TETRACYCLINE HYDROCHLORIDE capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Amneal Pharmaceuticals NY LLC

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 , Streptococcus pneumoniae , Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp. ) - 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 caused by Chlamydophila psittaci . - Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum. - Granuloma inquinale caused by Klebsiella granulomatis . - Relapsing fever caused by Borrelia sp. - Bartonellosis caused by Bartonella bacilliformis . - Chancroid caused by Hemophilus ducreyi . - Tularemia caused by Francisella tularensis . - Plaque caused by Yersinia pestis . - Cholera caused by Vibrio cholerae . - Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside). - Infections due to Campylobacter fetus . - As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica . - Urinary tract infections caused by susceptible strains of Escherichia coli , Klebsiella , etc. - Other infections caused by susceptible gram-negative organisms such as E. coli , Enterobacter aerogenes , Shigella sp. , Acinetobacter sp. , Klebsiella sp. , and Bacteroides sp . - In severe acne, adjunctive therapy with tetracycline may be useful. When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of the following infections: - Syphilis and yaws caused by Treponema pallidum and pertenue , respectively, - Vincent’s infection caused by Fusobacterium fusiforme , - Infections caused by Neisseria gonorrhoeae , - Anthrax caused by Bacillus anthracis , - Infections due to Listeria monocytogenes , - Actinomycosis caused by Actinomyces species, - Infections due to Clostridium species. This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Produkt oppsummering:

Tetracycline hydrochloride capsules, USP, 250 mg, are supplied as hard gelatin capsules with light blue opaque cap and yellow opaque body printed AMNEAL on cap and 1522 on body with black ink. They are available as follows: Bottles of 100:                        NDC 60219-1522-1 Tetracycline hydrochloride capsules, USP, 500 mg, are supplied as hard gelatin capsules with light blue opaque cap and yellow opaque body printed AMNEAL on cap and 1523 on body with black ink. They are available as follows: Bottles of 100:                        NDC 60219-1523-1 Dispense in a tight, light-resistant container 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.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TETRACYCLINE HYDROCHLORIDE- TETRACYCLINE HYDROCHLORIDE CAPSULE
AMNEAL PHARMACEUTICALS NY LLC
----------
TETRACYCLINE HYDROCHLORIDE CAPSULES, USP
(250 MG AND 500 MG)
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, USP 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, USP is
(4S,4aS,5aS,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-
12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide
monohydrochloride. Its structural formula is as follows:
Each capsule, for oral administration, contains 250 mg or 500 mg
tetracycline
hydrochloride, USP.
INACTIVE INGREDIENTS: Colloidal silicon dioxide, pregelatinized starch
(corn), and stearic
acid.
The 250 mg and 500 mg capsule shells contain D&C yellow #10, FD&C blue
#1, FD&C
yellow #6, gelatin, and titanium dioxide.
The imprinting ink for the 250 mg and 500 mg capsules contains D&C
yellow #10,
ethanol, FD&C blue #1, FD&C blue #2, FD&C red #40, iron oxide black,
methanol, n-
butyl alcohol, propylene glycol and shellac glaze.
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 e