Label: METHOCARBAMOL tablet

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

Drug Label Information

Updated February 11, 2019

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  • DESCRIPTION

    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 C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below.

    structure.jpg

    Methocarbamol USP 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.

    Methocarbamol tablets USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets USP 500 mg and 750 mg contain the following inactive ingredients: sodium lauryl sulfate, sodium starch glycolate, povidone K 90, polyethylene glycol, magnesium stearate, colloidal silicon dioxide, low substituted hydroxypropyl cellulose and stearic acid.

  • 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 (±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.

  • INDICATIONS AND USAGE

    Methocarbamol tablets 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.

  • CONTRAINDICATIONS

    Methocarbamol tablets are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

  • WARNINGS

    Since methocarbamol may possess a general CNS depressant effect, patients receiving methocarbamol tablets should be cautioned about combined effects with alcohol and other CNS depressants.

    Safe use of methocarbamol tablets 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, methocarbamol tablets 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.

  • 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 -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. Methocarbamol tablets should be given to a pregnant woman only if clearly needed.

    Safe use of methocarbamol tablets 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, methocarbamol tablets 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 methocarbamol tablets are administered to a nursing woman.

    Pediatric Use

    Safety and effectiveness of methocarbamol tablets in pediatric patients below the age of 16 have not been established.

  • 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, urticarial

  • 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.

  • DOSAGE & ADMINISTRATION

    Methocarbamol Tablets USP 500 mg – Adults:
    Initial dosage: 3 tablets q.i.d.
    Maintenance dosage: 2 tablets q.i.d.

    Methocarbamol Tablets USP 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.

  • HOW SUPPLIED

    Methocarbamol tablets USP, 500 mg are white to off white, capsule shaped, tablets debossed with ‘H’ on scored side and ‘114’ on unscored side . They are supplied as follows:
    Unit dose packages of 100 (10 x 10) NDC 68084-056-01

    Methocarbamol tablets USP, 750 mg are white to off white, capsule shaped, tablets debossed with ‘H’ on one side and ‘115’ on other side . They are supplied as follows:
    Unit dose packages of 100 (10 x 10) NDC 68084-057-01

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

    FOR YOUR PROTECTION: Do not use if blister is torn or broken.

    PACKAGING INFORMATION
    American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Camber Pharmaceuticals Inc. as follows:
    (500 mg / 100 UD) NDC 68084-056-01 packaged from NDC 31722-533
    (750 mg / 100 UD) NDC 68084-057-01 packaged from NDC 31722-534

    Distributed by:
    American Health Packaging
    Columbus, OH 43217

    8205601/0418

  • Package/Label Display Panel – Carton - 500 mg

    500 mg Methocarbamol Tablets Carton

    NDC 68084-056-01

    Methocarbamol
    Tablets USP

    500 mg

    100 Tablets (10 x 10)

    Each Uncoated Tablet Contains:
    Methocarbamol USP ......................................500 mg

    Usual Dosage: Two to four tablets four times daily. See
    package insert for full prescribing information.

    Store at 20° to 25°C (68° to 77°F); excursions permitted
    between 15° to 30°C (59° to 86°F) [see USP Controlled Room
    Temperature].

    Keep this and all drugs out of reach of children.

    FOR YOUR PROTECTION: Do not use if blister is torn
    or broken.

    Rx Only

    The drug product contained in this package is from
    NDC # 31722-533, Camber Pharmaceuticals, Inc.

    Distributed by:
    American Health Packaging
    Columbus, Ohio 43217

    005601
    0205601/0216PS

  • Package/Label Display Panel – Blister - 500 mg

    500 mg Methocarbamol Tablet Blister

    Methocarbamol
    Tablet USP

    500 mg

  • Package/Label Display Panel – Carton - 750 mg

    750 mg Methocarbamol Tablets Carton

    NDC 68084-057-01

    Methocarbamol
    Tablets USP

    750 mg

    100 Tablets (10 x 10)

    Each Uncoated Tablet Contains:
    Methocarbamol USP .......................................750 mg

    Usual Dosage: Two tablets three times daily. See
    package insert for full prescribing information.

    Store at 20° to 25°C (68° to 77°F); excursions
    permitted between 15° to 30°C (59° to 86°F)
    [see USP Controlled Room Temperature].

    Keep this and all drugs out of reach of children.

    FOR YOUR PROTECTION: Do not use if blister is torn
    or broken.

    Rx Only

    The drug product contained in this package is from
    NDC # 31722-534, Camber Pharmaceuticals, Inc.

    Packaged and Distributed by:
    American Health Packaging
    Columbus, Ohio 43217

    005701
    0205701/0418

  • Package/Label Display Panel – Blister - 750 mg

    750 mg Methocarbamol Tablet Blister

    Methocarbamol
    Tablet USP

    750 mg

  • INGREDIENTS AND APPEARANCE
    METHOCARBAMOL 
    methocarbamol tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68084-056(NDC:31722-533)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X) METHOCARBAMOL500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (White to Off white) Score2 pieces
    ShapeOVAL (Capsule shaped) Size15mm
    FlavorImprint Code 114;H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68084-056-01100 in 1 BOX, UNIT-DOSE06/11/201303/31/2020
    1NDC:68084-056-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09020006/11/201303/31/2020
    METHOCARBAMOL 
    methocarbamol tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68084-057(NDC:31722-534)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X) METHOCARBAMOL750 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (White to Offwhite) Scoreno score
    ShapeOVAL (Capsule shaped) Size19mm
    FlavorImprint Code 115;H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68084-057-01100 in 1 BOX, UNIT-DOSE06/11/201306/30/2020
    1NDC:68084-057-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09020006/11/201306/30/2020
    Labeler - American Health Packaging (929561009)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Health Packaging929561009repack(68084-056, 68084-057)