Orphenadrine (oral)

Revision as of 14:57, 10 November 2014 by Vignesh Ponnusamy (talk | contribs)
Jump to navigation Jump to search

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]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

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 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.
  • 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 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


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

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

Orphenadrine (oral)
Clinical data
Trade namesInvagesic
AHFS/Drugs.comMonograph
MedlinePlusa682162
Pregnancy
category
  • AU: B2
  • US: C (Risk not ruled out)
Routes of
administration
Oral, intravenous, intramuscular
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability90%
Protein binding95%
MetabolismHepatic demethylation
Elimination half-life13-20 hours[1]
ExcretionRenal and biliary
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
E number{{#property:P628}}
ECHA InfoCard{{#property:P2566}}Lua error in Module:EditAtWikidata at line 36: attempt to index field 'wikibase' (a nil value).
Chemical and physical data
FormulaC18H23NO
Molar mass269.381 g/mol
3D model (JSmol)
  (verify)

Mechanism of Action

Structure

File:Orphenadrine (oral)01.png
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

  • 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

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

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

Drug Shortage Status

Price

References

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

  1. Labout, JJ; Thijssen, C; Keijser, GG; Hespe, W (1982). "Difference between single and multiple dose pharmacokinetics of orphenadrine hydrochloride in man". European journal of clinical pharmacology. 21 (4): 343–50. doi:10.1007/BF00637624. PMID 7056281.
  2. Empty citation (help)
  3. "http://www.ismp.org". External link in |title= (help)


{{#subobject:

 |Page Name=Orphenadrine (oral)
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage=
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}


{{#subobject:

 |Label Page=Orphenadrine (oral)
 |Label Name=Orphenadrine (oral)11.png

}}


{{#subobject:

 |Label Page=Orphenadrine (oral)
 |Label Name=Orphenadrine (oral)11.png

}}