Label: METHOCARBAMOL  - methocarbamol tablet 

  • NDC Code(s): 43063-419-01, 43063-419-10, 43063-419-12, 43063-419-14, view more
    43063-419-18, 43063-419-20, 43063-419-24, 43063-419-28, 43063-419-30, 43063-419-40, 43063-419-60, 43063-419-90, 43063-419-93
  • Packager: PD-Rx Pharmaceuticals, Inc.
  • This is a repackaged label.
  • Source NDC Code(s): 0603-4485
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 08/10

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Rx only

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  • DESCRIPTION

    Methocarbamol Tablets, USP, 500 mg and 750 mg, 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.

    This is an image of the structural formula for methocarbamol.

    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.

    Each tablet, for oral administration, contains either 500 mg or 750 mg of methocarbamol, USP. The inactive ingredients present are colloidal silicon dioxide, magnesium stearate, povidone, pregelatinized corn starch, purified water, sodium starch glycolate, and stearic acid.

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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 (± 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

    Methocarbamol is 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

    Methocarbamol is 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 methocarbamol tablets should be cautioned about combined effects with alcohol and other CNS depressants.

    Safe use of methocarbamol 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.

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

    Safe use of methocarbamol 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 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 is administered to a nursing woman.

    Pediatric Use

    Safety and effectiveness of methocarbamol 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

    Methocarbamol, 500 mg — Adults: Initial dosage: 3 tablets q.i.d.
    Maintenance dosage: 2 tablets q.i.d.

    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

    Methocarbamol Tablets, USP 500 mg — white, round, convex face, debossed "4211" bisect over "V" on one side and plain on the reverse side. Available in bottles of 10, 100, 500 and 1000.

    Methocarbamol Tablets, USP 750 mg — white, capsule shape, convex face, debossed "4212" on one side and debossed "V" on the reverse side. Available in bottles of 10, 100, 500, 1000 and unit-dose packs of 100.

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

    Dispense in tight container.

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  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    QUALITEST PHARMACEUTICALS
    Huntsville, AL 35811

    8180464
    R1/08-R2

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    METHOCARBAMOL  
    methocarbamol tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43063-419(NDC:0603-4485)
    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
    SILICON DIOXIDE  
    MAGNESIUM STEARATE  
    POVIDONE  
    STARCH, PREGELATINIZED CORN  
    WATER  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND Size 13mm
    Flavor Imprint Code 4211;V
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43063-419-10 10 in 1 BOTTLE, PLASTIC
    2 NDC:43063-419-12 12 in 1 BOTTLE, PLASTIC
    3 NDC:43063-419-14 14 in 1 BOTTLE, PLASTIC
    4 NDC:43063-419-20 20 in 1 BOTTLE, PLASTIC
    5 NDC:43063-419-24 24 in 1 BOTTLE, PLASTIC
    6 NDC:43063-419-28 28 in 1 BOTTLE, PLASTIC
    7 NDC:43063-419-30 30 in 1 BOTTLE, PLASTIC
    8 NDC:43063-419-40 40 in 1 BOTTLE, PLASTIC
    9 NDC:43063-419-60 60 in 1 BOTTLE, PLASTIC
    10 NDC:43063-419-90 90 in 1 BOTTLE, PLASTIC
    11 NDC:43063-419-01 100 in 1 BOTTLE, PLASTIC
    12 NDC:43063-419-93 180 in 1 BOTTLE, PLASTIC
    13 NDC:43063-419-18 18 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040489 01/29/2003
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    Name Address ID/FEI Business Operations
    PD-Rx Pharmaceuticals, Inc. 156893695 repack(43063-419)
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