Label: METHOCARBAMOL tablet
Contains inactivated NDC Code(s)
NDC Code(s): 67544-662-20, 67544-662-53, 67544-662-60, 67544-662-70, view more67544-662-80, 67544-747-30, 67544-747-53, 67544-747-60, 67544-747-70, 67544-747-80, 67544-747-90, 67544-747-92
- Packager: Aphena Pharma Solutions - Tennessee, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0143-1290, 0143-1292
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated July 16, 2012
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
Methocarbamol Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is:
The chemical name for Methocarbamol is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24.
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 500 mg or 750 mg of methocarbamol, USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate.
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.
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.
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.
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.
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 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 congential 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).
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.
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.
DOSAGE AND ADMINISTRATION:
500 mg – Adults: Initial dosage, 3 tablets q.i.d.; maintenance dosage, 2 tablets q.i.d.
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.
Repackaged by Aphena Pharma Solutions - TN.
See Repackaging Information for available configurations.
Methocarbamol Tablets 500 mg: White, Round, Scored, Compressed Tablet; Debossed “West-ward 290”
Bottles of 100 tablets
Bottles of 500 tablets
Methocarbamol Tablets 750 mg: White, Capsule Shaped, Scored Tablet; Debossed “West-ward 292”
Bottles of 100 tablets
Bottles of 500 tablets
Store at 20-25oC (68-77oF) [See USP Controlled Room Temperature]. Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724
Revised July 2009
Please reference the How Supplied section listed above for a description of individual tablets or capsules. 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 750mg 20 - 67544-662-20 30 67544-747-30 - 60 67544-747-53 67544-662-53 90 67544-747-60 67544-662-60 120 67544-747-70 67544-662-70 180 67544-747-80 67544-662-80 240 67544-747-90 - 270 67544-747-92 -
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.
Cookeville, TN 38506
- PRINCIPAL DISPLAY PANEL - 500mg
- PRINCIPAL DISPLAY PANEL - 750mg
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67544-747(NDC:0143-1290) 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 METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color WHITE (WHITE) Score 2 pieces Shape ROUND (ROUND) Size 20mm Flavor Imprint Code West;ward;290 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67544-747-30 30 in 1 BOTTLE, PLASTIC 2 NDC:67544-747-53 60 in 1 BOTTLE, PLASTIC 3 NDC:67544-747-60 90 in 1 BOTTLE, PLASTIC 4 NDC:67544-747-70 120 in 1 BOTTLE, PLASTIC 5 NDC:67544-747-80 180 in 1 BOTTLE, PLASTIC 6 NDC:67544-747-90 240 in 1 BOTTLE, PLASTIC 7 NDC:67544-747-92 270 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA085159 01/01/2000 METHOCARBAMOL
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67544-662(NDC:0143-1292) 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 METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color WHITE (WHITE) Score 2 pieces Shape OVAL (CAPSULE) Size 27mm Flavor Imprint Code West;ward;292 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67544-662-20 20 in 1 BOTTLE, PLASTIC 2 NDC:67544-662-53 60 in 1 BOTTLE, PLASTIC 3 NDC:67544-662-60 90 in 1 BOTTLE, PLASTIC 4 NDC:67544-662-70 120 in 1 BOTTLE, PLASTIC 5 NDC:67544-662-80 180 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA085159 01/01/2000 Labeler - Aphena Pharma Solutions - Tennessee, Inc. (128385585) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, Inc. 128385585 Repack(67544-662, 67544-747)