DOXYCYCLINE- doxycycline capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

DOXYCYCLINE

Composition:

DOXYCYCLINE ANHYDROUS 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 is

Product summary:

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: 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: 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: 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE- DOXYCYCLINE CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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 antibiotic 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. 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. Its molecular
weight is 462.46. The chemical
designation of the light-yellow crystalline powder is
alpha-6-deoxy-5-oxytetracycline.
Structural formula:
C
H N O •H 0
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.
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
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/