Sumycin (Tetracycline) - Summary

SUMYCIN SUMMARY

Sumycin for oral administration contains tetracycline, an antibiotic isolated from Streptomyces aureofaciens.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Sumycin Syrup (Tetracycline Oral Suspension, USP) and other antibacterial drugs, Sumycin Syrup (Tetracycline Oral Suspension, USP) 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 hydrochloride is indicated for the treatment of the following infections:

Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsial pox and tick fevers caused by Rickettsiae

Respiratory tract infections caused by Mycoplasma pneumoniae

Lymphogranuloma venereum caused by Chlamydia trachomatis

Psittacosis and ornithosis due to Chlamydia psittaci

Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence

Inclusion conjunctivitis caused by Chlamydia trachomatis

Tetracycline hydrochloride is indicated for the treatment of uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis

Nongonococcal urethritis caused by Ureaplasma urealyticum

Relapsing fever due to Borrelia recurrentis

Tetracycline hydrochloride is also indicated for the treatment of infections caused by the following gramnegative microorganisms:

Chancroid caused by Haemophilus ducreyi

Plague due to Yersinia pestis (formerly Pasteurella pestis)

Tularemia due to Francisella tularensis (formerly Pasteurella tularensis)

Cholera caused by Vibrio cholerae (formerly Vibrio comma)

Campylobacter fetus infections caused by Campylobacter fetus (formerly Vibrio fetus)

Brucellosis due to Brucella species (in conjunction with streptomycin)

Bartonellosis due to Bartonella bacilliformis

Granuloma inguinale caused by Calymmatobacterium granulomatis

Because many strains of the following groups of microorganisms have been shown to be resistant to tetracycline hydrochloride, culture and susceptibility testing are recommended.

Tetracycline hydrochloride is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug:

Escherichia coli

Enterobacter aerogenes (formerly Aerobacter aerogenes)

Shigella species

Acinetobacter species (formally Mima species and Herellea species)

Respiratory tract infections caused by Haemophilus influenzae

Respiratory tract and urinary tract infections caused by Klebsiella species

Tetracycline hydrochloride is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicated appropriate susceptibility to the drug:

For upper respiratory infections caused by Streptococcus pneumoniae (formerly Diplococcus pneumoniae).

Skin and skin structure infections caused by Staphylococcus aureus.

Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.

When penicillin is contraindicated, tetracycline hydrochloride is an alternative drug in the treatment of the following infections:

Uncomplicated gonorrhea caused by Neisseria gonorrhoeae

Syphilis caused by Treponema pallidum

Yaws caused by Treponema pertenue

Listeriosis due to Listeria monocytogenes

Anthrax due to Bacillus anthracis

Vincent’s infection caused by Fusobacterium fusiforme

Actinomycosis caused by Actinomyces israelii

Infections caused by Clostridia species

In acute intestinal amebiasis, the tetracycline hydrochlorides may be a useful adjunctive therapy to amebicides.

In severe acne the tetracycline hydrochlorides may be useful adjunctive therapy.

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NEWS HIGHLIGHTS

Published Studies Related to Sumycin (Tetracycline)

Triple or quadruple tetracycline-based therapies versus standard triple treatment for Helicobacter pylori treatment. [2009.07]
BACKGROUND: Our aim was to compare lansoprazole-tetracycline-metranidazole (LTM) as first-line treatment with the classical lansoprazole-amoxicillin-clarithromycin (LAC) and bismuth-containing quadruple treatments... CONCLUSION: LTM treatment group achieved a significantly better eradication rate than the LAC treatment group. The success ratio of LTM therapy is comparable with quadruple bismuth-based treatments.

Effect of a Kampo preparation, byakkokaninjinto, on pharmacokinetics of ciprofloxacin and tetracycline. [2009.06]
The effect on the bioavailability of the antimicrobial agents (ciprofloxacin and tetracycline), which are well known to form chelates with cationic metals such as calcium, was evaluated in 20 healthy male volunteers according to an open, random crossover fashion using a Kampo preparation, byakkokaninjinto (TJ-34) which contains various cationic metals including calcium.

The efficacy of ranitidine bismuth citrate, amoxicillin and doxycycline or tetracycline regimens as a first line treatment for Helicobacter pylori eradication. [2009.01]
BACKGROUND: The eradication rates of Helicobacter pylori (H. pylori) clearly decreased with standard PPI-based triple therapies. AIM: To assess the efficacy of two different triple therapies consisting of ranitidine bismuth citrate-amoxicillin-doxycycline and ranitidine bismuth citrate-amoxicillin-tetracycline combinations as a first line treatment option... CONCLUSIONS: Two-week therapy with neither ranitidine bismuth citrate-amoxicillin-doxycycline nor ranitidine bismuth citrate-amoxicillin-tetracycline is adequately effective for H. pylori eradication as a first line therapy.

A randomized, double-blind study to assess the efficacy of addition of tetracycline to triamcinolone acetonide in the treatment of moderate to severe atopic dermatitis. [2008.09]
OBJECTIVE: To assess the efficacy of tetracycline in triamcinolone acetonide ointment compared with triamcinolone acetonide ointment in patients with moderate to severe atopic dermatitis... CONCLUSION: The addition of tetracycline was effective on skin colonization by S. aureus but did in our patients with atopic dermatitis not result in a significantly different improvement compared with the group treated without tetracycline.

Development and validation of a liquid chromatographic/tandem mass spectrometric method for determination of tetracycline in human plasma: application to bioequivalence study. [2008.07]
A fast, sensitive, and specific liquid chromatographic/tandem mass spectrometric method was developed and validated for determination of tetracycline in human plasma. Tetracycline and oxytetracycline [internal standard (IS)] were extracted from the plasma by protein precipitation... The proposed method was successfully applied for determination of tetracycline in human plasma samples to support bioequivalence studies.

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Clinical Trials Related to Sumycin (Tetracycline)

Randomised Double Blind Crossover Placebo Controlled Study to Evaluate the Efficacy of Tetracycline in Epidermolysis Bullosa [Not yet recruiting]
Epidermolysis Bullosa(EB) is an inherited bullous disease. Tetracycline is believed to have anti inflammatory properties. 20 patients with EB older than 13 years will be treated for 4 months with tetracycline or placebo. After one month of wash out they will be treated for additional 4 m with placebo or tetracycline. The patients will be examined each month to estimate bulla formation,rate of healing .

Tetracycline in Preventing Skin Rash in Patients Who Are Receiving Drugs Such as Gefitinib and Cetuximab for Cancer [Recruiting]
RATIONALE: Tetracycline may be effective in preventing skin rash that is caused by treatment with drugs such as gefitinib or cetuximab.

PURPOSE: This randomized clinical trial is studying tetracycline to see how well it works compared to placebo in preventing skin rash in patients who are receiving drugs such as gefitinib or cetuximab for cancer.

A Prospective Clinical Study Assessing the Effects of Tetracycline Antibiotic on Tear Film and Tear Lipid Composition Within a Population of Patients Diagnosed With Blepharitis and Dry Eye Disease [Terminated]
The purpose of this research project is to determine the effects of oral tetracycline such as Minocycline (Minocin) on tear film composition and tear lipid (meibomian gland secretions) characteristics in patients with chronic Blepharitis and associated dry eyes.

Tetracycline (Doxycycline) and Post Myocardial Infarction Remodeling [Recruiting]
The aim of the study is to assess the efficacy of an antibiotic treatment with tetracycline (doxycycline) in the early stage of large reperfused acute myocardial infarction (AMI), in preventing left ventricular (LV) remodeling.

Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis [Not yet recruiting]
The purpose of this study is to determine the Efficacy, Tolerability & Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream.

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