DOXYCYCLINE HYCLATE capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Proficient Rx LP

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Doxycycline Hyclate Capsules, USP 100 mg are available as a light blue capsule filled with yellow powder imprinted with "2985"containing doxycycline hyclate, equivalent to 100 mg of doxycycline. NDC 71205-518-02 100 mg capsules - Bottles of 2 capsules NDC 71205-518-06 100 mg capsules - Bottles of 6 capsules NDC 71205-518-10 100 mg capsules - Bottles of 10 capsules NDC 71205-518-14 100 mg capsules - Bottles of 14 capsules NDC 71205-518-20 NDC 71205-518-30 NDC 71205-518-42 NDC 71205-518-60 NDC 71205-518-90 100 mg capsules - Bottles of 20 capsules 100 mg capsules - Bottles of 30 capsules 100 mg capsules - Bottles of 42 capsules 100 mg capsules - Bottles of 60 capsules 100 mg capsules - Bottles of 90 capsules 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)

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE
PROFICIENT RX LP
REFERENCE LABEL SET ID: EC232BA8-51D8-4F1A-BF79-423B6D0EE9A2
REFERENCE LABEL SET ID: 10EF2080-8718-4AB9-8450-A28773E0247A
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DOXYCYCLINE HYCLATE CAPSULES, USP
DOXYCYCLINE FOR ORAL SUSPENSION, 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 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 oxi