DEMECLOCYCLINE HYDROCHLORIDE tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Epic Pharma, LLC

INN (International Name):

DEMECLOCYCLINE HYDROCHLORIDE

Sammensetning:

DEMECLOCYCLINE HYDROCHLORIDE 150 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 Campylobacter fetus ; Brucellosis due to Brucella species (in conjunction with streptomycin); Bartonellosis due to Bartonella bacilliformis ; Granuloma inguinale caused by Calymmatobacterium granulomatis ; Demeclocycline hydrochloride tablets USP is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug: Escherichia coli ; Enterobacter aerogenes ; Shigella species; Acinetobacter species; Respiratory tract infections caused by Haemophilus influenzae ; Respiratory tract and urinary tract infections caused by Klebsiella species. Demeclocycline hydrochloride tablets USP is indicated for treatment of infections caused by the following gram-positive microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory infections caused by Streptococcus pneumoniae; Skin and skin structure infections caused by Staphylococcus aureus . (Note: Tetracyclines, including demeclocycline, are not the drugs of choice in the treatment of any type of staphylococcal infection.) When penicillin is contraindicated, tetracyclines, including demeclocycline hydrochloride, are alternative drugs in the treatment of the following infections: Uncomplicated urethritis in men due to Neisseria gonorrhoeae , and for the treatment of other uncomplicated gonococcal infections; Infections in women caused by Neisseria gonorrhoeae ; Syphilis caused by Treponema pallidum subspecies pallidum ; Yaws caused by Treponema pallidum subspecies pertenue ; Listeriosis due to Listeria monocytogenes ; Anthrax due to Bacillus anthracis ; Vincent’s infection caused by Fusobacterium fusiforme ; Actinomycosis caused by Actinomyces israelii ; Clostridial diseases caused by Clostridium species. In acute intestinal amebiasis, demeclocycline hydrochloride tablets USP may be a useful adjunct to amebicides. In severe acne, demeclocycline hydrochloride tablets USP may be a useful adjunctive therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets USP and other antibacterial drugs, demeclocycline hydrochloride tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any of the components of the product formulation.

Produkt oppsummering:

Demeclocycline Hydrochloride Tablets USP, 150 mg, are round, biconvex, red film-coated tablets, debossed "Є" above "143" on one side and plain on the other side, and are supplied as follows: NDC 42806-143-30 - Bottle of 30 NDC 42806-143-01 - Bottle of 100 NDC 42806-143-05 - Bottle of 500 Demeclocycline Hydrochloride Tablets USP, 300 mg, are round, biconvex, red, film-coated tablets, debossed "Є" above "144" on one side and plain on the other side, and are supplied as follows: NDC 42806-144-30 - Bottle of 30 NDC 42806-144-48 - Bottle of 48 NDC 42806-144-01 - Bottle of 100 Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure as required. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

DEMECLOCYCLINE HYDROCHLORIDE- DEMECLOCYCLINE HYDROCHLORIDE TABLET,
FILM COATED
EPIC PHARMA, LLC
----------
DEMECLOCYCLINE HYDROCHLORIDE TABLETS, USP
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:
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%. Demeclocycline hydrochloride penetrates well
into various
body fluids and tissues. The percent of demeclocycline hydrochloride
bound to plasma
protein is about 40% using a dialysis equilibrium meth