Label: ORPHENADRINE CITRATE - orphenadrine citrate tablet, extended release

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

Drug Label Information

Updated August 11, 2011

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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-methyl-benzhydryl 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 0115-2011-01
    Bottles of 500 NDC 0115-2011-02

    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 by: Impax Laboratories, Inc.
    Hayward, California 94544

    Dist. by: Global Pharmaceuticals
    Division of IMPAX Laboratories, Inc.
    Philadelphia, PA 19124


    Repacked by: H.J. Harkins Company, Inc.
    Nipomo, California 93444

    Rev. 01/00
    124-02

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  • PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label

    GLOBAL®

    NDC 0115-2011-02

    Orphenadrine
    Citrate
    Extended-Release Tablets

    100 mg

    Rx only

    500 TABLETS

    PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
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  • INGREDIENTS AND APPEARANCE
    ORPHENADRINE CITRATE  
    orphenadrine citrate tablet, extended release
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-527(NDC:0115-2011)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ORPHENADRINE CITRATE (UNII: X0A40N8I4S) (ORPHENADRINE - UNII:AL805O9OG9) ORPHENADRINE CITRATE 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONE (UNII: FZ989GH94E)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND (convex) Size 9mm
    Flavor Imprint Code G;2011
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52959-527-30 30 in 1 BOTTLE
    2 NDC:52959-527-60 60 in 1 BOTTLE
    3 NDC:52959-527-20 20 in 1 BOTTLE
    4 NDC:52959-527-10 10 in 1 BOTTLE
    5 NDC:52959-527-14 14 in 1 BOTTLE
    6 NDC:52959-527-90 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040368 06/23/2000
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Establishment
    Name Address ID/FEI Business Operations
    Impax Laboratories Inc 790947167 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    H.J. Harkins Company, Inc. 147681894 REPACK
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