DOXYCYCLINE injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional LLC

INN (International Name):

DOXYCYCLINE HYCLATE

Composition:

DOXYCYCLINE ANHYDROUS 100 mg in 10 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline for injection and other antibacterial drugs, doxycycline for injection 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 in infections caused by the following microorganisms: The following gram-negative microorganisms: Because many strains of the following groups of microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug

Product summary:

Each vial of Doxycycline for Injection, USP (equivalent to 100 mg doxycycline with 480 mg ascorbic acid and 300 mg mannitol), is supplied in lyophilized form in a USP Type I tubular amber vial. NDC Doxycycline for Injection, USP Package 67457-437-10 100 mg per vial 10 vials per carton Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from Light. Retain in carton until time of use. The brands listed are trademarks of their respective owners. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Bangalore, India JULY 2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE- DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
MYLAN INSTITUTIONAL LLC
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DOXYCYCLINE FOR INJECTION, USP
FOR INTRAVENOUS USE ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
doxycycline and other antibacterial drugs, doxycycline should be used
only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
Doxycycline for injection, USP is a sterile pale yellow lyophilized
powder or cake and an
antibacterial drug synthetically derived from oxytetracycline, and is
available as
doxycycline hyclate USP. The chemical designation of this yellow to
light yellow crystalline
powder 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
monohydrochloride,
compound with ethyl alcohol (2:1), monohydrate. It has the following
structural formula:
Doxycycline freely soluble in water and in methanol. Sparingly soluble
in ethanol (96%). It
dissolves in solutions of alkali hydroxides and carbonates.
Practically insoluble in
chloroform, in ether and in other organic solvents.
Each 100 mg vial contains doxycycline hyclate, USP equivalent to 100
mg doxycycline. It
also contains ascorbic acid 480 mg and mannitol 300 mg as inactive
ingredients and
does not contain preservatives. The pH of the reconstituted solution
(10 mg/mL) is
between 1.8 and 3.3.
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.
Following a single 100 mg dose administered in a concentration of 0.4
mg/mL in a one-
hour infusion, normal adult volunteers average a peak of 2.5 mcg/mL,
while 200 mg of a
concentration of 0.4 mg/mL administered over two hours averaged a peak
of 3.6
mcg/mL. Excretion of doxycycline by the kidney is about 40 percent/72
hours in
individuals with normal fun