Usual Adult Dose for Muscle Spasm

Initial dose: 2 mg orally every 6 to 8 hours as needed

• Peak effects occur in approximately 1 to 2 hours and last for 3 to 6 hours; treatment can be repeated as needed to a maximum of 3 doses in 24 hours; gradually increase dose by 2 to 4 mg at intervals of 1 to 4 days until satisfactory reduction of muscle tone is achieved.

• Clinically significant differences in absorption are expected between capsules and tablets when taken with or without food; these differences could result in changes in efficacy and tolerability.
• Once a formulation is decided on and a decision is made to take with or without food, this regimen should not be altered.

Renal Dose Adjustments

Severe renal impairment (CrCl less than 25 mL/min): Individualize therapy with lower doses during dose titration; if higher doses are required, individual doses should be increased rather increasing the dosing frequency; closely monitor for toxicity

Liver Dose Adjustments

Not recommended

Dose Adjustments

Use with caution in elderly patients, especially those with renal impairment.

Drug withdrawal:

• Decrease by 2 to 4 mg per day, especially in patients who have been receiving doses of 20 to 36 mg per day for periods of 9 weeks or more.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• May take orally with or without food; however, once a formulation is decided on and a decision is made to take with or without food, this regimen should not be altered.

• Because this drug has a relatively short duration of effect, dosing should occur at times when relief of spasticity is most important, such as before activities of daily living.
• Considerable variation in response has been observed and therefore careful titration is necessary in order to not exceed the dose producing the desired effect.
• Gradual dose reduction is advised on discontinuation so as to minimize risk of withdrawal and rebound hypertension, tachycardia, and hypertonia.

• Obtain aminotransferase levels at baseline, 1 month after maximum dose is achieved, and as clinically indicated (e.g. if hepatic injury is suspected).
• Consider obtaining baseline renal function in elderly patients.
• Monitor for hypotension in at-risk patients and those receiving concomitant antihypertensive therapy.
• Monitor for sedation in patients receiving concomitant CNS depressant agents.

• Patients may take this drug with or without food, but once the decision is made to take with or without food it should be taken this way consistently.
• Patients should check with their healthcare provider before starting or stopping any medications as this drug is known to interact with other medications.
• Patients should be advised not to abruptly stop taking this medication without first talking with their healthcare provider.
• Patients should be advised that this drug may cause hypotension and they should be careful when changing positions form lying to standing.
• Patients should be advised this drug may cause significant somnolence, especially if taken with other CNS depressants or alcohol; they should refrain from activities requiring mental alertness until the effects of the drug are known.

Frequently asked questions

• What is Miderizone used for?