Dantrium

国家: 新西兰

语言: 英文

来源: Medsafe (Medicines Safety Authority)

有效成分:

Dantrolene sodium hemiheptahydrate 50mg

可用日期:

Pfizer New Zealand Limited

INN（国际名称）:

Dantrolene sodium hemiheptahydrate 50 mg

剂量:

50 mg

药物剂型:

Capsule

组成:

Active: Dantrolene sodium hemiheptahydrate 50mg

每包单位数:

Unknown,

类:

Prescription

处方类型:

Prescription

厂商:

Procter & Gamble Pharmaceuticals Inc

產品總結:

Package - Contents - Shelf Life: Unknown, -   - 36 months from date of manufacture stored at or below 30°C

授权日期:

1976-09-08

产品特点

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