CICLOPIROX shampoo

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ciclopirox (UNII: 19W019ZDRJ) (ciclopirox - UNII:19W019ZDRJ)

Available from:

Taro Pharmaceuticals, Inc.

INN (International Name):

ciclopirox

Composition:

ciclopirox 10 mg in 0.96 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ciclopirox Shampoo is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. Ciclopirox Shampoo is contraindicated in individuals who have shown hypersensitivity to any of its components.

Product summary:

Ciclopirox Shampoo, 1% is supplied in 120 mL plastic bottles (NDC 51672-1351-8). Discard unused product after initial treatment duration. Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CICLOPIROX- CICLOPIROX SHAMPOO
TARO PHARMACEUTICALS, INC.
----------
CICLOPIROX SHAMPOO, 1%
RX ONLY
FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE
KEEP OUT OF REACH OF CHILDREN
DESCRIPTION
Ciclopirox Shampoo 1% contains the synthetic antifungal agent,
ciclopirox.
Each gram (equivalent to 0.96 mL) of Ciclopirox Shampoo contains 10 mg
ciclopirox in a shampoo
base consisting of disodium laureth sulfosuccinate, laureth-2,
purified water USP, sodium chloride
USP and sodium laureth sulfate.
Ciclopirox Shampoo is a colorless to yellowish, translucent solution.
The chemical name for
ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1_H_)-pyridone, with
the empirical formula
C
H NO and a molecular weight of 207.27. The CAS Registry Number is
[29342-05-0]. The
chemical structure is:
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Ciclopirox is a hydroxypyridone antifungal agent although the
relevance of this property for the
indication of seborrheic dermatitis is not known. Ciclopirox acts by
chelation of polyvalent cations
(Fe
or Al
), resulting in the inhibition of the metal-dependent enzymes that are
responsible for the
degradation of peroxides within the fungal cell.
PHARMACOKINETICS AND PHARMACODYNAMICS
In a study in patients with seborrheic dermatitis of the scalp,
application of 5 mL ciclopirox shampoo
1% twice weekly for 4 weeks, with an exposure time of 3 minutes per
application, resulted in detectable
serum concentrations of ciclopirox in 6 out of 18 patients. The serum
concentrations measured
throughout the dosing interval on Days 1 and 29 ranged from 10.3 ng/mL
to 13.2 ng/mL. Total urinary
excretion of ciclopirox was less than 0.5% of the administered dose.
CLINICAL STUDIES
In two randomized, double-blind clinical trials, patients 16 years and
older with seborrheic dermatitis of
12
17
2
3+
3+
the scalp applied Ciclopirox Shampoo or its vehicle two times per week
for 4 weeks. Patients who
were immunocompromised, those with psoriasis or atopic dermatitis,
women of childbearing potential
not using adequ