METHOCARBAMOL- methocarbamol tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X)
Available from:
Direct_Rx
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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
Product summary:
Methocarbamol tablets USP 500 mg are white to off white, capsule shaped, tablets debossed with ‘H’ on scored side and ‘114’ on unscored side . They are supplied as follows: Bottles of 30 Bottles of 60 Bottles of 100 Bottles of 500 Bottles of 1000 Methocarbamol tablets USP 750 mg are white to off white, capsule shaped, tablets debossed with ‘H’ on one side and ‘115’ on other side . They are supplied as follows: Bottles of 30 Bottles of 60 Bottles of 100 Bottles of 500 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Labs Limited 2012754 Jeedimetla, Hyderabad- 500 055, India
Authorization status:
Abbreviated New Drug Application
Authorization number:
61919-903-30

METHOCARBAMOL- methocarbamol tablet

Direct_Rx

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METHOCARBAMOL

Methocarbamol tablets USP a carbamate derivative of guaifenesin, is 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 C 11H 15NO 5. 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: sodium

lauryl sulfate, sodium starch glycolate, povidone K 90, polyethylene glycol, magnesium stearate,

colloidal silicon dioxide, low substituted hydroxypropyl cellulose and stearic acid.

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

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

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

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.

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.

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).

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.

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 & OR 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.

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,

urticarial

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.

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 to off white, capsule shaped, tablets debossed with ‘H’

on scored side and ‘114’ on unscored side . They are supplied as follows:

Bottles of 30

Bottles of 60

Bottles of 100

Bottles of 500

Bottles of 1000

Methocarbamol tablets USP 750 mg are white to off white, capsule shaped, tablets debossed with ‘H’

on one side and ‘115’ on other side . They are supplied as follows:

Bottles of 30

Bottles of 60

Bottles of 100

Bottles of 500

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in tight container.

Manufactured for:

Camber Pharmaceuticals, Inc.

Piscataway, NJ 08854

By: Hetero Labs Limited 2012754

Jeedimetla, Hyderabad- 500 055, India

METHOCARBAMOL

methocarbamol tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 19 19 -9 0 3(NDC:31722-534)

Route of Administration

ORAL

Dire ct_Rx

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

METHO CARBAMO L (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X)

METHOCARBAMOL

750 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

HYDRO XYPRO PYL CELLULO SE ( 16 0 0 0 0 0 WAMW) (UNII: RFW2ET6 71P)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

PO VIDO NE K9 0 (UNII: RDH8 6 HJV5Z)

Product Characteristics

Color

white ((White to Offwhite))

S core

no sco re

S hap e

OVAL ((Capsule shaped))

S iz e

19 mm

Flavor

Imprint Code

115;H

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 19 19 -9 0 3-30

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /27/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 0 20 0

0 8 /27/20 19

Labeler -

Direct_Rx (079254320)

Registrant -

Direct_Rx (079254320)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Dire c t_Rx

0 79 254320

re pa c k(6 19 19 -9 0 3)

Revised: 8/2019

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