Tetracycline (Tetracycline Hydrochloride) - Summary

TETRACYCLINE SUMMARY

TETRACYCLINE HYDROCHLORIDE CAPSULES, USP

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.

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.

NEWS HIGHLIGHTS

Published Studies Related to 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 Tetracycline

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 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.

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 (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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PATIENT REVIEWS / RATINGS / COMMENTS

Tetracycline review by 42 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Razor Bumps
Dosage & duration:		Once per day, rub onto the skin (dosage frequency: once per day) for the period of 9 months
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		The product took great care of my razor bumps. If I applied it at night, I was clear by the morning. I only stopped taking it as the condition itself lessened.
Side effects:		None
Comments:		I would apply it to my skin, after washing, either at night (best time), or in the morning. I would also use a good spf to protect my skin from sun in the day

Tetracycline review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		acne
Dosage & duration:		one tablet twice a day taken until problem cleared for the period of 6 months
Other conditions:		iron dificiency
Other drugs taken:		iron supplements
		Reported Results
Benefits:		cleared bacteria on skin slightly
Side effects:		stomach pains sickness
Comments:		tetracycline is a antibiotic and a hormone used to control infections and regulate hormonal imbalances.

Tetracycline review by 39 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		acne-I was 22 yrs old when I took it
Dosage & duration:		cannot remember (dosage frequency: 2 times a day) for the period of 10 DAYS
Other conditions:		NONE
Other drugs taken:		NONE
		Reported Results
Benefits:		I started with headaches on the 9th day of taking the medication. I eventually needed 2 yrs of spinal taps to reduce the fluid build on in my spinal cord which was putty pressure on my brain.
Side effects:		none see above
Comments:		The Doctors told me this is a very rare side effect but it ruined my life for over two years.