Land: New Zealand
Språk: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Dantrolene sodium hemiheptahydrate 50mg
Pfizer New Zealand Limited
Dantrolene sodium hemiheptahydrate 50 mg
50 mg
Capsule
Active: Dantrolene sodium hemiheptahydrate 50mg
Unknown,
Prescription
Prescription
Procter & Gamble Pharmaceuticals Inc
Package - Contents - Shelf Life: Unknown, - - 36 months from date of manufacture stored at or below 30°C
1976-09-08
Version: pfddantc10219 Version: pfddantc10415 Page 1 of 10 NEW ZEALAND DATA SHEET 1. PRODUCT NAME DANTRIUM ® Capsule, 25 mg DANTRIUM ® Capsule, 50 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DANTRIUM Capsule 25 mg contains 25 mg dantrolene sodium hemiheptahydrate DANTRIUM Capsule 50 mg contains 50 mg dantrolene sodium hemiheptahydrate Dantrolene sodium is1-{[5-(p-nitrophenyl) furfurylidene]amino} hydantoin sodium hydrate. The anhydrous salt has a molecular weight of 336. The hydrated salt contains approximately 15% water (3 1/2 moles) and has a molecular weight of 399. Excipient(s) with known effect Lactose monohydrate Sodium lauril sulfate Sunset yellow FCF. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules It is an orange powder, slightly soluble in water, but due to its slightly acidic nature the solubility increases somewhat in alkaline solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications 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 section 4.2), as manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without DANTRIUM. Version: pfddantc10219 Version: pfddantc10415 Page 2 of 10 Occasionally, subtle but meaningful improvements in spasticity may occur with DANTRIUM therapy. In such instances information regarding i read_full_document