Methocarbamol Injection

It is very important that your doctor check your progress closely while you are receiving methocarbamol. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.

Your doctor will only give you a few doses of methocarbamol until your condition improves, and then you will be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Check with your doctor before using methocarbamol with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with risperidone may worsen the side effects of methocarbamol, 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, including some dental anesthetics.

methocarbamol may cause some people to become dizzy or drowsy. Make sure you know how you react to methocarbamol before you drive, use machines, or do anything else that could be dangerous if you are not alert.

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

The vial stopper of methocarbamol injection contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using methocarbamol.

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.

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:

• Black, tarry stools
• blurred vision
• changes in skin color
• chest pain or discomfort
• chills
• clay-colored stools
• confusion
• convulsions
• cough
• dark urine
• difficulty swallowing
• dizziness, faintness, or lightheadedness when suddenly getting up from a lying or sitting position
• drowsiness
• fast heartbeat
• fever
• headache
• 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
• muscle spasm or jerking of all extremities
• nausea
• pain, tenderness, or swelling of the foot or leg
• painful or difficult urination
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash, hives, itching, red skin
• slow or irregular heartbeat
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain
• sudden loss of consciousness
• sweating
• swollen glands
• tightness in the chest
• 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:

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

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:

• Belching
• bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• burning, dry, or itching eyes
• discharge, excessive tearing
• double vision
• feeling of constant movement of self or surroundings
• feeling of warmth
• heartburn
• indigestion
• metallic taste
• redness of the face, neck, arms, and occasionally, upper chest
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• sensation of spinning
• stuffy nose
• trouble sleeping
• uncontrolled eye movements
• vomiting

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.

• If you have an allergy to methocarbamol or any other part of methocarbamol injection.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take methocarbamol injection. This includes your doctors, nurses, pharmacists, and dentists.
• If you have a latex allergy, talk with your doctor. Some products have latex.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take methocarbamol injection.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• This medicine is used with rest, PT (physical therapy), pain drugs, and other therapies.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use methocarbamol injection as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle or vein.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

The injectable form of methocarbamol is 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.

For Intravenous and Intramuscular Use Only. Total adult dosage should not exceed 30 mL (three vials) a day for more than 3 consecutive days except in the treatment of tetanus. If the condition persists, a like course may be repeated after a drug-free interval of 48 hours. Dosage and frequency of injection should be based on the severity of the condition being treated and therapeutic response noted.For the relief of symptoms of moderate degree, one dose of 1 gram (one 10 mL vial) may be adequate. Ordinarily this injection need not be repeated, as the administration of the oral form will usually sustain the relief initiated by the injection. For the severest cases or in postoperative conditions in which oral administration is not feasible, additional doses of 1 gram may be repeated every 8 hours up to a maximum of 3 g/day for no more than 3 consecutive days.

Directions for Intravenous Use: Methocarbamol Injection may be administered undiluted directly into the vein at a maximum rate of three mL per minute. It may also be added to an intravenous drip of Sodium Chloride Injection (Sterile Isotonic Sodium Chloride Solution for Parenteral Use) or five percent Dextrose Injection (Sterile 5 percent Dextrose Solution); one vial given as a single dose should not be diluted to more than 250 mL for intravenous infusion. AFTER MIXING WITH INTRAVENOUS INFUSION FLUIDS, DO NOT REFRIGERATE. Care should be exercised to avoid vascular extravasation of this hypertonic solution, which may result in thrombophlebitis. It is preferable that the patient be in a recumbent position during and for at least 10 to 15 minutes following the injection.

Directions for Intramuscular Use: When the intramuscular route is indicated, not more than 5 mL (one-half vial) should be injected into each gluteal region. The injections may be repeated at 8 hour intervals, if necessary. When satisfactory relief of symptoms is achieved, it can usually be maintained with tablets.

Not Recommended for Subcutaneous Administration.

Special Directions for Use in Tetanus: There is clinical evidence which suggests that methocarbamol may have a beneficial effect in the control of the neuromuscular manifestations of tetanus. It does not, however, replace the usual procedure of debridement, tetanus antitoxin, penicillin, tracheotomy, attention to fluid balance, and supportive care. Methocarbamol Injection should be added to the regimen as soon as possible.

For Adults: Inject one or two vials directly into the tubing of the previously inserted indwelling needle. An additional 10 mL or 20 mL may be added to the infusion bottle so that a total of up to 30 mL (three vials) is given as the initial dose (see PRECAUTIONS). This procedure should be repeated every 6 hours until conditions allow for the insertion of a nasogastric tube.

For Pediatric Patients: A minimum initial dose of 15 mg/kg or 500 mg/m2 is recommended. This dosage may be repeated every 6 hours, if required. The total dose should not exceed 1.8 g/m2 for 3 consecutive days. The maintenance dosage may be given by injection into tubing or by intravenous infusion with an appropriate quantity of fluid. See directions for intravenous use.

Methocarbamol Injection USP, 1,000 mg/10 mL (100 mg/mL) is a clear, colorless solution. It is available as follows:

NDC 67457-273-10
10 mL single-dose vials per carton of 25

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

This product is preservative free.

Discard unused portion.

Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.

Manufactured by:
Mylan Institutional
Galway, Ireland

APRIL 2014
MI:MTHCIJ:R1
0853L100