DEMECLOCYCLINE HYDROCHLORIDE tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Marlex Pharmaceuticals Inc

Designación común internacional (DCI):

DEMECLOCYCLINE HYDROCHLORIDE

Composición:

DEMECLOCYCLINE HYDROCHLORIDE 150 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Demeclocycline hydrochloride tablets USP is 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 Campyloba

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

DEMECLOCYCLINE HYDROCHLORIDE- DEMECLOCYCLINE HYDROCHLORIDE TABLET,
FILM COATED
MARLEX PHARMACEUTICALS INC
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DEMECLOCYCLINE HYDROCHLORIDE TABLETS
DEMECLOCYCLINE HYDROCHLORIDE- DEMECLOCYCLINE HYDROCHLORIDE TABLET,
FILM COATED
MARLEX PHARMACEUTICALS, INC.
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DEMECLOCYCLINE HYDROCHLORIDE TABLETS RX ONLY
FULL PRESCRIBING INFORMATION
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.
Its structural formula is:
Each film-coated tablet, for oral administration contains 150 mg or
300 mg of demeclocycline
hydrochloride, USP and has the following inactive ingredients:
carnauba wax, colloidal silicon dioxide,
crospovidone, hydroxypropyl cellulose, hypromelloses, magnesium
stearate, microcrystalline
cellulose, polydextrose, polyethylene glycol, pregelatinized starch,
talc, titanium dioxide, triacetin,
D&C Red No. 27 Aluminum Lake, D&C Red No. 30 Aluminum Lake, FD&C Blue
No. 1 Aluminum
Lake and FD&C Yellow No. 6 Aluminum Lake.
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%. Demecloc