Adoxa TT

Name: Adoxa TT

Uses For Adoxa TT

Doxycycline is used to treat bacterial infections in many different parts of the body. It is also used to treat pimples and abscesses (usually on the face) that are caused by rosacea, also known as acne rosacea or adult acne.

Doxycycline delayed-release tablets and tablets are also used to prevent malaria and treat anthrax infection after possible exposure and other conditions as determined by your doctor.

Doxycycline belongs to the class of medicines known as tetracycline antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

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

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 Adoxa TT. 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.

For the Consumer

Applies to doxycycline: oral capsule, oral capsule delayed release, oral capsule extended release, oral powder for suspension, oral syrup, oral tablet, oral tablet delayed release

Along with its needed effects, doxycycline (the active ingredient contained in Adoxa TT) 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 while taking doxycycline:

Incidence not known
  • 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 of doxycycline 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:

Incidence not known
  • 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

For Healthcare Professionals

Applies to doxycycline: injectable powder for injection, oral capsule, oral delayed release capsule, oral delayed release tablet, oral kit, oral powder for reconstitution, oral syrup, oral tablet, oral and topical kit

Nervous system

Very common (10% or more): Headache (up to 26%)
Common (1% to 10%): Sinus headache
Rare (0.01% to 0.1%): Bulging fontanels (in infants), benign intracranial hypertension (pseudotumor cerebri [symptoms include blurred vision, scotomata, diplopia]), tinnitus
Frequency not reported: Hypoesthesia, increased intracranial pressure, paresthesia, somnolence, stupor, taste loss, drowsiness, amnesia, paresthesias of body areas exposed to sunlight, phrenic nerve paralysis after sclerotherapy
Postmarketing reports: Pseudotumor cerebri, headache, dizziness[Ref]

Benign intracranial hypertension resulting in permanent loss of vision has been reported.

A 70-year-old female patient with no significant medical history suddenly developed a severe headache followed by vomiting about 15 minutes after the initial dose of this drug. The patient also experienced memory dysfunction; she could not remember the events of the afternoon prior to the dose of this drug and could not retain the information after she was reminded. The incident lasted about 30 minutes and she was transported to the hospital for further evaluation. No further cause, such as intoxication or trauma, could be elicited. Once at the hospital, the patient was able to remember the events of the afternoon and could retain new information, but amnesia regarding the events of the 30 minutes following the onset of the headache persisted. The patient's laboratory results, computerized tomography scan, MRI scan, cerebrospinal fluid, and electroencephalogram showed no pathology. When the patient was discharged 2 days later, the amnesia for the 30 minutes continued. After elimination of other symptomatic causes, the amnesia was concluded to be due to this drug because of the close relation of the dose and the onset of symptoms.[Ref]

Other

Very common (10% or more): Common cold (up to 22%), influenza symptoms (up to 11%)
Common (1% to 10%): Injury/accidental injury, pain, infection, fungal infection, influenza
Rare (0.01% to 0.1%): Candida infection/candidiasis, flushing, retrosternal pain
Frequency not reported: Malaise, overgrowth of nonsusceptible organisms (superinfection)
Postmarketing reports: Asthenia[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 13.4%)
Common (1% to 10%): Nausea/vomiting, toothache, tooth disorder, dyspepsia, diarrhea, periodontal abscess, acid indigestion, upper abdominal pain, abdominal distention, abdominal pain, stomach discomfort, dry mouth
Uncommon (0.1% to 1%): Gum pain, heartburn/gastritis
Rare (less than 0.1%): Glossitis, dysphagia, enterocolitis, inflammatory lesions (with candidal/monilial overgrowth) in the anogenital region, esophagitis, esophageal ulcerations, pancreatitis, pseudomembranous colitis, Clostridium difficile colitis, stomatitis
Frequency not reported: Clostridium difficile-associated diarrhea, esophageal irritation, ulceration, epigastric burning, black hairy tongue, tooth discoloration/adult tooth staining, vomiting, enamel hypoplasia, staphylococcal enterocolitis
Postmarketing reports: Bloody diarrhea, colitis, constipation, superficial tooth discoloration[Ref]

Numerous cases of esophageal ulceration have been reported. In most cases, the patients had taken their medication at bedtime, usually without enough liquid. Patients often presented with severe retrosternal pain and difficulty swallowing. Ulcerations generally resolved within a week after discontinuing the drug. In 1 case report, severe hiccups of 4-day duration associated with esophagitis followed the first dose of this drug.

Esophagitis and esophageal ulcerations have been reported in patients taking the capsule or tablet formulations of tetracycline-class antibiotics. Most of these patients took the drug immediately before going to bed.[Ref]

Musculoskeletal

Common (1% to 10%): Joint pain/arthralgia, back pain/back ache
Uncommon (0.1% to 1%): Muscle pain/myalgia[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, sore throat, sinus congestion, coughing, sinusitis, bronchitis, nasal congestion, pharyngolaryngeal pain
Frequency not reported: Bronchospasm

Dermatologic

Common (1% to 10%): Rash (including maculopapular rash, erythematous rash), photosensitivity reaction/dermatitis
Rare (0.01% to 0.1%): Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, photoonycholysis, drug reaction with eosinophilia and systemic symptoms (DRESS)
Frequency not reported: Nail discoloration, phototoxicity, photoallergic reaction, morbilliform rash, onycholysis, pustular rash
Postmarketing reports: Pruritus, urticaria

Tetracyclines:
-Frequency not reported: Hyperpigmentation[Ref]

In a double-blinded study, this drug was found to be more phototoxic than minocycline and demeclocycline. Paresthesias of the body areas exposed to sunlight may be early signs of sunburn reactions.

A case report of a possible photoallergic reaction described scaly erythema and vesicles on the face and neck associated with administration of this drug. Upon rechallenge, a flare with erythema, itching, and burning occurred in the same area.

Another case report was documented in Australian troops treated with 100 mg daily for malaria prophylaxis while on deployment in East Timor, a group of islands within the Malaysian archipelago located close to the equator. Of the 135 troops, 22 exhibited phototoxic reactions to low doses of this drug that resembled severe sunburn with erythematous plaques on the sun-exposed areas. The troops used a sunscreen containing oxybenzone.

An 11-year-old boy treated with this drug for brucellosis was evaluated for painless brown nail discoloration. This drug was initiated for brucellosis but stopped when the boy developed photosensitivity, but 15 days after the initiation of therapy brown nail discoloration developed. Other than the brown discoloration, the boy's physical condition was normal and the discoloration disappeared within 1 month.[Ref]

Genitourinary

Common (1% to 10%): Menstrual cramps, bacterial vaginitis, vulvovaginal mycotic infection
Uncommon (0.1% to 1%): Vaginal infection
Frequency not reported: Vaginal itch, vaginitis
Postmarketing reports: Vaginal candidiasis/moniliasis, anogenital moniliasis[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, increased blood pressure
Frequency not reported: Phlebitis (with IV administration)

Hepatic

Common (1% to 10%): Increased AST
Rare (0.01% to 0.1%): Abnormal hepatic function, hepatic failure, hepatitis, hepatotoxicity, jaundice
Frequency not reported: Acute hepatocellular injury, cholestatic reactions, cholestatic hepatitis, fatty liver degeneration, transient increases in liver function tests[Ref]

Metabolic

Hypoglycemia in a nondiabetic patient has been reported.[Ref]

Common (1% to 10%): Increased blood LDH, increased blood glucose
Rare (0.01% to 0.1%): Decreased appetite, porphyria
Frequency not reported: Hypoglycemia, anorexia[Ref]

Psychiatric

Common (1% to 10%): Anxiety
Frequency not reported: Confusion, depression, hallucination

Hypersensitivity

Common (1% to 10%): Anaphylactic reaction (including angioedema, exacerbation of systemic lupus erythematosus, pericarditis, hypersensitivity, serum sickness, Henoch-Schonlein purpura, hypotension, dyspnea, tachycardia, peripheral edema, urticaria)
Frequency not reported: Hypersensitivity reactions (including urticaria, angioneurotic edema, anaphylactic shock, anaphylaxis, anaphylactoid reactions, anaphylactoid purpura, serum sickness, hypotension, pericarditis, exacerbation of systemic lupus erythematosus, dyspnea, peripheral edema, tachycardia)
Postmarketing reports: Mild allergic reactions[Ref]

Hematologic

Rare (0.01% to 0.1%): Hemolytic anemia, thrombocytopenia, neutropenia, eosinophilia
Frequency not reported: Increased prothrombin time, leukopenia, thrombocytopenic purpura[Ref]

Renal

Rare (0.01% to 0.1%): Increased BUN/blood urea (dose-related)
Frequency not reported: Acute renal failure[Ref]

Endocrine

The long-term use of tetracyclines has been associated with microscopic brown-black discoloration of the thyroid gland; abnormal thyroid function has not been reported.[Ref]

Rare (0.01% to 0.1%): Microscopic brown-black discoloration of the thyroid gland[Ref]

Ocular

Frequency not reported: Diplopia, papilledema, loss of vision (associated with drug-induced benign intracranial hypertension), conjunctivitis, periorbital edema[Ref]

Immunologic

Tetracyclines:
-Frequency not reported: Autoimmune syndromes

Some side effects of Adoxa TT may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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