ORACEA DOXYCYCLINE

Brand Name: ORACEA

Generic Name: DOXYCYCLINE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: CAPSULE

Data Current As Of: 2018-10-05

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.

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.

One ORACEA Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals.

Administration of adequate amounts of fluid along with the capsules is recommended to wash down the capsule to reduce the risk of esophageal irritation and ulceration [see Adverse Reactions (6)].

The dosage of ORACEA differs from that of doxycycline used to treat infections. Exceeding the recommended dosage may result in an increased incidence of side effects including the development of resistant organisms.

40 mg beige opaque capsule imprinted with “GLD 40”

​This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Absorption of tetracyclines is impaired by bismuth subsalicylate, proton pump inhibitors, antacids containing aluminum, calcium or magnesium and iron-containing preparations.

Doxycycline may interfere with the effectiveness of low dose oral contraceptives. To avoid contraceptive failure, females are advised to use a second form of contraceptive during treatment with doxycycline.

There have been reports of pseudotumor cerebri (benign intracranial hypertension) associated with the concomitant use of isotretinoin and tetracyclines. Since both oral retinoids, including isotretinoin and acitretin, and the tetracyclines, primarily minocycline, can cause increased intracranial pressure, the concurrent use of an oral retinoid and a tetracycline should be avoided.

Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

Teratogenic Effects: Pregnancy Category D [see Warnings and Precautions (5.1) ]. Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues.

Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in infants from doxycycline, ORACEA should not be used in mothers who breastfeed.

ORACEA should not be used in infants and children less than 8 years of age [see Warnings and Precautions (5.1) ]. ORACEA has not been studied in children of any age with regard to safety or efficacy, therefore use in children is not recommended.

Clinical studies of ORACEA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

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 (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).

Storage:

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).

Keep out of reach of children.

See FDA-approved patient labeling (Patient Information)

Patients taking ORACEA Capsules 40 mg should receive the following information and instructions:

• It is recommended that ORACEA not be used by individuals of either gender who are attempting to conceive a child
• It is recommended that ORACEA not be used by pregnant or breast feeding women
• Patients should be advised that pseudomembranous colitis can occur with doxycycline therapy. If patients develop watery or bloody stools, they should seek medical attention.
• Patients should be advised that pseudotumor cerebri can occur with doxycycline therapy. If patients experience headache or blurred vision they should seek medical attention.
• Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including doxycycline. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using doxycycline. If patients need to be outdoors while using doxycycline, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. Treatment should be discontinued at the first evidence of sunburn.
• Concurrent use of doxycycline may render oral contraceptives less effective.
• Autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with tetracycline-class drugs, including doxycycline. Symptoms may be manifested by arthralgia, fever, rash and malaise. Patients who experience such symptoms should be cautioned to stop the drug immediately and seek medical help.
• Patients should be counseled about discoloration of skin, scars, teeth or gums that can arise from doxycycline therapy.
• Take ORACEA exactly as directed. Increasing doses beyond 40 mg every morning may increase the likelihood that bacteria will develop resistance and will not be treatable by other antibacterial drugs in the future.

Read this Patient Information before you start taking ORACEA and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

What is ORACEA?
ORACEA is a tetracycline-class medicine. ORACEA is a prescription medicine used in adults to treat only pimples or bumps (papules and pustules) caused by a condition called rosacea. ORACEA does not lessen redness caused by rosacea.
ORACEA should not be used for the treatment or prevention of infections.
It is not known if ORACEA is:
effective for use for longer than 16 weeks.
safe for use longer than 9 months.
safe and effective in children. ORACEA should not be used in infants and children less than 8 years of age because it may cause stained teeth in infants and children.

Who should not take ORACEA?
Do not take ORACEA if you are allergic to doxycycline or other medicines in the tetracycline-class. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

What should I tell my doctor before taking ORACEA?
Before you take ORACEA tell your doctor if you:
have kidney problems.
have liver problems.
have diarrhea or watery stools.
have vision problems.
have had surgery on your stomach (gastric surgery).
have or had a yeast or fungal infection in your mouth or vagina.
have any other medical condition.
are pregnant or plan to become pregnant. ORACEA may harm your unborn baby. Taking ORACEA while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Stop taking ORACEA and call your doctor right away if you become pregnant while taking ORACEA.
are breastfeeding or plan to breastfeed. ORACEA can pass into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take ORACEA. You and your doctor should decide if you will take ORACEA or breastfeed. You should not do both.

You should not take ORACEA if you are a male with a female sexual partner who plans to become pregnant at any time while you are being treated with ORACEA.

Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. ORACEA and other medicines can affect each other causing serious side effects.

Especially tell your doctor if you take:
birth control pills. ORACEA may reduce the effectiveness of birth control pills. Talk to your doctor about what types of birth control you can use to prevent pregnancy while taking ORACEA.
a blood thinner medicine.
a penicillin (antibacterial medicine).
proton pump inhibitors or antacids that contain aluminum, calcium, or magnesium.
products containing iron or bismuth subsalicylate.
a medicine taken by mouth that contains isotretinoin or acitretin.
a medicine to treat seizures, such as carbamazepineor or phenytoin.

Ask your doctor or pharmacist for a full list of these medicines, if you are not sure.

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?
Take ORACEA exactly as prescribed by your doctor. Taking more than your prescribed dose may increase your chance of side effects, including the chance that bacteria will become resistant to ORACEA.
Take ORACEA 1 time a day in the morning on an empty stomach.
You should take ORACEA at least one hour before or two hours after a meal.
Take ORACEA with enough fluid to completely swallow the capsule and to lower your risk of getting irritation or ulcer in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.
If you took too much ORACEA call your doctor right away.
Your doctor may do blood tests during treatment with ORACEA to check for side effects.

What should I avoid while taking ORACEA?
Avoid sunlight or artificial sunlight, such as a tanning booth or sunlamp. You could get severe sunburn. Use sunscreen and wear clothes that cover your skin while out in sunlight.

What are the possible side effects of ORACEA?
ORACEA may cause serious side effects, including:
Harm to an unborn baby. See “What should I tell my doctor before taking ORACEA?”
Permanent teeth discoloration. ORACEA may permanently turn a baby or child's teeth yellow-grey-brown during tooth development. ORACEA should not be used during tooth development. Tooth development happens in the last half of pregnancy, and from birth to 8 years of age. See “What should I tell my doctor before taking ORACEA?”
Intestine infection (pseudomembranous colitis). Pseudomembranous colitis can happen with most antibiotics, including ORACEA. Call your doctor right away if you get diarrhea or bloody stools.
Immune system reactions including a lupus-like syndrome, hepatitis,
and inflammation of blood or lymph vessels (vasculitis). Stop taking ORACEA and tell your doctor right away if you get joint pain, fever, rash, or body weakness.
Discoloration (hyperpigmentation). ORACEA can cause darkening of your skin, scars, teeth, gums, nails, and whites of your eyes.
Benign intracranial hypertension, also called pseudotumor cerebri. This is a condition where there is high pressure in the fluid around the brain. This swelling may lead to vision changes and permanent vision loss. Stop taking ORACEA and tell your doctor right away if you have blurred vision, vision loss, or unusual headaches.

These are not all the possible side effects of ORACEA. For more information, ask your doctor or pharmacist.The most common side effects of ORACEA include:

soreness in the nose and throat
sinus infection
fungus infection
flu-like symptoms
diarrhea
stomach (abdominal) bloating or pain
high blood pressure (hypertension)
change in certain blood tests

Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of ORACEA.  For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137.

How should I store ORACEA?
Store ORACEA at room temperature between 59°F to 86°F (15°C to 30°C).
Keep ORACEA in a tightly closed container.
Keep ORACEA inside container and out of light.

Keep ORACEA and all medicine out of the reach of children.

General information about ORACEA
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take ORACEA for a condition for which it was not prescribed. Do not give ORACEA to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about ORACEA. If you would like more information, talk with your doctor. You can also ask your doctor or pharmacist for information that is written for health professionals.

What are the ingredients in ORACEA?
Active ingredient: doxycycline
Inactive ingredients: hypromellose, iron oxide red, iron oxide yellow, methacrylic acid copolymer, polyethylene glycol, Polysorbate 80, sugar spheres, talc, titanium dioxide, and triethyl citrate.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Marketed by:
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA

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