TETRACYCLINE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

INN (International Name):

TETRACYCLINE HYDROCHLORIDE

Composition:

TETRACYCLINE HYDROCHLORIDE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 Strep

Product summary:

Tetracycline Hydrochloride Capsules, USP are available as: 250 mg: Light Blue Opaque Cap/Yellow Opaque Body, Cap and Body Imprinted HP 17 in Black Ink. Available in bottles of: 100  NDC 23155-017-01 500 mg: Light Blue Opaque Cap/Yellow Opaque Body, Cap and Body Imprinted HP 18 in Black Ink. Available in bottles of: 100  NDC 23155-018-01 Dispense in a tight, light-resistant container as defined in the USP. Use child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Authorization status:

New Drug Application

Summary of Product characteristics

TETRACYCLINE HYDROCHLORIDE- TETRACYCLINE HYDROCHLORIDE CAPSULE
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
----------
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-
naphthacenecarboxamide monohydrochloride. Its structural formula is as
follows:
Each capsule, for oral administration, contains 250 mg or 500 mg
tetracycline
hydrochloride.
INACTIVE INGREDIENTS: Lactose, light mineral oil, and magnesium
stearate.
The 250 mg and 500 mg capsule shells contain D&C yellow no. 10, FD&C
blue no. 1,
FD&C yellow no. 6, gelatin, and titanium dioxide.
The imprinting ink for the 250 mg and 500 mg capsules contains D&C
yellow #10, FD&C
blue no. 1, FD&C blue no. 2, FD&C red no. 40, iron oxide black,
pharmaceutical shellac
glaze, propylene glycol and n-butyl alcohol.
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to plasma protein 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
inhibition of protein synthesis by binding to the 30S ri