ROBAXIN 100 mg/mL

methocarbamol · INJECTION · Hikma Pharmaceuticals USA Inc.

No Recall History

Plain English

ROBAXIN is a injection containing methocarbamol at 100 mg/mL, taken intramuscular. Manufactured by Hikma Pharmaceuticals USA Inc..

Key Facts

Brand Name: ROBAXIN
Generic Name: methocarbamol
NDC Code (Product): 0641-6217
Manufacturer: Hikma Pharmaceuticals USA Inc.
Strength: 100 mg/mL
Dosage Form: INJECTION
Route: INTRAMUSCULAR, INTRAVENOUS
Marketing Status
Application #: NDA011790
Drug Class: Muscle Relaxant [EPC]
Marketing Start: 10/17/2017

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE 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.

Dosage & Administration

DOSAGE AND ADMINISTRATION For Intravenous and Intramuscular Use Only. Total adult dosage should not exceed 30 mL (3 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 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 In…

Warnings

WARNINGS Since methocarbamol may possess a general CNS depressant effect, patients receiving ROBAXIN Injectable should be cautioned about combined effects with alcohol and other CNS depressants. Safe use of ROBAXIN Injectable has not been established with regard to possible adverse effects upon fetal development. There have been very rare 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 PRECAUTIONS, Pregnancy ). Use in Activities Requiring Mental Alertness Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities.

Contraindications

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. 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.

Drug Interactions

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.

Adverse Reactions

ADVERSE REACTIONS The following adverse reactions have been reported coincident with the administration of methocarbamol. Some events may have been due to an overly rapid rate of intravenous injection. Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headache Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis In most cases of syncope there was spontaneous recovery. In others, epinephrine, injectable steroids, and/or injectable antihistamines were employed to hasten recovery. Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting Hemic and lymphatic system: Leukopenia Immune system: Hypersensitivity reactions Nervous system: Amnesia, confusion, diplopia, dizziness or light-headedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo The onset of convulsive seizures during intravenous administration of methocarbamol has been reported in patients with seizure disorders. The psychic trauma of the procedure may have been a contributing factor. Although several observers have reported success in terminating epileptiform seizures with RO…

Frequently Asked Questions

What is ROBAXIN used for?

ROBAXIN contains methocarbamol. It is a injection taken intramuscular. Consult your doctor for specific uses.

Is ROBAXIN a controlled substance?

ROBAXIN is not classified as a controlled substance by the DEA.

What is the generic name for ROBAXIN?

The generic name for ROBAXIN is methocarbamol. There are 12 other brand versions of methocarbamol.

What is the NDC code for ROBAXIN 100 mg/mL?

The NDC (National Drug Code) for ROBAXIN 100 mg/mL is 0641-6217, listed by Hikma Pharmaceuticals USA Inc..

Product NDC

0641-6217

Package NDC

0641-6217-10

Other Methocarbamol Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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