ALTRENO- tretinoin lotion

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)

Beschikbaar vanaf:

Bausch Health US, LLC

Toedieningsweg:

TOPICAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

ALTRENO® (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. None. Risk Summary Available data from published observational studies of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are no data on ALTRENO use in pregnant women. The systemic levels following topical administration are lower than with administration of oral tretinoin; however, absorption of this product may result in fetal exposure. There are reports of major birth defects similar to those seen in infants exposed to oral retinoids, but these case reports do not establish a pattern or association with tretinoin-related embryopathy (see Data). Animal reproduction studies have not been conducted with ALTRENO. Topical administration of tretinoin in a different formulation to pregnant rats during organogenesis was associated with malformations (craniofacial abnorma

Product samenvatting:

ALTRENO (tretinoin) lotion, 0.05% is an opaque, pale yellow topical lotion and available as: Storage and Handling Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing. Store pump upright.

Autorisatie-status:

New Drug Application

Productkenmerken

ALTRENO- TRETINOIN LOTION
BAUSCH HEALTH US, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALTRENO SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ALTRENO.
ALTRENO (TRETINOIN) LOTION, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1973
INDICATIONS AND USAGE
ALTRENO is a retinoid indicated for the topical treatment of acne
vulgaris in patients 9 years of age and older. (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Lotion, 0.05% (3)
Each gram of ALTRENO contains 0.5 mg (0.05%) tretinoin. (3)
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: 3/2020
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 Skin Irritation
5.2 Ultraviolet Light and Environmental Exposure
5.3 Fish Allergies
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
®
Apply a thin layer of ALTRENO to affected areas once daily. Avoid
eyes, mouth, paranasal creases, and mucous
membranes. (2)
Not for ophthalmic, oral, or intravaginal use. (2)
Skin Irritation: Dryness, pain, erythema, irritation and exfoliation
may occur with use of ALTRENO. (5.1)
Ultraviolet Light and Environmental Exposure: Minimize exposure to
sunlight and sunlamps. Use sunscreen and
protective clothing when sun exposure cannot be avoided. (5.2)
Fish Allergies: Use ALTRENO with caution if allergic to fish due to
potential for allergenicity to fish protein. Advise
patients to contact their healthcare provider if they develop pruritus
or urticaria. (5.3)
The most common adverse reactions occurring in ≥1% of subjects and
greater than vehicle were dryness, pain,
erythema, ir