Dantrium

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Dantrolene sodium hemiheptahydrate 50mg

MAH:

Pfizer New Zealand Limited

INN:

Dantrolene sodium hemiheptahydrate 50 mg

dosage:

50 mg

pharmaceutical_form:

Capsule

composition:

Active: Dantrolene sodium hemiheptahydrate 50mg

units_in_package:

Unknown,

class:

Prescription

prescription_type:

Prescription

manufactured_by:

Procter & Gamble Pharmaceuticals Inc

leaflet_short:

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

authorization_date:

1976-09-08

SPC

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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.
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Occasionally, subtle but meaningful improvements in spasticity may
occur with DANTRIUM
therapy. In such instances information regarding i