DEMECLOCYCLINE HYDROCHLORIDE tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

DEMECLOCYCLINE HYDROCHLORIDE (UNII: 29O079NTYT) (DEMECLOCYCLINE - UNII:5R5W9ICI6O)

Beszerezhető a:

Teva Pharmaceuticals USA, Inc.

INN (nemzetközi neve):

DEMECLOCYCLINE HYDROCHLORIDE

Összetétel:

DEMECLOCYCLINE HYDROCHLORIDE 150 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Demeclocycline hydrochloride tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by rickettsiae; Respiratory tract infections caused by Mycoplasma pneumoniae ; Lymphogranuloma venereum due to Chlamydia trachomatis ; Psittacosis (Ornithosis) due to Chlamydia psittaci ; Trachoma due to Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence; Inclusion conjunctivitis caused by Chlamydia trachomatis ; Nongonococcal urethritis in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis ; Relapsing fever due to Borrelia recurrentis ; Chancroid caused by Haemophilus ducreyi ; Plague due to Yersinia pestis ; Tularemia due to Francisella tularensis ; Cholera caused by Vibrio cholerae ; Campylobacter fetus infections caused by Campylobacter fetus ; Br

Termék összefoglaló:

Demeclocycline Hydrochloride Tablets USP, 150 mg are available as pink, round, biconvex, film-coated, unscored tablets, debossed with “stylized b ” 701 on one side and 150 on the other, packaged in bottle of 100 (NDC 0555-0701-02) tablets. Demeclocycline Hydrochloride Tablets USP, 300 mg are available as pink, round, biconvex, film-coated, unscored tablets, debossed with “stylized b ” 702 on one side and 300 on the other, packaged in bottle of 48 (NDC 0555-0702-84) tablets. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

DEMECLOCYCLINE HYDROCHLORIDE- DEMECLOCYCLINE HYDROCHLORIDE TABLET,
FILM COATED
TEVA PHARMACEUTICALS USA, INC.
----------
DEMECLOCYCLINE HYDROCHLORIDE TABLETS USP
0701
0702
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of demeclocycline
hydrochloride tablets and other antibacterial drugs, demeclocycline
hydrochloride tablets should be
used only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Demeclocycline hydrochloride, USP is an antibiotic isolated from a
mutant strain of Streptomyces
aureofaciens. Chemically it is
7-Chloro-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,
12a-pentahydroxy-1,11-dioxo-2-naphthacenecarboxamide
monohydrochloride. The structural formula
is:
C
H ClN O • HCl M.W. 501.32
Each film coated tablet, for oral administration, contains 150 mg or
300 mg of demeclocycline
hydrochloride, USP and has the following inactive ingredients:
colloidal silicon dioxide,
crospovidone, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose,
magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polysorbate 80,
povidone, sodium stearyl fumarate,
and titanium dioxide.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
The absorption of demeclocycline is slower than that of tetracycline.
The time to reach the peak
concentration is about 4 hours. After a 150 mg oral dose of
demeclocycline tablet, the mean
concentrations at 1 hour and 3 hours are 0.46 and 1.22 mcg/mL (n = 6),
respectively. The serum half-life
ranges between 10 and 16 hours. When demeclocycline hydrochloride is
given concomitantly with
some dairy products, or antacids containing aluminum, calcium, or
magnesium, the extent of absorption
is reduced by more than 50%. Demeclocycline hydrochloride penetrates
well into various body fluids
21
21
2
8
and tissues. The percent of demeclocycline hydrochloride bound to
plasma protein is about 40% using
a dialysis equilibrium method and 90% using an ultra-filtration
method. Demeclocycline hydrochl