Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DANTROLENE SODIUM
SpePharm Holding B.V.
25 Milligram
Capsule
2009-01-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dantrium 25mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Dantrium Capsules 25 mg contain 25 mg dantrolene sodium per capsule. Excipients - Contains Lactose Monohydrate 161.0mg and Sunset Yellow (E110) For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard Dantrium capsules are presented in white/orange hard capsules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of chronic, severe spasticity resulting from such disorders as stroke, multiple sclerosis, spinal cord injury and cerebral palsy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND THE ELDERLY The dosage should be titrated against clinical improvement and increased until the maximum benefit compatible with the patient's neurological deficit is achieved. The lowest dose compatible with optimal response is recommended. A recommended dosage increment scale is shown below:- ADULTS AND THE ELDERLY Each dosage level should be maintained for seven days in order to determine the patient's response. The maximum daily dose should not exceed 400mg. In view of the potential for hepatoxicity in long term use, if no observable benefit is derived from the administration of Dantrium after a total of 45 days, therapy should be discontinued. Many patients experience side-effects such as weakness and fatigue during the first four weeks of therapy whilst they adjust to the changes in muscle tone induced by the drug. They are usually transient and mild in nature. Should it be necessary, the dosage may be reduced and then gradually increased according to the patient's tolerance. _Week_ _Recommended dosage_ First One 25mg capsule daily Second One 25mg capsule twice daily Third Two 25mg capsules twice daily Fourth Two Read the complete document