DOXYCYCLINE capsule

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

Fáanlegur frá:

Par Pharmaceutical, Inc.

INN (Alþjóðlegt nafn):

DOXYCYCLINE

Samsetning:

DOXYCYCLINE ANHYDROUS 100 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline capsules USP and other antibacterial drugs, doxycycline capsules 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 Capsules USP 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

Vörulýsing:

Doxycycline Capsules USP 50 mg have a buff opaque cap printed “par 726” in brown ink/white opaque body printed “par 726” in brown ink. Each capsule contains doxycycline monohydrate equivalent to 50 mg of doxycycline. They are supplied as follows: Bottles of 100 NDC 49884-726-01 Doxycycline Capsules USP 100 mg have a brown opaque cap printed “par 727” in white ink/white opaque body printed “par 727” in brown ink. Each capsule contains doxycycline monohydrate equivalent to 100 mg of doxycycline. They are supplied as follows: Bottles of 50 NDC 49884-727-03 Bottles of 250 NDC 49884-727-04 Doxycycline Capsules USP 150 mg have a peach opaque cap printed “par” in black ink/peach opaque body printed “305” in black ink. Each capsule contains doxycycline monohydrate equivalent to 150 mg of doxycycline. They are supplied as follows: Bottles of 60 NDC 49884-305-02 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light. DISPENSE IN A TIGHT LIGHT RESISTANT CONTAINER AS DEFINED IN THE USP/NF.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

DOXYCYCLINE- DOXYCYCLINE CAPSULE
PAR PHARMACEUTICAL, INC.
----------
DOXYCYCLINE CAPSULES USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
doxycycline capsules and other antibacterial drugs, doxycycline
capsules should be
used only to treat or prevent infections that are proven or strongly
suspected to be
caused by bacteria.
DESCRIPTION
Doxycycline Capsules USP is a broad-spectrum antibacterial
synthetically derived from
oxytetracycline. Doxycycline 150 mg, 100 mg and 50 mg capsules contain
doxycycline
monohydrate equivalent to 150 mg, 100 mg or 50 mg of doxycycline for
oral
administration. The chemical designation of the light-yellow
crystalline powder is alpha-6-
deoxy-5-oxytetracycline.
Structural formula:
C
H
N O •H 0
M.W. = 462.45
Doxycycline Capsules USP has a high degree of lipid 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 include colloidal silicon dioxide, gelatin,
magnesium stearate,
microcrystalline cellulose, sodium starch glycolate and titanium
dioxide. In addition, the
50 mg strength contains FD&C Yellow #6 and D&C Yellow #10. The 100 mg
strength
also contains black iron oxide, red iron oxide and yellow iron oxide.
The 150 mg strength
includes FD&C Red #40 and FD&C Yellow #6.
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to plasma proteins in
varying degrees.
They are concentrated by the liver in the bile and excreted in the
urine and feces at high
concentrations in a biologically active form. Doxycycline is virtually
completely absorbed
22
24
2
8
2
after oral administration.
Following a 200 mg dose of doxycycline monohydrate, 24 normal adult
volunteers
averaged the following serum concentration values:
Time (hr):
0.5
1.0
1.5
2.0
3.0
4.0
8.0
12.0
24.0
48.0
72.0
Conc.
(mcg/mL):
1.02
2.26
2.67
3.01
3.16
3.03
2.03
1.62
0.95
0.37
0.15
Average Observed Values
Maximum
Concentration
3.61 mcg/mL (± 0.9 sd)
Time of
Ma