DOXYCYCLINE HYCLATE tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

A-S Medication Solutions

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline and other antibacterial drugs, Doxycycline 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 is indicated for the treatment of the following infections - 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 caused by Chlamydia trachomatis . - Psittacosis (ornithosis) caused by Chlamydophila psittaci . - Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judg

產品總結:

Product: 50090-3859 NDC: 50090-3859-3 20 TABLET, FILM COATED in a BOTTLE NDC: 50090-3859-0 10 TABLET, FILM COATED in a BOTTLE, PLASTIC NDC: 50090-3859-1 14 TABLET, FILM COATED in a BOTTLE, PLASTIC NDC: 50090-3859-5 28 TABLET, FILM COATED in a BOTTLE, PLASTIC NDC: 50090-3859-6 30 TABLET, FILM COATED in a BOTTLE, PLASTIC NDC: 50090-3859-8 60 TABLET, FILM COATED in a BOTTLE, PLASTIC

授权状态:

Abbreviated New Drug Application

产品特点

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
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DOXYCYCLINE HYCLATE CAPSULES, USP
DOXYCYCLINE HYCLATE TABLETS, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Doxycycline and other antibacterial drugs, Doxycycline should be used
only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
Doxycycline is an antibacterial drug synthetically derived from
oxytetracycline, and is
available as Doxycycline Hyclate Tablets and Capsules; for oral
administration.
The structural formula of doxycycline monohydrate is
with a molecular formula of C
H
N O ∙H O and a molecular weight of 462.46. The
chemical designation for doxycycline is
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-
octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-
naphthacenecarboxamide monohydrate. The molecular formula for
doxycycline
hydrochloride hemiethanolate hemihydrate is (C
H
N O ∙HCl) ∙C H O∙H O and the
molecular weight is 1025.89. Doxycycline is a light-yellow crystalline
powder. Doxycycline
hyclate is soluble in water, while doxycycline monohydrate is very
slightly soluble in
water.
Doxycycline has a high degree of lipoid solubility and a low affinity
for calcium binding. It
is highly stable in normal human serum. Doxycycline will not degrade
into an epianhydro
form.
Inactive ingredients in the capsule formulations are: colloidal
silicon dioxide, lactose
anhydrous, magnesium stearate, methylcellulose, microcrystalline
cellulose, polyethylene
glycol, sodium starch glycolate, and stearic acid. 50 mg gelatin
capsule shell contains:
FD&C Blue #1, D&C Yellow #10, titanium dioxide and gelatin. 100 mg
gelatin capsule
shell contains: FD&C Blue #1, titanium dioxide and gelatin. Black ink
contains shellac
glaze in SD-45, black iron oxide, propylene glycol, FD&C Blue #2, FD&C
Red # 40, FD&C
Blue # 1, D&C Yellow # 10, butyl alcohol, denatured alcohol. Each
capsule, for oral
administration, contains doxycyclin