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:

G&W Laboratories, Inc.

INN (International Name):

Doxycycline

Composition:

Doxycycline Anhydrous 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain 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 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 infec

Product summary:

Doxycycline Capsules, USP 50 mg have a yellow opaque cap and a white opaque body. The capsules are imprinted “NL 790” with white ink on the cap and “50 mg” with brown ink on the body, filled with yellow to beige powder. Each capsule contains doxycycline monohydrate equivalent to 50 mg doxycycline. Doxycycline Capsules, USP 50 mg is available in:       Bottles of 100 capsules ...................................................... NDC 0713-0427-01 Doxycycline Capsules, USP 75 mg have a brown opaque cap and a white opaque body. The capsules are imprinted “NL 791” with white ink on the cap and “75 mg” with brown ink on the body, filled with yellow to beige powder. Each capsule contains doxycycline monohydrate equivalent to 75 mg doxycycline. Doxycycline Capsules, USP 75 mg is available in:       Bottles of 100 capsules ...................................................... NDC 0713-0428-01 Doxycycline Capsules, USP 100 mg have a brown opaque cap and a yellow opaque body. The capsules are imprinted “NL 792” with white ink on the cap and “100 mg” with brown ink on the body, filled with yellow to beige powder. Each capsule contains doxycycline monohydrate equivalent to 100 mg doxycycline. Doxycycline Capsules, USP 100 mg is available in:       Bottles of 50 capsules ........................................................ NDC 0713-0429-50       Bottles of 250 capsules ....................................................... NDC 0713-0429-93 STORE AT 20° to 25°C (68° to 77°F). [SEE USP CONTROLLED ROOM TEMPERATURE.] DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER AS DEFINED IN THE USP/NF. PROTECT FROM LIGHT.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE- DOXYCYCLINE CAPSULE
G&W LABORATORIES, INC.
----------
DOXYCYCLINE CAPSULES, USP
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 is a broad-spectrum antibacterial synthetically derived
from oxytetracycline. Doxycycline
capsules USP, 50 mg, 75 mg, and 100 mg contain doxycycline monohydrate
equivalent to 50 mg, 75mg,
and 100 mg of doxycycline for oral administration. The chemical
designation of the light yellow to pale
yellow powder is
2-Naphthacenecarboxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-
3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-,[4_S_-4α,4aα,5α,5aα,6α,12aα)]-,
monohydrate.
Structural formula:
C
H N O • H O M.W. = 462.45
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.
Inert ingredients: colloidal silicon dioxide; magnesium stearate;
microcrystalline cellulose; sodium
starch glycolate; and a hard gelatin capsule which contains titanium
dioxide, FD&C Red # 3, D&C
Yellow # 10, gelatin, sodium lauryl sulfate, for the 50 mg strength;
iron oxide black, iron oxide red,
iron oxide yellow, titanium dioxide, gelatin, sodium lauryl sulfate
for the 75 mg strength and iron oxide
black, iron oxide red, iron oxide yellow, titanium dioxide, FD & C Red
# 3, D&C Yellow # 10, gelatin,
sodium lauryl sulfate for the 100 mg strength. The capsules are
printed with edible ink containing
shellac, titanium dioxide, black iron oxide, brown iron oxide and
potassium hydroxide for 50 mg, 75 mg
and 100 mg strengths.
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