DOXYCYCLINE HYCLATE capsule DOXYCYCLINE HYCLATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Doxycycline Hyclate (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

Available from:

Alvogen, Inc.

INN (International Name):

Doxycycline Hyclate

Composition:

DOXYCYCLINE ANHYDROUS 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain 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 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 no

Product summary:

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. NDC 47781-489-50 Bottles of 50 capsules 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 doxycycline. NDC 47781-490-50 Bottles of 50 capsules NDC 47781-490-05 Bottles of 500 capsules Doxycycline Hyclate Tablets, USP 100 mg are available as a round, orange film-coated tablet engraved with “3626” on one side, and plain on the other side, containing doxycycline hyclate equivalent to 100 mg doxycycline. NDC 47781-491-50 Bottles of 50 tablets NDC 47781-491-05 Bottles of 500 tablets Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE
DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
ALVOGEN, INC.
----------
DOXYCYCLINE HYCLATE CAPSULES, USP 50 MG AND 100 MG DOXYCYCLINE HYCLATE
TABLETS, USP 100
MG
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 is an antibacterial drug synthetically derived from
oxytetracycline, and is available as
doxycycline hyclate (doxycycline hydrochloride hemiethanolate
hemihydrate) for oral administration.
The structural formula of doxycycline hyclate is
with a molecular formula of (C
H N O •HCl) •C H O•H O and a molecular weight of 1025.89.
The chemical designation for doxycycline hyclate 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
monohydrochloride, compound with ethyl alcohol (2:1), monohydrate.
Doxycycline is a light-yellow
crystalline powder. Doxycycline hyclate is 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.
Each capsule, for oral administration, contains doxycycline hyclate
equivalent to 50 mg or 100 mg of
doxycycline. In addition, the capsules contain the inactive
ingredients anhydrous lactose, colloidal
silicon dioxide, magnesium stearate, methylcellulose, microcrystalline
cellulose, polyethylene glycol,
sodium starch glycolate, and stearic acid. The 50 mg capsule shell is
composed of D&C Yellow #10,
FD&C Blue #1, gelatin, and titanium dioxide. The 100 mg capsule shell
is composed of FD&C Blue #1,
gelatin, and titanium dioxide. The capsule imprinting ink contains
butyl alcohol, denatured alcohol, D&C
Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide