Doxycycline (oral): Difference between revisions
Kiran Singh (talk | contribs) No edit summary |
Kiran Singh (talk | contribs) No edit summary |
||
Line 26: | Line 26: | ||
* 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===== | ||
Line 98: | Line 112: | ||
<!--Contraindications--> | <!--Contraindications--> | ||
|contraindications=* | |contraindications=* This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines. | ||
|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
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Black Box Warning
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
|
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:
|
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
- 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
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
{{#ask: Page Name::Doxycycline (oral) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
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
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ Empty citation (help)
- ↑ "http://www.ismp.org". External link in
|title=
(help)
{{#subobject:
|Page Name=Doxycycline (oral) |Pill Name=No image.jpg |Drug Name= |Pill Ingred=|+sep=; |Pill Imprint= |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}} |Pill Color=|+sep=; |Pill Shape= |Pill Size (mm)= |Pill Scoring= |Pill Image= |Drug Author= |NDC=
}}
{{#subobject:
|Label Page=Doxycycline (oral) |Label Name=Doxycycline (oral)11.png
}}
{{#subobject:
|Label Page=Doxycycline (oral) |Label Name=Doxycycline (oral)11.png
}}