SUMYCIN

SUMYCIN- tetracycline hydrochloride tablet, film coated
Par Pharmaceutical, Inc.

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,6,11,12a­octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecar-boxamide monohydrochloride. Its structural formula is as follows:

tetracycline-hydrochloride-tablets-1.jpg
(click image for full-size original)

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.

G ram- negative B acteria

Acinetobacter species

Bartonella bacilliformis

Brucella species

C ampylobacter fetus

Enterobacter aerogenes

Escherichia coli

Francisella tularensis

Haemophilus ducreyi

Haemophilus influenzae

Klebsiella species

K l ebsiella granulomatis

N eisseria gonorrhoeae

Shigella species

Vibrio cholerae

Y e rsinia pestis

G ram-positive Bacteria

Bacillus anthracis

Streptococcus pyogenes

Streptococcus pneumoniae

Staphylococcus aureus

Listeria monocytogenes

A naerobes

Bacteroides species

C l ostridium species

Fusobacterium fusiforme

Propionibacterium acnes

Ot her Bacteria

Actinomyces species

Borrelia recurrentis

C hlamydophila psittaci

C hlamydia trachomatis

Rickettsiae

Treponema pallidum

Treponema pallidum subspecies pertenue

P arasites

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.

D il ution 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.

Di f f u sion 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.

A naerobic 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.

T able 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

Bacillus anthracisa

<1

-

-

-

-

-

-

-

-

Brucella speciesa

<1

-

-

-

-

-

-

-

-

Enterobacteriaceae

<4

8

>16

>15

12-14

<11

-

-

-

Franciscella tularensisa

<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 plasmid­mediated 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.

Q uality 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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