TETRACYCLINE HYDROCHLORIDE capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T)

Commercializzato da:

Chartwell RX, LLC

INN (Nome Internazionale):

TETRACYCLINE HYDROCHLORIDE

Composizione:

TETRACYCLINE HYDROCHLORIDE 250 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

TETRACYCLINE HYDROCHLORIDE - TETRACYCLINE HYDROCHLORIDE CAPSULE
CHARTWELL RX, LLC
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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,6,11,12aoctahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2naphthacenecar-
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 sodium lauryl sulfate,
gelatin, FD&C yellow no. 6,
D&C Yellow No.10, and titanium dioxide.
The imprinting ink for the 250 mg and 500 mg capsules contains D&C
yellow #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