CICLOPIROX shampoo

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Taro Pharmaceuticals U.S.A., Inc.

INN (International Adı):

ciclopirox

Kompozisyon:

ciclopirox 10 mg in 0.96 mL

Uygulama yolu:

TOPICAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

Ciclopirox Shampoo, 1% is colorless and translucent, and 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]. Keep out of reach of children.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

CICLOPIROX- CICLOPIROX SHAMPOO
TARO PHARMACEUTICALS U.S.A., INC.
----------
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
Ciclopirox Shampoo 1% is an antifungal indicated for the topical
treatment of seborrheic dermatitis of the scalp in
adults. (1)
DOSAGE AND ADMINISTRATION
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)
DOSAGE FORMS AND STRENGTHS
Shampoo, 1% (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
If signs of irritation occur, discontinue use. (5.1)
Avoid contact with eyes. (5.1)
Hair discoloration has been reported with Ciclopirox use. (5.1)
ADVERSE REACTIONS
The most frequently reported adverse reactions are pruritus, burning,
and erythema. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TARO AT 1-866-923-4914
OR FDA AT 1-800-FDA-1088 OR
HTTP://WWW.FDA.G O V/M E DWATC H.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 12/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATION 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
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, and Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*
FULL PRESCRIBING INFORMATION
1 INDICATION AND USAGE
Ciclopirox Shampoo 1% is indicated for the topical