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| Product NDC Code | 61919-616 | ||||||||
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| Drug Name | Methocarbamol |
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| Type | Generic | ||||||||
| Pharm Class | Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | TABLET, COATED | ||||||||
| RxCUI drug identifier | 197943, 197944 |
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| Application Number | ANDA209312 | ||||||||
| Labeler Name | DIRECT RX | ||||||||
| Packages |
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Overdosage of Methocarbamol
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.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.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.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
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.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.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Methocarbamol tablets, USP are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION 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-meth-oxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. [Methocarbamol Chemical Structure] 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: povidone, sodium starch glycolate and magnesium stearate.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION 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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE 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.
Spl product data elements
Usually a list of ingredients in a drug product.Methocarbamol Methocarbamol METHOCARBAMOL METHOCARBAMOL STEARIC ACID FD&C YELLOW NO. 6 FOOD YELLOW 3 FREE ACID HYPROMELLOSE 2910 (6 MPA.S) POLYSORBATE 80 TITANIUM DIOXIDE SILICON DIOXIDE SODIUM LAURYL SULFATE HYDROXYPROPYL CELLULOSE (1600000 WAMW) PROPYLENE GLYCOL STARCH, CORN POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO G;750 METHOCARBAMOL METHOCARBAMOL POVIDONE METHOCARBAMOL METHOCARBAMOL SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE White to off White S226 Capsule Shaped METHOCARBAMOL METHOCARBAMOL SODIUM LAURYL SULFATE MAGNESIUM STEARATE SILICON DIOXIDE HYDROXYPROPYL CELLULOSE (1600000 WAMW) STEARIC ACID POLYETHYLENE GLYCOL, UNSPECIFIED METHOCARBAMOL METHOCARBAMOL SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE K90 White to Offwhite 114;H Capsule shaped
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL 750MG METHOCARBAMOL 750mg 120TABS
368-30
616-30
61919-616-60
368-40
368-60
61919-368-90
368-07
61919-616-20
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.Methocarbamol tablets, USP 500 mg are white to off white, capsule shaped, tablets debossed with ‘H’ on scored side and ‘114’ on unscored side . Methocarbamol tablets, USP 750 mg are light orange colored, capletshaped film coated tablets debossed with "G" on one side and"750" on other side. Store between 20ºC and 25ºC (68ºF and 77º F) [see USP Controlled Room Temperature]. Dispense in tight container. Manufactured for: Granules USA, Inc. Parsippany, NJ 07054 Toll-free: 1-877-770-3183 Manufactured by: Granules India Limited Hyderabad-500 081 Made in India Issued: January 2017
Storage and handling
Information about safe storage and handling of the drug product.STORAGE Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F). [see USP Controlled Room Temperature]. Dispense in tight container.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.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 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). 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 are administered to a nursing woman. Pediatric use Safety and effectiveness of Methocarbamol tablets, USP in pediatric patients below the age of 16 have not been established.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS 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). 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
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API