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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DOXYCYCLINE NEWS HIGHLIGHTS

Published Studies Related to Doxycycline

Subantimicrobial-dose doxycycline in the treatment of moderate facial acne. [2008.12]
BACKGROUND: Acne is a common inflammatory skin disorder. Oral antibiotics play a significant clinical role in treating acne. OBJECTIVE: The purpose of this study was to compare the efficacy of doxycycline at antimicrobial and subantimicrobial doses for the treatment of acne... CONCLUSION: Subantimicrobial-dose doxycycline is an effective treatment for patients with moderate acne vulgaris.

Failure of cefoxitin and doxycycline to eradicate endometrial Mycoplasma genitalium and the consequence for clinical cure of pelvic inflammatory disease. [2008.10]
OBJECTIVES: As Mycoplasma genitalium is associated with pelvic inflammatory disease (PID), we examined the efficacy of a commonly used PID antimicrobial in treating M genitalium upper genital tract infection... CONCLUSIONS: M genitalium is associated with endometritis and short-term PID treatment failure. Cefoxitin and doxycycline, a Centers for Disease Control and Prevention recommended PID treatment regimen, is ineffective for the treatment of M genitalium upper genital tract infection.

Wolbachia endobacteria depletion by doxycycline as antifilarial therapy has macrofilaricidal activity in onchocerciasis: a randomized placebo-controlled study. [2008.09]
In a randomized, placebo-controlled trial in Ghana, 67 onchocerciasis patients received 200-mg/day doxycycline for 4-6 weeks, followed by ivermectin (IVM) after 6 months. After 6-27 months, efficacy was evaluated by onchocercoma histology, PCR and microfilariae determination... Doxycycline may be developed as second-line drug for onchocerciasis, to be administered in areas without transmission, in foci with IVM resistance and in areas with Loa co-infections.

A randomized, placebo-controlled trial of doxycycline after endoluminal aneurysm repair. [2008.09]
BACKGROUND: The late durability of endovascular aneurysm repair (EVAR) has been limited by progressive aortic degeneration believed to be mediated by matrix metalloproteases (MMP). The goal of this study was to evaluate the effect of a MMP inhibitor, doxycycline, on EVAR... CONCLUSION: There is evidence of persistent MMP release representing ongoing aortic degradation after endografting which can be inhibited by doxycycline therapy. In analyses based on the endograft used, treatment with doxycycline also demonstrated evidence of increased aortic dimensional stability, a surrogate marker for long-term success of EVAR. Although encouraging, these results require confirmation in larger patient populations. Doxycycline should undergo more thorough evaluation as a potential adjuvant treatment to improve the results of EVAR, particularly in certain subgroups.

Doxycycline plus levamisole: combination treatment for severe nodulocystic acne. [2008.08]
BACKGROUND: Levamisole is an agent without much potential use alone, but through immunomodulation, may synergistically improve the efficacy of other drugs like doxycycline in the treatment of acne vulgaris. OBJECTIVE: The goal of this study was to determine the efficacy of levamisole in addition to doxycycline in the treatment of patients suffering from severe nodulocystic acne... CONCLUSION: Results indicated that adding oral levamisole to doxycycline is an effective treatment for severe nonresponsiveness to conventional treatments of acne vulgaris. In the patient group, levamisole was well tolerated with an acceptable safety profile. At the time of publication, this study is the first clinical trial that suggests levamisole as an effective new treatment for severe acne vulgaris.

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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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DOXYCYCLINE 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 57 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		rosacea
Dosage & duration:		100 mg taken once a day for the period of 3 months, but need to take forever
Other conditions:		eye involvement
Other drugs taken:		natural hormone replacement
		Reported Results
Benefits:		I didn't know I was suppose to keep taking, so after one month, stop the medication & that's when the rosacea got worse & the eye involvement started. I had to go to an eye doctor & get eye drops. My dermatologist started me back on the doxycycline & said I had to take it "forever".
Side effects:		If if take the 100 mg, I get an upset stomach, so I called the doctor & asked him to replace the medication with two 50mg tablets each day, which I've been taking for a week & it works much better.
Comments:		I need to take the medication twice a day, but one hour before eating or two hours after, which has turned out to be a really big nuisance, since I like to eat six small meals a day.

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.