Usual Adult Dose for Muscle Spasm

ORAL:
Initial Dose: 1500 mg orally 4 times a day

• Doses of 6000 mg per day are generally used for the first 48 to 72 hours
• In severe cases, doses up to 8000 mg per day may be used

Maintenance dose:
500 mg tablets: 1000 mg orally 4 times a day
750 mg Tablets: 750 mg orally every 4 hours OR 1500 mg orally 3 times a day

PARENTERAL:

• For the relief of moderate symptoms: 1 g IV or IM once, then switch to oral
• For relief of severe symptoms or postoperative conditions: 1 g IV or IM every 8 hours

Maximum Dose: 3 g in 24-hours
Maximum Duration: 3 consecutive days; may repeat after a drug-free interval of 48 hours

Comments:

• Higher doses are recommended in the first 48 to 72 hours of treatment, then doses can usually be reduced to approximately 4000 mg per day.
• Oral tablets should be administered whenever feasible; IV/IM therapy should not be administered for more than 3 consecutive days without a drug-free interval of 48 hours.

Use: As an adjunct to rest and physical therapy for the relief of discomfort associated with acute, painful musculoskeletal conditions.

Usual Adult Dose for Tetanus

Initial dose: 1 to 2 g IV followed by an additional 1 to 2 g via IV infusion
Maximal Initial Dose: 3 g

Repeat initial IV dose every 6 hours until NG tube or oral therapy is possible

Once NG tube is in place, may crush tablets, suspend in water or saline and administer through tube

• Total oral doses of up to 24 g may be needed based on patient response

Comments:

• There is clinical evidence to suggest this drug may have a beneficial effect in the control of the neuromuscular manifestations of tetanus.
• This drug should not replace the usual procedure of debridement, tetanus antitoxin, penicillin, tracheotomy, attention to fluid balance, and supportive care; if used, this drug should be added to the regimen as soon as possible.

Use: To control the neuromuscular manifestations of tetanus.

Usual Pediatric Dose for Tetanus

Initial dose: 15 mg/kg or 500 mg/m2 IV; repeat initial dose every 6 hours as needed
Maximum dose: 1.8 g/m2/day IV for 3 consecutive days

Maintenance dose: May be given by injection into tubing or by IV infusion with an appropriate quantity of fluid

Comments:

• There is clinical evidence to suggest this drug may have a beneficial effect in the control of the neuromuscular manifestations of tetanus.
• This drug should not replace the usual procedure of debridement, tetanus antitoxin, penicillin, tracheotomy, attention to fluid balance, and supportive care; if used, this drug should be added to the regimen as soon as possible.

Use: To control the neuromuscular manifestations of tetanus.

Renal Dose Adjustments

Oral therapy: No adjustment recommended
Injectable therapy: Not recommended in patients with renal insufficiency due to the high concentration of polyethylene glycol in the solution

Liver Dose Adjustments

Use with caution, dose adjustment may be required, especially in patients with cirrhosis; however, no specific guidelines have been suggested

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to active substance or any product excipients
• Known or suspected renal pathology (injection; due to presence of polyethylene glycol 300 in the vehicle)

Safety and efficacy or oral therapy have not been established in patients younger than 16 years.
Safety and efficacy or injectable therapy have not been established in patients younger than 18 years, except in tetanus.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
Oral Therapy: Take orally with or without food

Injectable Therapy:

• For IV and IM administration only; do not administer subcutaneously
• Total daily dose should not exceed 3 g per day (3 vials) for more than 3 consecutive days except in the treatment of tetanus; see below for special directions for use in tetanus

For IV Administration:

• May administer undiluted IV directly into vein at a maximum rate of 300 mg/minute (3 mL/minute)
• May dilute and administer via IV infusion using normal saline or D5W; 1 g (1 vial) should be diluted in no more than 250 mL
• Use caution to avoid vascular extravasation; this hypertonic solution may cause thrombophlebitis
• Patient should remain recumbent during and for at least 10 to 15 minutes following injection

For IM Administration:

• Inject no more than 500 mg (5 mL) into each gluteal region
• Injections may be repeated at 8-hour intervals; switch to oral therapy as soon as feasible

Special Directions for Use in Tetanus:

• Inject 1 or 2 g (10 or 20 mL) directly into tubing of inserted indwelling needle.
• Add 1 or 2 g (10 or 20 mL) to infusion bottle to allow for a total of 3 g (3 vials) as initial dose

Storage requirements:

• Once IV infusion is prepared: Do not refrigerate

IV compatibility: Compatible in normal saline and dextrose 5% solution

General:

• Polyethylene glycol 300 is present in the injectable formulation; large doses of polyethylene glycol 300 are known to increase preexisting acidosis and urea retention in patients with renal impairment; while the amount present is within the limits of safety, use is contraindicated in patients with renal impairment out of an abundance of caution.

Patient advice:

• Patients should understand that this drug may impair their mental and/or physical abilities to perform hazardous tasks such as driving, and they should be counseled appropriately.
• Patients should understand that this drug is a CNS depressant and patients should be cautioned about concomitant use of alcohol or other CNS depressants.
• Patients should be instructed to speak with their healthcare provider if they are pregnant, intending to become pregnant or breastfeeding.

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