DOXYCYCLINE HYCLATE tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Proficient Rx LP

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria when bacteriologic testing indicates appropriat

ملخص المنتج:

Doxycycline Hyclate Tablets, USP equivalent to 100 mg doxycycline: Round, orange film-coated tablet engraved with "3626" on one side, and plain on the other side. NDC 71205-697-10 Bottles of 10 tablets NDC 71205-697-14 Bottles of 14 tablets NDC 71205-697-20 Bottles of 20 tablets NDC 71205-697-30 Bottles of 30 tablets NDC 71205-697-60 Bottles of 60 tablets NDC 71205-697-90 Bottles of 90 tablets Dispense in a tight, light-resistant container as defined in the USP. Use child-resistant closure (as required). Store at 20° to 25° C (68° to 77° F) (see USP controlled room temperature)

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
PROFICIENT RX LP
----------
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 and Doxycycline
for Oral
Suspension; 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 doxycycline hycl