methocarbamol 1000 MG in 10 ML Injection
Generic Name: METHOCARBAMOL
Brand Name: ROBAXIN
- Substance Name(s):
- METHOCARBAMOL
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.
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.
OVERDOSAGE
Limited information is available on the acute toxicity of methocarbamol.
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.
Treatment Management of overdose includes symptomatic and supportive treatment.
Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary.
The usefulness of hemodialysis in managing overdose is unknown.
DESCRIPTION
ROBAXIN (methocarbamol injection, USP) Injectable, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties.
It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration.
Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q.s.
The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.
The chemical name of methocarbamol is 3‑(2‑methoxyphenoxy)‑1,2-propanediol 1‑carbamate and has the empirical formula of C 11 H 15 NO 5 .
Its molecular weight is 241.24.
The structural formula is shown below: Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n ‑hexane.
ROBAXIN Injectable has a pH between 3.5 and 6.0.
AFTER MIXING WITH I.V.
INFUSION FLUIDS, DO NOT REFRIGERATE.
Structural formula
HOW SUPPLIED
ROBAXIN Injectable (100 mg/mL) supplied in – 10 mL single dose vials in packages of 25 (NDC 0641-6103-25).
Store at 20 ° – 25 ° C (68 ° – 77 ° F), excursions permitted to 15 ° – 30 ° C (59 ° – 86 ° F).
Not made with natural rubber latex.
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp.
at 1-877-845-0689 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
For Product Inquiry call 1-877-845-0689.
Manufactured by: WEST-WARD A HIKMA COMPANY Eatontown, NJ 07724 USA Revised October 2017 462-153-03
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.
PEDIATRIC USE
Pediatric Use Safety and effectiveness of ROBAXIN Injectable in pediatric patients have not been established except in tetanus.
See DOSAGE AND ADMINISTRATION, Special Directions for Use in Tetanus , For Pediatric Patients .
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 ).
NUSRING MOTHERS
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.
INFORMATION FOR PATIENTS
Information for Patients Patients should be cautioned that methocarbamol may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery.
Because methocarbamol may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.
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 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.
The injections may be repeated at eight 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.
ROBAXIN Injectable 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 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.
See directions for I.V.
use.