Topicals (Antiviral)

DOSAGE AND ADMINISTRATION
Apply sufficient quantity to adequately cover all lesions every 3 hours, 6 times per day for 7 days. The dose size per application will vary depending upon 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 ZOVIRAX to prevent autoinoculation of other body sites and transmission of infection to other persons. Therapy should be initiated as early as possible following onset of signs and symptoms.

Supplied:
[5% ointment]

Uses: Treats cold sore/fever blisters on the face or lips. Shortens healing time and duration of symptoms: tingling, pain, burning, and/or itching.

ABREVA® is effective through all stages of a cold sore but for the fastest healing, use it as soon as possible. It is especially important to be aware of early warning signs that a cold sore is coming, like itching or tingling, and to be sure to avoid close physical contact when you have one. Always use ABREVA as directed, five times a day for a maximum of 10 days. Follow the directions on the package for maximum effectiveness.

DOSAGE:
For Adults and children 12 years and over.
ABREVA should be used five times a day, for a maximum of 10 days, until the cold sore is healed.
Apply it directly to the cold sore at the first sign of a tingle, redness, bump or itch for best results.
If you wish, you can apply cosmetics such as lipstick over ABREVA. However, use a separate applicator, like a cotton swab, to apply cosmetics over an unhealed cold sore to avoid spreading the infection.

For best results, remove any cosmetics prior to applying ABREVA.
Wash your hands before and after treating the cold sore.

As soon as you notice the first symptom (tingling, redness, bump or itch), apply ABREVA immediately.
Continue applying it five times a day until your cold sore is healed. And remember to always wash your hands before and after applying ABREVA.

Mechanism of Action
The mechanism of action of Aldara Cream in treating AK and sBCC lesions is unknown.

INDICATIONS
Actinic Keratosis
Aldara Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults.

Superficial Basal Cell Carcinoma
Aldara Cream is indicated for the topical treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with a maximum tumor diameter of 2.0 cm, located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured.

The histological diagnosis of superficial basal cell carcinoma should be established prior to treatment, since safety and efficacy of Aldara Cream have not been established for other types of basal cell carcinomas, including nodular and morpheaform (fibrosing or sclerosing) types.

External Genital Warts
Aldara Cream is indicated for the treatment of external genital and perianal warts/condyloma acuminata in patients 12 years or older.

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Limitations of Use
Aldara Cream has been evaluated in children ages 2 to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy.
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Unevaluated Populations
The safety and efficacy of Aldara Cream in immunosuppressed patients have not been established.

Aldara Cream should be used with caution in patients with pre-existing autoimmune conditions.

The efficacy and safety of Aldara Cream have not been established for patients with Basal Cell Nevus Syndrome or Xeroderma Pigmentosum.

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DOSAGE AND ADMINISTRATION
The application frequency for Aldara Cream is different for each indication.
Aldara is not for oral, ophthalmic, or intravaginal use.

Actinic Keratosis
Aldara Cream should be applied 2 times per week for a full 16 weeks to a defined treatment area on the face or scalp (but not both concurrently). The treatment area is defined as one contiguous area of approximately 25 cm2 (e.g., 5 cm x 5 cm) on the face (e.g. forehead or one cheek) or on the scalp. Examples of 2 times per week application schedules are Monday and Thursday, or Tuesday and Friday. Aldara Cream should be applied to the entire treatment area and rubbed in until the cream is no longer visible. No more than one packet of Aldara Cream should be applied to the contiguous treatment area at each application. Aldara Cream should be applied prior to normal sleeping hours and left on the skin for approximately 8 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of Aldara Cream therapy.

It is recommended that patients wash their hands before and after applying Aldara Cream. Before applying the cream, the patient should wash the treatment area with mild soap and water and allow the area to dry thoroughly (at least 10 minutes).

Contact with the eyes, lips and nostrils should be avoided.

Local skin reactions in the treatment area are common. A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction. However, the treatment period should not be extended beyond 16 weeks due to missed doses or rest periods. Response to treatment cannot be adequately assessed until resolution of local skin reactions. Lesions that do not respond to treatment should be carefully re-evaluated and management reconsidered.

Aldara Cream is packaged in single-use packets, with 12 packets supplied per box. Patients should be prescribed no more than 3 boxes (36 packets) for the 16-week treatment period.

Unused packets should be discarded. Partially-used packets should be discarded and not reused.

Superficial Basal Cell Carcinoma
Aldara Cream should be applied 5 times per week for a full 6 weeks to a biopsy-confirmed superficial basal cell carcinoma. An example of a 5 times per week application schedule is to apply Aldara Cream, once per day, Monday through Friday. Aldara Cream should be applied prior to normal sleeping hours and left on the skin for approximately 8 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of Aldara Cream therapy.

It is recommended that patients wash their hands before and after applying Aldara Cream. The patient should wash the treatment area with mild soap and water before applying the cream, and allow the area to dry thoroughly.

The target tumor should have a maximum diameter of 2 cm and be located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet). The treatment area should include a 1 cm margin of skin around the tumor. Sufficient cream should be applied to cover the treatment area, including 1 centimeter of skin surrounding the tumor. Aldara Cream should be rubbed into the treatment area until the cream is no longer visible.

Amount of Aldara Cream to Use for sBCC

Contact with the eyes, lips and nostrils should be avoided.

Local skin reactions in the treatment area are common. A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction.

Early clinical clearance cannot be adequately assessed until resolution of local skin reactions (e.g. 12 weeks post-treatment). Local skin reactions or other findings (e.g. infection) may require that a patient be seen sooner than the post-treatment assessment for clinical clearance. If there is clinical evidence of persistent tumor at the post-treatment assessment for clinical clearance, a biopsy or other alternative intervention should be considered. Lesions that do not respond to therapy should be carefully re-evaluated and management reconsidered; the safety and efficacy of a repeat course of Aldara Cream treatment have not been established. If any suspicious lesion arises in the treatment area at any time after a determination of clinical clearance, the patient should seek a medical evaluation. [see Clinical Studies].

Aldara Cream is packaged in single-use packets, with 12 packets supplied per box. Patients should be prescribed no more than 3 boxes (36 packets) for the 6-week treatment period. Unused packets should be discarded. Partially-used packets should be discarded and not reused.

External Genital Warts
Aldara Cream should be applied 3 times per week to external genital/perianal warts. Aldara Cream treatment should continue until there is total clearance of the genital/perianal warts or for a maximum of 16 weeks. Examples of 3 times per week application schedules are: Monday, Wednesday, Friday or Tuesday, Thursday, Saturday. Aldara Cream should be applied prior to normal sleeping hours and left on the skin for 6 -10 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of Aldara Cream therapy.

It is recommended that patients wash their hands before and after applying Aldara Cream.

A thin layer of Aldara Cream should be applied to the wart area and rubbed in until the cream is no longer visible. The application site should not be occluded. Following the treatment period the cream should be removed by washing the treated area with mild soap and water. Local skin reactions at the treatment site are common. [see ADVERSE REACTIONS]. A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction. Treatment may resume once the reaction subsides. Non-occlusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reactions.

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Supplied:[5% cream-single use packet]

Aldara Cream is packaged in single-use packets which contain sufficient cream to cover a wart area of up to 20 cm2; use of excessive amounts of cream should be avoided.

INDICATIONS
Denavir (penciclovir cream) is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age and older.

DOSAGE AND ADMINISTRATION
Denavir should be applied every 2 hours during waking hours for a period of 4 days. Treatment should be started as early as possible (i.e., during the prodrome or when lesions appear).

Diagnosis
Although genital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma (so-called "Bowenoid papulosis") is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus but should not be treated with Condylox 0.5% Solution.

Mechanism of Action
Treatment of genital warts with podofilox results in necrosis of visible wart tissue. The exact mechanism of action is unknown.

DOSAGE:
Topical: Adults: Apply twice daily (morning and evening) for 3 consecutive days, then withhold use for 4 consecutive days; this cycle may be repeated up to 4 times until there is no visible wart tissue

Patient Education
Apply to warts with a cotton-tipped applicator supplied with the drug, dispose carefully after use; allow the solution to dry before allowing the return of opposing skin surfaces to their normal positions; wash hands after application

SUPPLIED:
Gel: 0.5% (3.5 g)
Solution, topical: 0.5% (3.5 mL)

ADDITIONAL INFO:
In order to ensure that the patient is fully aware of the correct method of therapy and to identify which specific warts should be treated, the technique for initial application of the medication should be demonstrated by the prescriber.

Apply twice daily morning and evening (every 12 hours), for 3 consecutive days, then withhold use for 4 consecutive days. This one week cycle of treatment may be repeated up to four times until there is no visible wart tissue. If there is incomplete response after four treatment weeks, alternative treatment should be considered. Safety and effectiveness of more than four treatment weeks have not been established.

Podofilox Topical Solution 0.5% is applied to the warts with an applicator supplied with the drug. The drug-dampened applicator should be touched to the wart to be treated, applying the minimum amount of solution necessary to cover the lesion. Treatment should be limited to less than 10 cm2 of wart tissue and to no more than 0.5 mL of the solution per day. There is no evidence to suggest that more frequent application will increase efficacy, but additional applications would be expected to increase the rate of local adverse reactions and systemic absorption.

Care should be taken to allow the solution to dry before allowing the return of opposing skin surfaces to their normal positions. After each treatment, the used applicator should be carefully disposed of and the patient should wash his or her hands.