Methocarbamol (Page 2 of 2)

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 Methocarbamol injection is administered to a nursing woman.

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.

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

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.

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/m2 is recommended. This dosage may be repeated every six hours if required. The total dose should not exceed 1.8 g/m2 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.

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 tray,

– 10 vials per tray and

– 25 vials per tray.

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

Hollywood, FL 33024

Made in India

Code No.:KR/DRUGS/KTK/28/289/97

ST-MET11/P/03

Revised: July, 2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container label – 10 mL

Container label (10 mL)
(click image for full-size original)

Carton label — Pack of 5 Vials

Carton Label -- 5
(click image for full-size original)

Carton label — Pack of 10 Vials

Carton label (Pack of 10)
(click image for full-size original)

Carton label — Pack of 25 Vials

Carton label (pack of 25)
(click image for full-size original)
METHOCARBAMOL
methocarbamol injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70069-101
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHOCARBAMOL (METHOCARBAMOL) METHOCARBAMOL 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 300 0.5 mL in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Product Characteristics
Color WHITE (Clear, colorless solution) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70069-101-25 25 VIAL in 1 CARTON contains a VIAL
1 10 mL in 1 VIAL This package is contained within the CARTON (70069-101-25)
2 NDC:70069-101-10 10 VIAL in 1 CARTON contains a VIAL
2 10 mL in 1 VIAL This package is contained within the CARTON (70069-101-10)
3 NDC:70069-101-05 5 VIAL in 1 CARTON contains a VIAL
3 10 mL in 1 VIAL This package is contained within the CARTON (70069-101-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207522 07/31/2017
Labeler — Somerset Therapeutics, LLC (079947873)
Registrant — Somerset Therapeutics, LLC (079947873)
Establishment
Name Address ID/FEI Operations
Somerset Therapeutics Limited 677236695 ANALYSIS (70069-101), LABEL (70069-101), MANUFACTURE (70069-101), PACK (70069-101)

Revised: 12/2023 Somerset Therapeutics, LLC

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