Tetracycline Hydrochloride
TETRACYCLINE HYDROCHLORIDE — tetracycline hydrochloride tablet, film coated
Pharmaka Generics 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 is a yellow, crystalline powder. Tetracycline is soluble in water, slightly soluble in ethanol (96%), practically insoluble in acetone. It dissolves in solutions of alkali hydroxides and carbonates. Solutions in water become turbid on standing, owing to the precipitation of tetracycline. 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. Its structural formula is as follows:
Each tablet, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride.
Inactive Ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. The film coating for the 250 mg and 500 mg are made of D&C RED # 30 / helendon pink aluminium lake, hypromellose and titanium dioxide.
In addition to these, the 250 mg tablet film coating includes triacetin and 500 mg tablet film coating includes polyethylene glycol.
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 USAGE section 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 cholerae
Yersinia pestis
Gram-positive Bacteria
Bacillus anthracis
Streptococcus pyogenes
Streptococcus pneumoniae
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 pallidum
Treponema pallidum subspecies pertenue
Parasites
Entamoeba species
Balantidium coli
Susceptibility Test Methods
When available, the clinical microbiology laboratory should provide the results of in vitro susceptibility test results for antimicrobial drugs used in resident hospitals to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting the most effective antimicrobial.
Dilution Techniques
Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test method1,2,4 (broth and/or agar). The MIC values should be interpreted according to the criteria provided in Table 1.
Diffusion Techniques
Quantitative methods that require measurement of zone diameters can also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size provides an estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standard test method1,3,4. This procedure uses paper disks impregnated with 30 mcg tetracycline to test the susceptibility of bacteria to tetracycline. The disk diffusion interpretive criteria are provided in Table 1.
Anaerobic Techniques
For anaerobic bacteria, the susceptibility to tetracycline can be determined by a standardized test method5. The MIC values obtained should be interpreted according to the criteria provided in Table 1.
Table 1: Susceptibility Test Interpretive Criteria for Tetracycline | |||||||||
Bacteriaa | Minimal Inhibitory Concentration (mcg/mL) | Zone Diameter (mm) | Agar Dilution (mcg/mL) | ||||||
S | I | R | S | I | R | S | I | R | |
Acinetobacter spp. | <4 | 8 | >16 | >15 | 12-14 | <11 | – | – | – |
Anaerobes | – | – | – | – | – | – | <4 | 8 | >16 |
Bacillusanthracisa | <1 | – | – | – | – | – | – | – | – |
Brucella speciesa | <1 | – | – | – | – | – | – | – | – |
Enterobacteriaceae | <4 | 8 | >16 | >15 | 12-14 | <11 | – | – | – |
Franciscellatularensisa | <4 | – | – | – | – | – | – | – | – |
Haemophilus influenzae | <2 | 4 | >8 | >29 | 26-28 | <25 | – | – | – |
Mycoplasma pneumoniae | – | – | – | – | – | – | < 2 | – | – |
Neisseria gonorrhoeaeb | – | – | – | >38 | 31-37 | <30 | <0.25 | 0.5-1 | >2 |
Staphylococcus aureus | <4 | 8 | >16 | >19 | 15-18 | <14 | – | – | – |
Streptococcus pneumoniae | <1 | 2 | >4 | >28 | 25-27 | <24 | – | – | – |
Streptococcus pyogenes | <2 | 4 | >8 | >23 | 19-22 | <18 | – | – | – |
Vibrio cholerae | <4 | 8 | >16 | >15 | 12-14 | <11 | – | – | – |
Yersinia pestis | <4 | 8 | >16 | – | – | – | – | – | – |
a The current absence of resistance isolates precludes defining any results other than “Susceptible”. If isolates yielding MIC results other than susceptible, they should be submitted to a reference laboratory for further testing.b Gonococci with 30 mcg tetracycline disk zone diameters of less than 19 mm usually indicate a plasmid- mediated tetracycline resistant Neisseria gonorrhoeae isolate. Resistance in these strains should be confirmed by a dilution test (MIC greater than or equal to 16 mcg/mL). |
A report of Susceptible (S) indicates that the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations usually achievable at the site of infection. A report of Intermediate (I) indicates that the result should be considered equivocal, and, if the bacteria is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant (R) indicates that the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations usually achievable at the infection site; other therapy should be selected.
Quality Control
Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of the supplies and reagents used in the assay, and the techniques of the individuals performing the test1,2,3,4,5,6,7. Standard tetracycline powders should provide the following range of MIC values noted in Table 2. For the diffusion technique using the 30 mcg tetracycline disk the criteria noted in Table 2 should be achieved.
Table 2: Acceptable Quality Control Ranges for Susceptibility Testing for Tetracycline | |||
QC Strain | Minimal Inhibitory Concentration (mcg/mL) | Zone Diameter (mm) | Agar Dilution (mcg/mL) |
Enterococcus faecalis ATCC 29212 | 8 — 32 | – | – |
Escherichia coli ATCC 25922 | 0.5 — 2 | 18 — 25 | – |
Haemophilus influenzae ATCC 49247 | 4 — 32 | 14 — 22 | – |
Mycoplasma pneumoniae ATCC 29342 | 0.06-0.5 | – | 0.06-0.5 |
Neisseria gonorrhoeae ATCC 49226 | – | 30 — 42 | 0.25 — 1 |
Staphylococcus aureus ATCC 25923 | – | 24 — 30 | – |
Staphylococcus aureus ATCC 29213 | 0.12 — 1 | – | – |
Streptococcus pneumoniae ATCC 49619 | 0.06 — 0.5 | 27 — 31 | – |
Bacteroides fragilis ATCC 25285 | – | – | 0.12 — 0.5 |
Bacteroides thetaiotaomicron ATCC 29741 | – | – | 8 — 32 |
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