TETRACYCLINE HYDROCHLORIDE- 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:

Harris Pharmaceutical, 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 HCl Capsules, USP and other antibacterial drugs, Tetracycline HCl 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. Tetracycline HCl Capsules, USP 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 HCl Capsules, USP should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. - Lower respiratory t

Product summary:

Tetracycline HCl Capsules, USP are available as: 250 mg: Yellow Opaque Cap /Yellow Opaque Body, Cap and Body Imprinted 5225 in Black Ink. Available in bottles of: 20 capsules – NDC 67405-660-02 100 capsules -NDC 67405-660-10 500 capsules -NDC 67405-660-50 500 mg: Orange Opaque Cap/Yellow Opaque Body, Cap and Body Imprinted 5266 in Black Ink. Available in bottles of: 20 capsules – NDC 67405-661-02 100 capsules -NDC 67405-661-10 500 capsules -NDC 67405-661-50 Dispense in a tight, light-resistant containers 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 HARRIS Pharmaceutical at 1-800-983-4708 or FDA at 1-800- FDA-1088.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TETRACYCLINE HYDROCHLORIDE- TETRACYCLINE HYDROCHLORIDE CAPSULE
HARRIS PHARMACEUTICAL, INC
----------
TETRACYCLINE HCL CAPSULES, USP FOR ORAL USE
RX ONLY
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
TETRACYCLINE HCL CAPSULES, USP AND OTHER ANTIBACTERIAL DRUGS.
TETRACYCLINE HCL CAPSULES, USP
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 ·HCl M.W. 480.90
Each capsule, for oral administration, contains 250 mg or 500 mg
tetracycline hydrochloride.
INACTIVE INGREDIENTS: Lactose, and magnesium stearate.
The 250 mg and 500 mg capsule shells contain D&C Yellow No. 10, FD&C
yellow No. 6, gelatin,
sodium lauryl sulfate, water, and titanium dioxide.
The imprinting ink for the 250 mg and 500 mg capsules contain D&C
Yellow No. 10, FD&C Blue No.1,
FD&C Blue No. 2, FD&C Red No. 40, ferrosoferric oxide, pharmaceutical
shellac, propylene glycol,
n-butyl alcohol, ethanol and methanol.
Product complies with USP Dissolution Test 2.
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 t