Methocarbamol

Dosage Form: Tablets

Rev. 01/03
Rx Only

Methocarbamol Description

Methocarbamol is an aromatic glycerol ether and is a close chemical relative to mephenesin carbamate, the oldest and most extensively studied of the drugs in this class. The chemical name for Methocarbamol is 3-(o- Methoxyphenoxy)-1,2-propanediol 1-carbamate. The structural formula is:

Each tablet, for oral administration, contains 500 mg or 750 mg of Methocarbamol. 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.

Methocarbamol - Clinical Pharmacology

The mechanism of action of Methocarbamol in humans has not been established, but may be due to central nervous system depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.

Indications and Usage for Methocarbamol

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 this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.

Contraindications

Methocarbamol tablets are contraindicated in patients hypersensitive to any of the ingredients.

Warnings

Since Methocarbamol tablets may possess a general central nervous system depressant effect, patients receiving Methocarbamol tablets should be cautioned about combined effects with alcohol and other CNS depressants.

Safe use of Methocarbamol has not been established with regard to possible adverse effects upon fetal development. Therefore, Methocarbamol tablets should not be used in woman who are, or may become, pregnant and particularly during early pregnancy unless in the judgement of the physician, the potential benefits outweigh the possible hazards.

Precautions

Safety and effectiveness in children below the age of twelve (12) years have not been established.

It is not known whether this drug is secreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk. Methocarbamol may cause a color interference in certain screening tests for 5-hydroxyindoleacetic acid (5-HIAA) and vanilmandelic acid (VMA).

Adverse Reactions

Lightheadedness, dizziness, drowsiness, nausea, allergic manifestations such as urticaria, pruritus, rash, conjunctivitis with nasal congestion, blurred vision, headache, fever.

Methocarbamol 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.

How is Methocarbamol Supplied

Methocarbamol Tablets 500 mg: White, round, scored, compressed tablet imprinted “West-ward 290”.

 

Bottles of 100 tablets.

 

Bottles of 500 tablets.

 

Unit Dose Boxes of 100 tablets.

Methocarbamol Tablets 750 mg: White, capsule-shaped, scored, compressed tablet imprinted “West-ward 292”.

 

Bottles of 100 tablets.

 

Bottles of 500 tablets.

 

Unit Dose Boxes of 100 tablets.

Store at 20-25°C (68-77°F) [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.

Manufactured by:
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724
Rev January 2003

Methocarbamol (Methocarbamol)

PRODUCT INFO Product Code 0143-1290 Dosage Form TABLET Route Of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Methocarbamol (Methocarbamol) Active 500 MILLIGRAM  In 1 TABLET Methylcellulose Inactive   Lactose Mononhydrate Inactive   Pregelantinized Starch 1500 Inactive   Colloidal Silicon Dioxide Inactive   Magnesium Stearate Inactive

IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color WHITE (WHITE) Score 2 Shape ROUND (ROUND) Symbol false Imprint Code West-ward;290 Coating false Size 20mm

PACKAGING # NDC Package Description Multilevel Packaging 1 0143-1290-01 100 TABLET In 1 BOTTLE, PLASTIC None 2 0143-1290-05 500 TABLET In 1 BOTTLE, PLASTIC None 3 0143-1290-25 10 BLISTER PACK In 1 BOX, UNIT-DOSE contains a BLISTER PACK 3 10 TABLET In 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (0143-1290-25)

Methocarbamol (Methocarbamol)

PRODUCT INFO Product Code 0143-1292 Dosage Form TABLET Route Of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Methocarbamol (Methocarbamol) Active 750 MILLIGRAM  In 1 TABLET Methylcellulose Inactive   Lactose Mononhydrate Inactive   Pregelantinized Starch 1500 Inactive   Colloidal Silicon Dioxide Inactive   Magnesium Stearate Inactive

IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color WHITE (WHITE) Score 2 Shape OVAL (CAPSULE) Symbol false Imprint Code West-ward;292 Coating false Size 27mm

PACKAGING # NDC Package Description Multilevel Packaging 1 0143-1292-01 100 TABLET In 1 BOTTLE, PLASTIC None 2 0143-1292-05 500 TABLET In 1 BOTTLE, PLASTIC None 3 0143-1292-25 10 BLISTER PACK In 1 BOX, UNIT-DOSE contains a BLISTER PACK 3 10 TABLET In 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (0143-1292-25)

Revised: 12/2006