doxycycline monohydrate- Doxycycline tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Doxycycline (UNII: N12000U13O) (Doxycycline - UNII:N12000U13O)

Available from:

Doak Dermatologics

INN (International Name):

Doxycycline

Pharmaceutical form:

TABLET

Composition:

50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline tablets 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 pneumoniae . Lymphogranuloma venereum caused by Chlamydia trachomatis . Psittacosis (omithosis) caused by Chlamydia psittaci . Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated

Product summary:

Doxycycline Tablets 50 mg are a yellow, film coated, round, biconvex tablet, debossed “D” on one side and “50” on the other side. Each tablet contains doxycycline monohydrate equivalent to 50 mg of doxycycline. They are supplied as follows: Doxycycline Tablets 75 mg are a light orange, film coated, round, biconvex tablet, debossed “D” on one side and “75” on the other side. Each tablet contains doxycycline monohydrate equivalent to 75 mg of doxycycline. They are supplied as follows: Doxycycline Tablets 100 mg are a yellow, film coated, round, biconvex tablet, debossed “D” on one side and “100” on the other side. Each tablet contains doxycycline monohydrate equivalent to 100 mg of doxycycline. They are supplied as follows: Doxycycline Tablets 150 mg are a peach colored, film coated, round, scored, biconvex tablet debossed “D|D” on one side and “150” on the other side. Each tablet contains doxycycline monohydrate equivalent to 150 mg of doxycycline. They are supplied as follows: Store at 20°-25°C (68°-77°F). [See USP]. PROTECT FROM LIGHT.

Summary of Product characteristics

DOXYCYCLINE MONOHYDRATE- DOXYCYCLINE TABLET
DOAK DERMATOLOGICS
----------
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of doxycycline
tablets and other antibacterial drugs, doxycycline tablets should be
used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Doxycycline is a broad-spectrum antibiotic synthetically derived from
oxytetracycline. Doxycycline
150 mg, 100 mg, 75 mg and 50 mg tablets contain doxycycline
monohydrate equivalent to 150 mg, 100
mg, 75 mg or 50 mg of doxycycline for oral administration. Inactive
ingredients include colloidal
silicon dioxide, FD&C yellow #6, magnesium stearate, microcrystalline
cellulose, sodium starch
glycolate, and titanium dioxide. In addition, doxycycline 100 mg and
50 mg tablets contain hypromellose
3cP, hypromellose 6cP, D&C yellow #10 lake, polyethylene glycol 400,
polysorbate 80; doxycycline
150 mg and 75 mg tablets contain hypromellose, lactose monohydrate,
synthetic yellow iron oxide and
triethyl citrate. 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 O
Doxycycline 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
1.5
2
3
4
8
12
24
48
72
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 s