DOXYCYCLINE HYCLATE tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

A-S Medication Solutions

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. Treatment 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 no

Přehled produktů:

Product: 50090-2446 NDC: 50090-2446-0 10 TABLET, FILM COATED in a BOTTLE NDC: 50090-2446-1 14 TABLET, FILM COATED in a BOTTLE NDC: 50090-2446-3 20 TABLET, FILM COATED in a BOTTLE NDC: 50090-2446-5 28 TABLET, FILM COATED in a BOTTLE NDC: 50090-2446-6 30 TABLET, FILM COATED in a BOTTLE NDC: 50090-2446-8 60 TABLET, FILM COATED in a BOTTLE NDC: 50090-2446-9 100 TABLET, FILM COATED in a BOTTLE NDC: 50090-2446-2 7 TABLET, FILM COATED in a BOTTLE, PLASTIC

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
DOXYCYCLINE HYCLATE CAPSULES, USP 50 MG AND 100 MG DOXYCYCLINE HYCLATE
TABLETS, USP 100 MG
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
doxycycline hyclate and other antibacterial drugs, doxycycline hyclate
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 (doxycycline hydrochloride
hemiethanolate hemihydrate)
for oral administration.
The structural formula of doxycycline hyclate is
with a molecular formula of (C
H
N O •HCl) •C H O•H O and a molecular weight of
1025.89. The chemical designation for doxycycline hyclate 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 monohydrochloride, compound with ethyl alcohol
(2:1),
monohydrate. Doxycycline is a light-yellow crystalline powder.
Doxycycline hyclate is
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.
Each capsule, for oral administration, contains doxycycline hyclate
equivalent to 50 mg
or 100 mg of doxycycline. In addition, the capsules contain the
inactive ingredients
anhydrous lactose, colloidal silicon dioxide, magnesium stearate,
methylcellulose,
microcrystalline cellulose, polyethylene glycol, sodium starch
glycolate, and stearic acid.
The 50 mg capsule shell is composed of D&C Yellow #10, FD&C Blue #1,
gelatin, and
titanium dioxide. The 100 mg capsule shell is composed of FD&C Blue
#1, gelatin, and
titanium dioxide. The capsule imprinting ink contains butyl alcohol,
denatured alcohol,
22
24
2
8
2
2
6
2
D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide
black,
propylene gl