Orphenadrine (injection)

Orphenadrine (injection)
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: Adeel Jamil, M.D. [2]

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Overview

Orphenadrine (injection) is an antimuscarinic agent that is FDA approved for the treatment of the relief of discomfort associated with acute painful musculoskeletal conditions. Common adverse reactions include transient syncope, nausea, vomiting, xerostomia, dizziness and blurred vision.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Orphenadrine citrate injection is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. The mode of action of the drug has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense skeletal muscles in man.

Dosing Information

• INJECTION: Adults - One 2 mL vial (60 mg) intravenously or intramuscularly; may be repeated every 12 hours.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Orphenadrine (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

• Contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm (megaesophagus) and myasthenia gravis.

• 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 citrate 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.

• Orphenadrine citrate injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than nonasthmatic people.

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.

DRUG ABUSE AND DEPENDENCE:

• Orphenadrine has been chronically abused for its euphoric effects. The mood elevating effects may occur at therapeutic doses of orphenadrine.

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 Orphenadrine (injection) Postmarketing Experience in the drug label.

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

• Safe use of orphenadrine has not been established with respect to adverse effects upon fetal development. Therefore, orphenadrine should be used in women of childbearing potential and particularly during early pregnancy only when in the judgment of the physician the potential benefits outweigh the possible hazards.

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Orphenadrine (injection) in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Orphenadrine (injection) in women who are nursing.

Pediatric Use

• Safety and effectiveness in children have not been established; therefore, this drug is not recommended for use in the pediatric age group.

Geriatic Use

There is no FDA guidance on the use of Orphenadrine (injection) in geriatric settings.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Injection

Monitoring

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

IV Compatibility

There is limited information regarding the compatibility of Orphenadrine (injection) and IV administrations.

Overdosage

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

Pharmacology

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

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 ((±)-N, N-Dimethyl- 2-[(o-methyl-a-phenylbenzyl)oxy]ethylamine citrate (1:1)) with a molecular weight of 461.50; empirical formula C18H23NO•C6H8O7. The structural formula of orphenadrine citrate is:

This image is provided by the National Library of Medicine.

• It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol.

• Orphenadrine citrate injection contains 60 mg of orphenadrine citrate in aqueous solution in each vial. Orphenadrine citrate injection also contains: sodium chloride USP 5.8 mg; sodium metabisulfite NF, 2.0 mg; sodium hydroxide NF, to adjust pH (5.0 to 6.0); and water for injection USP, q.s. to 2 mL.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

INJECTION: Boxes of 10 (NDC 17478-538-02) 2 mL vials, each vial containing 60 mg of orphenadrine citrate in aqueous solution.

Single dose vial. Discard unused portion.

AKORN

Manufactured by: Akorn, Inc.

Lake Forest, IL 60045

RF00N Rev. 03/12

Storage

• Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Images

Drug Images

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Package and Label Display Panel

Principal Display Panel Text for Container Label:

NDC 17478-538-02

Orphenadrine

Citrate

Injection, USP

60 mg (30 mg/mL)

Rx only 2 mL Sterile

For I.M. or I.V. Use.

Single dose vial.

This image is provided by the National Library of Medicine.

Principal Display Panel Text for Carton Label:

NDC 17478-538-02

Orphenadrine Citrate Injection, USP

60 mg (30 mg/mL)

For Intravenous or Intramuscular Use

Single-dose Vial

10 Sterile Vials (2 ml each)

Rx only Akorn Logo

This image is provided by the National Library of Medicine.

{{#ask: Label Page::Orphenadrine (injection) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Orphenadrine (injection) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Orphenadrine (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Orphenadrine (injection) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Orphenadrine (injection) 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.