DOXYCYCLINE HYCLATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

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: Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, w

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. Available: Carton of 30 capsules (10 capsules each blister pack x 3), NDC 0904-0428-04 Carton of 50 capsules (10 capsules each blister pack x 5), NDC 0904-0428-06 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
MAJOR PHARMACEUTICALS
----------
DOXYCYCLINE HYCLATE CAPSULES - HIKMA
DOXYCYCLINE HYCLATE CAPSULES, USP
Rev. 12/18
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 C22H24N2O8•H2O 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 (C22H24N2O8•HCl)2•C2H6O•H2O 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 100 mg
of doxycycline (anhydrous). Inactive ingredients: lactose monohydrate,
microcrystalline
cellulose, magnesium stearate.
The 100 mg capsule shell contains: 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 readily abs