Doxylamine succinate: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{KS}}
|authorTag={{KS}}
|aOrAn=a
|OTC=Yes
|adverseReactions=<!--Black Box Warning-->
|genericName=doxylamine succinate
|aOrAn=an
|drugClass=antihistamine
|indicationType=treatment
|indication=[[allergic rhinitis]], common cold, [[insomnia]]
|adverseReactions=[[somnolence]]
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult===Indications==
* Nighttime sleep-aid


* Dosing Information
==Dosage==
*Take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Doxylamine Succinate in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Doxylamine Succinate  in adult patients.
|fdaLIADPed===Indications==


:* Dosage
* Nighttime sleep-aid


=====Condition2=====
==Dosing==


* Dosing Information
* Children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor


:* Dosage
* Children under 12 years of age: do not use
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Doxylamine Succinate in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Doxylamine Succinate in pediatric patients.
|warnings='''Do not give'''


=====Condition3=====
* To children under 12 years of age


* Dosing Information
'''Ask a doctor before use if you have'''


:* Dosage
* A breathing problem such as asthma, emphysema or chronic bronchitis
* Glaucoma
* Trouble urinating due to an enlarged prostate gland


=====Condition4=====
'''Ask a doctor or pharmacist before use if you are'''


* Dosing Information
* Taking any other drugs


:* Dosage
'''When using this product'''


<!--Off-Label Use and Dosage (Adult)-->
* Avoid alcoholic beverages
* Take only at bedtime


<!--Guideline-Supported Use (Adult)-->
'''Stop use and ask a doctor if'''
|offLabelAdultGuideSupport======Condition1=====


* Developed by:
* Sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.


* Class of Recommendation:
'''If pregnant or breast-feeding''',


* Strength of Evidence:
* Ask a health professional before use'''


* Dosing Information
'''Keep out of reach of children'''


:* Dosage
* In case of overdose, get medical help or contact a Poison Control Center right away.
 
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of Doxylamine Succinate in the drug label.
=====Condition2=====
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of Doxylamine Succinate in the drug label.
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
|contraindications=* Condition1
 
<!--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.
 
=====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-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} 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-->
|drugInteractions=* Drug
:* Description
 
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Doxylamine Succinate  in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInLaborDelivery=There is no FDA guidance on use of Doxylamine Succinate during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInNursing=There is no FDA guidance on the use of Doxylamine Succinate with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInPed=There is no FDA guidance on the use of Doxylamine Succinate with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGeri=There is no FDA guidance on the use of Doxylamine Succinate with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInGender=There is no FDA guidance on the use of Doxylamine Succinate with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRace=There is no FDA guidance on the use of Doxylamine Succinate with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInRenalImpair=There is no FDA guidance on the use of Doxylamine Succinate in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInHepaticImpair=There is no FDA guidance on the use of Doxylamine Succinate  in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInReproPotential=There is no FDA guidance on the use of Doxylamine Succinate in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
|useInImmunocomp=There is no FDA guidance one the use of Doxylamine Succinate in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
|administration=* Oral
|administration=* Oral
 
|monitoring=There is limited information regarding <i>Monitoring</i> of Doxylamine Succinate in the drug label.
* Intravenous
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of Doxylamine Succinate in the drug label.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|overdose=There is limited information regarding <i>Chronic Overdose</i> of Doxylamine Succinate in the drug label.
 
|drugBox=[[File:doxylamine structure.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
* Description
|PD=There is limited information regarding <i>Pharmacodynamics</i> of Doxylamine Succinate in the drug label.
 
|PK=There is limited information regarding <i>Pharmacokinetics</i> of Doxylamine Succinate in the drug label.
<!--IV Compatibility-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of Doxylamine Succinate  in the drug label.
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of Doxylamine Succinate in the drug label.
 
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of Doxylamine Succinate in the drug label.
<!--Overdosage-->
|alcohol=* Alcohol-Doxylamine Succinate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|overdose====Acute Overdose===
|brandNames=*7 SELECT SLEEP AID
 
* Unisom
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*
 
<!--Structure-->
|structure=*
 
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
 
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
 
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
 
<!--How Supplied-->
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
 
<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title =  | url =  }}</ref>
 
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
 
<!--Drug Shortage Status-->
|drugShortage=
|drugShortage=
}}
}}
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}}
}}
{{LabelImage
{{LabelImage
|fileName={{PAGENAME}}11.png
|fileName=Sleep aid ingredients.png
}}
}}
{{LabelImage
{{LabelImage
|fileName={{PAGENAME}}11.png
|fileName=Sleep Aid tablets.jpg
}}
}}
<!--Pill Image-->
<!--Pill Image-->
Line 349: Line 115:
<!--Category-->
<!--Category-->


[[Category:H1 receptor antagonists]]
[[Category:Antiemetics]]
[[Category:Drug]]
[[Category:Drug]]

Latest revision as of 18:42, 9 March 2015

Doxylamine succinate
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

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.
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Doxylamine succinate is an antihistamine that is FDA approved for the treatment of allergic rhinitis, common cold, insomnia. Common adverse reactions include somnolence.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • Nighttime sleep-aid

Dosage

  • Take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Doxylamine Succinate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Doxylamine Succinate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

  • Nighttime sleep-aid

Dosing

  • Children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
  • Children under 12 years of age: do not use

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Doxylamine Succinate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Doxylamine Succinate in pediatric patients.

Contraindications

There is limited information regarding Doxylamine succinate Contraindications in the drug label.

Warnings

Do not give

  • To children under 12 years of age

Ask a doctor before use if you have

  • A breathing problem such as asthma, emphysema or chronic bronchitis
  • Glaucoma
  • Trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

  • Taking any other drugs

When using this product

  • Avoid alcoholic beverages
  • Take only at bedtime

Stop use and ask a doctor if

  • Sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,

  • Ask a health professional before use

Keep out of reach of children

  • In case of overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Doxylamine Succinate in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Doxylamine Succinate in the drug label.

Drug Interactions

There is limited information regarding Doxylamine succinate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Doxylamine succinate in women who are pregnant.
Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Doxylamine Succinate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Doxylamine Succinate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Doxylamine Succinate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Doxylamine Succinate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Doxylamine Succinate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Doxylamine Succinate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Doxylamine Succinate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Doxylamine Succinate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Doxylamine Succinate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Doxylamine Succinate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Doxylamine Succinate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral

Monitoring

There is limited information regarding Monitoring of Doxylamine Succinate in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Doxylamine Succinate in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Doxylamine Succinate in the drug label.

Pharmacology

This image is provided by the National Library of Medicine.

Mechanism of Action

There is limited information regarding Doxylamine succinate Mechanism of Action in the drug label.

Structure

There is limited information regarding Doxylamine succinate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Doxylamine Succinate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Doxylamine Succinate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Doxylamine Succinate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Doxylamine Succinate in the drug label.

How Supplied

There is limited information regarding Doxylamine succinate How Supplied in the drug label.

Storage

There is limited information regarding Doxylamine succinate Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Doxylamine succinate |?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::Doxylamine succinate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Doxylamine Succinate in the drug label.

Precautions with Alcohol

  • Alcohol-Doxylamine Succinate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • 7 SELECT SLEEP AID
  • Unisom

Look-Alike Drug Names

There is limited information regarding Doxylamine succinate 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.

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