CICLOPIROX shampoo

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Actavis Pharma, Inc.

INN (Mezinárodní Name):

CICLOPIROX

Složení:

CICLOPIROX 10 mg in .96 mL

Podání:

TOPICAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 administere

Přehled produktů:

Ciclopirox Shampoo 1% is colorless and translucent, and supplied in 120 mL plastic bottles (NDC 0591-2159-90). Discard unused product after initial treatment duration. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep out of reach of children.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CICLOPIROX- CICLOPIROX SHAMPOO
ACTAVIS PHARMA, 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 Shampoo 1% use.
(5.1)
ADVERSE REACTIONS
The most frequently reported adverse reactions are pruritus, burning,
and erythema. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ACTAVIS AT
1-800-272-5525 OR FDA AT 1-800-FDA-1088
OR HTTP://_WWW.FDA.GOV/MEDWATCH._
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 9/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORM AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 LOCAL EFFECTS
6 ADVERSE REACTIONS
6.1 CLINICAL TRIALS EXPERIENCE
6.2 POSTMARKETING 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, IMPAIRMENT OF FERTILITY
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Ciclopirox Shampoo 1% is indicated for the topical treatme