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:

NuCare 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, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP 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   pneumonia e . - Lymphogranuloma venereum caused by Chlamydia trachomatis . - Psittacosis (ornithosis) caused by Chlamydophila   psittaci . - Trachoma caused by Chlamydia trachomatis , although the

Ringkasan produk:

Doxycycline Hyclate Tablets, USP equivalent to 100 mg doxycycline: Orange Coated, Round, Unscored Tablets; Debossed WW 112. NDC 68071-4110-1 Bottles of 10 NDC 68071-4110-7 Bottles of 14 NDC 68071-4110-2 Bottles of 20 NDC 68071-4110-3 Bottles of 30 NDC 68071-4110-4 Bottles of 40 NDC 68071-4110-5 Bottles of 45 NDC 68071-4110-6 Bottles of 60 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
NUCARE PHARMACEUTICALS,INC.
----------
DOXYCYCLINE HYCLATE TABLETS
DOXYCYCLINE HYCLATE
TABLETS, USP
REV. 01/17
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 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.
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.
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
biological