Label: ORPHENADRINE CITRATE- orphenadrine citrate tablet 

  • Label RSS
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 02/13

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  • SPL UNCLASSIFIED SECTION

    Rx only

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  • DESCRIPTION

    Orphenadrine citrate is the citrate salt of orphenadrine (2-dimethylaminoethyl 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. Each orphenadrine citrate tablet contains 100 mg orphenadrine citrate, USP. Orphenadrine citrate tablets also contain ethylcellulose NF, povidone USP, lactose monohydrate NF, and magnesium stearate NF.

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  • ACTIONS

    The mode of therapeutic action has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate also possesses anticholinergic actions.

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  • INDICATIONS

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

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  • CONTRAINDICATIONS

    Contraindicated in patients with glaucoma, pyloric or duodenal obstruction, stenosing peptic ulcers, prostatic hypertrophy or obstruction of the bladder neck, cardiospasm (megaesophagus) and myasthenia gravis. Contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.

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  • 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.

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  • PREGNANCY

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

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  • USAGE IN CHILDREN

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

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  • PRECAUTIONS

    Confusion, anxiety and tremors have been reported in a 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, or 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.

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  • ADVERSE REACTIONS

    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, dilation 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.

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  • DOSAGE AND ADMINISTRATION

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

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  • HOW SUPPLIED

    Tablets 100 mg-Each round, white, convex tablet imprinted with "G" on one side and "2011" on the other side.

    Bottles of 100 NDC 42291-530-01

    Store at controlled room temperature 15° to 30°C (59° to 86°F).

    Dispense in tightly-closed, light-resistant container (USP).

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  • SPL UNCLASSIFIED SECTION

    Manufactured for: AvKARE, Inc.
    Pulaski, TN 38478

    Mfg. Rev. 01/00
    AV Rev. 06/12

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  • PRINCIPAL DISPLAY PANEL

    AvKARE

    NDC 42291-530-01

    Orphenadrine Citrate
    Extended-Release Tablets

    100mg

    100 Tablets        Rx Only

    USUAL DOSAGE:
    See accompanying outsert for complete prescribing information.

    Dispense in a tightly-closed, light-resistant container as defined in the USP, with child-resistant closure, as required.

    Store at controlled room temperature, 15oC to 30oC (59oF - 86oF).

    Keep this and all medication out of the reach of children.

    Manufactured for:
    AvKARE, Inc.
    Pulaski, TN 38478

    Mfg. Rev. 06/01       AV Rev. 02/13 (P) 

    N3   42291 53001   0

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  • INGREDIENTS AND APPEARANCE
    ORPHENADRINE CITRATE 
    orphenadrine citrate tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42291-530(NDC:0115-2011)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ORPHENADRINE CITRATE (ORPHENADRINE) ORPHENADRINE CITRATE 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    Ethylcelluloses  
    POVIDONE  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code G;2011
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42291-530-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040368 06/24/2000
    Labeler - AvKARE, Inc. (796560394)
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