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:

NuCare Pharmaceuticals, Inc.

INN (International Name):

DOXYCYCLINE HYCLATE

Composition:

DOXYCYCLINE ANHYDROUS 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain effectiveness of Doxycycline Hyclate Capsules, USP and other antibacterial drugs, Doxycycline Hyclate 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 Chlamydophil a   psittaci . - Tra

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. Bottles of 2 NDC 68071-3243-2 Bottles of 3 NDC 68071-3243-3 Bottles of 4 NDC 68071-3243-4 Bottles of 6 NDC 68071-3243-6 Bottles of 14 NDC 68071-3243-1 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
NUCARE PHARMACEUTICALS, INC.
----------
DOXYCYCLINE HYCLATE CAPSULES
DOXYCYCLINE HYCLATE CAPSULES, USP
Rev. 01/17
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 monohydrate is
with a molecular formula of C
H
N
O
•H
O and a molecular weight of 462.46. The chemical
designation for doxycycline is
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-
pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate.
The molecular formula
for doxycycline hydrochloride hemiethanolate hemihydrate is (C
H
N
O
•HCl)
•C
H
O•H
O
and the molecular weight is 1025.89. Doxycycline is a light yellow
crystalline powder. Doxycycline
hyclate is soluble in water, while doxycycline monohydrate is very
slightly 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, diacetylated
monoglycerides, sucrose fatty acid
esters, glacial acetic acid, sodium lauryl sulfate, colloidal silicon
dioxide, FD&C Blue #1 and titanium
dioxide. The printing ink may contain: Shellac Glaze, Iron Oxide
Black, N-Butyl Alcohol, Propylene
Glycol, SDA 3A Alcohol, FD&C Blue #2, FD&C Red #40, FD&C Blue #1, D&C
Yellow #10.
CLINICAL PHARMACOLOGY
Tetracyclines are readil