ZYCLARA Cream (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch Health US, LLC

Λέξεις κλειδιά

99207-270 99207-271 99207-276

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1. Indications and Usage

1.1 Actinic Keratosis ZYCLARA Cream, 2.5% and 3.75% are indicated for the topical treatment of clinically typical visible or palpable, actinic keratoses (AK) of the full face or balding scalp in im...

2. Dosage and Administration

For topical use only; ZYCLARA Cream is not for oral, ophthalmic, intra-anal or intravaginal use. 2.1 Actinic Keratosis ZYCLARA Cream should be applied once daily before bedtime to the skin of the a...

3. Dosage Forms and Strengths

ZYCLARA Cream, 2.5% is a white to faintly yellow cream available in pump bottles. Each pump bottle, when actuated after priming, delivers 0.235 grams of cream. ZYCLARA Cream, 3.75% is a white to fa...

4. Contraindications

None.

5. Warnings and Precautions

5.1 Local Skin Reactions Intense local skin reactions including skin weeping or erosion can occur after a few applications of ZYCLARA Cream and may require an interruption of dosing [see Dosage an...

6. Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials o...

6.3. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of imiquimod. Because these reactions are reported voluntarily from a population of uncertain size, it is not always po...

8.1. Pregnancy

Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. ZYCLARA Cream should be used during pregnancy only if the potential benefit justifies the potential risk to...

8.3. Nursing Mothers

It is not known whether imiquimod is excreted in human milk following use of ZYCLARA Cream. Because many drugs are excreted in human milk, caution should be exercised when ZYCLARA Cream is administ...

8.4. Pediatric Use

AK is a condition not generally seen within the pediatric population. The safety and effectiveness of ZYCLARA Cream for AK in patients less than 18 years of age have not been established. Safety an...

8.5. Geriatric Use

Of the 320 subjects treated with ZYCLARA Cream in the AK clinical studies, 150 subjects (47%) were 65 years or older. No overall differences in safety or effectiveness were observed between these s...

10. Overdosage

Topical overdosing of ZYCLARA Cream could result in an increased incidence of severe local skin reactions and may increase the risk for systemic reactions. Hypotension was reported in a clinical tr...

11. Description

ZYCLARA (imiquimod) Cream, 2.5% or 3.75% is intended for topical administration. Each gram contains 25 mg or 37.5 mg of imiquimod, respectively, in a white to faintly yellow oil-in-water cream base...

12.1. Mechanism of Action

The mechanism of action of ZYCLARA Cream in treating AK and EGW lesions is unknown.

12.2. Pharmacodynamics

The pharmacodynamics of ZYCLARA Cream are unknown. Imiquimod is a Toll-like receptor 7 agonist that activates immune cells. Topical application to skin is associated with increases in markers for c...

12.3. Pharmacokinetics

Following dosing with two packets of ZYCLARA Cream, 3.75% once daily (18.75 mg imiquimod/day) for up to 3 weeks, systemic absorption of imiquimod was observed in all subjects when ZYCLARA Cream was...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In an oral (gavage) rat carcinogenicity study, imiquimod was administered to Wistar rats on a 2X/week (up to 6 mg/kg/day) or daily (3 mg/kg/day) dosing schedule for 24 months. No treatment-related ...

14. Clinical Studies

14.1 Actinic Keratosis In two double-blind, randomized, vehicle-controlled clinical studies, 479 subjects with AK were treated with ZYCLARA Cream, 3.75%, ZYCLARA Cream, 2.5%, or vehicle cream. Stud...

16.1. How Supplied

ZYCLARA (imiquimod) Cream, 3.75% is white to faintly yellow in color and supplied in single-use plastic laminate packets which contain 0.25 g of the cream available as: Box of 28 packets containing...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid freezing. Store ZYCLARA Cream pumps upright.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Instructions for Administration ZYCLARA Cream should be used as directed by a physician. ZYCLARA Cream is for ext...