METHOCARBAMOL- methocarbamol tablet, coated

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 are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.
Product summary:
Methocarbamol tablets, USP 500 mg are light orange colored, roundshaped film coated tablets debossed with "G" above the score line onone side and "500" on other side. They are supplied as follows Bottles of 24 tablets Bottles of 100 tablets N Bottles of 500 tablets Bottles of 1000 tablets Methocarbamol tablets, USP 750 mg are light orange colored, capletshaped film coated tablets debossed with "G" on one side and"750" on other side. Bottles of 24 tablets Bottles of 100 tablets Bottles of 500 tablets Bottles of 1000 tablets 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
Authorization status:
Abbreviated New Drug Application
Authorization number:
61919-616-90

METHOCARBAMOL- methocarbamol tablet, coated

Direct_Rx

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METHOCARBAMOL 750mg

Methocarbamol tablet, 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 1,2-Propanediol,3-(2-methoxyphenoxy)-,1-Carbamate,(±)-.(or)

(±)-3-(o-Methoxyphenoxy)-1,2-Propanediol 1-carbamate and has the empirical formula C11H15NO5. Its

molecular weight is 241.24g/mol. The structural formula is shown below.

[str]

Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol

(only with heating), insoluble in benzene and in n-hexane.

Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration.

Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets

debossed with "G" above the score line on one side and "500" on other side.

Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets

debossed with "G" on one side and "750" on other side.

Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: colloidal

silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid.

The tabets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose,

hypromellose, polysorbate 80, propylene glycol, and titanium dioxide

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 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 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.

DRUG INTERACTIONS

See WARNINGS and PRECAUTIONSfor 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 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 should be given to a pregnant woman only if clearly needed.

Safe use of methocarbamol tablet 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 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 are administered to a nursing

woman.

PEDIATRIC USE

Safety and effectiveness of methocarbamol tablets 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,

Urticaria

To report SUSPECTED ADVERSE REACTIONS, contact Granules USA, Inc. at 1-877-770-3183 or

FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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 4 times daily

Maintenance dosage: 2 tablets 4 times daily

Methocarbamol Tablets, USP 750 mg – Adults:

Initial dosage: 2 tablets 4 times daily

Maintenance dosage: 1 tablet every 4 hours or 2 tablets three times daily

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 light orange colored, roundshaped film coated tablets

debossed with "G" above the score line onone side and "500" on other side.

They are supplied as follows

Bottles of 24 tablets

Bottles of 100 tablets N

Bottles of 500 tablets

Bottles of 1000 tablets

Methocarbamol tablets, USP 750 mg are light orange colored, capletshaped film coated tablets

debossed with "G" on one side and"750" on other side.

Bottles of 24 tablets

Bottles of 100 tablets

Bottles of 500 tablets

Bottles of 1000 tablets

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

METHOCARBAMOL

methocarbamol tablet, coated

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 19 19 -6 16 (NDC:70 0 10 -770 )

Route of Administration

ORAL

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

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

STARCH, CO RN (UNII: O8 232NY3SJ)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

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

HYPRO MELLO SE 2 9 10 ( 6 MPA.S) (UNII: 0 WZ8 WG20 P6 )

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

Product Characteristics

Color

o ra nge

S core

no sco re

S hap e

CAPSULE

S iz e

19 mm

Flavor

Imprint Code

G;750

Dire ct_Rx

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 19 19 -6 16 -9 0

9 0 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

ANDA20 9 312

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 -6 16 )

Revised: 8/2019

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