DOXYCYCLINE HYCLATE tablet, film coated DOXYCYCLINE HYCLATE capsule DOXYCYCLINE powder, for suspension

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Chartwell RX LLC

INN（国際名）:

Doxycycline Hyclate

構図:

Doxycycline Anhydrous 100 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 - 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

製品概要:

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. Doxycycline Hyclate Tablets, USP equivalent to 50 mg doxycycline: Round, orange, film-coated tablet de-bossed with "CE over 30" on one side, and plain on the other side. NDC 62135-625-60                                                    Bottles of 60 tablets Doxycycline for Oral Suspension USP is available as a raspberry-flavored, pink dry powder for oral suspension. When reconstituted, each teaspoonful (5 mL) contains doxycycline monohydrate equivalent to 25 mg of doxycycline in a 2 oz (60 mL) bottle. NDC 62135-417-46 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)

認証ステータス:

Abbreviated New Drug Application

製品の特徴

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE
DOXYCYCLINE- DOXYCYCLINE POWDER, FOR SUSPENSION
CHARTWELL RX LLC
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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 oxide, propylene