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:

Contract Pharmacy Services-PA

INN (International Name):

Tetracycline Hydrochloride

Composition:

Tetracycline Hydrochloride 500 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 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

Product summary:

Tetracycline Hydrochloride Capsules USP, 500 mg are available as black and yellow capsules, imprinted with company logo and 2407, containing 500 mg of tetracycline hydrochloride, packaged in blisters of 30 capsules. PHARMACIST: 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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TETRACYCLINE HYDROCHLORIDE- TETRACYCLINE HYDROCHLORIDE CAPSULE
CONTRACT PHARMACY SERVICES-PA
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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. In
addition, each capsule contains the following inactive ingredients:
colloidal silicon dioxide,
pregelatinized starch and stearic acid. The inactive ingredients for
the gelatin capsules include: (250
mg) FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide; (500
mg): FD&C Blue No. 1,
FD&C Red No. 40, D&C Yellow No. 10, and titanium dioxide.
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 inhibition of protein
synthesis. Tetracycline is active against a wide range of
gram-nega