Doryx (Oral)

Doxycycline is used to treat bacterial infections in various parts of the body. It is also used to treat pimples and abscesses (usually on the face) caused by rosacea, which is also called acne rosacea or adult acne.

Doxycycline capsules, delayed-release capsules, delayed-release tablets, tablets, and Acticlate® Cap capsules are also used to prevent malaria and treat anthrax infection after possible exposure, as well as other conditions your doctor may decide.

Doxycycline is part of a group of medicines called tetracycline antibiotics. It works by killing bacteria or stopping their growth. However, this medicine will not work for colds, flu, or other viral infections.

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

If your symptoms do not improve within a few days, or if they get worse, contact your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy. If you think you might be pregnant while using this medicine, tell your doctor immediately.

This medicine may darken your skin, nails, eyes, teeth, gums, or scars. Talk to your doctor if you have any concerns.

Doxycycline may cause diarrhea, and sometimes it can be severe. Diarrhea may happen 2 months or more after you stop taking this medicine. Do not take any medicine for diarrhea without checking with your doctor first. Diarrhea medicines may worsen the diarrhea or prolong it. If you have any questions about this, or if mild diarrhea continues or worsens, consult your doctor.

Birth control pills (containing estrogen) may not work properly while you are taking doxycycline. To avoid pregnancy, use other forms of birth control, such as condoms, a diaphragm, or contraceptive foam or jelly.

Doxycycline may make your skin more sensitive to sunlight than usual. Sunlight exposure, even for short times, may lead to skin rash, itching, redness, or other discoloration of the skin, or a severe sunburn. When you start taking this medicine:

• Avoid direct sunlight, especially between 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Use a sunblock product with a sun protection factor (SPF) of at least 15. Some patients may need a product with a higher SPF, particularly if they have a fair complexion. If you have questions about this, check with your doctor.
• Use a sunblock lipstick with an SPF of at least 15 to protect your lips.
• Do not use a sun lamp or tanning bed or booth.

If you have a severe reaction to the sun, contact your doctor.

Serious skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with this medicine. Contact your doctor immediately if you have blistering, peeling, or loosening skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, fever or chills, cough, sore throat, swollen or painful lymph nodes in the neck, armpit, or groin, or yellowing of the skin or eyes while using this medicine.

This medicine may increase pressure inside the head (intracranial hypertension). This is more likely in women of childbearing age who are overweight or have a history of intracranial hypertension. Tell your doctor right away if you have a headache, blurred vision, or changes in vision.

Contact your doctor immediately if you experience fever, rash, joint pain, or tiredness. These could be signs 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, including vitamin or mineral supplements.

If you are using this medicine to prevent malaria, take extra precautions to avoid mosquito bites. Use protective clothing, mosquito netting or screens, and an insect repellent.

Before any medical tests, inform the medical staff that you are taking this medicine. Some test results may be affected by it.

Do not take other medicines without discussing them with your doctor. This includes prescription or over-the-counter (OTC) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to weigh the risks of taking the medicine against the benefits. Here are some important points to consider:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also let your healthcare provider know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Doxycycline may cause permanent discoloration of teeth and may slow down bone growth. This medicine should not be given to children 8 years of age and younger (except for treating inhalational anthrax exposure or rickettsia infection), unless directed by the child's doctor.

Geriatric

Studies so far have not shown specific problems in older adults that would limit the usefulness of doxycycline. However, older patients are more likely to have kidney, liver, or heart issues that may require caution and a dose adjustment for those taking doxycycline.

There is no information on how age affects the effects of doxycycline capsules in older patients.

Breast Feeding

There are no adequate studies on the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medicine while nursing.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose, or other precautions may be necessary. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions may be significant and are not necessarily a complete list.

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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Amoxicillin
• Ampicillin
• Ascorbic Acid
• Bacampicillin
• Bexarotene
• Cholera Vaccine, Live
• Cloxacillin
• Desogestrel
• Dicloxacillin
• Dienogest
• Drospirenone
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etretinate
• Gestodene
• Isotretinoin
• Levonorgestrel
• Magnesium Sulfate
• Mestranol
• Methicillin
• Methotrexate
• Methoxyflurane
• Nafcillin
• Nomegestrol
• Norethindrone
• Norgestimate
• Norgestrel
• Oxacillin
• Palovarotene
• Penicillin G
• Penicillin G Benzathine
• Penicillin G Procaine
• Penicillin V
• Piperacillin
• Pivampicillin
• Porfimer
• Quizartinib
• Sultamicillin
• Temocillin
• Tretinoin

Using this medicine with any of the following medicines may increase the 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
• Aminolevulinic Acid
• Bismuth Subsalicylate
• Calcium
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Iron
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Rifampin
• Rifapentine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around mealtime or with certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Asthma—Vibramycin® syrup has sodium metabisulfite, which can cause allergic and serious reactions in patients with this condition.

• Diarrhea or
• Intracranial hypertension (pseudotumor cerebri), or history of or
• Vaginal candidiasis (yeast) infections—Use with caution. This may worsen these conditions.

• Kidney disease—Use with caution. Effects may be stronger due to slower removal of the medicine from the body.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical attention.

Check with your doctor right away if any of the following side effects occur:

Less common

• Diarrhea
• itching of the vagina or genital area
• pain during sexual intercourse
• thick, white vaginal discharge with no odor or with a mild odor

Incidence not known

• Back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine or stools
• blurred vision
• change in the ability to see colors, especially blue or yellow
• chest pain or tightness
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• decreased appetite
• diarrhea
• diarrhea, watery and severe, which may also be bloody
• difficulty with swallowing
• discoloration of the thyroid glands
• 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, itching, or rash
• increased sensitivity of the skin to sunlight
• increased thirst
• indigestion
• inflammation of the joints
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• lower back or side pain
• nausea
• numbness or tingling of the face, hands, or feet
• pain in the stomach, side, or abdomen, possibly radiating to the back
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• redness and soreness of the eyes
• redness of the skin
• redness or other discoloration of the skin
• severe sunburn
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach cramps, pain, or tenderness
• swelling of the feet or lower legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tooth discoloration
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight loss
• vomiting
• yellow eyes or skin

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. 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:

Incidence not known

• Bulging soft spot on the head of an infant
• chest discomfort or burning
• cracks in the skin
• decrease in vision
• difficulty breathing
• double vision
• general body swelling
• heartburn
• loss of heat from the body
• nosebleeds
• pain or burning in the throat
• rash with flat lesions or small raised lesions on the skin
• red, swollen skin
• redness or other discoloration of the skin
• redness, swelling, or soreness of the tongue
• scaly skin
• severe nausea
• severe stomach pain
• 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.

In the U.S.

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

Available Dosage Forms:

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

Therapeutic Class: Antibiotic

Chemical Class: Tetracycline (class)

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you are using Doryx® delayed-release capsules:

• It may be taken with food or milk, if it upsets your stomach.
• You may open the capsule and sprinkle the contents on a spoonful of cold, soft applesauce. Do not lose any pellets when transferring the contents. The mixture should be swallowed right away without chewing and followed with a glass of cool water to ensure complete swallowing of the pellets. Do not store the mixture for later use.

Swallow the delayed-release tablets whole. Do not chew or crush it.

If you are using the delayed-release tablets or tablets:

• It may be taken with food or milk, if it upsets your stomach.
• You may take this medicine by breaking the tablets. Hold the tablet between your thumb and index fingers close to the appropriate score (separation) line. Then, apply enough pressure to snap the tablet segments apart. Do not use the tablet if it does not break on the scored lines.
• You may also take this medicine by sprinkling the broken tablets onto cold, soft food, including applesauce. Swallow the mixture right away without chewing and drink with a glass of water. Do not store the mixture for later use.

Swallow the capsule whole. Do not break, crush, chew, or open it. You may take the Acticlate® Cap capsules and Doxycycline capsules with food or milk to avoid stomach irritation.

Shake the oral liquid well just before each use. Measure the dose with a marked measuring spoon, oral syringe, or medicine cup.

Drink plenty of fluids to avoid throat irritation and ulceration.

If you are using this medicine to prevent malaria while traveling, start taking the medicine 1 or 2 days before you travel. Take the medicine every day during your trip and continue taking it for 4 weeks after you return. However, do not use the medicine for longer than 4 months.

If you are using Oracea™ delayed-release capsules:

• You should take this medicine on an empty stomach, preferably at least 1 hour before or 2 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.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

To switch from Doryx® delayed-release tablets to Doryx® MPC delayed-release tablets:

• Replace a 50 milligram (mg) dose of Doryx® delayed-release tablet with a 60 mg dose of Doryx® MPC delayed-release tablet.
• Replace a 100 mg dose of Doryx® delayed-release tablet with a 120 mg dose of Doryx® MPC delayed-release tablet.

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.

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 forms (capsules, suspension, syrup, tablets): For infections: Adults—100 milligrams (mg) every 12 hours on the first day, then 100 mg once a day or 50 to 100 mg every 12 hours. Children 8 years of age or older weighing 45 kilograms (kg) or more—100 mg every 12 hours on the first day, then 100 mg once a day or 50 to 100 mg every 12 hours. Children 8 years of age or older weighing less than 45 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 4.4 mg per kg of body weight per day and divided into 2 doses on the first day of treatment. This is followed by 2.2 mg per kg of body weight per day, taken as a single dose or divided into two doses on the following days. Children up to 8 years of age—Use and dose must be determined by your doctor. For the prevention of malaria: Adults—100 milligrams (mg) once a day. You should take the first dose 1 or 2 days before traveling to an area where malaria may occur, and continue taking the medicine every day throughout your travel and for 4 weeks after you leave the malarious area. Children 8 years of age or older weighing 45 kilograms (kg) or more—100 mg once a day. You should take the first dose 1 or 2 days before traveling to an area where malaria may occur, and continue taking the medicine every day throughout your travel and for 4 weeks after you leave the malarious area. Children 8 years of age or older weighing less than 45 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 2 mg per kg of body weight per day, taken as a single dose. You should take the first dose 1 or 2 days before traveling 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 up to 8 years of age—Use is not recommended. For anthrax after possible exposure: Adults and children weighing 45 kilograms (kg) or more—100 milligrams (mg) 2 times a day (every 12 hours) for 60 days. Children weighing less than 45 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 2.2 mg per kg of body weight per day, 2 times a day for 60 days.
• For oral dosage form (delayed-release capsules):For the treatment of pimples from rosacea: Adults—40 milligrams (mg) or one capsule once a day, in the morning. Children—Use and dose must be determined by your doctor.
• For oral dosage form (Doryx® delayed-release capsules, Doryx® delayed-release tablets): For anthrax after possible exposure: Delayed-release capsules: Adults and children weighing 45 kilograms (kg) or more—100 milligrams (mg) 2 times a day (every 12 hours) for 60 days. Children weighing less than 45 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 2 mg per kg of body weight per day, 2 times a day for 60 days. Delayed-release tablets: Adults and children weighing 45 kilograms (kg) or more—100 milligrams (mg) 2 times a day (taken every 12 hours) for 60 days. Children weighing less than 45 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 2.2 mg per kg of body weight per day, 2 times a day for 60 days. For infections: Adults and children weighing 45 kilograms (kg) or more—100 milligrams (mg) every 12 hours on the first day, then 100 mg once a day or 50 to 100 mg every 12 hours. Children weighing less than 45 kg with severe or life threatening infections (eg, anthrax, Rocky Mountain spotted fever)—Dose is based on body weight and must be determined by your doctor. The dose is usually 2.2 mg per kg of body weight taken every 12 hours. Children older than 8 years of age and weighing less than 45 kg with less severe infections—Dose is based on body weight and must be determined by your doctor. The dose is usually 4.4 mg per kg of body weight per day and divided into 2 doses on the first day of treatment. This is followed by 2.2 mg per kg of body weight per day, taken as a single dose or divided into two doses on the following days. Children up to 8 years of age—Use and dose must be determined by your doctor. For the prevention of malaria: Adults—100 milligrams (mg) once a day. You should take the first dose 1 or 2 days before traveling to an area where malaria may occur, and continue taking the medicine every day throughout your travel and for 4 weeks after you leave the malarious area. Children 8 years of age or older weighing 45 kilograms (kg) or more—100 mg once a day. You should take the first dose 1 or 2 days before traveling to an area where malaria may occur, and continue taking the medicine every day throughout your travel and for 4 weeks after you leave the malarious area. Children 8 years of age or older weighing less than 45 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 2 mg per kg of body weight per day, taken as a single dose. You should take the first dose 1 or 2 days before traveling 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 up to 8 years of age—Use is not recommended.
• For oral dosage form (Doryx® MPC delayed-release tablet): For infections: Adults and children older than 8 years of age and weighs 45 kilograms (kg) or more, with or without severe or life-threatening infections—120 milligrams (mg) every 12 hours on the first day, then 120 mg once a day or 60 to 120 mg every 12 hours. Children older than 8 years of age and weighs less than 45 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 5.3 mg per kg of body weight per day and divided into 2 doses on the first day of treatment. This is followed by 2.6 mg per kg of body weight per day, taken as a single dose or divided into two doses on the following days. Children weighing less than 45 kg with severe or life-threatening infections—Dose is based on body weight and must be determined by your doctor. The dose is usually 2.6 mg per kg of body weight per day given every 12 hours. Children 8 years of age and younger—Use is not recommended. For prevention of malaria: Adults and children weighing more than 45 kilograms (kg)—120 milligrams (mg) once a day. You should take the first dose 1 or 2 days before traveling to an area where malaria may occur, and continue taking the medicine every day throughout your travel and for 4 weeks after you leave the malarious area. Children 8 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 2.4 milligrams (mg) per kilogram (kg) of body weight per day, taken as a single dose. You should take the first dose 1 or 2 days before traveling to an area where malaria may occur, and continue taking the medicine every day throughout your travel and for 4 weeks after you leave the malarious area. Children up to 8 years of age—Use is not recommended. For anthrax after possible exposure: Adults and children weighing 45 kilograms (kg) or more—120 milligrams (mg) two times a day for 60 days. Children weighing less than 45 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 2.6 milligrams (mg) per kilogram (kg) of body weight per day, two times a day for 60 days.

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

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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