Doxycycline (oral): Difference between revisions

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* Efficacy of ORACEA beyond 16 weeks and safety beyond 9 months have not been established.
* 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.
* 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”
 
 
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport======Condition1=====


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<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|contraindications=* This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.
 
<!--Warnings-->
|warnings=* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->


<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.



Revision as of 16:01, 4 December 2014

Doxycycline (oral)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Doxycycline (oral) is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

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

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Doxycycline (oral) in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Doxycycline (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Doxycycline (oral) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Doxycycline (oral) in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Doxycycline (oral) in pediatric patients.

Contraindications

  • This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.

Warnings

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

There is limited information regarding Doxycycline (oral) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Doxycycline (oral) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Doxycycline (oral) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Doxycycline (oral) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Doxycycline (oral) with respect to geriatric patients.

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

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Doxycycline (oral) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Doxycycline (oral) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Doxycycline (oral) in the drug label.

Pharmacology

There is limited information regarding Doxycycline (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Doxycycline (oral)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Doxycycline (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Doxycycline (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Doxycycline (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Doxycycline (oral) in the drug label.

How Supplied

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

{{#ask: Label Page::Doxycycline (oral) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Doxycycline (oral) in the drug label.

Precautions with Alcohol

  • Alcohol-Doxycycline (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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