DOXYCYCLINE HYCLATE capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

DIRECT RX

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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. 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 not always el

Povzetek izdelek:

Doxycycline Hyclate Capsules, USP 50 mg are available as a blue and white capsule filled with yellow powder, imprinted with "2984", containing Doxycycline Hyclate, equivalent to 50 mg Doxycycline; 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. 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. 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)

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE
DIRECT RX
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DOXYCYCLINE HYCLATE
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
[Chemical Structure]
with a molecular formula of C22H24N2O8·H2O 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
(C22H24N2O8·HCl)2·C2H6O·H2O 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 hyclate equivalent to 50
mg or 100 mg of doxycycline.
Inactive ingredients for the tablet formulation are: anhydrous
lactose, colloidal silicon dioxide, FD&C
Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium stearate,
methylcellulose,
microcrystalline cellulose, polyethylene glycol, sodium starch
glycolate, stearic