Methocarbamol tablets, USP 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.
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...
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Methocarbamol tablets, USP, a carbamate derivative of guaifenesin, are 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.
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.
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: acacia, calcium stearate, colloidal silicon dioxide, corn starch, croscarmellose sodium, and methylcellulose.
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.
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.
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).
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.
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.
Methocarbamol tablets, USP 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.
Methocarbamol tablets, USP are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.
Since methocarbamol may possess a general CNS depressant effect, patients receiving methocarbamol tablets, USP should be cautioned about combined effects with alcohol and other CNS depressants.
Safe use of methocarbamol tablets, USP 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, USP 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).
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.
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.
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.
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.
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.
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, USP should be given to a pregnant woman only if clearly needed.
Safe use of methocarbamol tablets, USP 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, USP 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).
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, USP are administered to a nursing woman.
Safety and effectiveness of methocarbamol tablets, USP in pediatric patients below the age of 16 have not been established.
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
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.
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.
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.
Methocarbamol Tablets, USP, 500 mg are white, round, bisected tablets, debossed with LAN over 1302, supplied in bottles of 100 and 500 tablets.
100 Tablets NDC 0527-1302-01
500 Tablets NDC 0527-1302-05
Methocarbamol Tablets, USP, 750 mg are white, scored, capsule-shaped tablets debossed with LAN besides 1152, supplied in bottles of 100 and 500 tablets.
100 Tablets NDC 0527-1152-01
500 Tablets NDC 0527-1152-05
Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F) [see USP Controlled Room Temperature].
Dispense in a tight container as defined in the USP with a child-resistant closure (as required).
MANUFACTURED BY
LANNETT CO., INC.
PHILADELPHIA, PA 19136
Revised 01/07
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0527-1302-01 | EA - Each | 0527-1302 | 7f85174b-8a99-49dc-8299-ba004383cba6 | 1 | 2013-02-13 |
| 0527-1302-05 | EA - Each | 0527-1302 | 7411ce84-ef83-4685-8963-4f9c917c72a7 | 1 | 2013-02-13 |
| 0527-1152-01 | EA - Each | 0527-1152 | db8142fa-aabb-4e2f-bde2-4f01a2aed6d3 | 1 | 2013-02-13 |
| 0527-1152-05 | EA - Each | 0527-1152 | f3c50257-464d-4f65-bf2f-0da82b6bfa44 | 1 | 2013-02-13 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Methocarbamol | ACTIVE INGREDIENT | 125OD7737X | 1 | |
| Methocarbamol | ACTIVE MOIETY | 125OD7737X | 1 | |
| acacia | INACTIVE INGREDIENT | 1 | ||
| calcium stearate | INACTIVE INGREDIENT | 776XM7047L | 1 | |
| colloidal silicon dioxide | INACTIVE INGREDIENT | 1 | ||
| corn starch | INACTIVE INGREDIENT | 1 | ||
| croscarmellose sodium | INACTIVE INGREDIENT | 1 | ||
| methylcellulose | INACTIVE INGREDIENT | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0527-1302 | 0527-1302-01, 0527-1302-05 |
| 0527-1152 | 0527-1152-01, 0527-1152-05 |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| acacia | ACACIA | 5C5403N26O | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| acacia | ACACIA | 5C5403N26O | TABLET / ORAL | 70 mg | ||
| methylcellulose | METHYLCELLULOSE | Z944H5SN0H | SPONGE / TOPICAL | NA | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TROCHE / ORAL | 50 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE / ORAL | 280 mg | ||
| methylcellulose | METHYLCELLULOSE | Z944H5SN0H | INJECTION / INTRAMUSCULAR | 0.1 %w/v | ||
| acacia | ACACIA | 5C5403N26O | POWDER, FOR SOLUTION / ORAL | NA | ||
| methylcellulose | METHYLCELLULOSE | Z944H5SN0H | JELLY / NASAL | NA | ||
| calcium stearate | CALCIUM STEARATE | 776XM7047L | TABLET / ORAL | 280 mg | ||
| acacia | ACACIA | 5C5403N26O | TABLET, EXTENDED RELEASE / ORAL | 34.4 mg | ||
| acacia | ACACIA | 5C5403N26O | POWDER, FOR SUSPENSION / ORAL | 7386 mg | ||
| methylcellulose | METHYLCELLULOSE | Z944H5SN0H | JELLY / TOPICAL | NA | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | PELLET / ORAL | 162 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| methylcellulose | METHYLCELLULOSE | Z944H5SN0H | SUSPENSION / ORAL | 100 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | POWDER, FOR SUSPENSION / ORAL | 11.25 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 127 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, EXTENDED RELEASE / ORAL | 392 mg | ||
| calcium stearate | CALCIUM STEARATE | 776XM7047L | TABLET, FILM COATED / ORAL | 16 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE / ORAL | 72 mg | ||
| methylcellulose | METHYLCELLULOSE | Z944H5SN0H | CREAM / TOPICAL | 1.3 %w/w | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, ORALLY DISINTEGRATING / ORAL | 184 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | SUSPENSION / ORAL | 150 mg | ||
| calcium stearate | CALCIUM STEARATE | 776XM7047L | TABLET, CHEWABLE / ORAL | 240 mg | ||
| methylcellulose | METHYLCELLULOSE | Z944H5SN0H | AEROSOL, FOAM / TOPICAL | 0.11 %w/w | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE / ORAL | 257 mg | ||
| acacia | ACACIA | 5C5403N26O | CAPSULE / ORAL | 20 mg | ||
| acacia | ACACIA | 5C5403N26O | SYRUP / ORAL | NA | ||
| methylcellulose | METHYLCELLULOSE | Z944H5SN0H | SYRUP / ORAL | NA | ||
| methylcellulose | METHYLCELLULOSE | Z944H5SN0H | TABLET, CHEWABLE / ORAL | 50 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE, FOR SUSPENSION / ORAL | 282 mg | ||
| acacia | ACACIA | 5C5403N26O | POWDER / ORAL | 800 mg | ||
| methylcellulose | METHYLCELLULOSE | Z944H5SN0H | EMULSION / TOPICAL | NA | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, COATED PELLETS / ORAL | 198 mg | ||
| calcium stearate | CALCIUM STEARATE | 776XM7047L | TABLET / BUCCAL | 1.42 mg | ||
| acacia | ACACIA | 5C5403N26O | GUM, CHEWING / BUCCAL | 280 mg | ||
| acacia | ACACIA | 5C5403N26O | TABLET, CHEWABLE / ORAL | 121 mg | ||
| methylcellulose | METHYLCELLULOSE | Z944H5SN0H | TABLET / SUBLINGUAL | 4 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| calcium stearate | CALCIUM STEARATE | 776XM7047L | CAPSULE / ORAL | 21.1 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, CHEWABLE / ORAL | 216 mg | ||
| acacia | ACACIA | 5C5403N26O | SUSPENSION / ORAL | 2 mg | ||
| methylcellulose | METHYLCELLULOSE | Z944H5SN0H | SUSPENSION / OPHTHALMIC | 1 mg | ||
| methylcellulose | METHYLCELLULOSE | Z944H5SN0H | TABLET, COATED / ORAL | 138.3 mg | ||
| acacia | ACACIA | 5C5403N26O | TABLET, FILM COATED / ORAL | 0.14 mg | ||
| calcium stearate | CALCIUM STEARATE | 776XM7047L | TABLET, COATED / ORAL | 12.2 mg | ||
| calcium stearate | CALCIUM STEARATE | 776XM7047L | CAPSULE, EXTENDED RELEASE / ORAL | 91.9 mg | ||
| methylcellulose | METHYLCELLULOSE | Z944H5SN0H | TABLET, EXTENDED RELEASE / ORAL | 96 mg | ||
| acacia | ACACIA | 5C5403N26O | LOZENGE / ORAL | 108 mg | ||
| methylcellulose | METHYLCELLULOSE | Z944H5SN0H | TABLET / BUCCAL | 4 mg | ||
| acacia | ACACIA | 5C5403N26O | SUSPENSION / INTRAMUSCULAR | 1 mg | ||
| calcium stearate | CALCIUM STEARATE | 776XM7047L | TABLET, EXTENDED RELEASE / ORAL | 36 mg | ||
| methylcellulose | METHYLCELLULOSE | Z944H5SN0H | TABLET / ORAL | 816 mg | ||
| calcium stearate | CALCIUM STEARATE | 776XM7047L | TABLET / SUBLINGUAL | 2 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, COATED / ORAL | 224 mg | ||
| calcium stearate | CALCIUM STEARATE | 776XM7047L | POWDER / ORAL | 600 mg | ||
| methylcellulose | METHYLCELLULOSE | Z944H5SN0H | CAPSULE, EXTENDED RELEASE / ORAL | 4 mg | ||
| calcium stearate | CALCIUM STEARATE | 776XM7047L | TABLET, ORALLY DISINTEGRATING / ORAL | 112 mg | ||
| acacia | ACACIA | 5C5403N26O | TABLET, DELAYED RELEASE / ORAL | 30 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | INJECTION / INTRAMUSCULAR | 1 %w/v |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| FF05C699-8DAB-B9F1-AB84-710C3F40F661 | 92123CFA-5BD5-4554-8D5D-B877D5CB9C02 | 2007-06-19 | Warnings, Adverse reactions | FF05C699-8DAB-B9F1-AB84-710C3F40F661 92123CFA-5BD5-4554-8D5D-B877D5CB9C02 | ||
| 20ef388b-efce-44be-b321-fe7b729d3851 | 92123cfa-5bd5-4554-8d5d-b877d5cb9c02 | 2007-01-01 | Warnings, Adverse reactions | 92123cfa-5bd5-4554-8d5d-b877d5cb9c02 |
Adverse event summaries are temporarily unavailable. Other product information remains available.