Oracea

Generic Name: doxycycline (Oral route)

dox-i-SYE-kleen

Commonly used brand name(s):

In the U.S.

• Adoxa
• Adoxa CK
• Adoxa Pak
• Adoxa TT
• Alodox
• Doryx
• Monodox
• Oracea
• Periostat
• Vibramycin Calcium
• Vibramycin Hyclate
• Vibramycin Monohydrate
• Vibra-Tabs

Available Dosage Forms:

• Tablet
• Powder for Suspension
• Capsule
• Capsule, Extended Release
• Tablet, Delayed Release
• Capsule, Delayed Release
• Syrup

Therapeutic Class: Antibiotic

Chemical Class: Tetracycline (class)

Uses For Oracea

Doxycycline is used to treat infections and to help control acne. It is also used to treat the pimples and abscesses (usually on the face) that are caused by rosacea, also known as acne rosacea or adult acne. Doxycycline may also be used for other problems as determined by your doctor. Doxycycline will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Before Using Oracea

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Doxycycline may cause permanent discoloration of teeth and slow down the growth of bones. This medicine should not be given to children 8 years of age and younger unless directed by the child's doctor.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of doxycycline in the elderly with use in other age groups.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acitretin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Digoxin
• Isotretinoin
• Methotrexate

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Bismuth Subsalicylate
• Calcium
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Ethinyl Estradiol
• Fosphenytoin
• Iron
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Mestranol
• Norelgestromin
• Norethindrone
• Norgestrel
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Rifampin
• Rifapentine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Candida albicans (yeast) infection, in the past or if vulnerable to—You should use doxycycline with caution.

• Kidney problems—May increase chance of unwanted effects or may cause large amounts of the medicine to build up in the blood. Your doctor may lower your dose and monitor you for excess doxycycline in the blood.

Proper Use of doxycycline

This section provides information on the proper use of a number of products that contain doxycycline. It may not be specific to Oracea. Please read with care.

Do not give doxycycline to infants or children 8 years of age and younger unless directed by your doctor. Doxycycline may cause permanently discolored teeth and other problems in patients in these age groups.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

Take only the amount of doxycycline that is prescribed for you. If you take more than the correct dosage, you may have side effects and the medicine may not work.

Drink plenty of fluids to avoid esophageal irritation and ulceration.

For Doryx® delayed-release tablets—This medicine may be taken with food or milk if it upsets your stomach.

For Oracea™ delayed-release capsules—

• You should take this medicine on an empty stomach, preferably at least one hour before or two hours after meals.
• You should take this medicine with a full glass of water while sitting or standing.
• To prevent throat irritation, do not lay down right after taking this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (delayed-release tablets):
  • For infections:
    • Adults and children older than 8 years of age who weigh more than 100 pounds (45 kilograms or kg)—100 milligrams (mg) every 12 hours the first day, then 100 mg once a day or 50 to 100 mg every 12 hours.
    • Children older than 8 years of age who weigh 100 pounds (45 kg) or less—Dose is based on body weight. The usual dose is 2 milligrams (mg) per pound of body weight divided into two doses on the first day of treatment, followed by 1 mg per pound of body weight given as a single daily dose or divided into two doses on subsequent days.
    • Infants and children 8 years of age and younger—Doxycycline is not used in young children because it can permanently stain teeth.
  • For the prevention of malaria:
    • Adults and teenagers—100 milligrams (mg) once a day. You should take the first dose one or two days before travel to an area where malaria may occur, and continue taking the medicine every day throughout travel and for 4 weeks after you leave the malarious area.
    • Children older than 8 years of age—Dose is based on body weight. The usual dose is 2 milligrams per kilogram (mg per kg) of body weight once a day. You should take the first dose one or two days before travel to an area where malaria may occur, and continue taking the medicine every day throughout travel and for 4 weeks after you leave the malarious area.
    • Infants and children 8 years of age and younger—Doxycycline is not used in young children because it can permanently stain teeth.
  • For inhalation anthrax (post-exposure):
    • Adults and children weighing 100 pounds or more (45 kilograms or kg)—100 milligrams (mg) twice a day for 60 days.
    • Children weighing less than 100 pounds (45 kg)—1 milligram (mg) per pound (2.2 mg/kg) of body weight twice a day for 60 days.
• For oral dosage form (delayed-release capsules):
  • For the treatment of pimples from rosacea:
    • Adults—40 milligrams (mg) (one capsule) once a day in the morning.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Oracea

Oral contraceptives (birth control pills) containing estrogen may not work properly if you take them while you are taking doxycycline. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking doxycycline. If you have any questions about this, check with your health care professional.

You should contact your doctor right away if you experience stomach cramps, high fever, and bloody diarrhea. These could be symptoms of pseudomembranous colitis, a serious condition where the colon is severely inflamed.

Doxycycline may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sunblock product that has a skin protection factor (SPF) number of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sunblock lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sun lamp or tanning bed or booth.

Contact your doctor immediately if fever, rash, joint pain, or tiredness occurs. These could be symptoms of an autoimmune syndrome where the body attacks itself.

You should not take antacids that contain aluminum, calcium or magnesium, or any product that contains iron such as vitamin or mineral supplements.

Oracea Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Abdominal tenderness
• bloating
• clay-colored stools
• cough
• dark urine
• decreased appetite
• diarrhea
• diarrhea, watery and severe, which may also be bloody
• difficulty swallowing
• dizziness
• fast heartbeat
• feeling of discomfort
• fever
• headache
• hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• hives or welts
• increased thirst
• inflammation of joints
• itching
• joint or muscle pain
• large , hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• nausea and vomiting
• numbness or tingling of face, hands or feet
• pain
• rash
• redness and soreness of eyes
• redness of skin
• shortness of breath
• sore throat
• sores in mouth
• stomach cramps
• stomach pain or tenderness
• swelling of feet or lower legs
• swollen lymph glands
• tightness in chest
• unusual tiredness or weakness
• unusual weight loss
• wheezing
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• blood in urine or stools
• blurred vision
• bulging soft spot on head of an infant
• change in ability to see colors, especially blue or yellow
• chest pain, discomfort, or burning
• chills
• cracks in the skin
• decrease in vision
• difficulty breathing
• discoloration of thyroid glands
• double vision
• general body swelling
• heartburn
• increased sensitivity of skin to sunlight
• loss of heat from the body
• lower back or side pain
• nosebleeds
• pain or burning in throat
• pain with swallowing
• painful or difficult urination
• pale skin
• pinpoint red spots on skin
• rash with flat lesions or small raised lesions on the skin
• red, swollen skin
• redness or other discoloration of skin
• redness, swelling, or soreness of tongue
• scaly skin
• severe nausea
• severe stomach pain
• severe sunburn
• sores, ulcers, or white spots on lips or tongue or inside the mouth
• unusual bleeding or bruising
• vomiting blood

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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