Oracea Information
Oracea (Doxycycline) Indications And Usage
This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. Oracea (Doxycycline) 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 (Doxycycline) should be used only as indicated.
Efficacy of Oracea (Doxycycline) beyond 16 weeks and safety beyond 9 months have not been established.
Oracea (Doxycycline) has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea.
Oracea (Doxycycline) Dosage Forms And Strengths
40 mg capsule:beige opaque capsule imprinted with "GLD 40"
Oracea (Doxycycline) Contraindications
This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.
Oracea (Doxycycline) Warnings And Precautions
Oracea (Doxycycline) should not be used during pregnancy Doxycycline, like other tetracycline-class antibiotics, can cause fetal harm when administered to a pregnant woman. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, the patient should be informed of the potential hazard to the fetus and treatment stopped immediately.
The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs, therefore, should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated.
All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy
Oracea (Doxycycline) Adverse Reactions
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Note: Percentages based on total number of study participants in each treatment group.
Oracea (Doxycycline) Overdosage
In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdose.
Oracea (Doxycycline) Description
Oracea (Doxycycline) (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 (CHNO). The structural formula of doxycycline, USP is:
with an empirical formula of CHNO•HO and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate. It is very slightly soluble in water.Inert ingredients in the formulation are: hypromellose, iron oxide red, iron oxide yellow, methacrylic acid copolymer, polyethylene glycol, Polysorbate 80, sugar spheres, talc, titanium dioxide, and triethyl citrate. Active ingredients: Each capsule contains doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline.
Oracea (Doxycycline) Clinical Pharmacology
Oracea (Doxycycline) capsules are not bioequivalent to other doxycycline products. The pharmacokinetics of doxycycline following oral administration of Oracea (Doxycycline) was investigated in 2 volunteer studies involving 61 adults. Pharmacokinetic parameters for Oracea (Doxycycline) following single oral doses and at steady-state in healthy subjects are presented in .
Oracea (Doxycycline) Clinical Studies
The safety and efficacy of Oracea (Doxycycline) in the treatment of only inflammatory lesions (papules and pustules) of rosacea was evaluated in two randomized, placebo-controlled, multi-centered, double-blind, 16-week Phase 3 studies involving 537 subjects (total of 269 subjects on Oracea (Doxycycline) from the two studies) with rosacea (10 to 40 papules and pustules and two or fewer nodules). Pregnant and nursing women, subjects
Oracea (Doxycycline) How Supplied/storage And Handling
Oracea (Doxycycline) (beige opaque capsule imprinted with “GLD 40”) containing doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline. Bottle of 30 (NDC 0299-3822-30).
All products are to be stored at controlled room temperatures of 15°C - 30°C (59°F - 86°F) and dispensed in tight, light-resistant containers (USP).
Oracea (Doxycycline) Patient Counseling Information
Oracea (Doxycycline) ® (Or-RAY-sha) (doxycycline, USP) Capsules 40 mg
Read the Patient Information that comes with Oracea (Doxycycline) before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your treatment or your medical condition. If you have any questions about Oracea (Doxycycline) , ask your doctor or pharmacist.
What is Oracea (Doxycycline) ?
Who should not take Oracea (Doxycycline) ?
Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Oracea (Doxycycline) may affect the way other medicines work, and other medicines may affect how Oracea (Doxycycline) works. Especially tell your doctor if you take
Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
How should I take Oracea (Doxycycline) ?
What should I avoid while taking Oracea (Doxycycline) ?
Oracea (Doxycycline) may also cause
Some common side effects of Oracea (Doxycycline) are soreness in the nose and throat, diarrhea, sinus infection, high blood pressure, and increase in aspartate aminotransferase in the blood.These are not all the possible side effects of Oracea (Doxycycline) . For more information, ask your doctor or pharmacist.Tell your doctor if you have a side effect that bothers you or that does not go away.
You may report side effects to FDA at 1-800-FDA-1088 or to GALDERMA LABORATORIES, L.P. at 1-866-735-4137
How should I store Oracea (Doxycycline) ?
General Information about Oracea (Doxycycline)
What are the ingredients in Oracea (Doxycycline) ?
Rx Only
Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USAManufactured by:Catalent Pharma Solutions, LLCWinchester, Kentucky 40391 USAGalderma is a registered trademark.20050-0510
Oracea (Doxycycline) Package Label
INERT INGREDIENTS:Hypromellose, Iron Oxide Red, Iron OxideYellow, Methacrylic Acid Copolymer,Polyethylene Glycol, Polysorbate 80,Sugar Spheres, Talc, Titanium Dioxide,and Triethyl Citrate
DOSAGE: ONE CAPSULE PER DAY
Store at controlled room temperatureof 15°C - 30°C (59°F - 86°F).
Keep out of reach of children
Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USAManufactured by:Catalent Pharma Solutions, LLCWinchester, Kentucky 40391 USAGalderma is a registered trademark.
30154-0508
