Label: METHOCARBAMOL tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 43353-948-30, 43353-948-53, 43353-948-60, 43353-948-70, view more43353-948-80, 43353-948-90, 43353-948-92 - Packager: Aphena Pharma Solutions - Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 60429-118
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 20, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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DESCRIPTION
Methocarbamol Tablets USP, 500 mg, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties.
The chemical name of methocar-bamol 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 tablet, 500 mg is available as an orange, film coated, round convex tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, FD&C Yellow 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide.
- CLINICAL PHARMACOLOGY
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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
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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
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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.
- CONTRAINDICATIONS
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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.
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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.
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
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Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
Count 500mg 30 43353-948-30 60 43353-948-53 90 43353-948-60 120 43353-948-70 180 43353-948-80 240 43353-948-90 270 43353-948-92 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20160419MM - PRINCIPAL DISPLAY PANEL - 500mg
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INGREDIENTS AND APPEARANCE
METHOCARBAMOL
methocarbamol tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43353-948(NDC:60429-118) 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TRIACETIN (UNII: XHX3C3X673) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE Score 2 pieces Shape ROUND Size 13mm Flavor Imprint Code AP212 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43353-948-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/08/2014 2 NDC:43353-948-53 60 in 1 BOTTLE; Type 0: Not a Combination Product 06/02/2014 3 NDC:43353-948-60 90 in 1 BOTTLE; Type 0: Not a Combination Product 06/02/2014 4 NDC:43353-948-70 120 in 1 BOTTLE; Type 0: Not a Combination Product 06/27/2014 5 NDC:43353-948-80 180 in 1 BOTTLE; Type 0: Not a Combination Product 07/24/2014 6 NDC:43353-948-90 240 in 1 BOTTLE; Type 0: Not a Combination Product 10/17/2014 7 NDC:43353-948-92 270 in 1 BOTTLE; Type 0: Not a Combination Product 07/25/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA200958 02/20/2014 Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(43353-948)
