Methocarbamol

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Contraindications

Hypersensitivity

Renal impairment (parenteral)

Cautions

May cause drowsiness/dizziness; patients should not ingest alcohol or other CNS depressants

May take with food to avoid stomach upset

Half-life increases with hepatic impairment

IV formulation not for use in renal impairment (contains polyethylene glycol; injection rate should not exceed 3 mL/min

May interfere with screening tests for 5-HIAA and vanillylmandelic acid (VMA)

Use injection with caution in patients with a history of seizures

Sedative effects potentiated when used with other sedatives

Medication is poorly tolerated in the elderly

Pediatric IV dosing approved only for tetanus

robaxin® (methocarbamol tablets, USP) 500 mg tablets are light orange, round, film-coated tablets engraved with ROBAXIN 500 on the unscored side and SP above the score on the other side. They are supplied as follows:

Bottles of 100 NDC 5224442910

robaxin® 750 (methocarbamol tablets, USP) 750 mg tablets are orange, capsule-shaped, film-coated tablets engraved with ROBAXIN 750 on one side and SP on the other. They are supplied as follows:

Bottles of 100 NDC 5224444910

Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).

Dispense in tight container.

Distributed by: Actient Pharmaceuticals, LLC, Lake Forest, Illinois 60045. Revised: Mar 2011

Before taking methocarbamol, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to any ingredient in methocarbamol
• have kidney or liver disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

• Store tablets at room temperature between 20°C and 25°C (68°F and 77°F).
• Keep this and all medications out of the reach of children.

Methocarbamol is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) that are sent to your brain.

Methocarbamol is used together with rest and physical therapy to treat skeletal muscle conditions such as pain or injury.

Methocarbamol may also be used for purposes not listed in this medication guide.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Centrally acting skeletal muscle relaxant.b

Muscular Conditions

Adjunct to rest, physical therapy, analgesics, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.a b c

If pharmacologic therapy is required for acute low back pain (usually a benign and self-limiting condition105 106 108 ), an analgesic (e.g., acetaminophen, NSAIA) generally is recommended.104 105 106 108 117 Skeletal muscle relaxants may be used alone or in combination with analgesics for short-term relief; however, consider high incidence of adverse effects (e.g., CNS effects).104 106 107 108 Use skeletal muscle relaxants with caution and weigh risks against benefits.104 106 107 108

Various skeletal muscle relaxants appear to have comparable efficacy for low back pain relief.103 104 106 108

Methocarbamol is ineffective in the treatment of skeletal muscle hyperactivity secondary to chronic neurologic disorders (e.g., cerebral palsy) and other dyskinesias.b

Tetanus

Has been used as an adjunct to debridement, tetanus antitoxin, penicillin, tracheotomy, fluid and electrolyte replacement, and supportive therapy in the management of tetanus.b However, most authorities prefer other sedatives or muscle relaxants (e.g., diazepam) and, in severe cases, neuromuscular blocking agents.b

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 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
NDC 0143-1290-01 
500 mg
100 Tablets
Rx Only

(meth oh KAR ba mole)

Cl is decreased approximately 70%; t1/2 is prolonged ~ 3-fold in cirrhosis patients.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme drowsiness, fainting, or seizure (convulsions).

Applies to methocarbamol: oral tablet

Other dosage forms:

• injection solution

Along with its needed effects, methocarbamol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking methocarbamol:

• Black, tarry stools
• changes in skin color
• chest pain or discomfort
• chills
• clay-colored stools
• cough
• dark urine
• diarrhea
• difficulty in swallowing
• dizziness
• fast heartbeat
• feeling of warmth
• fever
• headache
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lightheadedness, dizziness, or fainting
• loss of appetite
• loss of bladder control
• loss or problems with memory
• nausea
• numbness or tingling of face, hands, or feet
• pain, tenderness, or swelling of foot or leg
• painful or difficult urination
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness and soreness of the eyes
• redness of the face, neck, arms, and occasionally, upper chest
• skin rash
• sleepiness
• slow or irregular heartbeat
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain
• sweating
• swollen glands
• tightness in the chest
• total body jerking
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking methocarbamol:

• Loss of consciousness
• shaking or jerking of one area or side of the body

Some side effects of methocarbamol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Belching
• double vision
• drowsiness
• feeling of constant movement of self or surroundings
• heartburn
• indigestion
• mood or mental changes
• sensation of spinning
• stomach discomfort, upset, or pain
• trouble sleeping
• uncontrolled eye movements

Data not available

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using methocarbamol and call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• slow heartbeats;

• fever, chills, flu symptoms;

• a seizure (convulsions); or

• jaundice (yellowing of your skin or eyes).

Common side effects may include:

• dizziness, drowsiness;

• nausea, vomiting, upset stomach;

• flushing (warmth, redness, or tingly feeling);

• confusion, problems with memory;

• blurred vision, double vision;

• sleep problems (insomnia); or

• lack of coordination.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking methocarbamol with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with methocarbamol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.