Doryx

• Take doxycycline exactly as prescribed.  Do not change the dose or stop taking doxycycline without talking to your doctor. 

Oral:

• This medication comes in tablet, capsule, and oral suspension (liquid) forms.
• Doxycycline is typically taken once or twice a day, with a glass of water and with or without food. 
• You should finish the entire course of treatment of the antibiotic to ensure your infection is treated appropriately. It is important not to skip doses of doxycycline.
• If doxycycline upsets your stomach, the drug should be taken with food or milk.
• The oral suspension should be shaken prior to taking the medication.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of doxycycline at the same time.
• Doxycycline also comes as a gel to be applied to the the tooth pocket. It is administered by a dentist in a clinic setting.

Injectable:

• This medication is also available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Oral:

• Take doxycycline exactly as prescribed.  Follow the directions on your prescription label carefully.
• Your doctor will determine the appropriate dosage and schedule of doxycycline depending on the type and severity of your infection, as well as your age.
• The range of doses for all forms of doxycycline is 100 to 200 mg a day, with a maximum daily dose of 600 mg.
• When taking doxycycline for the prevention of malaria, you should start taking the drug 1 to 2 days before traveling to an area with malaria. Continue taking doxycycline for 4 weeks after leaving the area with malaria, but not for longer than 4 months total.
• When being used in a dental setting for the treatment of periodontitis, the amount of doxycycline that is applied per administration is 50 mg. 

Injectable:

• The recommended dosing range for doxycycline injectable in adults is 100 to 300 mg per day.

Do not use this medicine if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life.

Doxycycline can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using doxycycline.

You should not take this medicine if you are allergic to doxycycline or to other tetracycline antibiotics 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 disease, kidney disease, asthma, or if you are allergic to sulfites.

Drink plenty of liquids while you are taking doxycycline.

Children should not use doxycycline. Doxycycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

You should not take this medicine if you are allergic to doxycycline or to other tetracycline antibiotics such as demeclocycline (Declomycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

To make sure you can safely take doxycycline, tell your doctor if you have any of these other conditions:

• liver disease;
• kidney disease; or
• asthma or sulfite allergy.

If you are using doxycycline to treat gonorrhea, your doctor may test you to make sure you do not also have syphilis, another sexually transmitted disease.

FDA pregnancy category D. Do not use doxycycline if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life. Tell your doctor right away if you become pregnant during treatment.

Doxycycline can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using doxycycline.

Doxycycline passes into breast milk and may affect bone and tooth development in a nursing baby. You should not breast-feed while you are taking doxycycline.

Children should not use doxycycline. Doxycycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

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

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 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 equally broken tablets onto cold, soft food, such as applesauce. This mixture must be swallowed immediately 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 capsule whole. Do not break, crush, chew, or open it.

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, Doryx® delayed-release tablets, 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 older than 8 years of age and weighs 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 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 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 is not recommended.
  • 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 older than 8 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 2 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 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 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) two 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 milligrams (mg) per kilogram (kg) of body weight per day, two 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® 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.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

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

Doxycycline may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Birth control pills (containing estrogen) may not work properly while you are using doxycycline. To keep from getting pregnant, use other forms of birth control. These include condoms, a diaphragm, or a contraceptive foam or jelly.

Doxycycline may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for short periods of time, may cause 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 sun 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 doctor.
• 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.

If you have a severe reaction from the sun, check with your doctor.

This medicine may cause intracranial hypertension. This is more likely to occur 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 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.

If you are using this medicine to prevent malaria, take extra care not to get bitten by mosquitoes. Use protective clothing, mosquito netting or screens, and an insect repellent.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 immediately if any of the following side effects occur:

• Bloating
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• decreased appetite
• diarrhea
• diarrhea, watery and severe, which may also be bloody
• difficulty with 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, itching, or rash
• 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
• nausea and vomiting
• numbness or tingling of the face, hands, or feet
• pain in the stomach, side, or abdomen, possibly radiating to the back
• redness and soreness of the eyes
• redness of the skin
• sore throat
• sores in the mouth
• stomach cramps
• stomach pain or tenderness
• swelling of the feet or lower legs
• swollen lymph glands
• tightness in the chest
• unusual tiredness or weakness
• unusual weight loss
• 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 the urine or stools
• blurred vision
• bulging soft spot on the head of an infant
• change in the ability to see colors, especially blue or yellow
• chest pain, discomfort, or burning
• cracks in the skin
• decrease in vision
• difficulty breathing
• discoloration of the thyroid glands
• double vision
• general body swelling
• heartburn
• increased sensitivity of the skin to sunlight
• loss of heat from the body
• lower back or side pain
• nosebleeds
• pain or burning in the throat
• pain with swallowing
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• 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
• severe sunburn
• sores, ulcers, or white spots on the 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.

• If you have an allergy to doxycycline or any other part of Doryx (doxycycline delayed-release tablets).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are taking any of these drugs: Acitretin, isotretinoin, or a penicillin.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Doryx with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Doryx or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Doryx (doxycycline delayed-release tablets). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic potential of doxycycline have not been conducted. However, there has been evidence of oncogenic activity in rats in studies with the related antibiotics, oxytetracycline (adrenal and pituitary tumors) and minocycline (thyroid tumors). Likewise, although mutagenicity studies of doxycycline have not been conducted, positive results in in vitro mammalian cell assays have been reported for related antibacterials (tetracycline, oxytetracycline).

Doxycycline administered orally at dosage levels as high as 250 mg/kg/day had no apparent effect on the fertility of female rats. Effect on male fertility has not been studied.

Animal Toxicology and/or Pharmacology

Hyperpigmentation of the thyroid has been produced by members of the tetracycline-class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO4, and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO4, and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline.

Minocycline, tetracycline PO4, methacycline, doxycycline, tetracycline base, oxytetracycline HCl, and tetracycline HCl, were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.

Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline); in chickens (chlortetracycline); and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.

Results of animal studies indicate that tetracyclines cross the placenta and are found in fetal tissues.

Doryx is a tetracycline antibiotic that fights bacteria in the body.

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

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

Some forms of Doryx are used to prevent malaria, to treat anthrax, or to treat infections caused by mites, ticks, or lice.

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

You should not take this medicine if you are allergic to any tetracycline antibiotic.

Children younger than 8 years old should use Doryx only in cases of severe or life-threatening conditions. This medicine can cause permanent yellowing or graying of the teeth in children

Using Doryx during pregnancy could harm the unborn baby or cause permanent tooth discoloration later in the baby's life.

You should not take this medicine if you are allergic to Doryx or other tetracycline antibiotics such as demeclocycline, minocycline, tetracycline, or tigecycline.

Tell your doctor if you have ever had:

• liver disease;

• kidney disease;

• asthma or sulfite allergy;

• increased pressure inside your skull; or

• if you also take isotretinoin, seizure medicine, or a blood thinner such as warfarin (Coumadin).

If you are using Doryx to treat gonorrhea, your doctor may test you to make sure you do not also have syphilis, another sexually transmitted disease.

Taking this medicine during pregnancy may affect tooth and bone development in the unborn baby. Taking Doryx during the last half of pregnancy can cause permanent tooth discoloration later in the baby's life. Tell your doctor if you are pregnant or if you become pregnant.

Doryx can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

Doxycycline can pass into breast milk and may affect bone and tooth development in a nursing infant. Do not breast-feed while you are taking doxycycline.

Doryx can cause permanent yellowing or graying of the teeth in children younger than 8 years old. Children should use this medicine only in cases of severe or life-threatening conditions such as anthrax or Rocky Mountain spotted fever. The benefit of treating a serious condition may outweigh any risks to the child's tooth development.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take Doryx with a full glass of water. Drink plenty of liquids while you are taking this medicine.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Most brands of doxycyline may be taken with food or milk if the medicine upsets your stomach.

Different brands of Doryx may have different instructions about taking them with or without food.

Take Oracea on an empty stomach, at least 1 hour before or 2 hours after a meal.

You may need to split a Doryx tablet to get the correct dose. Follow your doctor's instructions.

Swallow a delayed-release capsule or tablet whole. Do not crush, chew, break, or open it.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If you take Doryx to prevent malaria: Start taking the medicine 1 or 2 days before entering an area where malaria is common. Continue taking the medicine every day during your stay and for at least 4 weeks after you leave the area.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Doryx will not treat a viral infection such as the flu or a common cold.

Store at room temperature away from moisture, heat, and light.

Throw away any unused medicine after the expiration date on the label has passed. Using expired Doryx can cause damage to your kidneys.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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