Description

Methocarbamol is used to relieve the discomfort caused by acute (short-term), painful muscle or bone conditions. However, this medicine does not take the place of rest, exercise, physical therapy, or other treatment that your doctor may recommend for your medical problem.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Tablet

Suspension

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of methocarbamol in children younger than 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of methocarbamol in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Isocarboxazid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alfentanil

Alprazolam

Amobarbital

Anileridine

Aprobarbital

Aripiprazole

Aripiprazole Lauroxil

Asenapine

Baclofen

Benperidol

Benzhydrocodone

Bromazepam

Buprenorphine

Buspirone

Butabarbital

Butalbital

Butorphanol

Calcium Oxybate

Cannabidiol

Cannabis

Carbamazepine

Carbidopa

Carbinoxamine

Carisoprodol

Carphenazine

Cetirizine

Chloral Hydrate

Chlordiazepoxide

Chlorpromazine

Chlorzoxazone

Clobazam

Clomipramine

Clonazepam

Clorazepate

Clozapine

Codeine

Cyclobenzaprine

Cyproheptadine

Dantrolene

Daridorexant

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Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Tizanidine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Kidney disease or

Liver disease—Use with caution. The effects of this medicine may be increased because of slower removal from the body.

Myasthenia gravis (muscle weakness)—Use with caution. May make this condition worse.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.

Shake the oral liquid for 30 seconds before using it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For relaxing stiff muscles:

For oral dosage form (tablets):

Adults—At first, three tablets of 500 milligrams (mg) or two tablets of 750 mg (total dose of 1500 mg) 4 times a day. Your doctor may adjust your dose as needed.

Children—Use and dose must be determined by your doctor.

For oral dosage form (suspension):

Adults and children 16 years of age and older—At first, 1500 milligrams (mg) or 10 milliliters (mL) 4 times a day. Then, a maintenance dose of 750 mg or 5 mL every 4 hours or 1500 mg or 10 mL 3 times a day. 6 or 8 grams (g) per day is recommended for the first 48 to 72 hours of treatment. Your doctor may adjust your dose as needed.

Children younger than 16 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Check with your doctor before taking any of these medicines while you are using this medicine. The use of alcohol or other medicines that affect the CNS with risperidone may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics.

This medicine may cause some people to become dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once.Signs of an overdose include: blurred vision, change or loss of consciousness, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, nausea, pale or blue lips, fingernails, or skin, seizures, sleepiness, sweating, trouble breathing, or unusual tiredness or weakness.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine 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:

Incidence not known

Black, tarry stools

changes in skin color

chest pain, discomfort, or tightness

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

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:

Symptoms of Overdose

Blurred vision

change in consciousness

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

loss of consciousness

pale or blue lips, fingernails, or skin

seizures

shaking or jerking of one area or side of the body

sweating

trouble breathing

unusual tiredness or weakness

Some side effects 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:

Incidence not known

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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.