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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.


See all Oracea indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Oracea (Doxycycline)

Subantimicrobial-dose doxycycline treatment increases serum cholesterol efflux capacity from macrophages. [2013]
removal from macrophages... CONCLUSIONS: Our results suggest that SDD treatment may reduce the risk of

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.

more studies >>

Clinical Trials Related to Oracea (Doxycycline)

Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea� vs Placebo After 12 Weeks of Oracea� and MetroGel� 1% [Recruiting]
The purpose of this study is to assess relapse, efficacy and safety in subjects with rosacea during long-term treatment with either Oracea or placebo, after an initial 12-week regimen of Oracea and MetroGel 1%.

Doxycycline Outcomes in Lupus Erythematosus: (DOLE) [Not yet recruiting]
Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in SLE in developed countries. In a recent study the investigators have shown that high sensitivity C reactive protein (hs-CRP) is higher in SLE patients with (versus without) coronary calcium, a measure of subclinical atherosclerosis. In an ongoing two year intervention trial of atorvastatin, the investigators will determine if statins retard coronary calcium and reduce hs-CRP. However, 10% of the patients in the trial were intolerant of statins. The investigators want to now investigate whether there are additional, and potentially safer ways, to reduce hs-CRP in SLE. In this study, the investigators will determine if doxycycline reduces hs-CRP and other vascular inflammatory markers including interleukin 6 (IL-6), soluble vascular cell adhesion molecule (sVCAM-1), soluble inter cell adhesion molecule (s-ICAM-1) and matrix metalloproteinase 9 (MMP-9) in SLE.

Evaluation of Rosacea-related Inflammatory Biochemical Markers in Adult Skin When Treated With Oracea vs Placebo [Recruiting]
The objective of this study is to determine the clinical effects of doxycycline 40 mg (30 mg immediate release and 10 mg delayed release beads) capsules (Oracea) as compared to placebo in the skin of adults with papulopustular rosacea and to identify a correlation, if any, with rosacea-related inflammatory markers.

Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) Patients [Recruiting]
The purpose of this study is to examine the role of a well-known and well-tolerated antibiotic, doxycycline, in the treatment of cystic fibrosis patients who are hospitalized. This antibiotic does not effectively treat the bacteria in airways of cystic fibrosis patients, but may reduce the activity of inflammatory molecules in the disease.

Doxycycline In Lymphangioleiomyomatosis (LAM) [Recruiting]
The purpose of the study is to test if the drug doxycycline is effective in slowing the progression of lung disease in LAM. Lymphangioleiomyomatosis (LAM) is a rare lung disease which affects young women. Women with LAM develop enlarged air spaces in the lungs called cysts, caused by an excess of matrix metalloproteinases (MMPs), protein-digesting enzymes. LAM is associated with kidney tumours, called angiomyolipomas, and causes recurrent lung collapse, breathlessness and death or need for lung transplant. There is no proven treatment. Doxycycline, a commonly used antibiotic can block MMP production and a small number of patients have shown some benefit from doxycycline. The investigators will perform a study to test if doxycycline can slow the fall in lung function in patients with LAM. Forty patients who consent to participate will take doxycycline or a placebo (dummy) tablet for two years in addition to their standard treatment.

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Reports of Suspected Oracea (Doxycycline) Side Effects

Rash (3)LIP Swelling (2)Diverticulitis (2)Headache (2)Angioedema (2)Nausea (2)Blood Bilirubin Increased (1)Asthenopia (1)Pyrexia (1)Vaginal Haemorrhage (1)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 8 ratings/reviews, Oracea has an overall score of 6.75. The effectiveness score is 8 and the side effect score is 7.50. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

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 37 year old female patient

  Rating
Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Rosacea
Dosage & duration:   40 mg taken daily for the period of 6 months
Other conditions:   N/A
Other drugs taken:   Finacea topically
  
Reported Results
Benefits:   Did not notice much difference in decrease of rosacea bumps or redness but the bumps seemed to increase briefly after I got off the Oracea. For approximately one week after discontinuing use. I used in conjunction with topical Finacea, which I applied twice a day, also prescribed for rosacea.
Side effects:   None noticed though per the treatment details (see below) it was often difficult to take based on your eating schedule.
Comments:   Take one pill a day. Must take one hour befor eating or two hours after with plenty of water. Also need to avoid sunlight while on this product though that is a good recommendation for skincare regardless of medication.

 

Oracea review by 19 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   Mild Acne
Dosage & duration:   40 mg capsule taken once daily for the period of 3 weeks
Other conditions:   Acne
Other drugs taken:   Low Dose Oral Contraceptives
  
Reported Results
Benefits:   I only have mild acne, but it was immediately cleared up within a few days of taking Oracea.
Side effects:   Abdominal pain, Stomach discomfort, Flu-like symptoms, Anxiety, Nausea, Joint pain, Back pain, Sinus headache, Soar throat, Inflammatory lesions in the anogenital region. The sinus headache, nausea, and anxiety were immediate, but flu like symptoms and lesions didn't appear until start of 3rd week. I then stopped taking Oracea. It made me feel like my body was falling apart, the back pain, nausea, and flu like symptoms weren't worth having an acne-free face.
Comments:   I took one pill per day for 2-3 weeks.

See all Oracea reviews / ratings >>

Page last updated: 2014-11-30

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