Oracea (Doxycycline) - Summary

ORACEA SUMMARY

ORACEA (doxycycline, USP) Capsules

ORACEA (doxycycline, USP) capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C₂₂H₂₄N₂O₈).

ORACEA is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea. ORACEA has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea. Efficacy of ORACEA beyond 16 weeks and safety beyond 9 months have not been established.

This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. ORACEA should not be used for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease.

To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ORACEA should be used only as indicated.

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NEWS HIGHLIGHTS

Published Studies Related to Oracea (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 Oracea (Doxycycline)

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.

Doxycycline to Treat Mansonella Perstans Infection in Patients With and Without Lymphatic Filariasis [Active, not recruiting]
This study will examine: 1) the safety and effectiveness of the drug doxycycline in reducing the number of Mansonella perstans (Mp) worms in the blood of infected patients, and 2) the effects of doxycycline followed by albendazole and ivermectin treatment for lymphatic filariasis, caused by the parasitic worm Wuchereria bancofti (Wb).

Both Mp and Wb very small filarial worms that are spread by mosquitoes. Some people are infected with both Mp and Wb. Although most people do not become ill from infection with these parasites, some develop symptoms. Wb can cause swellings in the arms, legs, breast, and scrotum, and can progress to permanent swelling of the legs or arms called elephantiasis. Mp can cause itching, swelling, fever, headache, or other symptoms. Ivermectin and albendazole are medicines used to treat lymphatic filariasis. They eliminate the Wb parasite from the blood but do not affect Mp. Doxycycline is used to treat many kinds of infections and has also recently been shown to reduce the number of filarial worms in several types of filarial infections. The drug may be useful in Mp infections as well.

Residents of Sabougou and nearby villages in Mali who are infected with the Mp parasite, are between 14 and 65 years of age, are in good health, are not pregnant or breastfeeding, and weigh at least 40 kg (88 lb) may be eligible for this study. They may or may not also be infected with Wb. Candidates are screened with a brief medical history and physical examination and blood tests to look for infection with Mp and Wb.

Participants undergo a complete physical examination and medical history. Blood is drawn for routine blood tests. Participants are then randomly assigned to one of four treatment groups, as follows: 1) doxycycline for 6 weeks; 2) doxycycline for 6 weeks followed by a single dose of albendazole and ivermectin given 6 months after the beginning of doxycycline treatment; 3) a single dose of albendazole and ivermectin given 6 months after the beginning of doxycycline treatment; or 4) no treatment. Only patients infected with Wb receive albendazole and ivermectin treatment.

All participants, whether or not they receive doxycycline, come to the clinic every day for 6 weeks. Every 2 weeks during this time, they have a blood test and, in women of childbearing age, a urine pregnancy test. After 6 months, they have a medical history, physical examination, and blood tests. Subjects in the albendazole/ivermectin treatment group are given the pills to take at that time. One year and three years after beginning the study, participants return to the clinic for a final history, physical examination, and blood tests.

At the end of the first year of the study, all participants who tested positive for lymphatic filariasis but did not receive ivermectin and albendazole will be offered treatment with these medicines Ivermectin and albendazole will also be distributed by the Mali government to everyone in the villages as part of a program to eliminate lymphatic filariasis in the country.

Doxycycline and OA Progression [Completed]
This study will determine whether doxycycline decreases the severity or rate of progression of osteoarthritis (OA) in the knee. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most popular agents used to treat OA, but elderly women, in whom OA is especially common, are at greatest risk of developing serious side effects from NSAIDs.

Our study targets overweight middle-aged women who have OA in one knee. Half of the 432 study participants will receive the treatment (doxycycline) and half will receive a placebo (inactive pill). Treatment with doxycycline (or placebo) will last 30 months, and participants and researchers will not know who is receiving doxycycline and who is receiving placebo until the end of the study. We will look for narrowing of the joint space in the knee that was not affected by OA at the start of the study. Joint space narrowing is a sign of OA. We will also use questionnaires to evaluate participants' symptoms and functioning.

NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole) [Recruiting]
This study will look at the safety, effectiveness, and tolerability of combination medications for the initial treatment of non-gonococcal urethritis (NGU). NGU is inflammation of the tube that carries urine from the bladder. NGU is caused by bacteria that may be passed from person to person during sex. This study will compare the 2 currently recommended NGU treatments, doxycycline and azithromycin, taken with tinidazole (another medication to treat certain sexually transmitted infections). Tinidazole used with doxycycline or azithromycin may cure NGU better than when doxycycline or azithromycin is used alone. Study participants will be 300 men ages 16-45 years with NGU attending sexually transmitted disease clinics in Birmingham, AL; New Orleans, LA; Durham, NC; and Baltimore, MD. Study participation will last 7 weeks and involve 3 visits. At each visit, participants will provide a urine sample, have 2 urethral swabs, and have their urethra checked for discharge indicating infection.

The Effect of Doxycycline on Matrix Metalloproteinase Expression and Activity in the Abdominal Aneurysm [Completed]
The matrix metalloproteinase-9 (MMP-9) is considered to play a central role in abdominal aortic aneurysm (AAA) initiation. Doxycycline has direct MMP-9 inhibiting properties in vitro, and it effectively suppresses AAA development in rodents. Observed inhibition of AAA progression, and contradictory findings in human studies evaluating the effect of doxycycline therapy on aortic wall MMP-9 suggest that the effects of doxycycline extend beyond MMP-9 inhibition, and that the effect may be dose dependent.

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PATIENT REVIEWS / RATINGS / COMMENTS

Oracea review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		perioral dermatitis
Dosage & duration:		40 mg taken 1 cap once a day for the period of 6 months
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		It cured the rash around my upper lip and chin area
Side effects:		I personally had no side effects. This is a low dose tetracycline antibiotic, so you should avoid the sunlight and tanning beds while taking it. It's typical side effects are the same as any antibiotic.
Comments:		I took the prescribed dose for 6 months(even though my dermatologist said I could stay on it indefinitely). The rash disappeared within 1-2 weeks.I was very pleased with the medication. It has been 1 1/2 years since my breakout and so far I have not had the rash return.

Oracea review by 39 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Acne
Dosage & duration:		40 mg taken 1xd for the period of 1year
Other conditions:		Rosacea
Other drugs taken:		Provigil
		Reported Results
Benefits:		I liked this drug very much, because the stronger doses of antibiotics gave me horrible yeast infections. However, this one didn't quite so much. It still kept my acne at bay, and worked.
Side effects:		I still got yeast infections, however, they were not as bad and easier to get rid of than with the 75mg anitbiotic.
Comments:		I took a 75 mg antibiotic for acne for about a year, then, because it was giving me bad yeast infections, my derm switched me to Oracea. I got a card with the prescription that made it FREE with my insurance!!

Oracea review by 39 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Acne
Dosage & duration:		40 mg taken 1xd for the period of 1year
Other conditions:		Rosacea
Other drugs taken:		Provigil
		Reported Results
Benefits:		I liked this drug very much, because the stronger doses of antibiotics gave me horrible yeast infections. However, this one didn't quite so much. It still kept my acne at bay, and worked.
Side effects:		I still got yeast infections, however, they were not as bad and easier to get rid of than with the 75mg anitbiotic.
Comments:		I took a 75 mg antibiotic for acne for about a year, then, because it was giving me bad yeast infections, my derm switched me to Oracea. I got a card with the prescription that made it FREE with my insurance!!