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 study of the clinical activity of a gel combining monocaprin and doxycycline: a novel treatment for herpes labialis. [2012]
doxycycline in vivo against herpes labialis... CONCLUSION: Combining monocaprin with low-dose doxycycline offers an effective

Low-Dose Doxycycline Plus Additional Therapies may Lower Systemic Inflammation in Postmenopausal Women with Periodontitis. [2011.12]
ARTICLE TITLE AND BIBLIOGRAPHIC INFORMATION: The effect of subantimicrobial-dose-doxycycline periodontal therapy on serum biomarkers of systemic inflammation: a randomized, double-masked, placebo-controlled clinical trial.

Sub-antimicrobial doxycycline for periodontitis reduces hemoglobin A1c in subjects with type 2 diabetes: a pilot study. [2011.12]
In vitro and animal studies suggest a possible role for the tetracycline class of drugs in the inhibition of non-enzymatic protein glycation. We conducted a 3-month, randomized placebo-controlled pilot clinical trial of conventional sub-gingival debridement (periodontal therapy), combined with either a three month regimen of sub-antimicrobial-dose doxycycline (SDD), a two week regimen of antimicrobial-dose doxycycline (ADD), or placebo in 45 patients with long-standing type 2 diabetes (mean duration 9 years) and untreated chronic periodontitis...

A Randomized Study Comparing Levofloxacin, Omeprazole, Nitazoxanide, and Doxycycline versus Triple Therapy for the Eradication of Helicobacter pylori. [2011.11]
OBJECTIVES: Resistance to standard Helicobacter pylori (HP) treatment regimens has led to unsatisfactory cure rates in HP-infected patients. This study was designed to evaluate a novel four-drug regimen (three antibiotics and a proton pump inhibitor (PPI)) for eradication of HP infection in treatment-naive patients... CONCLUSIONS: This open-label, prospective trial demonstrates that LOAD is a highly active regimen for the treatment of HP in treatment-naive patients. A large randomized controlled trial is warranted to further evaluate the efficacy of this regimen.

A randomized controlled trial of subantimicrobial-dose doxycycline to prevent unscheduled bleeding with continuous oral contraceptive pill use. [2011.09.28]
BACKGROUND: Unscheduled bleeding is the main side effect of continuous oral contraceptive pills (OCPs) and has been correlated with the up-regulation of matrix metalloprotineases (MMPs). The study objective was to determine if prophylactic administration of doxycycline (an MMP inhibitor at low subantimicrobial doses) would prevent unscheduled bleeding during the initiation of a continuous OCP... CONCLUSION: The coadministration of subantimicrobial-dose doxycycline during initiation of continuous OCPs results in a significant reduction in the length of time needed to achieve amenorrhea. Copyright (c) 2011 Elsevier Inc. All rights reserved.

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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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Reports of Suspected Doxycycline Side Effects

Rash (32),  Vomiting (20),  Renal Failure Acute (16),  Pruritus (15),  Interstitial Lung Disease (14),  Oesophageal Ulcer (13),  Hyperkalaemia (12),  Headache (12),  Drug Hypersensitivity (12),  Foreign Body (12), more >>

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 male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Clamydia
Dosage & duration:		2 tablets a day taken twice a day for the period of 10 days
Other conditions:		acne
Other drugs taken:		None
		Reported Results
Benefits:		My chlamydia went a way and i made a complete recovery. My acne also temporarily went away, which was good. However, it did come back after i stopped taking it, which meant it was somewhat useless.
Side effects:		I had diahrea and some stomach upsets....While i wasn't taking it for my acne, it seemed to have helped it. However, the Diahrea is something i've had with most antibiotics. I countered it by having acidophilus supplements, which worked really well.
Comments:		None i can describe, just took two tablets a day. One before breakfast and one before dinner. The treatment lasted ten days and i took it religiously. I did have to take other acidophilus containing products to control the side effects but it was fortunate that it lasted only 10 days.

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.