DOXYCYCLINE HYCLATE tablet, film 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.

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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. This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Ringkasan produk:

Doxycycline hyclate tablets, USP equivalent to 100 mg of doxycycline: Beige color, round convex, film coated tablets debossed 312 below, B on one side and plain on the other. NDC 68071-4836-1 BOTLES OF 10 NDC 68071-4836-7 BOTTLES OF 14 NDC 68071-4836-8 BOTTLES OF 28 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 HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
NUCARE PHARMACEUTICALS,INC.
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DOXYCYCLINE HYCLATE TABLETS, USP
100 MG
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 is an antibacterial drug synthetically derived from
oxytetracycline, and is
available as doxycycline hyclate tablets for oral administration. The
chemical designation
of 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-naphthacene-carboxamide
monohydrochloride,
compound with ethyl alcohol (2:1), monohydrate.
The structural formula of doxycycline hyclate is:
with a molecular formula of (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.
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.
Active Ingredient: Doxycycline hyclate USP equivalent to 100 mg of
doxycycline.
Inactive Ingredient: Microcrystalline cellulose and magnesium
stearate.
Tablet coating contains hypromellose, titanium dioxide, polyethylene
glycol, FD&C yellow
#6, polysorbate 80 and FD&C blue #2.
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to plasma proteins in
varying degree.
22
24
2
8
2
2
6
2
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 adult volunteers averaged peak serum
levels of 2.6
mcg/mL of doxycycline at 2 hours, decreasing to 1.45 mcg/mL at 24
hours. Excretion of
doxycy