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Methocarbamol 100 mg/mL Injection — NDC 70069-0101-10 package photo

Methocarbamol 100 mg/mL Injection

by Somerset Therapeutics, LLC · 10 VIAL in 1 CARTON (70069-101-10) / 10 mL in 1 VIAL
NDC 70069-0101-10
🏷️ FDA NDC (as labeled) 70069-101-10 billing pads the product segment with a zero
This package
Contains10 mL in 1 vial Pack sizes3 compare ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🚨
Active recall for this product.
Class II · Mar 21, 2025 — Lack of Assurance of Sterility: Media fill with bacterial contamination (Somerset Therapeutics Private Limited) · FDA recall D-0354-2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Methocarbamol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Feb 15, 2024 — Presence of Particulate Matter (Eugia US LLC) · FDA recall D-0440-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 70069-101-10
Product NDC 70069-101
11-digit billing NDC 70069010110
RxCUI 238175
UNII 125OD7737X
UPC 0370069101018, 0370069101100, 0370069101254, 0370069101056
Application # ANDA207522
SPL Set ID 68dd9c24-4d41-48be-9f54-fceb787bb443
Established class (EPC) Muscle Relaxant
Physiologic effect Centrally-mediated Muscle Relaxation
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-07-31
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION
Substance METHOCARBAMOL
GPI-14 75100070002010
GPI class Methocarbamol
GCN Seq No 004653
GCN 17881
HICL code 001938
Ingredient (HICL) Methocarbamol
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6H
Therapeutic class — specific (HIC3) Skeletal Muscle Relaxants
AHFS code 12:20.04.00
AHFS class Centrally Acting Skeletal Muscle Relaxnt
FDB label name METHOCARBAMOL 1,000 MG/10 ML
FDB brand name Methocarbamol
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 70069-101-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 70069-0101-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Muscle Relaxant class.

Pharmacologic class Muscle Relaxant
Drug family (ATC) Carbamic acid esters
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerSomerset Therapeutics, LLC
Application holderSOMERSET THERAPEUTICS LLC
FDA applicationANDA207522 (ANDA)
Labeler code70069
First marketedJul 2017
Product typeHuman Prescription Drug
Portfolio182 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name METHOCARBAMOL 1,000 MG/10 ML Ingredient Methocarbamol
📗 Our plain-language guide HelloPharmacist
  • Methocarbamol is a muscle relaxant that works through your central nervous system — your brain and spinal cord — rather than directly on the muscles themselves. It's thought to red...
  • What exactly does methocarbamol do? Will it make my muscles stop hurting?
  • You really should not. Methocarbamol already causes drowsiness and slows your central nervous system down. Adding alcohol on top of that significantly increases those effects — we'...
  • Be careful, especially when you first start taking it. Methocarbamol can impair your alertness, coordination, and reaction time. Don't drive or operate heavy machinery until you kn...
📖 Read our full Methocarbamol guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 0.5 mL / 1 mL UNII 5655G9Y8AQ
    A synthetic liquid polymer used as a solvent and humectant in medications. It helps dissolve active ingredients, maintain moisture in the formulation, and improve how the medicine flows and is absorbed.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 5 vials 25 vials
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Methocarbamol 1000 mg/10mL 00404-9992-10 Henry 1 vial AP FDA listed
Robaxin 100 mg/mL 00641-6103-25 Hikma 25 vials AP FDA listed
Robaxin 100 mg/mL 00641-6217-25 Hikma 25 vials AP FDA listed
Methocarbamol 100 mg/mL 25021-0675-10 Sagent 25 vials AP FDA listed
Methocarbamol 100 mg/mL 25021-0689-10 Sagent 25 vials AP FDA listed
methocarbamol 100 mg/mL 36000-0302-25 Baxter 25 vials FDA listed
Methocarbamol 100 mg/mL 43598-0839-36 Dr.Reddys 10 vials AP FDA listed
Methocarbamol 1000 mg/10mL 55150-0223-10 Eugia 25 vials AP FDA listed
Methocarbamol 100 mg/mL 63323-0778-10 Fresenius 25 vials AP FDA listed
Methocarbamol 100 mg/mL 68083-0317-25 Gland 25 vials AP FDA listed
Methocarbamol 100 mg/mLthis 70069-0101-10 Somerset 10 vials AP FDA listed
methocarbamol 100 mg/mL 70436-0149-55 Slate 25 vials AP FDA listed
Methocarbamol 100 mg/mL 71288-0716-10 Meitheal 25 vials AP FDA listed
Methocarbamol 100 mg/mL 86211-0114-10 JVET 10 vials AP FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2017
On the market since
Jul 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
25 vials70069-0101-25 2,520 Rx · $81,702
5 vials70069-0101-05 955 Rx · $13,676
Drug total (last 4 qtrs): 3,475 Rx · 39,000 units · $95,378 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Methocarbamol — the program that covers self-administered drugs. 17 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Methocarbamol. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$13.41M
Claims incl. refills
1.1M
Beneficiaries
734.7K
Spend / beneficiary
$18.26
Spend / claim
$12.07
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Methocarbamol — the ingredient across all brands.

Top reported reactions

Pain1,731
Nausea1,679
Fatigue1,651
Headache1,300
Diarrhoea1,183
Fall1,096
Dyspnoea1,054

Age at onset

Neonate5
Infant2
Child21
Adolescent18
Adult2,749
Elderly1,386

Reporter sex

22,596 reports
Male · 29%
Female · 70%
Unknown · 0%

Serious outcomes

Hospitalization6,807
Death1,739
Disabling603
Life-threatening535
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,772 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70069-0101-05 5 VIAL in 1 CARTON (70069-101-05) / 10 mL in 1 VIAL 2017-07-31 Active
70069-0101-10 You're viewing this 10 VIAL in 1 CARTON (70069-101-10) / 10 mL in 1 VIAL 2017-07-31 Active
70069-0101-25 25 VIAL in 1 CARTON (70069-101-25) / 10 mL in 1 VIAL 2017-07-31 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 70069-0101-10?
NDC 70069-0101-10 is listed by the FDA — 10 vial in 1 carton / 10 ml in 1 vial.
What NDC number is used to bill for this package of Methocarbamol 100 mg/mL Injection?
Bill NDC 70069-0101-10 — the 11-digit billing format is 70069010110. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 70069-101-10, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70069-0101-10, written without dashes as 70069010110. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 70069-0101-10, the first segment (70069) is the labeler code FDA assigned to Somerset Therapeutics, LLC; the middle segment (0101) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Somerset Therapeutics, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 5 vials (70069-0101-05), 25 vials (70069-0101-25). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Somerset Therapeutics, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 61 words

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 and Administration ~3 min read

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 Methocarbamol injection 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. Methocarbamol injection 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.

Contraindications 96 words

CONTRAINDICATIONS Methocarbamol injection 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 Methocarbamol injection 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. Methocarbamol injection is contraindicated in patients hypersensitive to methocarbamol or to any of the injection components.

⚠️ Warnings 155 words

WARNINGS Since methocarbamol may possess a general CNS depressant effect, patients receiving methocarbamol injection should be cautioned about combined effects with alcohol and other CNS depressants. Safe use of methocarbamol injection 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, methocarbamol injection 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.

🤒 Adverse Reactions 194 words

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 methocarbamol injection, its administration to patients with epilepsy is not recommended (see PRECAUTIONS , General ). Skin and special senses : Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria Other : Pain and sloughing at the site of injection

🔄 Drug Interactions 36 words

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.

🤰 Pregnancy 116 words

Pregnancy Teratogenic Effects 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. Methocarbamol injection should be given to a pregnant woman only if clearly needed.

Safe use of methocarbamol injection 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 injection 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).

🧒 Pediatric Use 33 words

Pediatric Use Safety and effectiveness of methocarbamol injection in pediatric patients have not been established except in tetanus. See DOSAGE AND ADMINISTRATION , Special Directions for Use in Tetanus, For pediatric patients .

🆘 Overdosage 101 words

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.

🧬 Clinical Pharmacology ~1 min read

CLINICAL PHARMACOLOGY The mechanism of action of methocarbamol in humans has not been established, but may be due to general CNS depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber. Pharmacokinetics In healthy volunteers, the plasma clearance of methocarbamol ranges between 0.20 and

0.80L/h/kg, the mean plasma elimination half-life ranges between 1 and 2 hours, and the plasma protein binding ranges between 46% and 50%. Methocarbamol is metabolized via dealkylation and hydroxylation. Conjugation of methocarbamol also is likely.

Essentially all methocarbamol metabolites are eliminated in the urine. Small amounts of unchanged methocarbamol also are excreted in the urine. SPECIAL POPULATIONS Elderly The mean (±SD) elimination half-life of methocarbamol in elderly healthy volunteers (mean (±SD) age, 69 (±4) years) was slightly prolonged compared to a younger (mean (±SD) age, 53.3 (±8.8) years), healthy population (1.5 (±0.4) hours versus 1.1 (±0.27) hour, respectively).

The fraction of bound methocarbamol was slightly decreased in the elderly versus younger volunteers (41 to 43% versus 46 to 50%, respectively). Renally impaired The clearance of methocarbamol in 8 renally-impaired patients on maintenance hemodialysis was reduced about 40% compared to 17 normal subjects, although the mean (±SD) elimination half-life in these two groups was similar (1.2 (±0.6) versus 1.1 (± 0.3) hours, respectively). Hepatically impaired In 8 patients with cirrhosis secondary to alcohol abuse, the mean total clearance of methocarbamol was reduced approximately 70% compared to that obtained in 8 age- and weight-matched normal subjects.

The mean (±SD) elimination half-life in the cirrhotic patients and the normal subjects was 3.38 (±1.62) hours and 1.11 (±0.27) hours respectively. The percent of methocarbamol bound to plasma proteins was decreased to approximately 40 to 45% compared to 46 to 50% in the normal subjects.

📦 How Supplied / Storage and Handling 128 words

HOW SUPPLIED Methocarbamol Injection USP, 1,000 mg/10 mL (100 mg/mL) is a clear, colorless solution. Total Drug Content: Methocarbamol USP 1,000 mg in 10 mL. NDC Number Methocarbamol mg/mL Volume 70069- 101 -05 100 10 mL 70069- 101 -10 70069- 101 -25 10 mL vials are single dose vials packaged as; - 5 vials per carton, - 10 vials per carton and - 25 vials per carton.

Store at 20 °- 25°C (68°F - 77°F), excursions permitted to 15° - 30°C (59°F - 86°F). [see USP Controlled Room Temperature]. Discard unused portion. To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1-800-417-9175 or FDA at 1-800 FDA-1088 or www.fda.gov/medwatch Manufactured for: Somerset Therapeutics, LLC.

Somerset, NJ 08873 Made in India Code No.:KR/DRUGS/KTK/28/289/97 ST-MET21/P/00 Revised: August, 2024 1201014

📋 Description 144 words

DESCRIPTION Methocarbamol injection, USP 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. Methocarbamol injection, USP has a pH between 3.5 and 6.0.

AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE. Molecular Structure

💬 Information for Patients 46 words

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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.