Tetracycline Hydrochloride

TETRACYCLINE HYDROCHLORIDE- tetracycline hydrochloride capsule
Actavis Pharma, Inc.

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. 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.

Its structural formula is as follows:

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 antimicrobial effect by the inhibition of protein synthesis by binding to the 30S ribosomal subunit. Tetracycline is active against a broad range of gram-negative and gram-positive organisms. The drugs in the tetracycline class have closely similar antimicrobial spectra, and cross-resistance among them is common.

Tetracycline has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections as described in the INDICATIONS AND USAGEsection of the package insert.

Gram-negative Bacteria

Acinetobacter species
Bartonella bacilliformis
Brucella species
Campylobacter fetus
Enterobacter aerogenes
Escherichia coli
Francisella tularensis
Haemophilus ducreyi
Haemophilus influenzae
Klebsiella species
Klebsiella granulomatis
Neisseria gonorrhoeae
Shigella species
Vibrio cholera
Yersinia pestis

Gram-positive Bacteria

Bacillus anthracis
Streptococcus pyogenes
Streptococcus pneumonia
Staphylococcus aureus
Listeria monocytogenes

Anaerobes

Bacteroides species
Clostridium species
Fusobacterium fusiforme
Propionibacterium acnes

Other Bacteria

Actinomyces species
Borrelia recurrentis
Chlamydophila psittaci
Chlamydia trachomatis
Rickettsiae
Treponema pallidumTreponema pallidum subspecies pertenue

Parasites

Entamoeba species
Balantidium coli

Susceptibility Testing

For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

INDICATIONS AND USAGE

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 by Streptococcus pyogenes , Streptococcus pneumoniae , Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.)
• Skin and soft tissue infections caused by Streptococcus pyogenes , Staphylococcus aureus.
  (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 bacill iformis.
• Chancroid caused by Haemophilus 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.