Doxycycline (Systemic)
Brand names: Oracea
Drug class:
Antineoplastic Agents , Antineoplastic Agents
Usage of Doxycycline (Systemic)
Rosacea
Treatment of inflammatory lesions (papules and pustules) associated with rosacea (acne rosacea).
Safety and efficacy not established for treatment of the erythematous, telangiectatic, or ocular components of rosacea.
The 40-mg capsules of doxycycline (Oracea) are not indicated for the treatment or prevention of bacterial infections or to reduce the number of or eliminate organisms associated with bacterial disease. (See Selection and Use of Anti-infectives under Cautions).
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How to use Doxycycline (Systemic)
Administration
Oral Administration
Administer orally in the morning, on an empty stomach, at least 1 hour before or 2 hours after a meal.
Give with adequate amounts of fluid to reduce risk of esophageal irritation and ulceration.
Dosage
Adults
Rosacea Oral40 mg once daily in the morning.
Prescribing Limits
Adults
OralEfficacy of the 40-mg capsules of doxycycline (Oracea) not established beyond 16 weeks and safety not established beyond 9 months of therapy.
Exceeding the dosage of doxycycline recommended for rosacea may increase the incidence of adverse effects (e.g., development of drug-resistant bacteria).
Special Populations
Hepatic Impairment
No specific dosage recommendations at this time.
Renal Impairment
Dosage adjustment not required.
Geriatric Patients
No specific dosage recommendations at this time.
Warnings
Contraindications
Warnings/Precautions
Warnings
Fetal/Neonatal MorbidityAnimal studies indicate possible fetal toxicity (e.g., retardation of skeletal development) and embryotoxicity.
Use not recommended in pregnant women. Avoid pregnancy during therapy. If pregnancy occurs, immediately discontinue and apprise of potential fetal hazard.
Use not recommended for individuals of either gender who are attempting to conceive a child.
Dental and Bone EffectsAvoid use during tooth development (the last half of pregnancy, infancy, childhood up to 8 years of age); potential for permanent tooth discoloration and enamel hypoplasia.
Tetracyclines form a stable calcium complex in any bone-forming tissue. Reversible decrease in fibula growth rate has occurred in premature infants receiving oral tetracyclines.
Superinfection/Clostridium difficile-associated ColitisTreatment with anti-infectives may permit overgrowth of clostridia. Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.
Some mild cases of C. difficile-associated diarrhea and colitis may respond to discontinuance alone. Manage moderate to severe cases with fluid, electrolyte, protein supplementation, and appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) as clinically indicated.
Renal EffectsTetracyclines have antianabolic effects and may increase BUN concentrations. This effect usually is not clinically important in patients with normal renal function; however, high serum tetracycline concentrations may result in azotemia, hyperphosphatemia, and acidosis in patients with impaired renal function. (See Renal Impairment under Cautions.)
Sensitivity Reactions
Photosensitivity ReactionsPossible photosensitivity reaction (e.g., exaggerated sunburn reaction).
Avoid unnecessary exposure to sunlight or artificial UV light (sunlamps, solariums).
General Precautions
Superinfection/CandidiasisDoxycycline may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue doxycycline and initiate appropriate therapy.
Tetracyclines may increase the incidence of vaginal candidiasis. Use with caution in patients with a history of or predisposition to candidiasis.
Selection and Use of Anti-infectivesTo reduce development of drug-resistant bacteria and maintain effectiveness of other antibacterials, use the 40-mg capsules of doxycycline (Oracea) only for the treatment of rosacea.
Doxycycline 40-mg capsules are not to be used for the treatment or prevention of bacterial infections or to reduce or eliminate organisms associated with bacterial disease. The dosage regimen used for the treatment of rosacea results in doxycycline plasma concentrations that are too low for the treatment of bacterial infections.
Autoimmune SyndromesTetracyclines have been associated with autoimmune syndromes (e.g., lupus-like syndrome, autoimmune hepatitis, vasculitis, serum sickness).
If symptoms suggestive of an autoimmune syndrome develop (e.g., fever, rash, arthralgia, malaise), immediately discontinue use of tetracyclines and perform appropriate tests (liver function tests, ANA, CBC) to evaluate the patient.
Tissue HyperpigmentationTetracyclines are known to cause hyperpigmentation in many organs (e.g., nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity, sclerae, and heart valves).
Nervous System EffectsTetracyclines have been reported to cause bulging fontanels in infants and benign intracranial hypertension (pseudotumor cerebri) in adults. These effects usually resolve when the drug is discontinued.
Laboratory MonitoringPeriodically assess organ system function (including hematopoietic, renal, and hepatic function). Perform appropriate tests for autoimmune syndromes if indicated.
Specific Populations
PregnancyCategory D. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
LactationDistributed into milk. Discontinue nursing or the drug.
Pediatric UseSafety and efficacy not established; use not recommended.
Possible permanent tooth discoloration in children <8 years of age. (See Dental and Bone Effects under Cautions.) Do not use in infants or children <8 years of age.
Renal ImpairmentSerum half-life of doxycycline is not altered in patients with severe renal impairment; renal impairment does not appear to result in excessive accumulation of doxycycline. (See Renal Effects under Cautions.)
Excessive drug accumulation and possible liver toxicity may occur if usual dosages of some tetracyclines are used in patients with renal impairment. Dosage adjustment of tetracyclines may be necessary in patients with renal impairment; serum tetracycline concentrations should be monitored in patients receiving long-term therapy.
Common Adverse Effects
Nasopharyngitis, hypertension, sinusitis, increased AST, upper respiratory tract infection, headache, diarrhea.
What other drugs will affect Doxycycline (Systemic)
Specific Drugs and Laboratory Tests
Drug
Interaction
Comments
Antacids (aluminum-, calcium- or magnesium- containing)
Decreased absorption of doxycycline
Give antacids containing aluminum, calcium, or magnesium 1–2 hours before or after doxycycline
Anticoagulants, oral
Decreased plasma prothrombin activity
Monitor PT carefully; adjust anticoagulant dosage as needed
Anticonvulsants (Carbamazepine, barbiturates, phenytoin)
Possible decreased doxycycline half-life
Bismuth subsalicylate
Decreased absorption of doxycycline
If concomitant use cannot be avoided, give doxycycline at least 2-3 hours before bismuth subsalicylate
Hormonal contraceptives
Decreased effectiveness of oral contraceptive
Use of a second form of contraceptive during treatment with doxycycline is advised
Iron-containing preparations
Decreased absorption of doxycycline
Give doxycycline 2 hours before or 3 hours after iron-containing preparations
Methoxyflurane (no longer commercially available in the US)
Fatal renal toxicity
Penicillins
Decreased efficacy of penicillins
Avoid concomitant use
Proton-pump inhibitors
Decreased absorption of doxycycline
Retinoids, oral (e.g., acitretin, isotretinoin)
Additive adverse CNS effect of pseudotumor cerebri (benign intracranial hypertension)
Avoid concomitant use
Urinary catecholamine assay
Possible false elevation secondary to interference with fluorescence test
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