DANTRIUM Capsules Ref.[8167] Active ingredients: Dantrolene

Posology

Dosage for Use in Spasticity for Adults

For the individual patient the lowest dose compatible with optimal response is recommended. A recommended dosage increment scale is shown below:

1^st week: One 25 mg capsule daily.

2^nd week: One 25 mg capsule twice daily.

3^rd week: Two 25 mg capsules twice daily.

4^th week: Two 25 mg capsules three times daily.

5^th week: Three 25 mg capsules three times daily.

6^th week: Three 25 mg capsules four times daily.

7^th week: One 100 mg capsule four times daily.

Each dosage level should be maintained for seven days in order to determine the patient’s response. Therapy with a dose four times daily may offer maximum benefit to some patients. Maximum daily dose should not exceed 400 mg. In view of the potential for hepatotoxicity with long term use, if no observable benefit is derived from the administration of Dantrium after a total of 6-8 weeks, therapy should be discontinued.

Elderly

A similar dosage titration schedule should be used with the elderly.

Paediatric population

Dantrium is not recommended for use in children.

Method of administration

For oral use.

There is no known constellation of symptoms with acute overdose. Symptoms that may occur include, but are not limited to, muscular weakness, alterations in the state of consciousness (e.g. lethargy, coma), vomiting, and diarrhoea. For acute overdosage, general supportive measures and gastric lavage should be employed as well as measures to reduce the absorption of Dantrium. The theoretical possibility of crystalluria in overdose has not been reported for Dantrium, but would be treated according to general principles, including administration of fluids. The value of dialysis in dantrolene sodium overdose is not known.

Shelf life: 3 years.

Store below 30°C.

Dantrium capsules are supplied in high density polyethylene (HDPE) bottles with HDPE caps. One bottle contains 100 capsules.

No special requirements.

A patient leaflet is provided for details of use and handling of the product.