TETRACYCLINE HYDROCHLORIDE — tetracycline hydrochloride capsule
State of Florida DOH Central Pharmacy
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.
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, edentate 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.
The structural formula is represented below:
C22 H24 N2 O8 Molecular Weight: 444.44
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-naphthacenecarboxamide monohydrochloride.
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.
Tetracyclines are primarily bacteriostatic and exert their antimicrobial effect by the inhibition of protein synthesis. Tetracycline is active against a wide 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.
While in vitro studies have demonstrated the susceptibility of most strains of the following microorganisms, clinical efficacy for infections other than those included in the INDICATIONS AND USAGE section has not been documented.
Haemophilus ducrey i
Yersinia pestis (formerly Pasteurella pestis)
Francisella tularensis (formerly Pasterurella tularensis)
Vibrio cholera (formerly Vibrio comma)
Because many strains of the following groups of gram-negative microorganisms have been shown to be resistant to tetracyclines, culture and susceptibility testing are recommended:
Acinetobacter species (formerly Mima species and Herellea species)
Because many strains of the following groups of gram-positive microorganisms have been shown to be resistant to tetracycline, culture and susceptibility testing are recommended. Up to 44 percent of strains of Streptococcus pyogenes and 74 percent of Streptococcus faecalis have been found to be resistant to tetracycline drugs. Therefore, tetracyclines should not be used for streptococcal disease unless the organisms have been demonstrated to be susceptible.
Enterococcus group (Streptococcus faecalis and Streptococcus faecium)
Alpha-hemolytic Streptococci (viridans group)
A tetracycline disk may be used to determine microbial susceptibility to drugs in the tetracycline class. If the Kirby-Bauer method of disk susceptibility testing is used, a 30 mcg tetracycline disk should give a zone of at least 19 mm when tested against a tetracycline susceptible bacterial strain. Microorganisms may be considered susceptible if the MIC (minimum inhibitory concentration) is not more than 4.0 mcg/mL and intermediate if the MIC is 4.0 to 12.5 mcg/mL.
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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