Doxycycline (Doxycycline Hyclate) - Summary

DOXYCYCLINE SUMMARY

DOXYCYCLINE FOR INJECTION USP

Doxycycline for Injection USP is a broad-spectrum antibiotic synthetically derived from oxytetracycline. It is a light yellow crystalline powder, and is available as doxycycline hydrochloride hemiethanolate hemihydrate.

Doxycycline is indicated in infections caused by the following microorganisms:

• Rickettsiae (Rocky Mountain spotted fever, typhus fever, and the typhus group, Q fever, rickettsialpox and tick fevers),
• Mycoplasma pneumoniae (PPLO, Eaton Agent),
• Agents of psittacosis and ornithosis,
• Agents of lymphogranuloma venereum and granuloma inguinale,
• The spirochetal agent of relapsing fever (Borrelia recurrentis).

The following gram-negative microorganisms:

• Haemophilus ducreyi (chancroid),
• Pasteurella pestis and Pasteurella tularensis,
• Bartonella bacilliformis,
• Bacteroides species,
• Vibrio comma and Vibrio fetus,
• Brucella species (in conjunction with streptomycin).

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

Doxycycline 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,
• Mima species and Herellea species,
• Haemophilus influenzae (respiratory infections),
• Klebsiella species (respiratory and urinary infections).

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

• Streptococcus species: Up to 44 percent of strains of Streptococcus pyogenes and 74 percent of Streptococcus faecalis have been found to be resistant to tetracycline drugs. Therefore, tetracyclines should not be used for streptoccal disease unless the organism has been demonstrated to be sensitive.
• Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

For upper respiratory infections due to group A beta-hemolytic streptococci, penicillin is the usual drug of choice, including prophylaxis of rheumatic fever.

• Diplococcus pneumoniae,
• Staphylococcus aureus, respiratory, skin and soft tissue infections.

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

When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to:

• Neisseria gonorrhoeae and N. meningitis,
• Treponema pallidum and Treponema pertenue (syphilis and yaws),
• Listeria monocytogenes,
• Clostridium species,
• Fusobacterium fusiforme (Vincent's infection),
• Actinomyces species.

In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides.

Doxycycline is indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline and other antibacterial drugs, doxycycline 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.

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NEWS HIGHLIGHTS

Published Studies Related to Doxycycline

A randomized trial of doxycycline for Mansonella perstans infection. [2009.10.08]
BACKGROUND: Mansonella perstans infection is common in areas of Africa where Wuchereria bancrofti, a causative agent of lymphatic filariasis, is endemic. M. perstans is refractory to standard antifilarial therapies. The recent discovery of bacterial endosymbionts (e.g., wolbachia) in most filarial species, including M. perstans, provides new therapeutic options for reducing microfilaremia... CONCLUSIONS: These results are consistent with previous findings that M. perstans harbors the intracellular endosymbiont, wolbachia, and suggest that doxycycline is an effective therapy for M. perstans infection. (ClinicalTrials.gov number, NCT00340691.) 2009 Massachusetts Medical Society

A multicenter study of topical azelaic acid 15% gel in combination with oral doxycycline as initial therapy and azelaic acid 15% gel as maintenance monotherapy. [2009.07]
This two-phase, multicenter study was undertaken to examine the safety and efficacy of combination therapy with oral doxycycline and topical azelaic acid (AzA) 15% gel in moderate-to-severe papulopustular rosacea and to determine the effect of subsequent maintenance monotherapy with AzA 15% gel alone...

A randomized comparison of azithromycin and doxycycline for the treatment of Mycoplasma genitalium-positive urethritis in men. [2009.06.15]
BACKGROUND: Several uncontrolled observational studies have suggested that the tetracycline class of antibiotics may not be effective in treating Mycoplasma genitalium infection. The present study compared the efficacy of 1 g of azithromycin given as a single dose with that of 100 mg of doxycycline given twice a day for 7 days in eliminating M. genitalium infection... CONCLUSIONS: A single 1-g dose of azithromycin is more effective than multidose doxycycline for the treatment of M. genitalium-associated urethritis in men. M. genitalium may be an important cause of recurrent nongonococcal urethritis after administration of the treatment regimens currently recommended by the Centers for Disease Control and Prevention.

Supportive periodontal therapy of furcation sites: non-surgical instrumentation with or without topical doxycycline. [2009.06]
CONCLUSION: Single subgingival application of doxycycline in addition to SRP had a short-term effect on furcation involvement. However, it failed to reduce the frequency of re-instrumentation up to 12 months at furcation sites.

Reduction in levels of plasma vascular endothelial growth factor-A and improvement in hydrocele patients by targeting endosymbiotic Wolbachia sp. in Wuchereria bancrofti with doxycycline. [2009.06]
The treatment for hydrocele is expensive, invasive surgery-hydrocelectomy... A six-week regimen of doxycycline treatment against filariasis showed amelioration of pathologic conditions of hydrocele patients with active infection.

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Clinical Trials Related to Doxycycline

Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions [Completed]

Bioequivalence Study Doxycycline Tablets and Monodox Capsules Under Fasting Conditions [Completed]

Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting Conditions [Completed]

Doxycycline Prophylaxis at Vacuum Aspiration Trial [Completed]
This study is a randomized, double-blinded, controlled trial comparing two regimens of doxycycline for the prevention of infection after surgical abortion. One thousand women undergoing surgical abortion in the first trimester will be enrolled from the clinic at Tu Du Hospital, Ho Chi Minh City, Vietnam. The standard regimen has been 100 mg twice daily for 5 days after the abortion. Subjects will be randomized to the standard regimen or to take 200 mg doxycycline pre-operatively. Subjects found to have a positive Chlamydia EIA test will receive a 7-day course of doxycycline regardless of study group. Subjects will complete questionnaires of symptoms, including nausea and emesis in the recovery room after the procedure and at a single follow-up visit two weeks later. The primary outcome will be infection after abortion, defined below. Analyses will be performed including and excluding Chlamydia-positive subjects. Secondary outcomes will be the proportion with nausea, emesis, and other side-effects.

Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens [Completed]
This is a randomized double-blind, controlled trial comparing two regimens of pre-abortion doxycycline. The aims of the study are to determine the serum levels of doxycycline when administered pre-operatively 4 hours or approximately 18 hours before a dilation and evacuation (D & E) abortion. The hypotheses being tested are that subjects who receive doxycycline with food the night before an abortion will have adequate serum levels, but less nausea and vomiting compared to women who take the doxycycline on an empty stomach on the morning of the abortion. Subjects will either take 200mg doxycycline on the night before and 2 caps placebo with a sip of water on the morning of surgery or 2 caps placebo the night before and 200mg doxycycline on the morning of surgery with a sip of water. All capsules will look identical. Diaries, questionnaires and a 10cc sample of blood for doxycycline levels will be collected from the subjects at the time of surgery.

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PATIENT REVIEWS / RATINGS / COMMENTS

Doxycycline review by 37 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		pneumonia
Dosage & duration:		100 mg taken bid for the period of 10 days
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		fast onset of action. quicker than a zpak with is erythromycin. for 5 days. Onset of action is faster and patient starts to feel better in two days versus a week.
Side effects:		mild nausea, mild stomach irritation, can develop yeast infection for can you can counter these effects by taking a little food by mouth with the antibiotics however the food cannot be dairy. Also to counter the possibility an yeast infection eat yogurt but only 1 hour before taking the pills or 2 hours after taking the pills
Comments:		take by mouth twice daily for 10 days

Doxycycline review by 24 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		perioral dermatitis
Dosage & duration:		100mg taken once a day for the period of 20 days
Other conditions:		none
Other drugs taken:		clyndamicin
		Reported Results
Benefits:		perioral dermatitis disappear completely during the treatment, but occured again after 2 months. During that time I used only natural toothpaste with no flouride in it. I haven't used any cosmetics during the treatment, but I started using facial cream after a week when dermatitis disappered avoiding the area around the mouth. Continue taking 100mg a day for 40 days and I'll see.
Side effects:		no side effects
Comments:		perioral dermatitis disappear completely during the treatment, but occured again after 2 months. Continue taking 100mg a day for 40 days and I'll see

Doxycycline review by 32 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		mastitis
Dosage & duration:		50 mg taken twice a day for the period of only 3-4 days because of side effects
Other conditions:		none
Other drugs taken:		ibuprophen for pain
		Reported Results
Benefits:		None because I had to stop taking it due to the side effects.
Side effects:		Severe abdominal spasms/pain and diarrhea
Comments:		Was supposed to take it to clear up my mastitis but couldn't complete the treatment because my abdominal pain was too severe. I was changed to a different antibiotic.