DOXYCYCLINE HYCLATE capsule, gelatin coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

Available from:

PD-Rx Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules and other antibacterial drugs, Doxycycline Hyclate Capsules 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

Product summary:

Doxycycline Hyclate Capsules, USP equivalent to 100 mg doxycycline: No. 0 Blue/Blue Opaque Hard Gelatin Capsule Printed “West-ward 3142” in Black Ink. NDC 55289-107-79: Bottle of 1 Capsules NDC 55289-107-02: Bottle of 2 Capsules NDC 55289-107-06: Bottle of 6 Capsules NDC 55289-107-10: Bottle of 10 Capsules NDC 55289-107-12: Bottle of 12 Capsules NDC 55289-107-14: Bottle of 14 Capsules NDC 55289-107-20: Bottle of 20 Capsules NDC 55289-107-28: Bottle of 28 Capsules NDC 55289-107-30: Bottle of 30 Capsules NDC 55289-107-40: Bottle of 40 Capsules NDC 55289-107-50: Bottle of 50 Capsules NDC 55289-107-56: Bottle of 56 Capsules NDC 55289-107-60: Bottle of 60 Capsules NDC 55289-107-90: Bottle of 90 Capsules NDC 55289-107-93: Bottle of 180 Capsules Store at 20° to 25°C (68° to 77°F), [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED
PD-RX PHARMACEUTICALS, INC.
----------
DOXYCYCLINE HYCLATE CAPSULES, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Doxycycline Hyclate Capsules and other antibacterial drugs,
Doxycycline Hyclate
Capsules should be used only to treat or prevent infections that are
proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Doxycycline Hyclate Capsules, USP are an antibacterial drug
synthetically derived from
oxytetracycline. The structural formula of doxycycline hyclate is:
with a molecular formula of C
H
N
O
•HCL•1/2C
N
OH•1/2H
O and a molecular
weight of 512.93.
The chemical designation for doxycycline is 2-Naphthacemecarboxamide,
4-
(dimethylamino)-1, 4, 4a, 5, 5a, 6, -11, 12a-octahydro-3,5,10, 12,
12a-pentahydroxy-6-
mothyl-1, 11-dioxo-monohydrochloride, compound with ethanol(2:1),
monohydrate,
[4s-(4α, 4aα, 5α, 5aα, 6α, 12aα)].
Doxycycline is a light yellow crystalline powder. Doxycycline hyclate
is soluble in water.
Doxycycline has a high degree of lipoid solubility and a low affinity
for calcium binding. It
is highly stable in normal human serum. Doxycycline will not degrade
into an epianhydro
form.
Each capsule for oral administration contains doxycycline hyclate
equivalent to 50 mg or
100 mg of doxycycline (anhydrous). Inactive ingredients: lactose
monohydrate,
microcrystalline cellulose, magnesium stearate.
The 50 mg and 100 mg capsule shells contain: gelatin, FD&C Blue #1 and
titanium
dioxide. The printing ink may contain: Shellac Glaze, Iron Oxide
Black, N-Butyl Alcohol,
22
24
2
8
2
5
2
Propylene Glycol, SD-45 Alcohol, FD&C Blue #2, FD&C Red #40, FD&C Blue
#1, D&C
Yellow #10.
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to plasma proteins in
varying degree.
They are concentrated by the liver in the bile and excreted in the
urine and feces at high
concentrations and in a biologically active form. Doxycycline is
virtually completely
absorbed af