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:

Actavis Pharma, 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 capsules and other antibacterial drugs, tetracycline hydrochloride capsules 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 Haemophilus influenzae . Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. - Lower respiratory tract infections caused

Product summary:

Tetracycline Hydrochloride Capsules USP are available as: 250 mg: Orange/yellow capsules, imprinted with “WPI ” on cap and “2234 ” on body. Available in bottles of 100 (NDC 0591-2474-01). 500 mg: Black/yellow capsules, imprinted with “WPI ” on cap and “2235 ” on body. Available in bottles of 100 (NDC 0591-2475-01). 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]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TETRACYCLINE HYDROCHLORIDE- TETRACYCLINE HYDROCHLORIDE CAPSULE
ACTAVIS PHARMA, INC.
----------
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, USP 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, USP 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.
Each capsule, for oral administration, contains tetracycline
hydrochloride USP, 250 mg
or 500 mg.
INACTIVE INGREDIENTS: Lactose, magnesium stearate, and sodium lauryl
sulfate.
The 250 mg capsule shell contains D&C yellow no. 10, FD&C yellow no.
6, gelatin,
sodium lauryl sulfate, and titanium dioxide. It may also contain
benzyl alcohol,
butylparaben, D&C red no. 22, edetate calcium disodium, methylparaben,
propylparaben, silicon dioxide, and sodium propionate.
The imprinting ink for the 250 mg capsule contains pharmaceutical
glaze, and synthetic
black iron oxide. It may also contain D&C yellow no. 10 (aluminum
lake),
dimethylpolysiloxane, distilled water, ethylene glycol monoethyl
ether, FD&C blue no. 1
(aluminum lake), FD&C blue no. 2 (aluminum lake), FD&C red no. 40
(aluminum lake),
lecithin, n-butyl alcohol, propylene alcohol, and SDA-3A alcohol.
The 500 mg capsule shell contains D&C yellow no. 10, FD&C blue no.1,
FD&C red no. 4