Doxycycline Hyclate
Generic: DOXYCYCLINE HYCLATE
Basic Information
Manufacturer
NuCare Pharmaceuticals,Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
860a1566-5857-ed88-e053-2991aa0ae2a4
Indications & Usage
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Warnings
WARNINGS The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy and childhood 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 drugs, but it has been observed following repeated short-term courses.
Enamel hypoplasia has also been reported.
Use doxycycline in pediatric patients 8 years of age or less only when the potential benefits are expected to outweigh the risks in severe or life-threatening conditions (e.g., anthrax, Rocky Mountain spotted fever), particularly when there are no alternative therapies.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including doxycycline hyclate tablets, 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 the use of antibacterial drugs.
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 use of antibacterial drugs not directed against C.
difficile may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C.
difficile , and surgical evaluation should be instituted as clinically indicated.
Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in patients receiving doxycycline.
(See ADVERSE REACTIONS .) If severe skin reactions occur, doxycycline should be discontinued immediately, and appropriate therapy should be instituted.
Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including doxycycline.
Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy.
Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH.
Concomitant use of isotretinoin and doxycycline should be avoided because isotretinoin is also known to cause pseudotumor cerebri.
Although IH typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists.
If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted.
0Since intracranial pressure can remain elevated for weeks after drug cessation patients should be monitored until they stabilize.
All tetracyclines form a stable calcium complex in any bone-forming tissue.
A decrease in fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every 6 hours.
This reaction was shown to be reversible when the drug was discontinued.
Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development).
Evidence of embryotoxicity has also been noted in animals treated early in pregnancy.
If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
The antianabolic action of the tetracyclines may cause an increase in BUN.
Studies to date indicate that this does not occur with the use of doxycycline in patients with impaired renal function.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines.
Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.
This adverse reaction is more common during long-term use of the drugs, but it has been observed following repeated short-term courses.
Enamel hypoplasia has also been reported.
Use doxycycline in pediatric patients 8 years of age or less only when the potential benefits are expected to outweigh the risks in severe or life-threatening conditions (e.g., anthrax, Rocky Mountain spotted fever), particularly when there are no alternative therapies.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including doxycycline hyclate tablets, 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 the use of antibacterial drugs.
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 use of antibacterial drugs not directed against C.
difficile may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C.
difficile , and surgical evaluation should be instituted as clinically indicated.
Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in patients receiving doxycycline.
(See ADVERSE REACTIONS .) If severe skin reactions occur, doxycycline should be discontinued immediately, and appropriate therapy should be instituted.
Intracranial hypertension (IH, pseudotumor cerebri) has been associated with the use of tetracyclines including doxycycline.
Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy.
Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH.
Concomitant use of isotretinoin and doxycycline should be avoided because isotretinoin is also known to cause pseudotumor cerebri.
Although IH typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists.
If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted.
0Since intracranial pressure can remain elevated for weeks after drug cessation patients should be monitored until they stabilize.
All tetracyclines form a stable calcium complex in any bone-forming tissue.
A decrease in fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every 6 hours.
This reaction was shown to be reversible when the drug was discontinued.
Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development).
Evidence of embryotoxicity has also been noted in animals treated early in pregnancy.
If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
The antianabolic action of the tetracyclines may cause an increase in BUN.
Studies to date indicate that this does not occur with the use of doxycycline in patients with impaired renal function.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines.
Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.
Adverse Reactions
ADVERSE REACTIONS Due to oral doxycycline’s virtually complete absorption, side effects of the lower bowel, particularly diarrhea, have been infrequent.
The following adverse reactions have been observed in patients receiving tetracyclines: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, inflammatory lesions (with monilial overgrowth) in the anogenital region, and pancreatitis.
Hepatotoxicity has been reported rarely.
These reactions have been caused by both the oral and parenteral administration of tetracyclines.
Superficial discoloration of the adult permanent dentition, reversible upon drug discontinuation and professional dental cleaning has been reported.
Permanent tooth discoloration and enamel hypoplasia may occur with drugs of the tetracycline class when used during tooth development.
(See WARNINGS .) Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of the drugs in the tetracycline class.
Most of these patients took medications immediately before going to bed.
(See DOSAGE AND ADMINISTRATION .) Skin: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, maculopapular and erythematous rashes.
Exfoliative dermatitis has been reported but is uncommon.
Photosensitivity is discussed above.
(See WARNINGS .) Renal toxicity: Rise in BUN has been reported and is apparently dose related.
(See WARNINGS .) Immune: Hypersensitivity reactions including urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, exacerbation of systemic lupus erythematosus, and drug reaction with eosinophilia and systemic symptoms (DRESS).
Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.
Other: Bulging fontanels in infants and intracranial hypertension in adults.
(See WARNINGS.
) When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland.
No abnormalities of thyroid function studies are known to occur.
To report SUSPECTED ADVERSE REACTIONS, contact Epic Pharma at 1-888-374-2791, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
The following adverse reactions have been observed in patients receiving tetracyclines: Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, inflammatory lesions (with monilial overgrowth) in the anogenital region, and pancreatitis.
Hepatotoxicity has been reported rarely.
These reactions have been caused by both the oral and parenteral administration of tetracyclines.
Superficial discoloration of the adult permanent dentition, reversible upon drug discontinuation and professional dental cleaning has been reported.
Permanent tooth discoloration and enamel hypoplasia may occur with drugs of the tetracycline class when used during tooth development.
(See WARNINGS .) Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving capsule and tablet forms of the drugs in the tetracycline class.
Most of these patients took medications immediately before going to bed.
(See DOSAGE AND ADMINISTRATION .) Skin: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, maculopapular and erythematous rashes.
Exfoliative dermatitis has been reported but is uncommon.
Photosensitivity is discussed above.
(See WARNINGS .) Renal toxicity: Rise in BUN has been reported and is apparently dose related.
(See WARNINGS .) Immune: Hypersensitivity reactions including urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, exacerbation of systemic lupus erythematosus, and drug reaction with eosinophilia and systemic symptoms (DRESS).
Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.
Other: Bulging fontanels in infants and intracranial hypertension in adults.
(See WARNINGS.
) When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland.
No abnormalities of thyroid function studies are known to occur.
To report SUSPECTED ADVERSE REACTIONS, contact Epic Pharma at 1-888-374-2791, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .