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

• 100 mg 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, achalasia (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

• Adverse reactions of orphenadrine are mainly due to the mild anticholinergic action of orphenadrine, and are usually associated with higher dosage. Dryness of the mouth is usually the first adverse effect to appear. When the daily dose is increased, possible adverse effects include: tachycardia, palpitation, urinary hesitancy or urinary retention, blurred vision, dilatation of pupils, increased ocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, hypersensitivity reactions, pruritus, hallucinations, agitation, tremor, gastric irritation, and rarely urticaria and other dermatoses. Infrequently, an elderly patient may experience some degree of mental confusion.

• These adverse reactions can usually be eliminated by reduction in dosage. Very rare cases of aplastic anemia associated with the use of orphenadrine tablets have been reported. No causal relationship has been established.

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category C

• Animal reproduction studies have not been conducted with orphenadrine. It is also not known whether orphenadrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Orphenadrine should be given to a pregnant woman only if clearly needed.

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

• Safety and effectiveness in pediatric patients have not been established.

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

Monitoring

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

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

• Orphenadrine is toxic when overdosed and typically induces anticholinergic effects. In a review of orphenadrine toxicity, the minimum lethal dose was found to be 2 to 3 grams for adults; however, the range of toxicity is variable and unpredictable.

Management

• Treatment for orphenadrine overdose is evacuation of stomach contents (when necessary), charcoal at repeated doses, intensive monitoring, and appropriate supportive treatment of any emergent anticholinergic effects.

Chronic Overdose

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

Pharmacology

Mechanism of Action

• The mode of therapeutic action has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense muscles in man. Orphenadrine citrate also possesses anti-cholinergic actions.

Structure

• Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate is (±)-N,N-Dimethyl-2-[(o-methyl-⟨-phenylbenzyl)oxy]ethylamine citrate (1:1) having molecular formula C18H23NO•C6H8O7 and molecular weight of 461.51. It has the following structural formula:

File:Orphenadrine (oral)01.png

This image is provided by the National Library of Medicine.

• Each tablet for oral administration contains 100 mg orphenadrine citrate. Each Orphenadrine citrate extended release tablet contains the following inactive ingredients: hydroxypropyl methylcellulose, lactose monohydrate and magnesium stearate.

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

• Orphenadrine citrate extended-release tablets 100 mg are round, white to off-white tablets, debossed NL4 on one side and plain on the other side and are supplied as:

• NDC 43386-480-24 in bottles of 100 tablets
• NDC 43386-480-26 in bottles of 500 tablets
• NDC 43386-480-28 in bottles of 1000 tablets

• Storage and Handling

• Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

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

• ORPHENADRINE CITRATE®

Look-Alike Drug Names

There is limited information regarding Orphenadrine (oral) 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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