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acyclovir topical (Rx)Brand and Other Names:Zovirax topical, Sitavig

 
 
 

Dosing & Uses

AdultPediatric

Dosing Strengths & Forms

topical cream

  • 5%

topical ointment

  • 5%

mucoadhesive buccal tablet

  • 50mg (Sitavig)

Herpes Labialis

Cream/ointment

  • Limited, non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients
  • Apply topically to lips and around mouth 5 times per day for 4 days; initiate as soon as possible after first signs and symptoms

Mucoadhesive buccal tablet

  • Recurrent herpes labialis (cold sores) in immunocompetent adults
  • Apply one 50 mg buccal tablet as a single dose to the upper gum (canine fossa) region
  • Should be applied within 1 hr after the onset of prodromal symptoms and before the appearance of any signs of Herpes labialis

Genital Herpes

Initial genital herpes

Apply sufficient quantity to adequately cover all lesions q3hr, 6 times/day for 7 days

Herpetic Keratitis (Orphan)

Acute herpetic keratitis caused by Herpes simplex virus types 1 and 2

Orphan indication sponsors

  • GlaxoSmithKline, One Franklin Plaza, Philadelphia, PA 19101
  • Fera Pharmaceuticals, 134 Birch Hill Road, Locust Valley, NY 11560

Administration

Cream/ointment

  • The dose size per application will vary depending on the total lesion area but should approximate a one-half-inch ribbon of ointment per 4 square inches of surface area
  • A finger cot or rubber glove should be used when applying, to prevent autoinoculation of other body sites and transmission of infection to other persons

Mucoadhesive buccal tablet

  • Do not crush, chew, suck, or swallow tablets

Dosing Strengths & Forms

topical cream

  • 5%

topical ointment

  • 5%

Herpes Labialis

Recurrent herpes labialis (cold sores) in adults and adolescents

<12 years: Safety and efficacy not established

≥12 years: As adults, apply cream/ointment topically to lips and around mouth 5 times per day for 4 days; initiate as soon as possible after first signs and symptoms

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Adverse Effects

>10%

Burning/stinging (30%)

1-10%

Pruritus (4%)

<1%

Dry lips (<1%)

Rash (0.3%)

Frequency Not Defined

Angioedema

Vulvitis

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Warnings

Contraindications

Hypersensitivity

Cautions

Not recommended for recurrent infections

Use caution in immunocompromised patients

Avoid physical contact when lesions are present

For external use only; not for use on the eye or inside mouth

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Pregnancy & Lactation

Pregnancy category: B

Lactation: Excretion in milk unknown; systemic exposure is minimal after topical application

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

more...
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Pharmacology

Mechanism of Action

Exerts its antiviral effect on herpes simplex viruses and varicella zoster virus by interfering with DNA synthesis and inhibiting viral replication

Helps shed herpes virus quicker and reduces pain and duration; used for management of initial episodes of herpes genitalis and in mucocutaneous herpes simplex viral infections in immunocompromised patients

Absorption

Minimal

Metabolism

In cells infected with herpes viruses, principally by intracellular phosphorylation of drug by virus-coded thymidine kinase and several cellular enzymes

Elimination

Excretion: Urine

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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