TETRACYCLINE HYDROCHLORIDE capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T)

Tilgjengelig fra:

STAT Rx USA LLC

INN (International Name):

TETRACYCLINE HYDROCHLORIDE

Sammensetning:

TETRACYCLINE HYDROCHLORIDE 250 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: - Upper respiratory tract infections caused by Streptococcus pyogenes , Streptococcus pneumoniae and Hemophilus influenzae . Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. - Lower respiratory tract infections caused by Streptococcus pyog

Produkt oppsummering:

Tetracycline Hydrochloride Capsules USP, 250 mg are available as orange opaque and yellow opaque capsules, imprinted with “Z” and “2416” in black ink, containing 250 mg of tetracycline hydrochloride, packaged in: Bottles of 28 - NDC # 16590-216-28 Tetracycline Hydrochloride Capsules USP, 500 mg are available as black and yellow capsules, imprinted with "Z" and "2407" in white ink, containing 500 mg of tetracycline hydrochloride, packaged in: Bottles of 28 - NDC # 16590-217-28 Bottles of 30 - NDC # 16590-217-30 Dispense in a tight, light resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA 30501

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TETRACYCLINE HYDROCHLORIDE - TETRACYCLINE HYDROCHLORIDE CAPSULE
STAT RX USA LLC
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TETRACYCLINE HYDROCHLORIDE CAPSULES USP
FOR ORAL USE
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of tetracycline
hydrochloride and other antibacterial drugs, tetracycline
hydrochloride should be used only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
Tetracycline is a yellow, odorless, crystalline powder. Tetracycline
is stable in air but exposure to
strong sunlight causes it to darken. Its potency is affected in
solutions of pH below 2 and is rapidly
destroyed by alkali hydroxide solutions. Tetracycline is very slightly
soluble in water, freely soluble in
dilute acid and in alkali hydroxide solutions, sparingly soluble in
alcohol, and practically insoluble in
chloroform and in ether. The chemical name for tetracycline
hydrochloride is 4-(Dimethylamino)-
1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-
boxamide monohydrochloride. Its structural formula is as follows:
C
H N 0 •HCI M.W. 480.90
Each capsule, for oral administration, contains 250 mg or 500 mg
tetracycline hydrochloride, and has
the following inactive ingredients: colloidal silicon dioxide, D&C
Yellow #10, gelatin, pregelatinized
starch, propylene glycol, shellac glaze (modified), stearic acid, and
titanium dioxide. The 250 mg
capsules also contain black iron oxide, FD&C Blue #1 Aluminum Lake,
FD&C Blue #2 Aluminum Lake,
FD&C Red #40 Aluminum Lake, and FD&C Yellow #6. The 500 mg capsules
also contain ammonium
hydroxide, FD&C Blue #1, FD&C Red #40, and simethicone.
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 high concentrations in a
biologically active form.
MICROBIOLOGY
Tetracyclines are primarily bacteriostatic and exert their
antimicrobial effect by the i