Oraxyl

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods.

Food, especially food and beverages high in calcium, can slightly decrease the absorption of tetracycline antibiotics, including doxycycline.  However, the absorption of doxycycline is not strongly influenced by food interactions.

Tell your doctor if you are breastfeeding or plan to breastfeed.  The active ingredient in doxycycline is excreted in human breast milk. The effect of doxycycline on the nursing infant is not known, although it may affect bone and tooth development.

• 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.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Keep taking Oraxyl (doxycycline tablets and capsules) as you have been told by your doctor or other health care provider, even if you feel well.
• Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take this medicine.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• Do not take bismuth (Pepto-Bismol®), calcium, iron, magnesium, zinc, multivitamins with minerals, colestipol, cholestyramine, didanosine, or antacids within 2 hours of Oraxyl.
• Take with a full glass of water.
• Do not lie down for at least 30 minutes after taking this medicine.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

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

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

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

Using doxycycline 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 doxycycline or other tetracycline antibiotics such as demeclocycline, minocycline, tetracycline, or tigecycline.

To make sure doxycycline is safe for you, 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 doxycycline 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 doxycycline 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 while using this medicine.

Doxycycline 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.

Doxycycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old. Children should use doxycycline 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.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Other drugs may interact with doxycycline, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.