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:

Alvogen 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 Streptococcus pyogenes , Stre

Product summary:

Tetracycline Hydrochloride 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: 100 capsules - NDC 47781-508-01 500 mg: Orange Opaque Cap/Yellow Opaque Body, Cap and Body Imprinted 5266 in Black Ink. Available in bottles of: 100 capsules - NDC 47781-509-01 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 FDA at 1-800-FDA-1088.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TETRACYCLINE HYDROCHLORIDE- TETRACYCLINE HYDROCHLORIDE CAPSULE
ALVOGEN INC.
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TETRACYCLINE HYDROCHLORIDE CAPSULE 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.
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, and titanium dioxide.
The imprinting ink for the 250 mg and 500 mg capsules contains D&C
Yellow No. 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, ferrosoferric oxide.
This 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 their
antimicr