Fresenius Kabi introduces 100 mg per mL 10 mL vial presentation
LAKE ZURICH, Ill.–(BUSINESS WIRE)–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
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 Kabi’s 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
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
company’s products and services are used to help care for critically and
chronically ill patients. The company’s U.S. headquarters is in Lake
Zurich, Illinois. The company’s global headquarters is in Bad Homburg,
Matt Kuhn, (847) 550-5751