Label: ROBAXIN- methocarbamol tablet, film coated

  • NDC Code(s): 52244-429-10, 52244-449-10
  • Packager: Endo Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 29, 2019

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  • SPL UNCLASSIFIED SECTION

    Rx Only

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  • DESCRIPTION

    robaxin®/robaxin®-750 (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.

    Robaxin structural formula

    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.

    robaxin® is 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.

    robaxin®-750 is 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 robaxin®, robaxin®-750 also 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 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 [±0.27] 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 (±0.3) 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 AND USAGE

    robaxin® and robaxin®-750 are 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

    robaxin® and robaxin®-750 are 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 robaxin® or robaxin®-750 should be cautioned about combined effects with alcohol and other CNS depressants.

    Safe use of robaxin® and robaxin®-750 has 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, robaxin® and robaxin®-750 should 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.

    Drug Interactions

    See WARNINGS and PRECAUTIONS for 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.

    Drug/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.

    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.

    Pregnancy

    Teratogenic Effects

    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. robaxin® and robaxin®-750 should be given to a pregnant woman only if clearly needed.

    Safe use of robaxin® and robaxin®-750 has 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, robaxin® and robaxin®-750 should 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).

    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®-750 is administered to a nursing woman.

    Pediatric Use

    Safety and effectiveness of robaxin® and robaxin®-750 in 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

    Limited information is available on the acute toxicity of methocarbamol. Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures, and coma.

    In post-marketing experience, deaths have been reported with an overdose of methocarbamol alone or in the presence of other CNS depressants, alcohol or psychotropic drugs.

    Treatment

    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 AND ADMINISTRATION

    robaxin® (methocarbamol), 500 mg – Adults:
    Initial dosage: 3 tablets q.i.d.
    Maintenance dosage: 2 tablets q.i.d.
    robaxin®-750 (methocarbamol): 750 mg – Adults:
    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 100          NDC 52244-429-10

    robaxin®-750 (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 100          NDC 52244-449-10

    Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).

    Dispense in tight container.

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  • SPL UNCLASSIFIED SECTION

    For more information, call Endo Pharmaceuticals Inc. at 1-800-462-3636. 

    Distributed by:
    Endo Pharmaceuticals, Inc.
    Malvern, PA 19355

    Revised: 01/2019

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  • PRINCIPAL DISPLAY PANEL - 500 mg
  • PRINCIPAL DISPLAY PANEL - 750 mg
  • INGREDIENTS AND APPEARANCE
    ROBAXIN 
    methocarbamol tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52244-429
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X) METHOCARBAMOL 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Color ORANGE (light orange) Score 2 pieces
    Shape ROUND Size 13mm
    Flavor Imprint Code Robaxin;500;SP
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52244-429-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA011011 05/15/2012
    ROBAXIN 
    methocarbamol tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52244-449
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X) METHOCARBAMOL 750 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Color ORANGE Score no score
    Shape OVAL (Capsule-shaped) Size 19mm
    Flavor Imprint Code Robaxin;750;SP
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52244-449-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/18/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA011011 08/18/2011
    Labeler - Endo Pharmaceuticals, Inc. (178074951)
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