TETRACYCLINE SUMMARY
TETRACYCLINE HYDROCHLORIDE CAPSULES, USP
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.
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, endocervical, or rectal infections, inclusion conjunctivitis, trachoma and lymphogranuloma venereum.
- Granuloma inquinale caused by Calymmatobacterium granulomatis.
- Relapsing fever caused by Borrelia sp.
- Bartonellosis caused by Bartonella bacilli-formis.
- 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 pallidumand 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.
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