DOXYCYCLINE HYCLATE capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Chartwell RX LLC

INN (الاسم الدولي):

DOXYCYCLINE HYCLATE

تركيب:

DOXYCYCLINE ANHYDROUS 50 mg

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: - 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 eliminated, as j

ملخص المنتج:

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. NDC 62135-984-50 50 mg capsules - Bottles of 50 capsules NDC 62135-985-50 100 mg capsules -Bottles of 50 capsules NDC 62135-985-05 100 mg capsules -Bottles of 500 capsules 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 62135-626-20 Bottles of 20 tablets NDC 62135-626-28 Bottles of 28 tablets NDC 62135-626-50 Bottles of 50 tablets NDC 62135-626-12 Bottles of 120 tablets NDC 62135-626-23 Bottles of 210 tablets NDC 62135-626-31 Bottles of 300 tablets NDC 62135-626-40 Bottles of 400 tablets NDC 62135-626-05 Bottles of 500 tablets NDC 62135-626-10 Bottles of 1000 tablets NDC 62135-626-96 Bottles of 2000 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)

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE
CHARTWELL RX LLC
----------
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 glycol, FD&C Blue #2,
FD&C Red # 40, FD&C Blue # 1, D&C Yellow # 10, butyl alcohol,
denatured alcohol. Each capsu