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)

Efficacy comparison between povidone iodine 2.5% and tetracycline 1% in prevention of ophthalmia neonatorum. [2011.07]
PURPOSE: To evaluate the efficacy of povidone iodine solution 2.5% and tetracycline ointment 1% in prevention of ophthalmia neonatorum (ON). DESIGN: Prospective, randomized, controlled observational study. PARTICIPANTS: Three-hundred ninety-four full-term neonates... CONCLUSIONS: Povidone iodine was associated with noninfective (sterile) conjunctivitis, probably because of its toxicity to the ocular surface in neonates. Tetracycline was marginally more effective against infective ON. For these reasons, tetracycline, rather than povidone iodine, is recommended for prevention of ON. Copyright (c) 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Helicobacter pylori eradication with a capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline given with omeprazole versus clarithromycin-based triple therapy: a randomised, open-label, non-inferiority, phase 3 trial. [2011.03.12]
BACKGROUND: Helicobacter pylori is associated with benign and malignant diseases of the upper gastrointestinal tract, and increasing antibiotic resistance has made alternative treatments necessary. Our aim was to assess the efficacy and safety of a new, single-capsule treatment versus the gold standard for H pylori eradication... INTERPRETATION: Quadruple therapy should be considered for first-line treatment in view of the rising prevalence of clarithromycin-resistant H pylori, especially since quadruple therapy provides superior eradication with similar safety and tolerability to standard therapy. FUNDING: Axcan Pharma Inc. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

Modulation of cytokine and cytokine receptor/antagonist by treatment with doxycycline and tetracycline in patients with dengue fever. [2011]
Dengue virus infection can lead to dengue fever (DF) or dengue hemorrhagic fever (DHF)... Further analysis demonstrated that doxycycline was significantly more effective at modulating cytokine and cytokine receptor/antagonist levels than tetracycline.

Clinical, histologic, and bacteriologic findings in dairy cows with digital dermatitis (footwarts) one month after topical treatment with lincomycin hydrochloride or oxytetracycline hydrochloride. [2010.09.01]
OBJECTIVE: To compare the effectiveness of lincomycin and oxytetracycline for treatment of digital dermatitis (DD) in dairy cows through gross visual examination, histologic evaluation, and bacteriologic evaluation...

In vivo effects of adjunctive tetracycline treatment on refractory corneal ulcers in dogs. [2010.08.15]
OBJECTIVE: To evaluate effect of adjunctive treatment with tetracycline analogues on time to complete corneal reepithelialization in dogs with nonhealing (ie, refractory) corneal ulcers... CONCLUSIONS AND CLINICAL RELEVANCE: Topical tetracycline ophthalmic ointment was a safe, inexpensive, and effective adjunctive treatment for refractory corneal ulcers in dogs.

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Clinical Trials Related to Sumycin (Tetracycline)

Tetracycline as a Prophylaxis for Rash in Patients With NSCLC Receiving Treatment With BIBW 2992 [Recruiting]
1. Advanced NSCLC have a poor prognosis and the positive impact of chemotherapy is limited by the development of intrinsic and acquired resistance. 2. Over the past decade, less toxic agents such as the innovative targeted therapies, i. e. erlotinib or gefitinib, have the potential to improve the effectiveness and keep a good quality of life with a low toxicity 3. BIBW 2992, an aniline-quinazoline, is an EGFR and HER-2 irreversible inhibitor, and it has activity against erlotinib-resistant isoforms having mutations in EGFR and HER-2 4. This molecule have shown benefits as a single agent in pre-treated patients who have progressed despite platinum-based chemotherapy, with a minimal toxicity compared to chemotherapy 5. BIBW 2992 is associated with adverse effects similar to those for erlotinib and gefitinib, such as rash and diarrhea. These symptoms can reduce the quality of life in patients and lead to inconsistent EGFR inhibitor dose administration 6. There is no a standard treatment for rash, but case reports have tried to demonstrate the benefit obtained with alcohol-free emollients, sunscreen with titanium dioxide or antibiotic (topic or oral) treatment such as clindamycin or doxycycline, anti-inflammatory drugs such as steroids and isotretinoin in the treatment of these cutaneous injuries. 7. In order to reduce the incidence and severity of cutaneous toxicities, we will compare the prophylactic antibiotic treatment using tetracycline and general dermatological recommendations versus using only dermatological recommendations, in patients initiating the treatment with BIBW 2992

Intralesional Tetracycline Injection in the Treatment of Chalazia [Not yet recruiting]
The investigators propose a study to investigate the role of tetracycline injection into chalazia versus observation alone. The investigators hypothesize tetracycline injection will result in a significant decrease in lesion size when compared to observation alone.

Root Biomodification With Citric Acid and Tetracycline Improves the Outcomes of Root Coverage [Completed]

The Effect of Tetracycline in Degradation and Permeability of Collagen Membrane [Completed]
The main objective of this study was to evaluate the histological impact of treatment with tetracycline (TTC) solution of two layers collagen membranes (CMs) bio-degradation, in ridge preservation technique (RPT). Additionally, secondary objectives were to evaluate the effect of TTC on bacterial colonization and inflammatory response. This is a randomized simple-blind clinical trial. Consecutive patients referred to the Department of Periodontology at Universitat Internacional de Catalunya (Barcelona, Spain), between November 2009 and April 2011, were included in the study. This study was based on data collected from 20 surgical sites in 10 systemically healthy patients requiring 2 extractions with SPT. Before starting the surgery, the two teeth of each selected patient were randomized in two groups. The test group underwent RPT with CMs embedded with TTC solution (CMs TTC), and the control group was performed without TTC solution (CMs NO TTC). Randomization was performed using SPSS software (version 18, SPSS Inc., Chicago, IL, USA). In the test group, both membranes were first dipped for 5 minutes in TTC solution (50 mg/ml). This involved the use of 250 mg tablets of TTC and 5 ml of saline that were mixed in a sterile trough. A sample of the membrane used in each SPT was retained as a negative control sample. The membrane sample was retrieved 7 days after initial surgery. At 14 days the suture was removed and a new control was performed within 1 month. A sample from the negative control, test and control group was analyzed from each patient. The specimens were fixed in a 10% formalin solution, dehydrated in a series of alcohols, embedded in paraffin, and sectioned in 4-5μ. The sections were stained with hematoxylin and eosin and examined with an Olympus BH-2 optical microscope. The stained sections were photographed with a digital camera mounted on an optical microscope at magnification (x100, x200 and x400). According to the findings of the present study, we can conclude that CMs exhibit rapid degradation when exposed to the oral environment. Histological interpretation suggests that CMs immersed in 50mg/ml TTC solution delay the CM degradation when exposed to the oral environment. Statistical evaluation did not show any difference in bacterial colonization and inflammatory response, but the findings may also be affected by the limited sample size. The limits of the present study are the absence of histomorphometric analysis, the sample size, and the lack of a long-term evaluation with clinical evidence of the advantages of this technique. More clinical studies in humans are require to confirm the effect of TTC in CMs degradation before we can make recommendations.

Tetracycline in Preventing Skin Rash in Patients Who Are Receiving Drugs Such as Gefitinib and Cetuximab for Cancer [Completed]
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.

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