Doxylamine succinate: Difference between revisions

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

VisualWikitext

Revision as of 16:57, 7 January 2015

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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Overview

Doxylamine succinate is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. Common adverse reactions include .

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

Condition1

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.

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 Doxylamine succinate 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): 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

Intravenous

Monitoring

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

Description

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

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

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

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

Look-Alike Drug Names

A® — B®^[1]

Drug Shortage Status

Price

References

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

↑ "http://www.ismp.org". External link in |title= (help)

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[1]

@@ Line 17: / Line 17: @@
 *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==
@@ Line 32: / Line 28: @@
 * 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.
 |contraindications=* Condition1
@@ Line 196: / Line 188: @@
 <!--Use in Specific Populations-->
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 |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.
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-|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
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-|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
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-|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
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-|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
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-|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
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-|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
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-|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
@@ Line 223: / Line 214: @@
 <!--Overdosage-->
-|overdose====Acute Overdose===
+|overdose=
+There is limited information regarding <i>Chronic Overdose</i> of Doxylamine Succinate in the drug label.
-====Signs and Symptoms====
-* Description
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-<!--Pharmacodynamics-->
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-<!--Pharmacokinetics-->
-|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
-<!--Nonclinical Toxicology-->
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@@ Line 269: / Line 243: @@
 <!--Brand Names-->
-|brandNames=* ®<ref>{{Cite web | title =  | url =  }}</ref>
+|brandNames=7 SELECT SLEEP AID
-<!--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>