DOXYCYCLINE HYCLATE tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

Doxycycline Hyclate (UNII: 19XTS3T51U) (Doxycycline Anhydrous - UNII:334895S862)

Tilgængelig fra:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

Doxycycline Hyclate

Sammensætning:

Doxycycline Anhydrous 20 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Doxycycline hyclate is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.

Produkt oversigt:

Doxycycline hyclate tablets USP equivalent to 20 mg of doxycycline, round, white, unscored, film coated tablet, debossed MP 573 on one side and blank on the other side. Bottles of 30 NDC 53489-647-07 Bottles of 60 NDC 53489-647-06 Bottles of 90 NDC 53489-647-90 Bottles of 100 NDC 53489-647-01 Bottles of 250 NDC 53489-647-03 Bottles of 500 NDC 53489-647-05 Bottles of 1000 NDC 53489-647-10 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
DOXYCYCLINE HYCLATE TABLETS USP
RX ONLY
DESCRIPTION
Doxycycline hyclate is available as a 20 mg tablet formulation of
doxycycline for oral administration.
The structural formula of doxycycline hyclate is:
with an empirical formula of (C
H N O •HCl) •C H O•H O and a molecular weight of 1025.89.
The chemical designation for doxycycline is 4-(dimethylamino)-1, 4,
4a, 5, 5a, 6, 11, 12a-octahydro-3,
5, 10, 12,
12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide
monohydrochloride,
compound with ethyl alcohol (2:1), monohydrate.
Doxycycline hyclate is a yellow to light-yellow crystalline powder
which is soluble in water.
Each tablet for oral administration contains 23 mg doxycycline hyclate
equivalent to 20 mg of
doxycycline. In addition, each tablet contains the following inactive
ingredients: anhydrous lactose,
carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate,
microcrystalline cellulose,
polydextrose, polyethylene glycol, titanium dioxide, and triacetin.
CLINICAL PHARMACOLOGY
After oral administration, doxycycline hyclate is rapidly and nearly
completely absorbed from the
gastrointestinal tract. Doxycycline is eliminated with a half-life of
approximately 18 hours by renal and
fecal excretion of unchanged drug.
MECHANISM OF ACTION
Doxycycline has been shown to inhibit collagenase activity _in vitro_.
Additional studies have shown that
doxycycline reduces the elevated collagenase activity in the gingival
crevicular fluid of patients with
adult periodontitis.
The clinical significance of these findings is not known.
MICROBIOLOGY
Doxycycline is a member of the tetracycline class of antibiotics. The
dosage of doxycycline achieved
with this product during administration is well below the
concentration required to inhibit
microorganisms commonly associated with adult periodontitis. Clinical
studies with this product
22
24
2
8
2
2
6
2
1
2,3
demonstrated no effect on total anaerobic a