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 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 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.

Effectiveness of Doxycycline for Treating Pleural Effusions Related to Cancer in an Outpatient Population [Recruiting]
Patients with cancer may experience problems with their breathing due to a fluid accumulation around their lungs called malignant pleural effusion (MPE). This fluid can be drained but draining may not stop the fluid from accumulating again. MPE can cause shortness of breath during activity and at rest leaving patients feeling as though they cannot catch their breath enough to be comfortable. Other symptoms can include pain, cough and weight loss.

One way to stop the fluid from accumulating is to create scar tissue between the lung and chest wall so there is no more room for fluid accumulation. This procedure is called pleurodesis. Pleurodesis is the standard of care at most centres across Canada. This procedure is done by injecting a drug into the space between the lung and chest wall through a catheter, Doxycycline is one of the drugs currently used for this purpose. Traditionally, patients are admitted for pleurodesis, mostly because the size of the catheter used to inject the medication is very large but also because of the potential complications that can happen with these larger chest tubes.

At our centre, most patients with MPE are managed at home with a smaller sized catheter known as a Pleurx catheter. The Pleurx catheter allows patients to remain at home for treatment and trained staff come into the home to both drain the MPE and monitor the patient. Sometimes, patients experience pleurodesis through use of the Pleurx catheter alone.

Pleurodesis with doxycycline can happen faster than with the Pleurx catheter alone. It has been our experience with a limited number of patients that it is safe to perform pleurodesis using the Pleurx catheter for doxycycline injection in an outpatient setting.

Safety, Efficacy and Pharmacokinetics of Doxycycline Plus Tauroursodeoxycholic Acid in Transthyretin Amyloidosis [Recruiting]
This study is being conducted to explore the potential benefits of a twelve-month doxycycline (at the best tolerated dose of 200 mg/day) and tauroursodeoxycholic acid (750 mg/day) treatment on disease progression in patients affected by transthyretin amyloidosis, including: 1) patients not eligible for liver transplantation; 2) patients eligible for liver transplantation, as a "bridge" therapy between the time of diagnosis and surgery, with the aim of stabilizing the disease; 3) patients showing disease progression after liver transplantation performed since at least 1 year.

It is a phase II, therapeutic exploratory, two-part, 18-month, single centre, prospective study.

Part I is a 12-month, open label treatment period in which doxycycline (200 mg/day, continuously) and tauroursodeoxycholic acid (750 mg/day continuously) are administered to 40 consenting subjects with transthyretin amyloidosis. Part II is a withdrawal period in which subjects will be monitored for disease progression. During part I, subjects will be evaluated at baseline (study Day 0), and then after 3, 6, 9 and 12 months of doxycycline plus tauroursodeoxycholic acid treatment or at premature treatment discontinuation; during part II, they will be assessed at months 15 and 18. Monthly phone contacts and blood tests will be performed to monitor potential adverse events.

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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

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.