DIAMOX SEQUELS- acetazolamide capsule, extended release

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

ACETAZOLAMIDE (UNII: O3FX965V0I) (ACETAZOLAMIDE - UNII:O3FX965V0I)

Mevcut itibaren:

Teva Women's Health, Inc.

INN (International Adı):

ACETAZOLAMIDE

Kompozisyon:

ACETAZOLAMIDE 500 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

For adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angleclosure glaucoma where delay of surgery is desired in order to lower intraocular pressure. DIAMOX is also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent. Hypersensitivity to acetazolamide or any excipients in the formulation. Since acetazolamide is a sulfonamide derivative, cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives is possible. Acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and in hyperchloremic acidosis. It is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy. Long-term administration of DIAMOX is contraindicated in patients with chronic non-congestive angle-c

Ürün özeti:

DIAMOX® SEQUELS® (Acetazolamide Extended-Release Capsules) are available as 500 mg: Orange opaque cap and orange opaque body filled with white to off-white pellets. Imprinted in black ink, DIAMOX 754 . Available in bottles of: 100 NDC 51285-754-02 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].   Distributed by: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. 1/2018

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

DIAMOX SEQUELS- ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE
TEVA WOMEN'S HEALTH, INC.
----------
DIAMOX SEQUELS
(ACETAZOLAMIDE EXTENDED-RELEASE CAPSULES)
RX ONLY
Rev. 1/2018
DESCRIPTION:
DIAMOX SEQUELS (Acetazolamide Extended-Release Capsules) are an
inhibitor of the enzyme
carbonic anhydrase.
DIAMOX is a white to faintly yellowish white crystalline, odorless
powder, weakly acidic, very
slightly soluble in water, and slightly soluble in alcohol. The
chemical name for DIAMOX is N-(5-
Sulfamoyl-1,3, 4-thiadiazol-2-yl) acetamide and has the following
chemical structure:
MW 222.24 C H N O S
DIAMOX SEQUELS are extended-release capsules, for oral administration,
each containing 500 mg of
acetazolamide and the following inactive ingredients:
Microcrystalline cellulose, sodium lauryl sulfate and talc.
The ingredients in the capsule shell are D&C red no. 28, D&C yellow
no. 10, FD&C red no. 40, gelatin
and titanium dioxide.
The ingredients in the imprinting ink are D&C yellow no. 10 aluminum
lake, FD&C blue no. 1 aluminum
lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake,
pharmaceutical glaze, propylene
glycol and synthetic iron oxide.
CLINICAL PHARMACOLOGY:
DIAMOX is a potent carbonic anhydrase inhibitor, effective in the
control of fluid secretion (e.g., some
types of glaucoma), in the treatment of certain convulsive disorders
(e.g., epilepsy), and in the
promotion of diuresis in instances of abnormal fluid retention (e.g.,
cardiac edema).
DIAMOX is not a mercurial diuretic. Rather, it is a non-bacteriostatic
sulfonamide possessing a
chemical structure and pharmacological activity distinctly different
from the bacteriostatic
sulfonamides.
DIAMOX is an enzyme inhibitor that acts specifically on carbonic
anhydrase, the enzyme that catalyzes
the reversible reaction involving the hydration of carbon dioxide and
the dehydration of carbonic acid.
In the eye, this inhibitory action of acetazolamide decreases the
secretion of aqueous humor and results
in a drop in intraocular pressure, a reaction considered desirabl