Doxycycline

Doxycycline capsules are a tetracycline- class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients (

This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. Do not use doxycycline capsules for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms   associated with any bacterial disease. (

    Doxycycline capsules have not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea.(

Take one doxycycline capsule (40 mg)  once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals (

Exceeding the recommended dosage may result in an increased incidence of side effects including the development of resistant microorganisms (

40 mg beige opaque capsules imprinted with "LU" on cap and "D09" on body.

Lactation: Breastfeeding is not recommended (

•   The use of doxycycline capsules during tooth development (the second and third  trimesters of pregnancy, infancy and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and reversible inhibition of bone growth (
  5.1

  Inhibition of Bone Growth During Fetal and Pediatric Development

  Doxycycline, like other tetracycline-class drugs, may cause inhibition of bone growth when administered during the second and third trimesters of pregnancy, infancy, and childhood. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued. If doxycycline is used during the second or third trimester of pregnancy, advise the patient of the potential risk to the fetus [see Use in Specific Populations ].
  ,
  5.2 Tooth Discoloration During Fetal and Pediatric Development

  The use of tetracycline class drugs orally during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Use of tetracycline drugs is not recommended during tooth development

  [see Use in Specific Populations ]

  .
  ,
  8.1 Pregnancy

  Risk Summary

  Doxycycline may cause reversible inhibition of bone growth and permanent discoloration of deciduous teeth when administered during the second and third trimesters of pregnancy [

  see Warnings and Precautions

  ]. Available data from published studies have not shown a difference in major birth defect risk with doxycycline exposure in the first trimester of pregnancy compared to unexposed pregnancies. Avoid use of doxycycline capsules during the second and third trimester of pregnancy.

  The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

  Data

  Human Data

  Published studies, including epidemiological and observational studies, with use of doxycycline during the first trimester of pregnancy have not identified drug-related increases in major birth defects.

  The use of tetracycline during tooth development (second and third trimester of pregnancy) may cause permanent discoloration of deciduous teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses.

  Animal Data

  Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues.
  ,
  8.4 Pediatric Use

  Doxycycline capsules should not be used in infants and children less than 8 years of age [

  see Warnings and Precautions

  ]. Doxycycline capsules have not been studied in children of any age with regard to safety or efficacy, therefore use in children is not recommended.
  ).
•   Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of
  Clostridium difficile
  . If
  C.
  difficile
   associated diarrhea occurs, discontinue doxycycline capsules. (
  5.3

  Clostridium Difficile

  Associated Diarrhea (CDAD)

  Clostridium difficile

  associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including doxycycline, and may range in severity from mild diarrhea to fatal colitis.

  Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of

  C. difficile.

  C. Difficile

  produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of

  C. difficile

  cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

  If CDAD is suspected or confirmed, ongoing antibiotic use not directed against

  C. difficile

  may need to be discontinued. Appropriate management should be instituted as clinically indicated.
  )
•   If renal impairment exists, doxycycline capsules doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver injury. (
  5.4 Metabolic Effects

  The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class antibiotics may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable.
  )
•   Photosensitivity can occur with doxycycline capsules; Patients should minimize or avoid exposure to natural or artificial sunlight. (
  5.5 Photosensitivity

  Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Although this was not observed during the duration of the clinical studies with doxycycline capsules, patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using doxycycline capsules. If patients need to be outdoors while using doxycycline capsules, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician.
  )
•   Tetracyclines have been associated with the development of autoimmune syndromes; if symptoms develop, discontinue doxycycline capsules immediately . (
  5.6 Autoimmune Syndromes

  Tetracyclines have been associated with the development of autoimmune syndromes. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In symptomatic patients, liver function tests, ANA, CBC, and other appropriate tests should be performed to evaluate the patients. Use of all tetracycline- class drugs should be discontinued immediately.
  )
•   Doxycycline capsules may cause pseudotumor cerebri (benign intracranial hypertension). Discontinue doxycycline capsules if symptoms occur. (
  5.8 Pseudotumor Cerebri

  Pseudotumor cerebri (benign intracranial hypertension) in adults has been associated with the use of tetracyclines. The usual clinical manifestations are headache and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. While both of these conditions and related symptoms usually resolve after discontinuation of the tetracycline, the possibility for permanent sequelae exists. Patients should be questioned for visual disturbances prior to initiation of treatment with tetracyclines and should be routinely checked for papiledema while on treatment.
  )
•   Bacterial resistance to tetracyclines may develop in patients using doxycycline capsules. It should only be used as indicated. (
  5.9 Development of Drug Resistant Bacteria

  Bacterial resistance to tetracyclines may develop in patients using doxycycline capsules. Because of the potential for drug-resistant bacteria to develop during the use of doxycycline capsules, it should only be used as indicated.
  )