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Product Summary

PRESCRIPTION REQUIRED

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

DOXYCYCLINE - ORAL

(dox-ee-SYE-kleen)

COMMON BRAND NAME(S): Monodox, Vibra-Tabs, Vibramycin

USES: This medication is used to treat a wide variety of bacterial infections, including those that cause acne. This medication is also used to prevent malaria. This medication is known as a tetracycline antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This drug may also be used to treat a certain skin condition (rosacea).

HOW TO USE: This medication is best taken by mouth on an empty stomach, at least 1 hour before or 2 hours after a meal, usually 1 or 2 times daily or as directed by your doctor. Take this medication with a full glass of water (8 ounces/240 milliliters) unless directed otherwise. If stomach upset occurs, taking it with food or milk may help. However, doxycycline may not work as well if you take it with food or milk (or anything high in calcium - more details below ), so ask your doctor or pharmacist if you may take it that way. Do not lie down for 10 minutes after taking this medication. Take this medication 2 to 3 hours before or after taking any products containing aluminum, calcium, iron, magnesium, zinc, or bismuth subsalicylate. Some examples include antacids, certain forms of didanosine (chewable/dispersible buffered tablets or pediatric oral solution), quinapril, vitamins/minerals, dairy products (such as milk, yogurt), and calcium-enriched juice. These products bind with doxycycline, preventing your body from fully absorbing the drug. When using to prevent malaria, this medication is usually taken once daily. Take the first dose of this medication 1 to 2 days before travel or as directed by your doctor. Continue to take this medication daily while in the malarious area. Upon returning home, you should keep taking this medication for 4 more weeks. If you are unable to finish this course of doxycycline, contact your doctor. If you are using the liquid form of this medication, shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. The dosage is based on your medical condition and response to treatment. For children, the dosage may also be based on weight. Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection. Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Stomach upset, diarrhea, nausea, or vomiting may occur. If any of these effects persist or worsen, tell 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), painful/difficult swallowing. Tell your doctor immediately if any of these rare but very serious side effects occur: vision changes (such as blurred vision), unusual/severe headache, change in the amount of urine. 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. 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, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. 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 other tetracyclines (such as minocycline); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites, soy found in some brands), 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: trouble swallowing, esophagus problems (such as hiatal hernia or reflux/heartburn). Before having surgery, tell your doctor or dentist that you are taking this medication. 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. This drug should not be used in children under 8 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. It may harm an unborn baby. Consult your doctor for more details and to discuss using reliable forms of birth control while taking this medication. This drug passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use section. The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval. Some products that may interact with this drug include: acitretin, alitretinoin, barbiturates (such as phenobarbital), "blood thinners" (such as warfarin), digoxin, isotretinoin, penicillins, anti-seizure medications (such as carbamazepine, phenytoin), strontium, tretinoin taken by mouth, live bacterial vaccines. Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic. This medication may interfere with certain laboratory tests (including urine catecholamine levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call their local poison control center.

NOTES: Do not share this medication with others. If this medication is being used to prevent malaria, it is important to understand that it is still possible to get the disease even if you have used this medication. Avoid being bitten by mosquitoes when trying to prevent malaria. Avoid contact with mosquitoes, especially from dusk to dawn, by staying in well-screened areas, wearing protective clothing, and using insect repellent and bed nets. This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case. Laboratory and/or medical tests (such as complete blood count, liver/kidney function) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.