País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T)
Chartwell RX, LLC
TETRACYCLINE HYDROCHLORIDE
TETRACYCLINE HYDROCHLORIDE 250 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
TETRACYCLINE HYDROCHLORIDE - TETRACYCLINE HYDROCHLORIDE CAPSULE CHARTWELL RX, LLC ---------- 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 Leer el documento completo