国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
DEMECLOCYCLINE HYDROCHLORIDE (UNII: 29O079NTYT) (DEMECLOCYCLINE - UNII:5R5W9ICI6O)
Carilion Materials Management
DEMECLOCYCLINE HYDROCHLORIDE
DEMECLOCYCLINE HYDROCHLORIDE 150 mg
ORAL
PRESCRIPTION DRUG
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 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. Demeclocycline hydrochloride 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 ; Lymphogranuloma venereum due to ; Psittacosis (Ornithosis) due to ; Trachoma due to , although the infectious
NDC:68151-0155-1 in a PACKAGE of 1 TABLETS
Abbreviated New Drug Application
Carilion Materials Management DEMECLOCYCLINE HYDROCHLORIDE - DEMECLOCYCLINE HYDROCHLORIDE TABLET CARILION MATERIALS MANAGEMENT ---------- DEMECLOCYCLINE HYDROCHLORIDE TABLETS, USP (FILM COATED) 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 is an antibiotic isolated from a mutant strain of . 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: _Streptomyces aureofaciens_ Demeclocycline hydrochloride film coated tablets for oral administration contain 150 mg or 300 mg of demeclocycline hydrochloride 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 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. PHARMACOKINETICS 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 m 完全なドキュメントを読む