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).

Relate drugs

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 Oral

40 mg once daily in the morning.

Prescribing Limits

Adults

Oral

Efficacy 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

  • Known hypersensitivity to doxycycline or other tetracyclines.

    • Warnings/Precautions

    Warnings

    Fetal/Neonatal Morbidity

    Animal 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 Effects

    Avoid 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 Colitis

    Treatment 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 Effects

    Tetracyclines 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 Reactions

    Possible photosensitivity reaction (e.g., exaggerated sunburn reaction).

    Avoid unnecessary exposure to sunlight or artificial UV light (sunlamps, solariums).

    General Precautions

    Superinfection/Candidiasis

    Doxycycline 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-infectives

    To 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 Syndromes

    Tetracyclines 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 Hyperpigmentation

    Tetracyclines 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 Effects

    Tetracyclines 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 Monitoring

    Periodically assess organ system function (including hematopoietic, renal, and hepatic function). Perform appropriate tests for autoimmune syndromes if indicated.

    Specific Populations

    Pregnancy

    Category D. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

    Lactation

    Distributed into milk. Discontinue nursing or the drug.

    Pediatric Use

    Safety 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 Impairment

    Serum 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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