Oracea (Doxycycline) - Summary

ORACEA SUMMARY

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).

Indication

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.

Limitations of Use

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.

Efficacy of ORACEA beyond 16 weeks and safety beyond 9 months have not been established.

ORACEA has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea.

See all Oracea indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Oracea (Doxycycline)

Effect of doxycycline vs placebo on retinal function and diabetic retinopathy progression in mild to moderate nonproliferative diabetic retinopathy: a randomized proof-of-concept clinical trial. [2014]
IMPORTANCE: Microglia have been associated with inflammatory changes underlying diabetic retinopathy. OBJECTIVE: To investigate whether low-dose oral doxycycline monohydrate, a drug capable of inhibiting microglial activation, can improve or slow the deterioration of retinal function and whether it can induce regression or slow progression of diabetic retinopathy in patients with mild to moderate nonproliferative diabetic retinopathy (NPDR)...

The effect of prolonged systemic doxycycline therapy on serum tissue degrading proteinases in coronary bypass patients: a randomized, double-masked, placebo-controlled clinical trial. [2014]
biomarkers during 4 months of doxycycline therapy in coronary bypass patients... CONCLUSIONS: Doxycycline decreases the systemic inflammatory burden in patients

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.

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Clinical Trials Related to Oracea (Doxycycline)

ORCA - Oracea® for Rosacea: A Community-based Assessment [Completed]
The objective of this study is to assess the effectiveness, safety, subject satisfaction and quality of life with Oracea® when used as monotherapy or as add-on therapy to existing topical regimens for the treatment of rosacea.

Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea [Completed]
The purpose of this study is to characterize rosacea patients', being treated with Oracea, perception through visual analog scale reporting.

NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole) [Completed]
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.

Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo [Completed]
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%.

Examination of the Anti-inflammatory and Insulin Sensitizing Properties of Doxycycline in Humans [Completed]
Obesity is a heightened state of inflammation in which production of cytokines and matrix metalloproteinases (MMPs) result in loss of function of insulin receptors and insulin resistance. Doxycycline (DOX) is a potent MMP inhibitor. We hypothesize that DOX will enhance insulin sensitivity and decreases inflammation in obese participants with type 2 diabetes (DM2).

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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.