Sirdalud Dosage/Direction for Use

Sirdalud has a narrow therapeutic index and a high inter-patient variability in tizanidine plasma concentrations which requires individualized dose adjustment.
A low starting dose of 2 mg three times daily can minimize the risk for adverse effects. The dose should be carefully adjusted upward according to the needs of the individual patient.
Relief of painful muscle spasms: Tablets: The usual dose is 2 to 4 mg three times daily in tablet form. In severe cases, an extra dose of 2 or 4 mg may be taken, preferably at night to minimize sedation.
Spasticity Due to Neurological Disorders: Tablets: The initial daily dose should not exceed 6 mg given in 3 divided doses. The initial daily dose should not exceed 6 mg given in 3 divided doses. It may be increased stepwise at half-weekly or weekly intervals by 2 to 4 mg. The optimum therapeutic response is generally achieved with a daily dose of between 12 and 24 mg, administered in 3 or 4 equally spaced doses. The daily dose of 36 mg should not be exceeded.
Special populations: Pediatric patients: Experience in patients below 18 years of age is limited and the use of Sirdalud in this population is not recommended.
Geriatric patients (65 years of age or older): Experience with the use of Sirdalud in the elderly is limited. Therefore, it is recommended to start treatment at the lowest dose and increases should be done in small steps according to tolerability and efficacy.
Renal impairment: In patients with renal impairment (creatinine clearance <25 mL/min), it is recommended to start treatment at 2 mg once daily. Increase in dosage should be done in small steps according to tolerability and efficacy. If efficacy has to be improved, it is advisable to first increase the strength of daily dose before increasing the frequency of administration (see PRECAUTIONS).
Hepatic impairment: Use of Sirdalud in patients with severe hepatic impairment is contraindicated (see CONTRAINDICATIONS).
While Sirdalud is extensively metabolized in the liver limited data are available in this population (see CLINICAL PHARMACOLOGY: Pharmacokinetics under Actions). Its use has been associated with reversible abnormality in liver function tests (see PRECAUTIONS and ADVERSE REACTIONS). Sirdalud should be used with caution in patients with moderate hepatic impairment and treatment should be started with the lowest dose. Afterwards, increase in dosage should be done carefully and according to patient tolerability.
Discontinuation of treatment: If Sirdalud has to be discontinued, the dosage should be slowly down titrated, particularly in patients who have received high doses for a longer period of time to avoid or minimize the risk of rebound hypertension and tachycardia (see PRECAUTIONS).