Manufacturer: JHP manufactures Dantrium.
The uses of Dantrium include:
DANTRIUM is indicated in controlling the manifestations of clinical spasticity resulting from serious chronic disorders such as spinal cord injury, stroke, cerebral palsy, or multiple sclerosis. It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. There is no evidence that patients with contractures will benefit. DANTRIUM is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders or electroconvulsive therapy.
If improvement occurs, it will ordinarily occur within the dosage titration schedule (see DOSAGE AND ADMINISTRATION), as manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without DANTRIUM.
Occasionally, subtle but meaningful improvements in spasticity may occur with DANTRIUM therapy. In such instances information regarding improvement should be solicited from the patient and those who are in constant daily contact and attendance with him. Brief withdrawal of DANTRIUM for a period of 2 to 4 days will frequently demonstrate exacerbation of the manifestation of spasticity and may serve to confirm a clinical impression.
A decision to continue the administration of DANTRIUM on a long term basis is justified if introduction of the drug into the patient's regimen produces a significant reduction in painful and/or disabling spasticity such as clonus, or permits a significant reduction in the intensity and/or degree of nursing care required, or rids the patient of an annoying manifestation of spasticity considered important by the patient himself.
Dosage and Administration:
Prior to the administration of DANTRIUM consideration should be given to the potential response to treatment. A decrease in spasticity sufficient to allow a daily function not otherwise attainable should be the therapeutic goal of treatment with DANTRIUM. Refer to the INDICATIONS section for a description of the response to be anticipated.
It is important to establish a therapeutic goal (regain and maintain a specific function such as therapeutic exercise program, utilisation of braces, transfer manoeuvres, etc.) before beginning DANTRIUM therapy. Dosage should be increased until the maximum performance compatible with the dysfunction due to underlying disease is achieved. No further increase in dosage is then indicated.
It is important that the dosage be titrated and individualised for maximum effect. The lowest dose compatible with optimal response is recommended.
In view of the potential for liver damage in long-term DANTRIUM use, therapy should be stopped if benefits are not evident within 45 days.
Begin therapy with 25 mg once daily; increase to 25 mg two, three, or four times daily and then by increments of 25 mg up to as high as 50 mg two, three or four times daily if necessary. The maximum recommended dose is 200 mg/day. As most patients will respond to this or a lower dose, and hepatotoxicity appears to be dose-related above 200 mg/day, higher doses should be used only rarely and with close monitoring. (See WARNINGS). Doses higher than 400 mg/day should not be used.
Each dosage level should be maintained for four to seven days to determine the patient's response. The dose should not be increased beyond, and may even have to be reduced to, the amount at which the patient received maximal benefit without adverse effects.
A similar approach should be utilised starting with 0.5 mg/kg of body weight twice daily; this is increased to 0.5 mg/kg three or four times daily and then by increments to a maximum of 2 mg/kg three times a day. Doses higher than 50 mg four times daily should not be used in children.