DOXYCYCLINE- doxycycline hyclate tablet, coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

PD-Rx Pharmaceuticals, Inc.

INN (Nama Internasional):

DOXYCYCLINE HYCLATE

Komposisi:

DOXYCYCLINE ANHYDROUS 100 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets 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

Ringkasan produk:

Doxycycline Hyclate Tablets, USP equivalent to 100 mg doxycycline: Orange Coated, Round, Unscored Tablets, Debossed “WW 112”. NDC 55289-866-02 : Bottle of 2 Tablets NDC 55289-866-04 : Bottle of 4 Tablets NDC 55289-866-06 : Bottle of 6 Tablets NDC 55289-866-07 : Bottle of 7 Tablets NDC 55289-866-10 : Bottle of 10 Tablets NDC 55289-866-14 : Bottle of 14 Tablets NDC 55289-866-20 : Bottle of 20 Tablets NDC 55289-866-28 : Bottle of 28 Tablets NDC 55289-866-30 : Bottle of 30 Tablets NDC 55289-866-60 : Bottle of 60 Tablets NDC 55289-866-71 : Bottle of 210 Tablets NDC 55289-866-74 : Bottle of 400 Tablets NDC 55289-866-85 : Bottle of 330 Tablets NDC 55289-866-86 : Bottle of 360 Tablets NDC 55289-866-87 : Bottle of 300 Tablets NDC 55289-866-90 : Bottle of 90 Tablets NDC 55289-866-93 : Bottle of 180 Tablets NDC 55289-866-98 : Bottle of 120 Tablets NDC 55289-866-01 : Bottle of 100 Tablets Store at 20° to 25°C (68° to 77°F), [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

DOXYCYCLINE- DOXYCYCLINE HYCLATE TABLET, COATED
PD-RX PHARMACEUTICALS, INC.
----------
DOXYCYCLINE HYCLATE TABLETS, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline
Hyclate Tablets
should be used only to treat or prevent infections that are proven or
strongly suspected
to be caused by bacteria.
DESCRIPTION
Doxycycline Hyclate Tablets, USP are an antibacterial drug
synthetically derived from
oxytetracycline. The structural formula of doxycycline hyclate is:
with a molecular formula of C
H
N
O
•HCL•1/2C
N
OH•1/2H
O and a molecular
weight of 512.93.
The chemical designation for doxycycline is 2-Naphthacemecarboxamide,
4-
(dimethylamino)-1, 4, 4a, 5, 5a, 6, -11, 12a-octahydro-3,5,10, 12,
12a-pentahydroxy-6-
mothyl-1, 11-dioxo-monohydrochloride, compound with ethanol(2:1),
monohydrate,
[4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)].
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 tablet for oral administration contains doxycycline hyclate
equivalent to 100 mg of
doxycycline (anhydrous). Inactive ingredients are: Colloidal Silicon
Dioxide, Corn Starch,
Croscarmellose Sodium, Docusate Sodium, Sodium Benzoate, Magnesium
Stearate, and
Microcrystalline Cellulose. Film Coating and Polishing contains: FD&C
Blue No. 2, FD&C
Yellow No. 6, Hydroxypropyl Methylcellulose, Polyethylene Glycol, and
Titanium Dioxide.
22
24
2
8
2
5
2
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 the
urine and feces at high
concentrations and in a biologically active form. Doxycycline is
virtually completely
absorbed after oral administration.
Following a 200 mg dose, normal adu