Rx Item-Zyclara 3.75% Cream 28 By Valeant Pharma

ZYCLARA- imiquimod cream
Medicis Pharmaceutical Corp
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 immunocompetent adults.
External Genital Warts


​ ZYCLARA Cream, 3.75% is indicated for the treatment of external genital and perianal warts (EGW)/condyloma acuminata in patients 12 years or older.

Limitations of Use
​ Imiquimod cream has been evaluated in children ages 2 to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy [see Use in Specific Populations (8.4) ​ ].

​ Treatment with ZYCLARA Cream has not been studied for prevention or transmission of HPV.

1.4 Unevaluated Populations
​ The safety and efficacy of ZYCLARA Cream have not been established in the treatment of:

�
urethral, intra-vaginal, cervical, rectal or intra-anal human papilloma viral disease.
�
actinic keratosis when treated with more than one 2-cycle treatment course in the same area.
�
patients with xeroderma pigmentosum.
�
superficial basal cell carcinoma.
�
immunosuppressed patients.
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 affected area (either entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period. ZYCLARA Cream should be applied as a thin film to the entire treatment area and rubbed in until the cream is no longer visible. Up to 0.5 grams (2 packets or 2 full actuations of the pump) of ZYCLARA Cream may be applied to the treatment area at each application. ZYCLARA Cream should be 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 ZYCLARA Cream therapy.

​ Patients should wash their hands before and after applying ZYCLARA Cream.

​ Avoid use in or on the lips and nostrils. Do not use in or near the eyes.

​ Local skin reactions in the treatment area are common [see Adverse Reactions (6.1) ​ ]. ​ A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction. However, neither 2-week treatment cycle should be extended due to missed doses or rest periods. A transient increase in lesion counts may be observed during treatment. Response to treatment cannot be adequately assessed until resolution of local skin reactions. The patient should continue dosing as prescribed. Treatment should continue for the full treatment course even if all actinic keratoses appear to be gone. Lesions that do not respond to treatment should be carefully re-evaluated and management reconsidered.

​ Prescribe no more than 2 boxes (56 packets), two 7.5g pumps or one 15g pump for the total 2-cycle treatment course. Partially-used packets should be discarded and not reused.
DOSAGE FORMS AND STRENGTHS

ZYCLARA Cream, 2.5% is a white to faintly yellow cream available in single-use packets and pump bottles. Each packet administers 0.25 grams of cream and each pump bottle, when actuated after priming, delivers 0.235 grams of cream (a similar amount as one packet).

ZYCLARA Cream, 3.75% is a white to faintly yellow cream available in single-use packets and pump bottles. Each packet administers 0.25 grams of cream and each pump bottle, when actuated after priming, delivers 0.235 grams of cream (a similar amount as one packet).

RX ITEM-Zyclara 3.75% Cream 28 By Valean
NDC 99207-0270-28 UPC/GTIN No.3-99207-27028-7 Mfg.Part No.27028

Zyclara 3.75% Cream 28 By Valeant Pharma
BRAND: ZYCLARA NDC: 99207-0270-28,99207027028 UPC: 3-99207-27028-7,399207270287 Valeant Pharma

IMIQUIMOD TOPICAL CREAM P
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Buy More Save More!
Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.