INFORMATION FOR PATIENTS SECTION.

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 general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.

NURSING MOTHERS SECTION.

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 USP, 500 mg or 750 mg is administered to nursing woman.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Adverse reactions reported coincident with the administration of methocarbamol include: Body as 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, and rash, urticarial.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

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.

CLINICAL PHARMACOLOGY SECTION.

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.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Methocarbamol Tablets USP, 500 mg and 750 mg are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

DESCRIPTION SECTION.

DESCRIPTION. Methocarbamol Tablets USP, carbamate derivative of guaifenesin, is central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is - (2-methoxyphenoxy) -1, 2- propanediol 1- carbamate and has the empirical formula 11 15 NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is 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, 500 mg is available as light orange colored, round, film- coated tablets, engraved with B134 on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow 6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material.Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with B135 on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contains Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow 10 Aluminum Lake, FD&C yellow 6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material.. The structural formula for Methocarbamol Tablets USP, carbamate derivative of guaifenesin, is central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The che.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Methocarbamol Tablets USP, 500 mg Adults: Initial dosage: tablets q.i.d. Maintenance dosage: tablets q.i.d.Methocarbamol Tablets USP, 750 mg Adults: Initial dosage: tablets q.i.d. Maintenance dosage: tablet q.4h. or tablets t.i.d. Six grams day are recommended for the first 48 to 72 hours of treatment. (For severe conditions grams day may be administered). Thereafter, the dosage can usually be reduced to approximately grams day.

DRUG & OR LABORATORY TEST INTERACTIONS SECTION.

Drug/Laboratory Test Interactions. Methocarbamol may cause 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.

DRUG INTERACTIONS SECTION.

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.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Methocarbamol Tablets USP, 500 mg are light orange colored, round, film-coated tablets, engraved with B134 on one side and scored on the other side. They are supplied as follows:Bottles of 100 NDC 10135-0664-01Bottles of 500 NDC 10135-0664-05Methocarbamol Tablets USP, 750 mg are orange colored, capsule shaped, film coated tablets, engraved with B135 on one side and plain on the other side. They are supplied as follows:Bottles of 100 NDC 10135-0665-01Bottles of 500 NDC 10135-0665-05Store at controlled room temperature, between 20C and 25C (68F and 77F). Dispense in tight container.Manufactured for Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev. 09/18B.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Methocarbamol Tablets USP, 500 mg and 750 mg 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.

OVERDOSAGE SECTION.

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.TreatmentManagement 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. NDC 10135-0664-01 Methocarbamol Tablets, USP 500 mg Rx Only 100 Tablets PRINCIPAL DISPLAY PANELNDC 10135-0664-01Methocarbamol Tablets, USP500 mgRx Only100 Tablets.

PEDIATRIC USE SECTION.

Pediatric Use. Safety and effectiveness of Methocarbamol Tablets USP, 500 mg and 750 mg in pediatric patients below the age of 16 have not been established.

PHARMACOKINETICS SECTION.

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 and 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.

PRECAUTIONS SECTION.

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 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 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 CAnimal reproduction studies have not been conducted with methocarbamol. It is also not known whether methocarbamol can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Methocarbamol Tablets USP, 500 mg and 750 mg should be given to pregnant woman only if clearly needed Safe use Methocarbamol Tablets USP, 500 mg and 750 mg 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, 500 mg and 750 mg 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 USP, 500 mg or 750 mg is administered to nursing woman.. Pediatric Use. Safety and effectiveness of Methocarbamol Tablets USP, 500 mg and 750 mg in pediatric patients below the age of 16 have not been established.

SPL UNCLASSIFIED SECTION.

Methocarbamol Tablets USP, 500 mg and 750 mg(Methocarbamol USP) Rx Only.

WARNINGS SECTION.

WARNINGS. Since methocarbamol may possess general CNS depressant effect, patients receiving Methocarbamol Tablets USP, 500 mg or 750 mg should be cautioned about combined effects with alcohol and other CNS depressants.Safe use of Methocarbamol Tablets USP, 500 mg and 750 mg 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, 500 mg and 750 mg 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).