DOXYCYCLINE capsule

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

American Health Packaging

INN (International Name):

DOXYCYCLINE

রচনা:

DOXYCYCLINE ANHYDROUS 100 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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

পণ্য সারাংশ:

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:    Unit dose packages of 20 (5 x 4) NDC 68084-743-32    Unit dose packages of 30 (3 x 10) NDC 68084-743-21 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

DOXYCYCLINE- DOXYCYCLINE CAPSULE
AMERICAN HEALTH PACKAGING
----------
DOXYCYCLINE CAPSULES, USP
8274332/1020
RX ONLY
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
after oral administration.
Following a 200 mg dose of doxycycline monohydrate, 24 normal adult
volunteers
22
24
2
8
2
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
Max