DOXYCYCLINE HYCLATE capsule

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Viona Pharmaceuticals Inc

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate  and other antibacterial drugs, doxycycline hyclate capsules  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 infectiou

Prehľad produktov:

Doxycycline hyclate capsules, USP contain doxycycline hyclate equivalent to doxycycline 50 mg or 100 mg. Doxycycline hyclate capsules USP, 50 mg are yellowish powder filled in size '3' hard gelatin capsule with light blue opaque cap imprinted with 'CHL' in white ink and white opaque body imprinted with 'D75' in black ink. NDC 72578-054-18 in bottle of 50 capsules with child-resistant closure NDC 72578-054-01 in bottle of 100 capsules NDC 72578-054-05 in bottle of 500 capsules NDC 72578-054-10 in bottle of 1000 capsules NDC 72578-054-77 in cartons of 100 capsules (10 x 10 unit-dose) Doxycycline hyclate capsules USP, 100 mg contains yellowish powder filled in size '1' hard gelatin capsule with light blue opaque cap imprinted with 'CHL' in white ink and light blue opaque body imprinted with 'D76' in black ink. NDC 72578-055-18 in bottle of 50 capsules with child-resistant closure NDC 72578-055-01 in bottle of 100 capsules NDC 72578-055-05 in bottle of 500 capsules NDC 72578-055-10 in bottle of 1000 capsules NDC 72578-055-77 in cartons of 100 capsules (10 x 10 unit-dose) Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers (USP).

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE
VIONA PHARMACEUTICALS INC
----------
DOXYCYCLINE HYCLATE CAPSULES, USP
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 hyclate is an antibacterial drug synthetically derived
from oxytetracycline,
and is available as doxycycline hyclate capsules for oral
administration.
The chemical designation for doxycyclin is
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-
octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacene-
carboxamide monohydrate.
The structural formula of doxycycline hyclate is
Doxycycline hyclate, USP is yellow to light yellow powder. It is
freely soluble in water and
methanol, sparingly soluble in alcohol; practically insoluble in
chloroform and in ether. It
dissolves in aqueous solution of alkali hydroxides and carbonates.
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 contains doxycycline hyclate equivalent to doxycycline 50
mg or 100 mg
and inactive ingredients: anhydrous lactose, croscarmellose sodium,
D&C red 28, FD &
C blue 1, gelatin, microcrystalline cellulose, magnesium stearate and
sodium lauryl
sulfate and titanium dioxide. Each capsule cap is printed with white
pharmaceutical ink
and capsule body is printed with black pharmaceutical ink which
contains following
ingredient butyl alcohol, dehydrated alcohol, isopropyl alcohol,
potassium hydroxide,
propylene glycol, strong ammonia solution, and shellac. Additionally
black pharmaceutical
ink also contains black iron oxide.
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to plasma proteins in
varying degree.
They are concentrated by the liver in the bile and excreted in th