CICLOPIROX shampoo

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

CICLOPIROX (UNII: 19W019ZDRJ) (CICLOPIROX - UNII:19W019ZDRJ)

Disponível em:

Padagis Israel Pharmaceuticals Ltd

DCI (Denominação Comum Internacional):

CICLOPIROX

Composição:

CICLOPIROX 1 g in 100 mL

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Ciclopirox Shampoo, 1% is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. None. Teratogenic Effects: Pregnancy Category B There are no adequate or well-controlled studies in pregnant women. Therefore, Ciclopirox Shampoo, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral embryofetal developmental studies were conducted in mice, rats, rabbits and monkeys. Ciclopirox or ciclopirox olamine was orally administered during the period of organogenesis. No maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 77, 125, 80 and 38.5 mg/kg/day ciclopirox in mice, rats, rabbits and monkeys, respectively (approximately 13, 42, 54 and 26 times the maximum recommended human dose based on body surface area comparisons, respectively). Dermal embryofetal developmental studies were conducted in rats and rabbits with ciclopirox olamine dissolved in PEG 400. Ciclopirox olamine was topically administered during the period of organogenesis. No maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 92 mg/kg/day and 77 mg/kg/day ciclopirox in rats and rabbits, respectively (approximately 31 and 54 times the maximum recommended human dose based on body surface area comparisons, respectively). It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ciclopirox Shampoo, 1% is administered to a nursing woman. No clinical trials have been conducted in subjects younger than 16 years. In clinical trials, the safety and tolerability of ciclopirox shampoo, 1% in the population 65 years and older was comparable to that of younger subjects. Results of the efficacy analysis in those subjects 65 years and older showed effectiveness in 25 of 85 (29%) subjects treated with ciclopirox shampoo, 1%, and in 15 of 61 (25%) subjects treated with the vehicle; due to the small sample size, a statistically significant difference was not demonstrated. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity to adverse effects in some older individuals cannot be ruled out.

Resumo do produto:

Ciclopirox Shampoo, 1% is colorless and translucent, and supplied in 120 mL plastic bottles (NDC 45802-401 -09). Discard unused product after initial treatment duration. Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

CICLOPIROX- CICLOPIROX SHAMPOO
PADAGIS ISRAEL PHARMACEUTICALS LTD
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CICLOPIROX SHAMPOO
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CICLOPIROX SHAMPOO.
CICLOPIROX SHAMPOO, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1982
INDICATIONS AND USAGE
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
•
To report SUSPECTED ADVERSE REACTIONS, contact Padagis at
1-866-634-9120 or FDA at 1-800-FDA-
1088 or www.fda.gov/medwatch.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 4/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Local Effects
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post Marketing Experience
8 USE IN SPECIFIC POPULATIONS
Ciclopirox Shampoo, 1% is an antifungal indicated for the topical
treatment of seborrheic dermatitis of
the scalp in adults. (1)
Apply approximately 1 teaspoon of Ciclopirox Shampoo, 1% to the scalp
twice per week for 4 weeks.
(2)
For topical use only. Not for ophthalmic, oral, or intravaginal use.
(2)
Shampoo, 1% (3)
If signs of irritation occur, discontinue use. (5.1)
Avoid contact with eyes. (5.1)
Hair discoloration has been reported with Ciclopirox Shampoo, 1% use.
(5.1)
The most frequently reported adverse reactions are pruritus, burning,
and erythema. (6.1)
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Ciclopirox Sham