Label: ORPHENADRINE CITRATE tablet, extended release

  • NDC Code(s): 71335-0117-0, 71335-0117-1, 71335-0117-2, 71335-0117-3, view more
    71335-0117-4, 71335-0117-5, 71335-0117-6, 71335-0117-7, 71335-0117-8, 71335-0117-9
  • Packager: Bryant Ranch Prepack
  • This is a repackaged label.
  • Source NDC Code(s): 0185-0022
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 19, 2020

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  • SPL UNCLASSIFIED SECTION

    Rx Only

  • DESCRIPTION

    Orphenadrine citrate, USP is the citrate salt of orphenadrine (2-dimethyl-aminoethyl 2-methylbenzhydryl ether citrate). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol and has a molecular weight of 461.51. The molecular formula C18H23NO • C6H8O7 is represented by the following structural formula:

    Image-01

    Each orphenadrine citrate extended-release tablet, USP contains 100 mg orphenadrine citrate, USP. Orphenadrine citrate extended-release tablets, USP also contain: calcium stearate, ethylcellulose and lactose monohydrate.

  • CLINICAL PHARMACOLOGY

    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 skeletal muscles in man. Orphenadrine citrate also possesses anti-cholinergic actions.

  • INDICATIONS AND USAGE

    Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute painful musculo skeletal conditions.

  • 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.

  • 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 citrate has not been established. Therefore, if orphenadrine citrate is prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended.

  • PREGNANCY

    Pregnancy Category C

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

  • PEDIATRIC USE

    Safety and effectiveness in pediatric patients have not been established.

  • ADVERSE REACTIONS

    Adverse reactions of orphenadrine citrate are mainly due to the mild anti-cholinergic action of orphenadrine citrate 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.

  • DRUG ABUSE AND DEPENDENCE

    Orphenadrine citrate has been chronically abused for its euphoric effects.[1] The mood elevating effects may occur at therapeutic doses of orphenadrine.[2]

  • OVERDOSAGE

    Orphenadrine citrate is toxic when overdosed and typically induces anti-cholinergic effects.[3] 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.[4] Treatment for orphenadrine citrate overdose is evacuation of stomach contents (when necessary), charcoal at repeated doses, intensive monitoring and appropriate supportive treatment of any emergent anti-cholinergic effects.[5]

  • DOSAGE AND ADMINISTRATION

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

  • HOW SUPPLIED

    Product: 71335-0117

    NDC: 71335-0117-0 56 TABLET, EXTENDED RELEASE in a BOTTLE

    NDC: 71335-0117-1 20 TABLET, EXTENDED RELEASE in a BOTTLE

    NDC: 71335-0117-2 60 TABLET, EXTENDED RELEASE in a BOTTLE

    NDC: 71335-0117-3 100 TABLET, EXTENDED RELEASE in a BOTTLE

    NDC: 71335-0117-4 90 TABLET, EXTENDED RELEASE in a BOTTLE

    NDC: 71335-0117-5 30 TABLET, EXTENDED RELEASE in a BOTTLE

    NDC: 71335-0117-6 28 TABLET, EXTENDED RELEASE in a BOTTLE

    NDC: 71335-0117-7 45 TABLET, EXTENDED RELEASE in a BOTTLE

    NDC: 71335-0117-8 14 TABLET, EXTENDED RELEASE in a BOTTLE

    NDC: 71335-0117-9 120 TABLET, EXTENDED RELEASE in a BOTTLE

  • Orphenadrine Citrate 100mg ER Tablet

    Label Image
  • INGREDIENTS AND APPEARANCE
    ORPHENADRINE CITRATE 
    orphenadrine citrate tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71335-0117(NDC:0185-0022)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9) ORPHENADRINE CITRATE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM STEARATE (UNII: 776XM7047L)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorWHITE (WHITE) Scoreno score
    ShapeROUND (ROUND) Size9mm
    FlavorImprint Code E;22
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-0117-120 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2008
    2NDC:71335-0117-745 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2008
    3NDC:71335-0117-490 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2008
    4NDC:71335-0117-530 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2008
    5NDC:71335-0117-260 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2008
    6NDC:71335-0117-814 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2008
    7NDC:71335-0117-9120 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2008
    8NDC:71335-0117-3100 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2008
    9NDC:71335-0117-628 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2008
    10NDC:71335-0117-056 in 1 BOTTLE; Type 0: Not a Combination Product02/15/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04032702/15/2000
    Labeler - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-0117) , RELABEL(71335-0117)