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t-stat (erythromycin) solution
[Bristol-Myers Squibb Company]
For topical use only. Not for ophthalmic
use.
DESCRIPTION
Erythromycin is an antibiotic produced from a strain of
Streptomyces erythraeus. It is basic and readily forms salts with acids. Each ml
of T-STAT (erythromycin) 2.0% Topical Solution contains 20 mg of erythromycin
base in a vehicle consisting of alcohol (71.2%), propylene glycol and fragrance.
It may contain citric acid to adjust pH.
ACTIONS
Although the mechanism by which T-STAT Solution acts in reducing
inflammatory lesions of acne vulgaris is unknown, it is presumably due to its
antibiotic action.
INDICATIONS
T-STAT Solution is indicated for the topical control of acne
vulgaris.
CONTRAINDICATIONS
T-STAT Solution is contraindicated in persons who have shown
hypersensitivity to any of its ingredients.
WARNING
The safe use of T-STAT (erythromycin) 2.0% Solution during
pregnancy or lactation has not been established.
PRECAUTIONS
General
The use of antibiotic agents may be associated with the
overgrowth of antibiotic-resistant organisms. If this occurs, administration of
this drug should be discontinued and appropriate measures taken.
Information for Patients
T-STAT Solution is for external use only and should be kept away
from the eyes, nose, mouth, and other mucous membranes. Concomitant topical acne
therapy should be used with caution because a cumulative irritant effect may
occur, especially with the use of peeling, desquamating, or abrasive
agents.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies to evaluate carcinogenic potential,
mutagenicity, or the effect on fertility of erythromycin have not been
performed.
Pregnancy: Pregnancy Category C
Animal reproduction studies have not been conducted with
erythromycin. It is also not known whether erythromycin can cause fetal harm
when administered to a pregnant woman or can affect reproduction capacity.
Erythromycin should be given to a pregnant woman only if clearly needed.
Nursing Mothers
Erythromycin is excreted in breast milk. Caution should be
exercised when erythromycin is administered to a nursing woman.
ADVERSE REACTIONS
Adverse conditions reported include dryness, tenderness,
pruritis, desquamation, erythema, oiliness, and burning sensation. Irritation of
the eyes has also been reported. A case of generalized urticarial reaction,
possibly related to the drug, which required the use of systemic steroid therapy
has been reported.
DOSAGE AND ADMINISTRATION
T-STAT Solution or Pads should be applied over the affected area
twice a day after the skin is thoroughly washed with warm water and soap and
patted dry. Acne lesions on the face, neck, shoulder, chest, and back may be
treated in this manner. Additional pads may be used, if needed.
This medication should be applied with applicator top or the disposable
applicator pads. If fingertips or pads are used, wash hands after application.
Drying and peeling may be controlled by reducing the frequency of
applications.
HOW SUPPLIED
T-STAT Solution, 60 ml plastic bottle with optional applicator,
NDC 0072-8300-60. T-STAT Pads, 60 disposable premoistened applicator pads in a
plastic jar. NDC 0072-8303-60. Store in a dry place at temperatures between 15°C
and 25°C (59°F and 77°F).
© 1987, 1990 Westwood-Squibb Pharmaceuticals Inc., Buffalo, N.Y.,
U.S.A. 14213
03-5964-0
Rev. 10/91
Revised: 05/2006Bristol-Myers Squibb Company
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