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:

State of Florida DOH Central Pharmacy

INN (International Name):

TETRACYCLINE HYDROCHLORIDE

Composition:

TETRACYCLINE HYDROCHLORIDE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 , Streptococcus pneumoniae , Mycoplasma pneumoniae (Eaton agent, and Klebsiellasp .) - Skin and soft tissue infections caused by Streptococcus pyogenes , Staphylococcus aureaus . (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.) - Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox. - Psittacosis of ornithosis caused by Chlamydia psittaci . - Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocer

Product summary:

Tetracycline Hydrochloride Capsules, USP are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TETRACYCLINE HYDROCHLORIDE - TETRACYCLINE HYDROCHLORIDE CAPSULE
STATE OF FLORIDA DOH CENTRAL PHARMACY
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TETRACYCLINE
HYDROCHLORIDE
CAPSULES, USP
DES CRIPTION:
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.
Each capsule, for oral administration, contains tetracycline
hydrochloride 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,
edentate 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. 40,
gelatin, sodium lauryl sulfate, and titanium dioxide. It may also
contain benzyl alcohol, butylparaben,
edetate calcium disodium, FD&C yellow no. 6, methylparaben,
propylparaben, silicon dioxide, and
sodium propionate.
The imprinting ink for the 500 mg capsule contains titanium dioxide.
It may also contain dimethyl
polysiloxane, distilled water, ethyl alcohol, ethylene glycol
monoethyl ether, pharmaceutical glaze,
pharmaceutical shellac, and soya lecithin.
The structural formula is represe