Topicals (Other)

INDICATIONS AND USAGE
Panretin® gel is indicated for topical treatment of cutaneous lesions in patients with AIDS-related Kaposi’s sarcoma. Panretin® gel is not indicated when systemic anti-KS therapy is required (e.g., more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement). There is no experience to date using Panretin® gel with systemic anti-KS treatment.

CONTRAINDICATIONS
Panretin® gel is contraindicated in patients with a known hypersensitivity to retinoids or to any of the ingredients of the product.

Dosing: 
Panretin® gel should initially be applied two times a day to cutaneous KS lesions. The application frequency can be gradually increased to three or four times a day according to individual lesion tolerance. If application site toxicity occurs, the application frequency can be reduced. Should severe irritation occur, application of drug can be temporarily discontinued for a few days until the symptoms subside.

Sufficient gel should be applied to cover the lesion with a generous coating. The gel should be allowed to dry for three to five minutes before covering with clothing. Because unaffected skin may become irritated, application of the gel to normal skin surrounding the lesions should be avoided. In addition, do not apply the gel on or near mucosal surfaces of the body.

A response of KS lesions may be seen as soon as two weeks after initiation of therapy but most patients require longer application. With continued application, further benefit may be attained. Some patients have required over 14 weeks to respond. In clinical trials, Panretin® gel was applied for up to 96 weeks. Panretin® gel should be continued as long as the patient is deriving benefit.

Occlusive dressings should not be used with Panretin® gel.

Supplied: Gel: 0.1% (60 g tube)

INDICATIONS AND USAGE
REGRANEX (becaplermin) Gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. When used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control, REGRANEX Gel increases the incidence of complete healing of diabetic ulcers.

The efficacy of REGRANEX Gel has not been established for the treatment of pressure ulcers and venous stasis ulcers (see Clinical Studies) and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue (Stage I or II, IAET staging classification) or ischemic diabetic ulcers.

CONTRAINDICATIONS
REGRANEX (becaplermin) Gel is contraindicated in patients with:
–
known hypersensitivity to any component of this product (e.g., parabens);
–
known neoplasm(s) at the site(s) of application.

Dosage:
Topical: Adults:
Diabetic ulcers: Apply appropriate amount of gel once daily with a cotton swab or similar tool, as a coating over the ulcer

The amount of becaplermin to be applied will vary depending on the size of the ulcer area. To calculate the length of gel applied to the ulcer, measure the greatest length of the ulcer by the greatest width of the ulcer in inches. Tube size will determine the formula used in the calculation. For a 15 or 7.5 g tube, multiply length x width x 0.6. For a 2 g tube, multiply length x width x 1.3.

Note: If the ulcer does not decrease in size by ~30% after 10 weeks of treatment or complete healing has not occurred in 20 weeks, continued treatment with becaplermin gel should be reassessed.

Supplied:
Gel, topical: 0.01% (15 g)

Initial U.S. Approval:  2013

Mechanism of Action: Brimonidine is a relatively selective alpha-2 adrenergic agonist. Topical application of MIRVASO topical gel may reduce erythema through direct vasoconstriction.

INDICATIONS AND USAGE:  MIRVASO (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older.

HOW SUPPLIED: Gel, 0.33%; Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base.

Calamine Lotion is a skin protectant. It works by soothing and protecting the skin.

HOW TO USE: Wash and completely dry the affected area before applying the lotion. Shake lotion well before use. Apply this medication to the affected area of skin, generally three to four times daily or as directed by your physician. Learn proper use of this medication. Consult your pharmacist. This medicine is for external use only. Notify your doctor if your condition does not improve in 7 days.

Mechanism of Action
Prolonged activation of neurons by capsaicin depletes presynaptic substance P, one of the body's neurotransmitters for pain and heat.

Dosing (Adults): Topical: Apply to affected area at least 3-4 times/day; application frequency less than 3-4 times/day prevents the total depletion, inhibition of synthesis, and transport of substance P resulting in decreased clinical efficacy and increased local discomfort

Admin: Wear gloves to apply; wash hands with soap and water after applying to avoid spreading to eyes or other sensitive areas of the body.

Supplied:
[Topical cream:  0.025% and HP: 0.075%]
[Topical gel:   Capsagel®: 0.025% (60 g); 0.05% (60 g); 0.075% (30 g).]

Once absorbed into the systemic circulation, doxepin undergoes hepatic metabolism that results in conversion to pharmacologically-active desmethyldoxepin. Further glucuronidation results in urinary excretion of the parent drug and its metabolites. Desmethyldoxepin has a half-life that ranges from 28 to 52 hours and is not affected by multiple dosing. Plasma levels of both doxepin and desmethyldoxepin are highly variable and are poorly correlated with dosage. Wide distribution occurs in body tissues including lungs, heart, brain, and liver. Renal disease, genetic factors, age, and other medications affect the metabolism and subsequent elimination of doxepin.

INDICATIONS AND USAGE
Zonalon® Cream is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus. (See DOSAGE AND ADMINISTRATION.)

CONTRAINDICATIONS
Because doxepin HCl has an anticholinergic effect and because significant plasma levels of doxepin are detectable after topical Zonalon® Cream application, the use of Zonalon® Cream is contraindicated in patients with untreated narrow angle glaucoma or a tendency to urinary retention.

Zonalon® Cream is contraindicated in individuals who have shown previous sensitivity to any of its components

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DOSAGE:
A thin film of Zonalon Cream should be applied four times each day with at least a 3 to 4 hour interval between applications. There are no data to establish the safety and effectiveness of Zonalon Cream when used for greater than 8 days. Chronic use beyond eight days may result in higher systemic levels and should be avoided. Use of Zonalon cream for longer than 8 days may result in an increased likelihood of contact sensitization.

The risk for sedation may increase with greater body surface area application of Zonalon cream. Clinical experience has shown that drowsiness is significantly more common in patients applying Zonalon Cream to over 10% of body surface area; therefore, patients with greater than 10% of body surface area affected should be particularly cautioned concerning possible drowsiness and other systemic adverse effects of doxepin. If excessive drowsiness occurs, it may be necessary to do one or more of the following: reduce the body surface area treated, reduce the number of applications per day, reduce the amount of cream applied, or discontinue the drug.

Occlusive dressings may increase the absorption of most topical drugs; therefore, occlusive dressings should not be utilized with Zonalon Cream.
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SUPPLIED:
Cream, as hydrochloride:
Prudoxin™: 5% (45 g)
Zonalon®: 5% (30 g, 45 g)

The onset, depth and duration of dermal analgesia on intact skin provided by EMLA Cream depend primarily on the duration of application. To provide sufficient analgesia for clinical procedures such as intravenous catheter placement and venipuncture, EMLA Cream should be applied under an occlusive dressing for at least 1 hour. To provide dermal analgesia for clinical procedures such as split skin graft harvesting, EMLA Cream should be applied under occlusive dressing for at least 2 hours. Satisfactory dermal analgesia is achieved 1 hour after application, reaches maximum at 2 to 3 hours, and persists for 1 to 2 hours after removal. Absorption from the genital mucosa is more rapid and onset time is shorter (5 to 10 minutes) than after application to intact skin. After a 5 to 10 minute application of EMLA Cream to female genital mucosa, the average duration of effective analgesia to an argon laser stimulus (which produced a sharp, pricking pain) was 15 to 20 minutes (individual variations in the range of 5 to 45 minutes).

Dermal application of EMLA Cream may cause a transient, local blanching followed by a transient, local redness or erythema.

INDICATIONS AND USAGE
EMLA Cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:

– normal intact skin for local analgesia.

– genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.

EMLA Cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies.

CONTRAINDICATIONS
EMLA Cream (lidocaine 2.5% and prilocaine 2.5%) is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.

DOSAGE:
Adult Patients - Intact Skin
A thick layer of EMLA Cream is applied to intact skin and covered with an occlusive dressing.

Minor Dermal Procedures: For minor procedures such as intravenous cannulation and venipuncture, apply 2.5 grams of EMLA Cream (1/2 the 5 g tube) over 20 to 25 cm2 of skin surface for at least 1 hour. In controlled clinical trials using EMLA Cream, two sites were usually prepared in case there was a technical problem with cannulation or venipuncture at the first site.

Major Dermal Procedures: For more painful dermatological procedures involving a larger skin area such as split thickness skin graft harvesting, apply 2 grams of EMLA Cream per 10 cm2 of skin and allow to remain in contact with the skin for at least 2 hours.

Adult Male Genital Skin: As an adjunct prior to local anesthetic infiltration, apply a thick layer of EMLA Cream (1 g/10 cm2) to the skin surface for 15 minutes. Local anesthetic infiltration should be performed immediately after removal of EMLA Cream.

Dermal analgesia can be expected to increase for up to 3 hours under occlusive dressing and persist for 1 to 2 hours after removal of the cream. The amount of lidocaine and prilocaine absorbed during the period of application can be estimated from the information in Table 2.

Adult Female Patients - Genital Mucous Membranes
For minor procedures on the female external genitalia, such as removal of condylomata acuminata, as well as for use as pretreatment for anesthetic infiltration, apply a thick layer (5-10 grams) of EMLA Cream for 5 to 10 minutes.

Occlusion is not necessary for absorption, but may be helpful to keep the cream in place. Patients should be lying down during the EMLA Cream application, especially if no occlusion is used. The procedure or the local anesthetic infiltration should be performed immediately after the removal of EMLA Cream.

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Pediatric Patients - Intact Skin
The following are the maximum recommended doses, application areas and application times for EMLA Cream based on a child's age and weight:

Please note: If a patient greater than 3 months old does not meet the minimum weight requirement, the maximum total dose of EMLA Cream should be restricted to that which corresponds to the patient's weight. (see Instruction For Application below).

Practitioners should carefully instruct caregivers to avoid application of excessive amounts of EMLA Cream.

When applying EMLA Cream to the skin of young children, care must be taken to maintain careful observation of the child to prevent accidental ingestion of EMLA Cream or the occlusive dressing. A secondary protective covering to prevent inadvertent disruption of the application site may be useful.

EMLA Cream should not be used in neonates with a gestational age less than 37 weeks nor in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents.

When EMLA Cream (lidocaine 2.5% and prilocaine 2.5%) is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered (see Individualization of Dose below). The amount absorbed in the case of EMLA Cream is determined by the area over which it is applied and the duration of application under occlusion.

Although the incidence of systemic adverse reactions with EMLA Cream is very low, caution should be exercised, particularly when applying it over large areas and leaving it on for longer than 2 hours. The incidence of systemic adverse reactions can be expected to be directly proportional to the area and time of exposure.

Instruction For Application
To measure 1 gram of EMLA, the Cream should be gently squeezed out of the tube as a narrow strip that is 1.5 inches (3.8 cm) long and 0.2 inches (5 mm) wide. The strip of EMLA cream should be contained within the lines of the diagram shown below.

˜1 g strip
1.5 X 0.2 inches

Use the number of strips that equals your dose, like the examples in the table below.

Dosing Information
1 gram = 1 strip
2 grams = 2 strips
2.5 grams = 2.5 strips

For adult and pediatric patients, apply ONLY as prescribed by your physician.

If your child is below the age of 3 months or small for their age, please inform your doctor before applying EMLA Cream, which can be harmful, if applied over too much skin at one time in young children.

When applying EMLA to the intact skin of young children, it is important that they be carefully observed by an adult in order to prevent the accidental ingestion of or eye contact with EMLA Cream.

EMLA® Cream must be applied to intact skin at least 1 hour before the start of a routine procedure and for 2 hours before the start of a painful procedure. A protective covering of the Cream is not necessary for absorption but may be helpful to keep the cream in place.

If using a protective covering, your doctor will remove it, wipe off the EMLA® Cream, clean the entire area with an antiseptic solution before the procedure. The duration of effective skin anesthesia will be at least 1 hour after removal of the protective covering.

PRECAUTIONS
1) Do not apply near eyes or on open wounds.
2) Keep out of reach of children.
3) If your child becomes very dizzy, excessively sleepy, or develops duskiness of the face or lips after applying EMLA Cream, remove the cream and contact the child's physician at once.

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EMLA CREAM MAXIMUM RECOMMENDED DOSE, APPLICATION AREA, AND APPLICATION TIME BY AGE AND WEIGHT* For Infants and Children Based on Application to Intact Skin

EMLA Cream is available as the following:

NDC 0186-1515-01.....................5 gram tube, box of 1

NDC 0186-1515-01
Product No. 0186-1515-03..............5 gram tube, box of 5

NDC 0186-1516-01................30 gram tube box of 1, the 30 gram tube of EMLA Cream is packaged in a child resistant tube.

The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with Efudex Cream and Solution is approximately 93%, based on 113 lesions in 54 patients. Twenty-five lesions treated with the solution produced 1 failure and 88 lesions treated with the cream produced 7 failures.

DOSAGE:
When Efudex is applied to a lesion, a response occurs with the following sequence: erythema, usually followed by vesiculation, desquamation, erosion and reepithelialization.

Efudex should be applied preferably with a nonmetal applicator or suitable glove. If Efudex is applied with the fingers, the hands should be washed immediately afterward.

Actinic or Solar Keratosis: Apply cream or solution twice daily in an amount sufficient to cover the lesions. Medication should be continued until the inflammatory response reaches the erosion stage, at which time use of the drug should be terminated. The usual duration of therapy is from 2 to 4 weeks. Complete healing of the lesions may not be evident for 1 to 2 months following cessation of Efudex therapy.

Superficial Basal Cell Carcinomas: Only the 5% strength is recommended. Apply cream or solution twice daily in an amount sufficient to cover the lesions. Treatment should be continued for at least 3 to 6 weeks. Therapy may be required for as long as 10 to 12 weeks before the lesions are obliterated. As in any neoplastic condition, the patient should be followed for a reasonable period of time to determine if a cure has been obtained.

SUPPLIED:
Cream, topical:
Carac™: 0.5% (30 g)
Efudex®: 5% (25 g, 40 g)
Fluoroplex®: 1% (30 g)

Solution, topical (Efudex®): 2% (10 mL); 5% (10 mL)

U.S. Approval:  2014

Mechanism of Action: The mechanism of action of SOOLANTRA cream in treating rosacea lesions is unknown.

INDICATIONS AND USAGE:   SOOLANTRA cream is indicated for the treatment of inflammatory lesions of rosacea.

DOSAGE AND ADMINISTRATION
Apply to the affected areas of the face once daily. Use a pea-size amount for each area of the face (forehead, chin, nose, each cheek) that is affected. Spread as a thin layer, avoiding the eyes and lips. SOOLANTRA cream is not for oral, ophthalmic, or intravaginal use.

HOW SUPPLIED: Cream, 1%, supplied in tubes of 30 g, 45 g and 60 g.

INDICATIONS:
Topical masoprocol is indicated for treatment of actinic (solar) keratoses

MECHANISM:
Masoprocol is a potent 5-lipoxygenase inhibitor {03} and has antiproliferative activity against keratinocytes in tissue culture, but the relationship between this activity and its effectiveness in actinic keratoses is unknown

Usual adult dose
Actinic (solar) keratoses
Topical, to the skin, as a 10% cream twice a day in a sufficient amount to cover the lesions

Supplied:[10% cream]

ELIDEL Cream is not indicated for use in children less than 2 years of age

DOSAGE AND ADMINISTRATION
The patient or care giver should apply a thin layer of ELIDEL® (pimecrolimus) Cream 1% to the affected skin twice daily. The patient or caregiver should stop using when signs and symptoms (e.g., itch, rash and redness) resolve and should be instructed on what actions to take if symptoms recur.

If signs and symptoms persist beyond 6 weeks, patients should be re-examined by their health care provider to confirm the diagnosis of atopic dermatitis.

Continuous long-term use of ELIDEL Cream should be avoided, and application should be limited to areas of involvement with atopic dermatitis.

The safety of ELIDEL Cream under occlusion, which may promote systemic exposure, has not been evaluated. ELIDEL Cream should not be used with occlusive dressings.

SUPPLIED:
Cream, topical: 1% (30 g, 60 g, 100 g)

DOSAGE AND ADMINISTRATION:
Topical:
Dandruff, seborrhea: Massage 5-10 mL into wet scalp, leave on scalp 2-3 minutes, rinse thoroughly

Tinea versicolor: Apply the 2.5% lotion to affected area and lather with small amounts of water; leave on skin for 10 minutes, then rinse thoroughly; apply every day for 7 days

Shake well before using. May damage jewelry; remove before treatment. For external use only; do not apply to broken or inflamed skin.

SUPPLIED:
Lotion, topical: 2.5% (120 mL)
Shampoo, topical: 1% (210 mL)

INDICATIONS:
PROTOPIC Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapyfor the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable.

PROTOPIC Ointment is not indicated for children younger than 2 years of age

DOSAGE AND ADMINISTRATION
Adult
PROTOPIC Ointment 0.03% and 0.1%

Apply a thin layer of PROTOPIC (tacrolimus) Ointment to the affected skin twice daily. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. Stop using when signs and symptoms of atopic dermatitis resolve.

If signs and symptoms (e.g. itch, rash, and redness) do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis.

Continuous long-term use of topical calcineurin inhibitors, including PROTOPIC Ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis. The safety of PROTOPIC Ointment under occlusion, which may promote systemic exposure, has not been evaluated. PROTOPIC Ointment should not be used with occlusive dressings.

PEDIATRIC - FOR CHILDREN 2-15 YEARS
PROTOPIC Ointment 0.03%

Apply a thin layer of PROTOPIC (tacrolimus) Ointment, 0.03% to the affected skin twice daily. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. Stop using when signs and symptoms of atopic dermatitis resolve.

If signs and symptoms (e.g. itch, rash, and redness) do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis.

Continuous long-term use of topical calcineurin inhibitors, including PROTOPIC Ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis.

The safety of PROTOPIC Ointment under occlusion, which may promote systemic exposure, has not been evaluated. PROTOPIC Ointment should not be used with occlusive dressings.

Supplied: Ointment (0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years).