Doxylamine succinate

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]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Nighttime sleep-aid

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 Doxylamine succinate in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Doxylamine succinate 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 Doxylamine succinate in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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):

• Pregnancy Category

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

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

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

Structure

File:Doxylamine succinate01.png

This image is provided by the National Library of Medicine.

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

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Package and Label Display Panel

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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

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

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

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