Adox Pak 2 / 100

Name: Adox Pak 2 / 100

What are some things I need to know or do while I take Adox Pak 2/100?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Have your blood work checked if you are on Adox Pak 2/100 for a long time. Talk with your doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
  • Do not use longer than you have been told. A second infection may happen.
  • Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
  • Do not switch between different forms of Adox Pak 2/100 without first talking with the doctor.
  • If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this medicine.
  • You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking Adox Pak 2/100.
  • This medicine may cause a change in tooth color to yellow-gray-brown in children younger than 8 years old. If this change of tooth color happens, it will not go away. Talk with the doctor.
  • Most of the time, this medicine is not for use in children younger than 8 years old. However, there may be times when these children may need to take Adox Pak 2/100. Talk with the doctor.
  • Change in tooth color has also happened in adults. This has gone back to normal after this medicine was stopped and teeth cleaning at a dentist's office. Talk with the doctor.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Adox Pak 2/100, call your doctor right away.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Chest pain.
  • Not able to pass urine or change in how much urine is passed.
  • Fever or chills.
  • Sore throat.
  • Throat irritation.
  • Trouble swallowing.
  • Any unexplained bruising or bleeding.
  • Joint pain.
  • Feeling very tired or weak.
  • Vaginal itching or discharge.
  • It is common to have diarrhea when taking Adox Pak 2/100. Rarely, a very bad form of diarrhea called Clostridium difficile (C diff)–associated diarrhea (CDAD) may occur. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while you are taking this medicine or within a few months after you stop taking it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor.
  • Raised pressure in the brain has happened with Adox Pak 2/100. Most of the time, this will go back to normal after this medicine is stopped. Sometimes, loss of eyesight may happen and may not go away even after Adox Pak 2/100 is stopped. Call your doctor right away if you have a headache or eyesight problems like blurred eyesight, seeing double, or loss of eyesight.

How do I store and/or throw out Adox Pak 2/100?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Do not take this medicine if it is outdated.
  • Do not take Adox Pak 2/100 if it has not been stored as you have been told.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Important information

You should not take doxycycline 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.

Before taking this medicine

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 this medicine.

Children should not use this medicine. 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.

How should I take doxycycline?

Take doxycycline exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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

Most brands of doxycyline may be taken with food or milk if the medicine upsets your stomach. Different brands of doxycycline 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 open a Doryx capsule or break up a Doryx tablet and sprinkle the medicine into a spoonful of applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Drink a full glass (8 ounces) of cool water right away.

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

You may need to split the Acticlate tablet to get the correct dose. The tablet is scored so you can break it apart easily.

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 doxycycline 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 protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

Use this medicine 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. Doxycycline will not treat a viral infection such as the flu or a common cold.

If you need surgery, tell the surgeon ahead of time that you are using doxycycline.

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 doxycycline can cause damage to your kidneys.

What happens if I miss a dose?

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.

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

Usual Adult Dose for Actinomycosis

IV:
-Initial dose: 200 mg IV on the first day, given in 1 or 2 infusions
-Maintenance dose: 100 to 200 mg/day IV

ORAL:
Most Products:
-Initial dose: 200 mg orally on the first day, given in 2 divided doses (100 mg every 12 hours)
-Maintenance dose: 100 mg orally once a day OR 50 mg orally every 12 hours
---More severe infections (especially chronic urinary tract infections): 100 mg orally every 12 hours

Doryx(R) MPC:
-Initial dose: 240 mg orally on the first day, given in 2 divided doses (120 mg every 12 hours)
-Maintenance dose: 120 mg orally once a day or 60 mg orally every 12 hours
---More severe infections (especially chronic urinary tract infections): 120 mg orally every 12 hours

Comments:
-The IV maintenance dose depends on the severity of the infection; the 200 mg dose may be given in 1 or 2 infusions.
-If using a monohydrate formulation, the initial oral dose may be given in 2 or 4 divided doses (100 mg every 12 hours or 50 mg every 6 hours).
-With trachoma, infectious agent is not always eliminated (as assessed by immunofluorescence).
-When used in streptococcal infections, duration of therapy should be 10 days.

Uses:
-For the treatment of the following infections: Psittacosis (ornithosis) due to Chlamydophila psittaci; chancroid due to Haemophilus ducreyi; relapsing fever due to Borrelia recurrentis; Campylobacter fetus infections; bartonellosis due to Bartonella bacilliformis; trachoma or inclusion conjunctivitis due to Chlamydia trachomatis; respiratory tract infections due to Mycoplasma pneumoniae
-For the treatment of infections due to the following bacteria when bacteriological testing shows suitable susceptibility to this drug: Escherichia coli; Enterobacter aerogenes; Shigella species; Acinetobacter species; respiratory tract infections due to H influenzae or Klebsiella species; upper respiratory infections due to Streptococcus pneumoniae; urinary tract infections due to Klebsiella species
-When penicillin is contraindicated, as an alternative agent for the treatment of the following infections: Yaws due to Treponema pallidum subspecies pertenue; listeriosis due to Listeria monocytogenes; Vincent's infection due to Fusobacterium fusiforme; actinomycosis due to Actinomyces israelii; infections due to Clostridium species
-As adjunctive therapy for: Acute intestinal amebiasis; severe acne

Usual Adult Dose for Amebiasis

IV:
-Initial dose: 200 mg IV on the first day, given in 1 or 2 infusions
-Maintenance dose: 100 to 200 mg/day IV

ORAL:
Most Products:
-Initial dose: 200 mg orally on the first day, given in 2 divided doses (100 mg every 12 hours)
-Maintenance dose: 100 mg orally once a day OR 50 mg orally every 12 hours
---More severe infections (especially chronic urinary tract infections): 100 mg orally every 12 hours

Doryx(R) MPC:
-Initial dose: 240 mg orally on the first day, given in 2 divided doses (120 mg every 12 hours)
-Maintenance dose: 120 mg orally once a day or 60 mg orally every 12 hours
---More severe infections (especially chronic urinary tract infections): 120 mg orally every 12 hours

Comments:
-The IV maintenance dose depends on the severity of the infection; the 200 mg dose may be given in 1 or 2 infusions.
-If using a monohydrate formulation, the initial oral dose may be given in 2 or 4 divided doses (100 mg every 12 hours or 50 mg every 6 hours).
-With trachoma, infectious agent is not always eliminated (as assessed by immunofluorescence).
-When used in streptococcal infections, duration of therapy should be 10 days.

Uses:
-For the treatment of the following infections: Psittacosis (ornithosis) due to Chlamydophila psittaci; chancroid due to Haemophilus ducreyi; relapsing fever due to Borrelia recurrentis; Campylobacter fetus infections; bartonellosis due to Bartonella bacilliformis; trachoma or inclusion conjunctivitis due to Chlamydia trachomatis; respiratory tract infections due to Mycoplasma pneumoniae
-For the treatment of infections due to the following bacteria when bacteriological testing shows suitable susceptibility to this drug: Escherichia coli; Enterobacter aerogenes; Shigella species; Acinetobacter species; respiratory tract infections due to H influenzae or Klebsiella species; upper respiratory infections due to Streptococcus pneumoniae; urinary tract infections due to Klebsiella species
-When penicillin is contraindicated, as an alternative agent for the treatment of the following infections: Yaws due to Treponema pallidum subspecies pertenue; listeriosis due to Listeria monocytogenes; Vincent's infection due to Fusobacterium fusiforme; actinomycosis due to Actinomyces israelii; infections due to Clostridium species
-As adjunctive therapy for: Acute intestinal amebiasis; severe acne

Usual Adult Dose for Inclusion Conjunctivitis

IV:
-Initial dose: 200 mg IV on the first day, given in 1 or 2 infusions
-Maintenance dose: 100 to 200 mg/day IV

ORAL:
Most Products:
-Initial dose: 200 mg orally on the first day, given in 2 divided doses (100 mg every 12 hours)
-Maintenance dose: 100 mg orally once a day OR 50 mg orally every 12 hours
---More severe infections (especially chronic urinary tract infections): 100 mg orally every 12 hours

Doryx(R) MPC:
-Initial dose: 240 mg orally on the first day, given in 2 divided doses (120 mg every 12 hours)
-Maintenance dose: 120 mg orally once a day or 60 mg orally every 12 hours
---More severe infections (especially chronic urinary tract infections): 120 mg orally every 12 hours

Comments:
-The IV maintenance dose depends on the severity of the infection; the 200 mg dose may be given in 1 or 2 infusions.
-If using a monohydrate formulation, the initial oral dose may be given in 2 or 4 divided doses (100 mg every 12 hours or 50 mg every 6 hours).
-With trachoma, infectious agent is not always eliminated (as assessed by immunofluorescence).
-When used in streptococcal infections, duration of therapy should be 10 days.

Uses:
-For the treatment of the following infections: Psittacosis (ornithosis) due to Chlamydophila psittaci; chancroid due to Haemophilus ducreyi; relapsing fever due to Borrelia recurrentis; Campylobacter fetus infections; bartonellosis due to Bartonella bacilliformis; trachoma or inclusion conjunctivitis due to Chlamydia trachomatis; respiratory tract infections due to Mycoplasma pneumoniae
-For the treatment of infections due to the following bacteria when bacteriological testing shows suitable susceptibility to this drug: Escherichia coli; Enterobacter aerogenes; Shigella species; Acinetobacter species; respiratory tract infections due to H influenzae or Klebsiella species; upper respiratory infections due to Streptococcus pneumoniae; urinary tract infections due to Klebsiella species
-When penicillin is contraindicated, as an alternative agent for the treatment of the following infections: Yaws due to Treponema pallidum subspecies pertenue; listeriosis due to Listeria monocytogenes; Vincent's infection due to Fusobacterium fusiforme; actinomycosis due to Actinomyces israelii; infections due to Clostridium species
-As adjunctive therapy for: Acute intestinal amebiasis; severe acne

Usual Adult Dose for Bacterial Infection

IV:
-Initial dose: 200 mg IV on the first day, given in 1 or 2 infusions
-Maintenance dose: 100 to 200 mg/day IV

ORAL:
Most Products:
-Initial dose: 200 mg orally on the first day, given in 2 divided doses (100 mg every 12 hours)
-Maintenance dose: 100 mg orally once a day OR 50 mg orally every 12 hours
---More severe infections (especially chronic urinary tract infections): 100 mg orally every 12 hours

Doryx(R) MPC:
-Initial dose: 240 mg orally on the first day, given in 2 divided doses (120 mg every 12 hours)
-Maintenance dose: 120 mg orally once a day or 60 mg orally every 12 hours
---More severe infections (especially chronic urinary tract infections): 120 mg orally every 12 hours

Comments:
-The IV maintenance dose depends on the severity of the infection; the 200 mg dose may be given in 1 or 2 infusions.
-If using a monohydrate formulation, the initial oral dose may be given in 2 or 4 divided doses (100 mg every 12 hours or 50 mg every 6 hours).
-With trachoma, infectious agent is not always eliminated (as assessed by immunofluorescence).
-When used in streptococcal infections, duration of therapy should be 10 days.

Uses:
-For the treatment of the following infections: Psittacosis (ornithosis) due to Chlamydophila psittaci; chancroid due to Haemophilus ducreyi; relapsing fever due to Borrelia recurrentis; Campylobacter fetus infections; bartonellosis due to Bartonella bacilliformis; trachoma or inclusion conjunctivitis due to Chlamydia trachomatis; respiratory tract infections due to Mycoplasma pneumoniae
-For the treatment of infections due to the following bacteria when bacteriological testing shows suitable susceptibility to this drug: Escherichia coli; Enterobacter aerogenes; Shigella species; Acinetobacter species; respiratory tract infections due to H influenzae or Klebsiella species; upper respiratory infections due to Streptococcus pneumoniae; urinary tract infections due to Klebsiella species
-When penicillin is contraindicated, as an alternative agent for the treatment of the following infections: Yaws due to Treponema pallidum subspecies pertenue; listeriosis due to Listeria monocytogenes; Vincent's infection due to Fusobacterium fusiforme; actinomycosis due to Actinomyces israelii; infections due to Clostridium species
-As adjunctive therapy for: Acute intestinal amebiasis; severe acne

Usual Adult Dose for Nongonococcal Urethritis

Most products: 100 mg orally twice a day
-Alternatively, Doryx(R) MPC: 120 mg orally twice a day
Duration of therapy: 7 days

Comments:
-According to the US CDC, this (100 mg orally twice a day) is a recommended regimen for chlamydial urethritis; current guidelines should be consulted for additional information.
-The patient's sexual partner(s) should also be evaluated/treated.

Use: For the treatment of nongonococcal urethritis due to C trachomatis or Ureaplasma urealyticum

Usual Adult Dose for Rickettsial Infection

IV:
-Initial dose: 200 mg IV on the first day, given in 1 or 2 infusions
-Maintenance dose: 100 to 200 mg/day IV

ORAL:
Most Products:
-Initial dose: 200 mg orally on the first day, given in 2 divided doses (100 mg every 12 hours)
-Maintenance dose: 100 mg orally once a day OR 50 mg orally every 12 hours
---More severe infections: 100 mg orally every 12 hours

Doryx(R) MPC:
-Initial dose: 240 mg orally on the first day, given in 2 divided doses (120 mg every 12 hours)
-Maintenance dose: 120 mg orally once a day or 60 mg orally every 12 hours
---More severe infections: 120 mg orally every 12 hours

Comments:
-The IV maintenance dose depends on the severity of the infection; the 200 mg dose may be given in 1 or 2 infusions.
-If using a monohydrate formulation, the initial oral dose may be given in 2 or 4 divided doses (100 mg every 12 hours or 50 mg every 6 hours).

Uses: For the treatment of rickettsial infections including Rocky Mountain spotted fever (RMSF), typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers due to Rickettsia species

US CDC Recommendations: 100 mg orally or IV twice a day

Duration of Therapy:
-RMSF, ehrlichiosis: At least 3 days after fever subsides and until evidence of clinical improvement
-Anaplasmosis: 10 days

Comments:
-Recommended as drug of choice for all tickborne rickettsial diseases
-Tickborne rickettsial diseases include RMSF due to Rickettsia rickettsii, other spotted fever group rickettsioses due to R parkeri and Rickettsia species 364D, Ehrlichia chaffeensis ehrlichiosis (i.e., human monocytic ehrlichiosis), other ehrlichioses due to E ewingii and E muris-like agent, and anaplasmosis due to Anaplasma phagocytophilum (i.e., human granulocytic anaplasmosis).
-The usual minimum duration of therapy for RMSF and ehrlichiosis is 5 to 7 days (total); severe/complicated disease may require longer therapy.
-According to some experts, typical duration of therapy for ehrlichiosis is 7 to 14 days.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Lyme Disease - Erythema Chronicum Migrans

IDSA Recommendations: 100 mg orally twice a day

Duration of Therapy:
-Acrodermatitis chronica atrophicans: 21 days
-Cardiac disease: 14 to 21 days
-Erythema migrans: 10 to 21 days
-Lyme arthritis: 28 days

Comments:
-Recommended for the treatment of early localized or early disseminated Lyme disease associated with erythema migrans when specific neurologic manifestations or advanced atrioventricular heart block absent, uncomplicated Lyme arthritis in patients without clinical evidence of neurologic disease, patients with atrioventricular heart block and/or myopericarditis associated with early Lyme disease, and acrodermatitis chronica atrophicans
-A parenteral antibiotic (e.g., ceftriaxone) is recommended as initial treatment of patients hospitalized for cardiac monitoring; an oral regimen may be used for completion of therapy and for ambulatory patients.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Proctitis

US CDC Recommendations: 100 mg orally twice a day for 7 days

Comments:
-With ceftriaxone, the recommended regimen for sexually-acquired acute proctitis
-The patient's sexual partner(s) should also be evaluated/treated.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Pneumonia

IV:
Less than 45 kg:
All patients with severe or life-threatening infections: 2.2 mg/kg IV every 12 hours

Patients older than 8 years with less severe infections:
-Initial dose: 4.4 mg/kg IV on the first day, given in 2 infusions
-Maintenance dose: 2.2 mg/kg IV once a day or 1.1 mg/kg IV twice a day

At least 45 kg:
-Initial dose: 200 mg IV on the first day, given in 1 or 2 infusions
-Maintenance dose: 100 to 200 mg/day IV

ORAL:
Most Products:
Less than 45 kg:
All patients with severe or life-threatening infections: 2.2 mg/kg orally every 12 hours

Patients older than 8 years with less severe infections:
-Initial dose: 4.4 mg/kg orally on the first day, given in 2 divided doses
-Maintenance dose: 2.2 mg/kg orally once a day or 1.1 mg/kg orally twice a day

At least 45 kg:
-Initial dose: 200 mg orally on the first day, given in 2 divided doses (100 mg every 12 hours)
-Maintenance dose: 100 mg orally once a day OR 50 mg orally every 12 hours
---More severe infections: 100 mg orally every 12 hours

Doryx(R) MPC:
Less than 45 kg:
All patients with severe or life-threatening infections: 2.6 mg/kg orally every 12 hours

Patients older than 8 years with less severe infections:
-Initial dose: 5.3 mg/kg orally on the first day, given in 2 divided doses
-Maintenance dose: 2.6 mg/kg orally once a day or 1.3 mg/kg orally twice a day

At least 45 kg:
-Initial dose: 240 mg orally on the first day, given in 2 divided doses (120 mg every 12 hours)
-Maintenance dose: 120 mg orally once a day or 60 mg orally every 12 hours
---More severe infections: 120 mg orally every 12 hours

Comments:
-The IV maintenance dose for patients weighing at least 45 kg depends on the severity of the infection; the 200 mg dose may be given in 1 or 2 infusions.
-For patients at least 45 kg using a monohydrate formulation, the initial oral dose may be given in 2 or 4 divided doses (100 mg every 12 hours or 50 mg every 6 hours).
-When used in streptococcal infections, duration of therapy should be 10 days.

Uses:
-For the treatment of respiratory tract infections due to M pneumoniae
-For the treatment of respiratory tract infections due to H influenzae or Klebsiella species and upper respiratory infections due to S pneumoniae when bacteriological testing shows suitable susceptibility to this drug

Pediatric Infectious Diseases Society (PIDS) and IDSA Recommendations:
-Older than 7 years: 1 to 2 mg/kg orally twice a day

Comments:
-Recommended as an alternative for step-down therapy or mild infection due to M pneumoniae, C trachomatis, or C pneumoniae
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Bronchitis

IV:
Less than 45 kg:
All patients with severe or life-threatening infections: 2.2 mg/kg IV every 12 hours

Patients older than 8 years with less severe infections:
-Initial dose: 4.4 mg/kg IV on the first day, given in 2 infusions
-Maintenance dose: 2.2 mg/kg IV once a day or 1.1 mg/kg IV twice a day

At least 45 kg:
-Initial dose: 200 mg IV on the first day, given in 1 or 2 infusions
-Maintenance dose: 100 to 200 mg/day IV

ORAL:
Most Products:
Less than 45 kg:
All patients with severe or life-threatening infections: 2.2 mg/kg orally every 12 hours

Patients older than 8 years with less severe infections:
-Initial dose: 4.4 mg/kg orally on the first day, given in 2 divided doses
-Maintenance dose: 2.2 mg/kg orally once a day or 1.1 mg/kg orally twice a day

At least 45 kg:
-Initial dose: 200 mg orally on the first day, given in 2 divided doses (100 mg every 12 hours)
-Maintenance dose: 100 mg orally once a day OR 50 mg orally every 12 hours
---More severe infections: 100 mg orally every 12 hours

Doryx(R) MPC:
Less than 45 kg:
All patients with severe or life-threatening infections: 2.6 mg/kg orally every 12 hours

Patients older than 8 years with less severe infections:
-Initial dose: 5.3 mg/kg orally on the first day, given in 2 divided doses
-Maintenance dose: 2.6 mg/kg orally once a day or 1.3 mg/kg orally twice a day

At least 45 kg:
-Initial dose: 240 mg orally on the first day, given in 2 divided doses (120 mg every 12 hours)
-Maintenance dose: 120 mg orally once a day or 60 mg orally every 12 hours
---More severe infections: 120 mg orally every 12 hours

Comments:
-The IV maintenance dose for patients weighing at least 45 kg depends on the severity of the infection; the 200 mg dose may be given in 1 or 2 infusions.
-For patients at least 45 kg using a monohydrate formulation, the initial oral dose may be given in 2 or 4 divided doses (100 mg every 12 hours or 50 mg every 6 hours).
-When used in streptococcal infections, duration of therapy should be 10 days.

Uses:
-For the treatment of respiratory tract infections due to M pneumoniae
-For the treatment of respiratory tract infections due to H influenzae or Klebsiella species and upper respiratory infections due to S pneumoniae when bacteriological testing shows suitable susceptibility to this drug

Pediatric Infectious Diseases Society (PIDS) and IDSA Recommendations:
-Older than 7 years: 1 to 2 mg/kg orally twice a day

Comments:
-Recommended as an alternative for step-down therapy or mild infection due to M pneumoniae, C trachomatis, or C pneumoniae
-Current guidelines should be consulted for additional information.

Other Comments

Administration advice:
-Avoid rapid IV administration; infusion duration may vary with dose, but is generally 1 to 4 hours; infuse 100 mg dose (of a 0.5 mg/mL solution) over at least 1 hour.
-Do not inject IV solutions IM or subcutaneously; use caution to avoid extravasation.
-Only use IV therapy short-term when oral therapy is not indicated; switch to oral therapy as soon as clinically feasible.
-Continue therapy for at least 24 to 48 hours after symptoms/fever subside.
-Administer oral formulations with plenty of fluid in an upright position to reduce the risk of esophageal irritation and ulceration.
-For most oral products, administer with food or milk if gastric irritation occurs; absorption not significantly affected by food or milk.
-May carefully break up a delayed-release tablet and sprinkle the contents (delayed-release pellets) on a spoonful of applesauce (to be swallowed at once without chewing); do not crush or damage delayed-release pellets when breaking up the tablet.
-Do not chew or crush Doryx(R) MPC tablets; this product is not substitutable on a mg per mg basis with other oral products.
-According to some manufacturers: Swallow capsules whole; do not break, open, crush, dissolve, or chew.
-Administer the 40 mg capsule formulation and the 20 mg capsule/tablet formulation on an empty stomach, 1 hour before or 2 hours after a meal.

Storage requirements:
-IV: The manufacturer product information should be consulted regarding storage and stability of reconstituted and/or further diluted solutions; protect solution from direct sunlight and/or artificial light.
-Oral formulations: Store below 30C (86F); protect from light.

Reconstitution/preparation techniques:
-The manufacturer product information should be consulted.
-IV: Reconstitution and further dilution needed, resulting in concentrations of 0.1 to 1 mg/mL; concentrations below 0.1 mg/mL or above 1 mg/mL are not recommended.

IV compatibility:
-Compatible: Sterile Water for Injection; Sodium Chloride Injection, USP; 5% Dextrose Injection, USP; Ringers Injection, USP; Invert Sugar, 10% in Water; Lactated Ringers Injection, USP; Dextrose 5% in Lactated Ringers; Normosol-M(R) in D5-W (5% dextrose in water) (Abbott); Normosol-R(R) in D5-W (Abbott); Plasma-Lyte(R) 56 in 5%Dextrose (Travenol); Plasma-Lyte(R) 148 in 5% Dextrose (Travenol)

General:
-The usual dose and dosing frequency of this drug are different from other tetracyclines; side effects may occur more often if recommended dose exceeded.
-Therapeutic antibacterial serum activity generally persists 24 hours after recommended dose.
-Thrombophlebitis may occur if IV therapy prolonged.
-Incision and drainage or other surgical procedures may be indicated in addition to antibiotic therapy.
-Absorption of tetracyclines impaired by iron-, zinc-, calcium-, aluminum-, or magnesium-containing products (e.g., antacids, sucralfate, mineral supplements, buffered didanosine).
-If the oral suspension is not available, emergency doses may be prepared from the tablets. The US FDA website should be consulted for information regarding preparation of this drug for patients who cannot swallow tablets (only recommended during a declared emergency).
-The 40 mg capsule formulation has not been evaluated for treatment or prevention of infections; it should not be used for treatment of bacterial infection, antibacterial prophylaxis, or reduction/elimination of microorganisms associated with any bacterial infection.

Monitoring:
-General: Organ system studies (periodically during long-term therapy)
-Hematologic: Hematopoietic studies (periodically during long-term therapy)
-Hepatic: Hepatic studies (periodically during long-term therapy)
-Renal: Renal studies (periodically during long-term therapy)

Patient advice:
-Read the US FDA-approved patient labeling (Patient Information), if applicable.
-Drink plenty of fluids.
-Avoid missing doses and complete the entire course of therapy.
-Avoid or minimize exposure to natural or artificial sunlight; use sun protection (e.g., protective clothing, sunscreen) if sun exposure cannot be avoided. Stop therapy if phototoxicity occurs.
-Consult physician at once if watery and bloody stools (with or without stomach cramps and fever) develop.
-Do not use this drug if it is outdated or decomposed; discard this drug by the expiration date.

Tips

  • Take doxycycline as directed. Some branded and generic versions of doxycycline need to be taken one hour prior to or two hours after meals. Ensure you know when to take your branded or generic version of doxycycline. Although tetracyclines, in general, are best taken on an empty stomach, the absorption of doxycycline is not markedly influenced by food or milk.
  • Ensure you maintain hydration while taking doxycycline. This may help reduce the incidence of gastrointestinal side effects.
  • Take exactly as directed and for the duration intended. Do not use to treat any other infection unless instructed to by your doctor. Doxycycline will not treat a cold.
  • Only use when prescribed by a doctor to treat infections caused by susceptible bacteria as improper use increases the chance of resistant bacteria developing.
  • Avoid excessive sun exposure or artificial ultraviolet light while receiving doxycycline; seek medical advice if skin redness or skin eruptions develop. Wear sun protective clothing and consider SPF50+ sun protection when outside if exposure to sunlight is unavoidable.
  • Talk to your doctor immediately if you develop watery or bloody stools, which may be associated with stomach cramps or fever, within a few months of discontinuing doxycycline.

Response and Effectiveness

  • Doxycycline is almost completely absorbed after oral administration. Peak concentrations are reached within two to three hours after dosing; however, it may take up to 48 hours before infection-related symptoms start to abate.
  • Doxycycline is concentrated by the liver in bile and excreted in an active form via the urine and feces.

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