Oracea

DRUG DESCRIPTION

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). The structural formula of doxycycline, USP is:

ORACEA® (doxycycline)  Structural Formula Illustration

with an empirical formula of C22H24N2O8•H2O 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-(4?, 4a?, 5?, 5a?, 6?,12a?)]-, 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.

What are the possible side effects of doxycycline?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using doxycycline and call your doctor at once if you have any of these serious side effects:

  • severe headache, dizziness, blurred vision;
  • fever, chills, body aches, flu symptoms;
  • severe blistering, peeling, and red skin rash;
  • urinating less than usual or not at all;
  • pale or yellowed skin, dark colored urine, fever, confusion or...

Read All Potential Side Effects and See Pictures of Oracea »

What are the precautions when taking doxycycline (Oracea)?

Before taking doxycycline, tell your doctor or pharmacist if you are allergic to it; or to tetracycline or related drugs (e.g., minocycline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, problems swallowing, esophagus problems (e.g., hiatal hernia, reflux disease-GERD), stomach surgery (e.g., gastrectomy, gastric bypass surgery), lupus.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when...

Read All Potential Precautions of Oracea »


Oracea Consumer (continued)

SIDE EFFECTS: Upset stomach, nausea, diarrhea, or mild headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: sunburn (sun sensitivity), difficult/painful swallowing, brown/gray tooth discoloration, blue/gray/brown discoloration of the skin/lips/tongue/gums, unusual tiredness, new signs of infection (e.g., fever, chills, persistent sore throat), change in the amount of urine, pink urine.

Tell your doctor immediately if any of these rare but very serious side effects occur: hearing changes (e.g., ringing in the ears, decreased hearing), easy bruising/bleeding, unusual/severe headache, vision changes (e.g., blurred vision), severe stomach/abdominal pain, persistent nausea/vomiting.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (fungal infections). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, skin lesions/sores, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, new or worsening swelling/pain in the joints, swollen glands, chest pain, fast/irregular heartbeat.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking doxycycline, tell your doctor or pharmacist if you are allergic to it; or to tetracycline or related drugs (e.g., minocycline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, problems swallowing, esophagus problems (e.g., hiatal hernia, reflux disease-GERD), stomach surgery (e.g., gastrectomy, gastric bypass surgery), lupus.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist that you are using doxycycline.

This medication should not be used in children younger than 8 years of age because it may cause permanent tooth discoloration and other problems. Tooth discoloration has also occurred in older children and young adults. Consult your doctor for more information.

This medication is not recommended for use during pregnancy because of possible harm to an unborn baby. It should not be used in women or men trying to have a child. Women of child-bearing age and men should use effective birth control while taking this medication. Consult your doctor for more details. If you become pregnant or think you may be pregnant, inform your doctor immediately.

This medication passes into breast milk in very small amounts. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.


Oracea Patient Information Including Side Effects

Brand Names: Adoxa, Alodox, Avidoxy, Doryx, Monodox, Oracea, Oraxyl, Periostat, Vibramycin, Vibramycin Calcium, Vibramycin Monohydrate, Vibra-Tabs

Generic Name: doxycycline (Pronunciation: DOX i SYE kleen)

  • What is doxycycline (Oracea)?
  • What are the possible side effects of doxycycline?
  • What is the most important information I should know about doxycycline?
  • What should I discuss with my healthcare provider before taking doxycycline?
  • How should I take doxycycline?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking doxycycline?
  • What other drugs will affect doxycycline?
  • Where can I get more information?

What is doxycycline (Oracea)?

Doxycycline is a tetracycline antibiotic. It fights bacteria in the body.

Doxycycline is used to treat many different bacterial infections, such as urinary tract infections, acne, gonorrhea, and chlamydia, periodontitis (gum disease), and others.

Doxycycline is also used to treat blemishes, bumps, and acne-like lesions caused by rosacea. Doxycycline will not treat facial redness caused by rosacea.

Doxycycline may also be used for other purposes not listed in this medication guide.

What are the possible side effects of doxycycline?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using doxycycline and call your doctor at once if you have any of these serious side effects:

  • severe headache, dizziness, blurred vision;
  • fever, chills, body aches, flu symptoms;
  • severe blistering, peeling, and red skin rash;
  • urinating less than usual or not at all;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • loss of appetite, jaundice (yellowing of the skin or eyes); or
  • easy bruising or bleeding, unusual weakness.

Less serious side effects may include:

  • swollen tongue, trouble swallowing;
  • mild nausea, vomiting, diarrhea, or stomach upset;
  • white patches or sores inside your mouth or on your lips;
  • sores or swelling in your rectal or genital area; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about doxycycline?

Do not use this medication if you are pregnant. It could cause harm to the unborn baby, including permanent discoloration of the teeth later in life. Doxycycline can make birth control pills less effective. Use a second method of birth control while you are taking doxycycline to keep from getting pregnant.

Doxycycline passes into breast milk and may affect bone and tooth development in a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication if you are allergic to doxycycline, or to similar medicines such as demeclocycline (Declomycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

Before taking doxycycline, tell your doctor if you have liver or kidney disease. You may not be able to take doxycycline, or you may need a dose adjustment or special tests during treatment.

Do not give doxycycline to a child younger than 8 years old. Doxycycline can cause permanent yellowing or graying of the teeth, and it can affect a child's growth.

Throw away any unused doxycycline when it expires or when it is no longer needed. Do not take any doxycycline after the expiration date printed on the bottle. Expired doxycycline can cause a dangerous syndrome resulting in damage to the kidneys.

Related Drug Centers
  • Monodox
  • Oracea
  • Vibramycin
  • Atridox
  • Periostat
  • Doryx
  • Adoxa


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