DOXY 100- TM DOXYCYCLINE injection, powder, lyophilized, for solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

Dostępny od:

HF Acquisition Co LLC, DBA HealthFirst

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline for Injection, USP and other antibacterial drugs, Doxycycline for Injection, 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. Doxycycline for Injection, USP is indicated in infections caused by the following microorganisms: Rickettsiae (Rocky Mountain spotted fever, typhus fever, and the typhus group, Q fever, rickettsial pox and tick fevers). Mycoplasma pneumoniae (PPLO, Eaton Agent). Agents of psittacosis and ornithosis. Agents of lymphogranuloma venereum and granuloma inguinale. The spirochetal agent of relapsing fever (Borrelia recurrentis). The following gram-negative microorganisms: Haemophilus ducreyi (chancroid). Yersinia pestis (formerly Pasteurella pestis) and Francisella tularensis (formerly Pasteurella tularensis). Bartonella bacilliformis. Bacteroides species. Vibrio cholerae (formerly Vibrio comma) and Campylobacter fetus (formerly Vibrio fetus). Brucella species (in conjunction with streptomycin). Because many strains of the following groups of microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended. Doxycycline 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 (formerly Aerobacter aerogenes). Shigella species. Acinetobacter species (formerly Mima species and Herellea species). Haemophilus influenzae (respiratory infections). Klebsiella species (respiratory and urinary infections). Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Streptococcus species: Up to 44 percent of strains of Streptococcus pyogenes and 74 percent of Enterococcus faecalis (formerly Streptococcus faecalis) have been found to be resistant to tetracycline drugs. Therefore, tetracyclines should not be used for streptococcal disease unless the organism has been demonstrated to be sensitive. For upper respiratory infections due to group A beta-hemolytic streptococci, penicillin is the usual drug of choice, including prophylaxis of rheumatic fever. Streptococcus pneumoniae (formerly Diplococcus pneumoniae). Staphylococcus aureus, respiratory, skin and soft tissue infections. Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to: Neisseria gonorrhoeae and N. meningitidis. Treponema pallidum and Treponema pertenue (syphilis and yaws). Listeria monocytogenes. Clostridium species. Fusobacterium fusiforme (Vincent's infection). Actinomyces species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. Doxycycline is indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence. This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Podsumowanie produktu:

DOXY 100(TM) DOXYCYCLINE FOR INJECTION, USP is supplied in the following dosage forms. NDC 51662-1402-1 DOXY 100(TM) DOXYCYCLINE FOR INJECTION, USP 100mg per VIAL 20mL VIAL NDC 51662-1402-2 DOXY 100(TM) DOXYCYCLINE FOR INJECTION, USP 100mg per VIAL 20mL VIAL, 1 VIAL PER POUCH NDC 51662-1402-3 DOXY 100(TM) DOXYCYCLINE FOR INJECTION, USP 100mg per VIAL 20mL VIAL, 1 VIAL PER POUCH, 10 POUCHES PER BOX HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Doxycycline for Injection, USP, sterile powder, supplied as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT. Retain in carton until time of use. The brand names mentioned in this document are the trademarks of their respective owners. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 45824K Revised: July 2019

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

DOXY 100(TM) DOXYCYCLINE- DOXY 100(TM) DOXYCYCLINE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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DOXY 100(TM) DOXYCYCLINE FOR INJECTION, USP 100MG PER VIAL 20ML
VIAL
SPL UNCLASSIFIED
FOR INTRAVENOUS INFUSION ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Doxycycline for Injection, USP and other antibacterial drugs,
Doxycycline for Injection,
USP should be used only to treat or prevent infections that are proven
or strongly
suspected to be caused by bacteria.
DESCRIPTION
Doxycycline hyclate is soluble in water and chars at 201°C without
melting. The base
doxycycline has a high degree of lipid solubility and a low affinity
for calcium binding. It is
highly stable in normal human serum.
Each 100 mg vial contains: Doxycycline hyclate equivalent to 100 mg
doxycycline;
ascorbic acid 480 mg; mannitol 300 mg. pH of the reconstituted
solution (10 mg/mL) is
between 1.8 and 3.3.
Doxycycline for Injection, USP is a sterile, lyophilized powder
prepared from a solution of
doxycycline hyclate, ascorbic acid and mannitol in Water for
Injection. Doxycycline
hyclate is a broad spectrum antibiotic derived from oxytetracycline.
It is meant for
INTRAVENOUS use only after reconstitution. Doxycycline hyclate is a
yellowish crystalline
powder which is chemically designated
4-(Dimethylamino)-1,4,4a,5,5a,6,11, 12a-
octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-de
monohydrochloride,
compound with ethyl alcohol (2:1), monohydrate. It has the following
structural formula:
Doxycycline hyclate is soluble in water and chars at 201°C without
melting. The base
doxycycline has a high degree of lipid solubility and a low affinity
for calcium binding. It is
highly stable in normal human serum.
Each 100 mg vial contains: Doxycycline hyclate equivalent to 100 mg
doxycycline;
ascorbic acid 480 mg; mannitol 300 mg. pH of the reconstituted
solution (10 mg/mL) is
between 1.8 and 3.3.
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to