Label: ROBAXIN - methocarbamol tablet

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

Drug Label Information

Updated 08/12

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  • DESCRIPTION

    robaxin(methocarbamol tablets, USP), a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties.
    The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below.
    MM1


    Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane.
    robaxinis available as a light orange, round, film-coated tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, FD&C Yellow 6, hydroxypropyl cellulose, hypromellose, magnesium stearate, polysorbate 20, povidone, propylene glycol, saccharin sodium, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide.
    robaxinis available as an orange capsule-shaped, film-coated tablet containing 750 mg of methocarbamol, USP for oral administration. In addition to the inactive ingredients present in robaxinrobaxinalso contains D&C Yellow 10.
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  • CLINICAL PHARMACOLOGY

    The mechanism of action of methocarbamol in humans has not been established, but may be due to general central nervous system (CNS) depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.

    Pharmacokinetics
    In healthy volunteers, the plasma clearance of methocarbamol ranges between 0.20 and 0.80 L/h/kg, the mean plasma elimination half-life ranges between 1 and 2 hours, and the plasma protein binding ranges between 46% and 50%.
    Methocarbamol is metabolized via dealkylation and hydroxylation. Conjugation of methocarbamol also is likely. Essentially all methocarbamol metabolites are eliminated in the urine. Small amounts of unchanged methocarbamol also are excreted in the urine.

    Special populations

    Elderly
    The mean (SD) elimination half-life of methocarbamol in elderly healthy volunteers (mean (SD) age, 69 (4) years) was slightly prolonged compared to a younger (mean (SD) age, 53.3 (8.8) years), healthy population (1.5 (0.4) hours versus 1.1 (hours, respectively). The fraction of bound methocarbamol was slightly decreased in the elderly versus younger volunteers (41 to 43% versus 46 to 50%, respectively).

    Renally impaired
    The clearance of methocarbamol in 8 renally-impaired patients on maintenance hemodialysis was reduced about 40% compared to 17 normal subjects, although the mean (SD) elimination half-life in these two groups was similar: 1.2 (0.6) versus 1.1 (hours, respectively.

    Hepatically impaired
    In 8 patients with cirrhosis secondary to alcohol abuse, the mean total clearance of methocarbamol was reduced approximately 70% compared to that obtained in 8 age- and weight-matched normal subjects. The mean (SD) elimination half-life in the cirrhotic patients and the normal subjects was 3.38 (1.62) hours and 1.11 (0.27) hours, respectively. The percent of methocarbamol bound to plasma proteins was decreased to approximately 40 to 45% compared to 46 to 50% in the normal subjects.
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  • INDICATIONS & USAGE

    robaxinand robaxinare indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.
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  • CONTRAINDICATIONS

    robaxinand robaxinare contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.
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  • WARNINGS

    Since methocarbamol may possess a general CNS depressant effect, patients receiving robaxinor robaxinshould be cautioned about combined effects with alcohol and other CNS depressants.
    Safe use of robaxinand robaxinhas not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, robaxinand robaxinshould not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see PRECAUTIONS,Pregnancy).
    Use In Activities Requiring Mental Alertness
    Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities.
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  • PRECAUTIONS

    Information for Patients
    Patients should be cautioned that methocarbamol may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery.
    Because methocarbamol may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.
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  • DRUG INTERACTIONS

    See WARNINGSandPRECAUTIONSfor interaction with CNS drugs and alcohol.
    Methocarbamol may inhibit the effect of pyridostigmine bromide. Therefore, methocarbamol should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.
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  • DRUG & OR LABORATORY TEST INTERACTIONS

    Methocarbamol may cause a color interference in certain screening tests for 5-hydroxyindoleacetic acid (5-HIAA) using nitrosonaphthol reagent and in screening tests for urinary vanillylmandelic acid (VMA) using the Gitlow method.
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  • CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

    Long-term studies to evaluate the carcinogenic potential of methocarbamol have not been performed. No studies have been conducted to assess the effect of methocarbamol on mutagenesis or its potential to impair fertility.
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  • PREGNANCY

    Teratogenic Effects

    Pregnancy Category C
    Animal reproduction studies have not been conducted with methocarbamol. It is also not known whether methocarbamol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. robaxinand robaxinshould be given to a pregnant woman only if clearly needed.
    Safe use of robaxinand robaxinhas not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, robaxinand robaxinshould not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see WARNINGS).
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  • NURSING MOTHERS

    Methocarbamol and/or its metabolites are excreted in the milk of dogs; however, it is not known whether methocarbamol or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when robaxin or robaxin is administered to a nursing woman.
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  • PEDIATRIC USE

    Safety and effectiveness of robaxinand robaxinin pediatric patients below the age of 16 have not been established.
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  • ADVERSE REACTIONS

    Adverse reactions reported coincident with the administration of methocarbamol include:
    Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headache
    Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis
    Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting
    Hemic and lymphatic system: Leukopenia
    Immune system: Hypersensitivity reactions
    Nervous system: Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo
    Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria
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  • OVERDOSAGE

    Management of overdose includes symptomatic and supportive treatment. Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary. The usefulness of hemodialysis in managing overdose is unknown.
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  • DOSAGE & ADMINISTRATION

    robaxin(methocarbamol), 500 mgAdults:
    Initial dosage: 3 tablets q.i.d.
    Maintenance dosage: 2 tablets q.i.d.
    robaxin(methocarbamol): 750 mgAdults:
    Initial dosage: 2 tablets q.i.d.
    Maintenance dosage: 1 tablet q.4h. or 2 tablets t.i.d.
    Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered). Thereafter, the dosage can usually be reduced to approximately 4 grams a day.
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  • HOW SUPPLIED

    robaxin(methocarbamol tablets, USP)
    500 mg tablets are light orange, round, film-coated tablets engraved with ROBAXIN 500 on the unscored side and SP above the score on the other side. They are supplied as follows:

    Bottles of 100NDC 52244-429-10robaxin(methocarbamol tablets, USP)
    750 mg tablets are orange, capsule-shaped, film-coated tablets engraved with ROBAXIN 750 on one side and SP on the other. They are supplied as follows:

    Bottles of 100NDC 52244-449-10
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  • STORAGE AND HANDLING

    Store at controlled room temperature, between 20and 25(68and 77
    Dispense in tight container.
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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

    DRUG: Robaxin
    GENERIC: Methocarbamol
    DOSAGE: TABLET
    ADMINSTRATION: ORAL
    NDC: 52125-024-02
    STRENGTH:500 mg
    COLOR: orange
    SHAPE: ROUND
    SCORE: Two even pieces
    SIZE: 13 mm
    IMPRINT: 30
    QTY: 30

    MM2







    MM3

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  • INGREDIENTS AND APPEARANCE
    ROBAXIN 
    methocarbamol tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52125-024(NDC:52244-429)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METHOCARBAMOL (METHOCARBAMOL) METHOCARBAMOL 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    TITANIUM DIOXIDE  
    FD&C YELLOW NO. 6  
    HYDROXYPROPYL CELLULOSE  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    D&C YELLOW NO. 10  
    POLYSORBATE 20  
    POVIDONE  
    SACCHARIN SODIUM  
    SODIUM LAURYL SULFATE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STARCH, CORN  
    STEARIC ACID  
    PROPYLENE GLYCOL  
    Product Characteristics
    Color orange Score 2 pieces
    Shape ROUND (TABLET) Size 13mm
    Flavor Imprint Code Robaxin;500;SP
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52125-024-02 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA011011 08/16/2012
    Labeler - REMEDYREPACK INC. (829572556)
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