Fresenius Kabi, a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition, announced today the immediate availability in the United States of Methocarbamol Injection, USP in a 100 mg per mL 10 mL vial presentation.
Methocarbamol Injection, USP is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The product is the newest addition to Fresenius Kabis broad portfolio of medicines for anesthesia and analgesia.
Fresenius Kabi is a leading developer, manufacturer and provider of injected and infused medicines in the United States with special expertise in producing high quality, affordable generic alternatives to more expensive brand-name drugs.
We are pleased to expand our anesthesia and analgesia portfolio with the introduction of Methocarbamol Injection, a medication that can provide relief for people with acute, painful musculoskeletal conditions, said John Ducker, president and CEO of Fresenius Kabi USA.
INDICATIONS AND USAGE
Methocarbamol Injection, USP is indicated for intravenous and intramuscular use only. 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.
IMPORTANT SAFETY INFORMATION
Due to the presence of polyethylene glycol 300 in the vehicle of the injection, Methocarbamol Injection, USP should not be administered to patients with known or suspected renal pathology. Methocarbamol Injection, USP is contraindicated in patients hypersensitive to methocarbamol or to any of the injection components.
May possess a general CNS depressant effect: patients should be cautioned about combined effects with alcohol and other CNS depressants.
IMPORTANT SAFETY INFORMATION (cont.)
Use caution in activities requiring mental alertness: patients should be cautioned that methocarbamol may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery.
Careful supervision of dose and rate of injection should be observed: rate of injection should not exceed 3 mL per minute“i.e., one 10 mL vial in approximately three minutes. Since Methocarbamol Injection, USP is hypertonic, vascular extravasation must be avoided.
Caution should be observed in using Methocarbamol Injection, USP in patients with suspected or known seizure disorders.
May inhibit the effect of pyridostigmine bromide: use with caution in patients with myasthenia gravis receiving anticholinesterase agents.
Teratogenic Effects-Pregnancy Category C: Methocarbamol Injection, USP 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.
The following adverse reactions have been reported coincident with the administration of Methocarbamol Injection, USP: Anaphylactic reaction, angioneurotic edema, fever, headache, bradycardia, flushing, hypotension, syncope, thrombophlebitis, dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting, leukopenia, hypersensitivity reactions, amnesia, confusion, diplopia, dizziness or light-headedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo, blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria, pain and sloughing at the site of injection.
Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures, and coma. In post-marketing experience deaths have been reported with an overdose of methocarbamol alone or in the presence of other CNS depressants, alcohol or psychotropic drugs
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This Important Safety Information does not include all the information needed to use Methocarbamol Injection, USP, safely and effectively. Please see full prescribing information for Methocarbamol Injection, USP at https://tinyurl.com/y2nklwal.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The companys products and services are used to help care for critically and chronically ill patients. The companys U.S. headquarters is in Lake Zurich, Illinois. The companys global headquarters is in Bad Homburg, Germany.
Matt Kuhn, (847) 550-5751