Label: ORPHENADRINE CITRATE- orphenadrine citrate tablet, extended release

  • NDC Code(s): 69784-905-01
  • Packager: Woodward Pharma Services LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 19, 2017

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  • SPL UNCLASSIFIED SECTION

    Orphenadrine Citrate Extended-Release Tablets

    Woodward Pharma Services LLC

    Rx Only

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  • DESCRIPTION:

    Orphenadrine citrate 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 C 18H 23NO•C 6H 8O 7 is represented by the following structural formula:

    orph-structure

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

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  • 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.

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  • INDICATIONS AND USAGE:

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

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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, cardio-spasm (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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  • 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.

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  • 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.

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  • PEDIATRIC USE

    Safety and effectiveness in pediatric patients have not been established.

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  • 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.

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  • DRUG ABUSE AND DEPENDENCE

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

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  • OVERDOSAGE

    Orphenadrine citrate is toxic when overdosed and typically induces anti-cholinergic 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. 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.

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  • DOSAGE AND ADMINISTRATION:

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

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  • HOW SUPPLIED:

    Orphenadrine Citrate Extended-Release Tablets, for oral administration, are available as

    100 mg

    White to off-white, round tablets debossed 'CL 71' on one side and plain on the other side and supplied as:

    NDC 69784-905-01 bottles of 100

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

    Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure.

    KEEP TIGHTLY CLOSED.

    To report SUSPECTED ADVERSE REACTIONS, contact Woodward Pharma Services LLC at 1-888-514-4727 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Manufactured for:

    Woodward Pharma Services LLC

    Birmingham, MI 48009

    Rev. 09/2017 A

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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:69784-905
    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
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code CL71
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69784-905-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/28/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040249 05/26/2017
    Labeler - Woodward Pharma Services LLC (026749066)
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