Methocarbamol 100 mg/mL
Methocarbamol · INJECTION, SOLUTION · Fresenius Kabi USA, LLC
Methocarbamol is a injection, solution containing methocarbamol at 100 mg/mL, taken intramuscular. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- Methocarbamol
- Generic Name
- Methocarbamol
- NDC Code (Product)
63323-778- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 100 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA209331
- Drug Class
- Muscle Relaxant [EPC]
- Marketing Start
- 04/17/2018
Recall History
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
Lack of sterility assurance.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Endo Pharmaceuticals, Inc.
Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."
Specialty Medicine Compounding Pharmacy
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Somerset Therapeutics Private Limited
Lack of Assurance of Sterility: Media fill with bacterial contamination
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Golden State Medical Supply Inc.
Presence of Foreign Substance: Presence of hair.
American Pharmaceutical Ingredients LLC
CGMP Deviations: Lack of quality assurance at the API manufacturer.
Aidapak Services, LLC
Labeling: Label Mixup: METHOCARBAMOL, Tablet, 500 mg may have potentially been mislabeled as the following drug: LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 00093736498, Pedigree: AD46312_16, EXP: 5/16/2014.
Eugia US LLC
Presence of Particulate Matter
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Methocarbamol tablets, USP are 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 methocarbamol 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 Methocarbamol tablets, USP, 500 mg – Adults: Initial dosage: 3 tablets q.i.d. Maintenance dosage: 2 tablets q.i.d. Methocarbamol tablets, USP: 750 mg – Adults: Initial dosage: 2 tablets q.i.d. Maintenance dosage: 1 tablet q.4h. or 2 tablets t.i.d. Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered). Thereafter, the dosage can usually be reduced to approximately 4 grams a day.
Warnings
WARNINGS Since methocarbamol may possess a general CNS depressant effect, patients receiving Methocarbamol tablets, USP should be cautioned about combined effects with alcohol and other CNS depressants. Safe use of Methocarbamol tablets, USP 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, Methocarbamol tablets, 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 (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 Methocarbamol tablets, USP are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet 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 Adverse reactions reported coincident with the administration of methocarbamol include: Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headache Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis 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 lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria
Frequently Asked Questions
What is Methocarbamol used for?
Methocarbamol contains Methocarbamol. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is Methocarbamol a controlled substance?
Methocarbamol is not classified as a controlled substance by the DEA.
What is the generic name for Methocarbamol?
The generic name for Methocarbamol is Methocarbamol. There are 2 other brand versions of Methocarbamol.
What is the NDC code for Methocarbamol 100 mg/mL?
The NDC (National Drug Code) for Methocarbamol 100 mg/mL is 63323-778, listed by Fresenius Kabi USA, LLC.
Other Methocarbamol Dosages
- Methocarbamol500 mg/172865-233
- Methocarbamol750 mg/180425-0490
- Methocarbamol500 mg/187063-040
- Methocarbamol500 mg/115014-910
- Methocarbamol500 mg/150090-0182
- Methocarbamol500 mg/163629-1123
- Methocarbamol500 mg/167046-0538
- Methocarbamol500 mg/168071-3636
- Methocarbamol500 mg/169306-500
- Methocarbamol750 mg/169584-612
Other Methocarbamol Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)