LOPROX- ciclopirox shampoo

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Bausch Health US, LLC

INN (Isem Internazzjonali):

ciclopirox

Kompożizzjoni:

ciclopirox 10 mg in 0.96 mL

Rotta amministrattiva:

TOPICAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

LOPROX® (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, LOPROX Shampoo 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 adm

Sommarju tal-prodott:

LOPROX (ciclopirox) Shampoo, 1% is colorless and translucent, and supplied in 120 mL plastic bottles (NDC 99207-010-10). Discard unused product after initial treatment duration. Store between 15° to 30°C (59° to 86°F). Keep out of reach of children.

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

LOPROX- CICLOPIROX SHAMPOO
BAUSCH HEALTH US, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LOPROX SHAMPOO SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LOPROX SHAMPOO.
LOPROX (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 BAUSCH HEALTH US, LLC
AT 1-800-321-
4576 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 5/2019
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 Postmarketing Experience
8 USE IN SPECIFIC POPULATIONS
®
LOPROX Shampoo is an antifungal indicated for the topical treatment of
seborrheic dermatitis of the
scalp in adults. (1)
Apply approximately 1 teaspoon of LOPROX Shampoo 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 LOPROX 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
LOPROX (ciclopirox) Shampoo, 1% is indicated fo