MESALAMINE kit

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

MESALAMINE (UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC)

Boleh didapati daripada:

Padagis Israel Pharmaceuticals Ltd

INN (Nama Antarabangsa):

MESALAMINE

Komposisi:

MESALAMINE 4 g in 60 mL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Mesalamine rectal suspension enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. Mesalamine rectal suspension enema is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, sulfites or any other component of this medication.

Ringkasan produk:

Mesalamine Rectal Suspension, USP Enema for rectal administration is an off-white to tan colored suspension. Each disposable enema bottle contains 4.0 grams of mesalamine in 60 mL aqueous suspension. Enema bottles are supplied in boxed, foil-wrapped trays as follows: Carton of 7 Bottles - NDC 45802-098 -51 Carton of 28 Bottles - NDC 45802-098 -28 Combo Kit with 7 Bottles and Wipes - NDC 45802-923 -41 Combo Kit with 28 Bottles and Wipes - NDC 45802-929 -49 Mesalamine rectal suspension enemas are for rectal use only. KEEP OUT OF REACH OF CHILDREN Patient instructions are included. Storage Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Once the foil-wrapped unit of seven bottles is opened, all enemas should be used promptly as directed by your physician. Contents of enemas removed from the foil pouch may darken with time. Slight darkening will not affect potency, however, enemas with dark brown contents should be discarded. NOTE: Mesalamine rectal suspension enema will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Take care in choosing a suitable location for administration of this product. For more information call Padagis® at 1-866-634-9120. Rx Only Manufactured by Padagis® Yeruham, Israel www.padagis.com Rev 11-23 2N900 RC PH13

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

MESALAMINE- MESALAMINE
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
MESALAMINE RECTAL SUSPENSION, USP ENEMA
4g/unit (60 mL)
RX ONLY
DESCRIPTION
The active ingredient in Mesalamine Rectal Suspension, USP Enema, a
disposable (60 mL)
unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA).
Chemically, mesalamine
is 5-amino-2-hydroxybenzoic acid.
The empirical formula is C H NO , representing a molecular weight of
153.14. The
structural formula is:
Each rectal suspension enema unit contains 4 grams of mesalamine. In
addition to
mesalamine the preparation contains the inactive ingredients carbomer
934P, edetate
disodium, potassium acetate, potassium metabisulfite, purified water
and xanthan gum.
Sodium benzoate is added as a preservative. The disposable unit
consists of an
applicator tip protected by a polyethylene cover and lubricated with
USP white
petrolatum. The unit has a one-way valve to prevent back flow of the
dispensed product.
CLINICAL PHARMACOLOGY
Each mesalamine rectal suspension enema delivers up to 4 g of
mesalamine to the left
side of the colon.
The mechanism of action of mesalamine (and sulfasalazine) is not fully
understood, but
appears to be a topical anti-inflammatory effect on colonic epithelial
cells. Mucosal
production of arachidonic acid (AA) metabolites, both through the
cyclooxygenase
pathways, i.e., prostanoids, and through the lipoxygenase pathways,
i.e., leukotrienes
(LTs) and hydroxyeicosatetraenoic acids (HETEs) is increased in
patients with ulcerative
colitis, and it is possible that mesalamine diminishes inflammation by
blocking
cyclooxygenase and inhibiting prostaglandin (PG) production in the
colon.
PRECLINICAL TOXICOLOGY -
7
7
3
Preclinical studies have shown the kidney to be the major target organ
for mesalamine
toxicity. Adverse renal function changes were observed in rats after a
single 600 mg/kg
oral dose, but not after a 200 mg/kg dose. Gross kidney lesions,
including papillary
necrosis, were observed after a single oral >900 mg/kg dose, and after
I.V. doses of >
214 m