Orphenadrine (oral)

Orphenadrine (oral)
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: Vignesh Ponnusamy, M.B.B.S. [2]

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Overview

Orphenadrine (oral) is an antimuscarinic agent that is FDA approved for the {{{indicationType}}} of musculoskeletal pain. Common adverse reactions include transient syncope, nausea, vomiting, xerostomia, dizziness and blurred vision.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Musculoskeletal pain

• Dosing Information

• Two tablets per day; one in the morning and one in the evening.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

• Orphenadrine citrate extended-release tablets are contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (mega-esophagus) and myasthenia gravis.

• Orphenadrine citrate tablets are contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.

Warnings

• Some patients may experience transient episodes of light-headedness, dizziness or syncope. Orphenadrine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly.

Precautions

• Confusion, anxiety and tremors have been reported in few patients receiving propoxyphene and orphenadrine concomitantly. As these symptoms may be simply due to an additive effect, reduction of dosage and/or discontinuation of one or both agents is recommended in such cases.

• Orphenadrine citrate should be used with caution in patients with tachycardia, cardiac decompensation, coronary insufficiency, cardiac arrhythmias.

• Safety of continuous long-term therapy with orphenadrine has not been established. Therefore, if orphenadrine is prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Orphenadrine (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 Orphenadrine (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 Orphenadrine (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Orphenadrine (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Orphenadrine (oral) with respect to nursing mothers.

Pediatric Use

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

Geriatic Use

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

Gender

There is no FDA guidance on the use of Orphenadrine (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Orphenadrine (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Orphenadrine (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Orphenadrine (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Orphenadrine (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Orphenadrine (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

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

• Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

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This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Precautions with Alcohol

• Alcohol-Orphenadrine (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

• 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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