SODIUM SULFACETAMIDE solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

sulfacetamide sodium (UNII: 4NRT660KJQ) (sulfacetamide - UNII:4965G3J0F5)

Dostopno od:

E. FOUGERA & Co., A division of Nycomed US Inc.

INN (mednarodno ime):

sulfacetamide sodium

Sestava:

sulfacetamide sodium 100 mg in 1 g

Pot uporabe:

TOPICAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Sodium Sulfacetamide Medicated Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. Sodium Sulfacetamide Medicated Pads are contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the preparation. Sodium Sulfacetamide Medicated Pads are not to be used by patients with kidney disease.

Povzetek izdelek:

Sodium Sulfacetamide Medicated Pads NDC 0168-0484-01 contain 30 Foil Pouches, each with a single-use medicated pad (2.5 mL each). Store at 15°-30° C (59°-86° F). Protect from freezing. Sodium Sulfacetamide Medicated Pads may darken after prolonged storage. Slight discoloration does not impair the efficacy or safety of the product. Manufactured for: E. FOUGERA & CO. A division of Nycomed US Inc., Melville New York 11747 Manufactured by: Pegasus Laboratories, Inc., Pensacola, FL 32514 IL302A R3/09

Status dovoljenje:

unapproved drug other

Lastnosti izdelka

SODIUM SULFACETAMIDE- SODIUM SULFACETAMIDE SOLUTION
E. FOUGERA & CO., A DIVISION OF NYCOMED US INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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SODIUM SULFACETAMIDE MEDICATED PADS 10%
in a Urea Vehicle
FOR DERMATOLOGIC USE ONLY
RX only
NOT FOR OPHTHALMIC USE
DESCRIPTION:
SODIUM SULFACETAMIDE MEDICATED PADS 10% contain a 10% solution of
sodium sulfacetamide on a
textured pad. Each gram of medicated solution contains 100 mg sodium
sulfacetamide, purified water,
sodium EDTA, sodium thiosulfate and urea ( 1 0%). SODIUM SULFACETAMIDE
MEDICATED PADS are
greaseless and leave no residue when applied to the skin.
Sodium sulfacetamide is a sulfonamide with antibacterial activity.
Chemically, sodium sulfacetamide is
C H N Na0 S•H O, with a molecular weight of 254.24. Chemically it is
acetamide, N- [(4
aminophenyl) sulfonyl]-, monosodium salt and monohydrate, with the
following structural formula:
CLINICAL PHARMACOLOGY:
Sodium sulfacetamide exerts a bacteriostatic effect against
sulfonamide-sensitive gram-positive and
gram-negative micro-organism including _P. acne_ commonly isolasted
from secondary cutaneous
pyogenic infections.
The most widely accepted mechanism of action of sulfonamides is the
Woods-Fildes theory, which is
based on the fact that sulfonamides act as competitive antagonists to
para-aminobenzoic acid P ( ABA),
an essential component for bacterial growth. While absorption through
intact skin in humans has not been
determined, sodium sulfacetamide is readily absorbed from the
gastrointestinal tract when taken orally
and excreted in the urine largely unchanged. The biological half-life
has variously been reported as 7 o
t 12.8 hours.
INDICATIONS AND USAGE:
SODIUM SULFACETAMIDE MEDICATED PADS are indicated in the topical
control of acne vulgaris, acne
rosacea and seborrheic dermatitis.
CONTRAINDICATIONS:
SODIUM SULFACETAMIDE MEDICATED PADS are contraindicated