Methocarbamol injection

FDA label, Hikma Pharmaceuticals USA Inc., intravenous, effective 2024-04-10. Full label on DailyMed

Other products: Methocarbamol

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Muscle Relaxant

Dosing in kidney impairment

CONTRAINDICATIONS ROBAXIN Injectable should not be administered to patients with known or suspected renal pathology. This caution is necessary because of the presence of polyethylene glycol 300 in the vehicle. A much larger amount of polyethylene glycol 300 than is present in recommended doses of ROBAXIN Injectable is known to have increased pre-existing acidosis and urea retention in patients with renal impairment.

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Preparation and administration

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Directions for Intravenous Use ROBAXIN Injectable 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 I.V. infusion.

AFTER MIXING WITH I.V. 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 five mL (one-half vial) should be injected into each gluteal region.

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 six hours until conditions allow for the insertion of a nasogastric tube. Crushed methocarbamol tablets suspended in water or saline may then be given through this tube.

Total daily oral doses up to 24 grams may be required as judged by patient response. For pediatric patients: A minimum initial dose of 15 mg/kg or 500 mg/m 2 is recommended. This dosage may be repeated every six hours, if required. The total dose should not exceed 1.8 g/m 2 for 3 consecutive days. The maintenance dosage may be given by injection into tubing or by I.V. infusion with an appropriate quantity of fluid.

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  • Methocarbamol injection
Label text (1 paragraph)

Drug Interactions See WARNINGS and PRECAUTIONS for 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.

Contraindications

Injectable should not be administered to patients with known or suspected renal pathology. This caution is necessary because of the presence of polyethylene glycol 300 in the vehicle. A much larger amount of polyethylene glycol 300 than is present in recommended doses of ROBAXIN Injectable is known to have increased pre-existing acidosis and urea retention in patients with renal impairment. Although the amount present in this preparation is well within the limits of safety, caution dictates this contraindication. ROBAXIN Injectable is contraindicated in patients hypersensitive to methocarbamol or to any of the injection components.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

E

Likelihood score E: Unlikely cause of clinically apparent liver injury.

Methocarbamol is a commonly used, centrally acting muscle relaxant and has not been linked to instances of liver injury.

ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.

Source: LiverTox: Methocarbamol (NIDDK, public domain)Chapter updated Jan 30, 2017

Pregnancy and lactation

Pregnancy

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. ROBAXIN Injectable should be given to a pregnant woman only if clearly needed. Safe use of ROBAXIN Injectable 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, ROBAXIN Injectable 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 ).

Lactation

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 ROBAXIN Injectable is administered to a nursing woman.

Breastfeeding (LactMed)

No information is available on the use of methocarbamol during breastfeeding. If a mother requires methocarbamol, it is not a reason to discontinue breastfeeding. Monitor the infant for sedation, poor feeding and poor weight gain.

Source: LactMed: Methocarbamol (NICHD, public domain)Revised Sep 15, 2025

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