Doxycycline (oral)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
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Overview
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Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indication
- ORACEA is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea.
Limitations of Use
- This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. ORACEA should not be used for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease.
- To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ORACEA should be used only as indicated.
- Efficacy of ORACEA beyond 16 weeks and safety beyond 9 months have not been established.
- ORACEA has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea.
Dosage
General Dosing Information
- One ORACEA Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals.
- Administration of adequate amounts of fluid along with the capsules is recommended to wash down the capsule to reduce the risk of esophageal irritation and ulceration.
Important Considerations for Dosing Regimen
- The dosage of ORACEA differs from that of doxycycline used to treat infections. Exceeding the recommended dosage may result in an increased incidence of side effects including the development of resistant organisms.
Dosage Forms And Strengths
- 40 mg beige opaque capsule imprinted with “GLD 40”
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Doxycycline in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Doxycycline in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Doxycycline (oral) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Doxycycline in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Doxycycline in pediatric patients.
Contraindications
There is limited information regarding Doxycycline (oral) Contraindications in the drug label.
Warnings
There is limited information regarding Doxycycline (oral) Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Doxycycline (oral) Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Doxycycline (oral) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Doxycycline (oral) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Doxycycline (oral) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Doxycycline (oral) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Doxycycline (oral) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Doxycycline (oral) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Doxycycline (oral) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Doxycycline (oral) in geriatric settings.
Gender
There is no FDA guidance on the use of Doxycycline (oral) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Doxycycline (oral) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Doxycycline (oral) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Doxycycline (oral) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Doxycycline (oral) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Doxycycline (oral) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Doxycycline (oral) Administration in the drug label.
Monitoring
There is limited information regarding Doxycycline (oral) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Doxycycline (oral) and IV administrations.
Overdosage
There is limited information regarding Doxycycline (oral) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Doxycycline (oral) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Doxycycline (oral) Mechanism of Action in the drug label.
Structure
There is limited information regarding Doxycycline (oral) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Doxycycline (oral) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Doxycycline (oral) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Doxycycline (oral) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Doxycycline (oral) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Doxycycline (oral) How Supplied in the drug label.
Storage
There is limited information regarding Doxycycline (oral) Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Doxycycline (oral) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Doxycycline interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Doxycycline (oral) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Doxycycline (oral) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.