DEMECLOCYCLINE HYDROCHLORIDE- demeclocycline tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Amneal Pharmaceuticals LLC

INN (International ime):

DEMECLOCYCLINE HYDROCHLORIDE

Sastav:

DEMECLOCYCLINE HYDROCHLORIDE 150 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Demeclocycline HCl 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 cause by Campylobacter fetus Brucellosis due to Brucella species (in conjunction with streptomycin); Bartonellosis due to Bartonella bacilliformis Granuloma inguinale caused by Calymmatobacterium granulomatis Demeclocycline HCl tablets are indicated for treatment of infections 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 HCl tablets are 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 HCl, 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 HCl may be a useful adjunct to amebicides. In severe acne, demeclocycline HCl may be a useful adjunctive therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of demeclocycline HCl tablets and other antibacterial drugs, demeclocycline HCl tablets 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.

Proizvod sažetak:

Demeclocycline HCl tablets, USP, 150 mg, are supplied as round, convex, red, film-coated tablets, debossed with “AN” above “54” on one side and plain on the other side. They are available as follows: Bottles of 100:                           NDC 65162-554-10 Demeclocycline HCl tablets, USP, 300 mg, are supplied as round, convex, red, film-coated tablets, debossed with “AN” above “55” on one side and plain on the other side. They are available as follows: Bottles of 48:                             NDC 65162-555-48 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Protect from light. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

DEMECLOCYCLINE HYDROCHLORIDE- DEMECLOCYCLINE TABLET
AMNEAL PHARMACEUTICALS LLC
----------
DEMECLOCYCLINE HYDROCHLORIDE TABLETS, USP
FOR ORAL USE
RX ONLY
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
DEMECLOCYCLINE HYDROCHLORIDE (HCL) TABLETS AND OTHER ANTIBACTERIAL
DRUGS, DEMECLOCYCLINE HCL
TABLETS SHOULD BE USED ONLY TO TREAT OR PREVENT INFECTIONS THAT ARE
PROVEN OR STRONGLY SUSPECTED TO
BE CAUSED BY BACTERIA.
DESCRIPTION
Demeclocycline HCl 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:
Demeclocycline HCl tablets, USP, for oral administration, contain 150
mg or 300 mg of
demeclocycline HCl, USP and the following inactive ingredients:
alginic acid, corn starch,
ethylcellulose, FD&C Red 40 aluminum lake, hypromellose, magnesium
stearate, microcrystalline
cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl
sulfate, talc and titanium dioxide. In
addition, the 150 mg tablet contains D&C Red 27 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 HCl 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 HCl penetrates well into various body
fluids and tissues. The
percent of demeclocycline HCl bound to plasma protein is about 40%
using a dialysis equilibrium
method and 90% using an ultra-filtration method. Demeclocycline HCl,
like other tetracyclines, is
concentrated in the liver and excreted into t