Usual Adult Dose for Muscle Spasm

Immediate-release:
Initial dose: 5 mg orally 3 times a day

• May increase to 10 mg orally 3 times a day based on individual patient response

Duration of therapy: Up to 3 weeks

Extended-release:
Initial dose: 15 mg orally once a day

• May increase to 30 mg orally based on individual patient response

Duration of therapy: Up to 3 weeks

Comments:

• Duration of therapy should be limited to 2 to 3 weeks.
• Response is measured by relief of muscle spasm and its associated signs and symptoms, namely pain, tenderness, and limitation of motion.

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

Usual Geriatric Dose for Muscle Spasm

Immediate-release:
Initial dose: 5 mg orally up to 3 times a day
Duration of therapy: Duration of therapy: Up to 3 weeks

Extended-release: Not recommended

Comments:

• Due to higher plasma levels in elderly patients, less frequent dosing should be considered.
• Extended-release capsules are not recommended in elderly patients.
• Duration of therapy should be limited to 2 to 3 weeks.

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

Usual Pediatric Dose for Muscle Spasm

15 years and older:
Immediate-release:
Initial dose: 5 mg orally 3 times a day

• May increase to 10 mg orally 3 times a day based on individual patient response

Duration of therapy: Up to 3 weeks

Extended-release: Safety and effectiveness has not been established

Comments:

• Duration of therapy should be limited to 2 to 3 weeks.
• Response is measured by relief of muscle spasm and its associated signs and symptoms, namely pain, tenderness, and limitation of motion.

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

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Immediate-release:
Mild hepatic impairment:

• Initial dose: 5 mg orally; titrate slowly upward

Moderate to severe hepatic impairment: Not recommended

Extended-release: Not recommended

Precautions

Safety and efficacy of immediate-release product have not been established in patients younger than 15 years.

Safety and efficacy of extended-release product have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally for up to 3 week's duration

Extended-release:

• Take at approximately the same time each day
• Swallow whole
• Alternatively, open capsule and sprinkle contents of capsule over 1 tablespoon of applesauce; consume immediately without chewing; rinse mouth to ensure all contents have been swallowed

Storage:

• Protect from light

General:

• This drug is ineffective in muscle spasm due to CNS disease including cerebral or spinal cord disease, or in children with cerebral palsy.
• Evidence of effectiveness beyond 2 to 3 weeks is not available; additionally, muscle spasms associated with acute, painful musculoskeletal conditions are generally of short duration.

Monitoring:

• Response to therapy is measured by relief of muscle spasm and its associated signs and symptoms, namely pain, tenderness, and limitation of motion.
• Monitor for anticholinergic toxicity
• Monitor for the development of serotonin syndrome in those patients on concomitant serotonergic drugs.

Patient advice:

• Patients should understand that this drug should be used for short periods along with rest and physical therapy.
• Patients should be informed that this drug may impair their ability to perform hazardous task such as driving and they should not undertake such tasks until they know how this drug affects them.
• Alcohol and other CNS depressants may enhance the impairment effects of this drug.
• Patients on concomitant serotonergic drugs should know the signs and symptoms of serotonin syndrome and when it is necessary to seek medical attention.

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