Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 03 February 2017
PRECAUTIONS General If a reaction suggesting sensitivity or chemical
Exposure to sunlight, including sunlamps, should be minimized during the use of TRETIN•X, and patients with sunburn should be advised not to use the product until fully recovered because of heightened
Use of sunscreen products and
Weather extremes, such as wind or
TRETIN•X preparations for acne treatment should be kept away from the eyes, the mouth, angles of the nose, and mucous membranes.
Topical use may induce
If the degree of local
Tretinoin has been reported to cause
Drug Interactions Concomitant topical medication, medicated or
It also is advisable to “rest” a patient 's skin until the effects of such preparations subside before use of TRETIN•X is begun.
A dose-related incidence of liver tumors in male mice was observed at those same doses.
The maximum systemic doses associated with the administered 0.017 % and 0.035 % formulations are 0.5 and 1.0 mg/kg/day, respectively.
These doses are two and four times the maximum human systemic dose, when
For purposes of comparisons of the animal exposure to systemic human exposure, the maximum human systemic dose is defined as 1 gram of 0.1 % TRETIN•X applied daily to a 50 kg person (0.02 mg tretinoin/ kg body weight).
Studies in hairless albino mice suggest that
This effect has been confirmed in a later study in pigmented mice, and
In dermal Segment I fertility studies of tretinoin in
A dermal Segment III study with TRETIN•X has not been performed in any species.
In oral Segment I and Segment III studies in
Pregnancy Teratogenic effects.
Pregnancy Category C. Oral tretinoin has been shown to be teratogenic in
It was teratogenic and fetotoxic in Wistar
In the cynomolgus monkey, which metabolically is
Similar results have also been reported in pigtail macaques.
Topical tretinoin in animal teratogenicity tests has generated
There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in
There are other reports in New Zealand White rabbits administered
In contrast, several
With widespread use of any drug, a
Thirty human cases of temporally associated congenital malformations have been reported during two decades of clinical use of tretinoin.
The significance of these spontaneous reports in terms of risk to the fetus is not known.
Nonteratogenic effects: Topical tretinoin has been shown to be fetotoxic in rabbits when administered 0.5 mg/kg/day (8 times
Oral tretinoin has been shown to be fetotoxic, resulting in skeletal variations and
Tretinoin should be used during pregnancy only if the potential
Nursing Mothers It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk,
If these effects occur, the medication should either be
Temporary hyper - or hypopigmentation has been reported with repeated application of a tretinoin preparation.
Some individuals have been reported to have heightened
To date, all
DOSAGE AND ADMINISTRATION TRETIN•X cream should be applied once a day, before retiring, to the skin where acne lesions appear, using enough to cover the entire
Application may cause a transitory feeling of
In cases where it has been necessary to
During the early weeks of therapy, an apparent
This is due to the action of the medication on deep, previously unseen lesions and should not be considered a reason to
Therapeutic results should be noticed after two to three weeks but more than
Patients treated with TRETIN•X preparations may use cosmetics, but the areas to be treated should be
|Date Last Revised||19-08-2013|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||STORAGE CONDITIONS TRETIN•X Cream, USP: store below 27°C (80°F) TRETIN•X is a registered trademark of Onset Dermatologics, LLC Manufactured for Onset Dermatologics, LLC Cumberland, RI 02864 by DPT Laboratories, San Antonio, TX 78215 P/N2634 R2 Onset Dermatologics|
|Marketing authorisation holder||Onset Dermatologics, LLC|