection and/or relief of              of antibacterial agents bacitracin and polymyxin B) and
symptoms associated with herpetic lesions. Many of         Neosporin® (a combination of antibacterial agents
these products contain camphor, menthol, and phenol,       bacitracin, polymyxin B, and neomycin). Individuals
and these ointments can help protect the lips and          should use these products in accordance with the
reduce the discomfort associated with herpetic             manufacturer’s directions.
lesions. Some products contain a sunscreen, which can
help prevent and/or reduce the risk of a recurrent         Viroxyn® is an isopropyl alcohol tincture of
herpetic infection. Common examples of these               benzylkonium chloride that has been marketed to
products include Blistex® Lip Ointment, Campho-            reduce the duration and symptoms of RHL lesions.10
                           Reference Section

    Benzylkonium chloride has been shown to be highly                   L-lysine is an essential amino acid that is available as a
    effective in inactivating HSV 1 by disrupting the viral             nutritional supplement that has shown to be effective
    capsid of the lipid-coated virus.11 The medication is               in inhibiting replication of HSV and shortening the
    dispensed as a kit containing three single-dose                     normal course and duration of infection.12 When
    applicators of the alcohol/benzylkonium solution.The                taken orally, individuals should start using the product
    manufacturer’s directions recommend applying the                    during the early stages of recurrent infection. The
    solution directly to the lesion with the applicator and             recommended dose is 2g every four hours until
    rubbing the medication into the area for approximately              symptoms subside.13 L-lysine is also a component of
    10 minutes.The solution may be used at any stage of a               several OTC ointments, including Herpecin-L.
    cold sore and should not be used more than three
    times per day, according to the manufacturer. Acid-                 Another natural product that has demonstrated efficacy
    containing products will neutralize the active                      in the treatment of herpes virus infections is honey.
    ingredient in the medication. Therefore, it is                      One study demonstrated that application of topical
    recommended to avoid any products containing citric-                honey to labial herpetic lesions decreased the pain and
    acid for at least one hour following application. The               duration of the lesions as compared to topical
    medication should not be used by pregnant or lactating              acyclovir.14 Further clinical trials need to be conducted
    females, children under two years of age, and those                 with honey for treatment of herpetic lesions. However,
    with hypersensitivity to any component of the                       this natural product could prove to be useful for
    solution. Since isopropyl alcohol is flammable, the                 management of this condition.
    manufacturer recommends avoiding use of the
    medication near sparks, flames, or high temperatures.               Various plant extracts, mostly derived from traditional
                                                                        Asian medicinal products, also exhibit antiviral activity
    Alter native OTC Products                                           against both HSV 1 and 2.15 These compounds may
                                                                        provide additional therapeutic options for treatment of
    Non-approved, alternative remedies are gaining                      HSV infections after further clinical investigation of
    popularity as OTC treatments for herpes infections.                 these products has been completed. ■

    4. Spruance SL, et al., “Penciclovir cream for the treatment of herpes simplex labialis. A randomized, multicenter, double-blind,
        placebo-controlled trial.Topical Penciclovir Collaborative Study Group”, JAMA (1997);277(17): pp. 1374–1379.
    5. Straten MV et al., “A review of antiviral therapy for herpes labialis”, Arch Dermatol (2001);137(9): pp. 1232–235.
    6. Abdel-Haq N, et al., “New antiviral agents”, Indian J Pediatr (2006);73: pp. 313–321.
    7. Sacks SL, et al.,“Clinical efficacy of topical docosanol 10% cream for herpes simplex labialis:A multicenter, randomized, placebo-
        controlled trial”, J Am Acad Dermatol (2001);45: pp. 222–230.
    8. Wynn RL, Meiller TF Crossley HL (eds.), Drug Information Handbook for Dentistry (2006), Ohio: Lexi-Comp, pp.
    9. Herpecin-L® website. <> Accessed August 24, 2006.
    10. Wynn RL, Meiller TF Crossley HL, (eds.), Drug Information Handbook for Dentistry (2006), Ohio: Lexi-Comp; pp.
    11. Wood A, Payne D, “The action of three antiseptics/disinfectants against enveloped and non-enveloped viruses”, J Hosp Inf
        (1998);38: pp. 283–295.
    12. Singh BB, et al., “Safety and effectiveness of L-lysine, zinc, and herbal-based product on the treatment of facial and circumoral
        herpes”, Altern Med Rev (2005);10: pp. 123–127.
    13. Wynn RL, Meiller TF Crossley HL, (eds), Drug Information Handbook for Dentistry (2006), Ohio: Lexi-Comp; pp. 959.
    14. Al-Waili NS, “Topical honey application vs acyclovir for the treatment of recurrent herpes simplex lesions”, Med Sci Monit
        (2004);10: pp. MT94-MT98.
    15. Khan MT, et al.,“Extracts and molecules from medicinal plants against herpes simplex viruses”, Antiviral Res (2005);67: pp.

3                                                                                                      US PHARMACY REVIEW 2006

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