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Name of the medicinal product
Dantrium Capsules 100 mg.
Qualitative and quantitative composition
Each capsule contains 100 mg dantrolene sodium.
Capsule, hard. Dantrium Capsules are presented in white-green capsules of size 1.
Dantrium Capsules is indicated for the treatment of chronic, severe spasticity of skeletal muscle in ...
Posology and method of administration
Dosage for Use in Spasticity for Adults For the individual patient the lowest dose compatible with optimal ...
Dantrium is contraindicated where spasticity is utilised to sustain upright posture and balance in locomotion ...
Special warnings and precautions for use
Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with Dantrium ...
Interaction with other medicinal products and other forms of interaction
Hyperkalemia and myocardial depression have been observed in malignant hyperthermia-susceptible patients ...
Pregnancy and lactation
Dantrolene sodium crosses the placenta, and has been detected in human milk. Although teratological studies ...
Effects on ability to drive and use machines
Patients should be advised not to drive a motor vehicle or undertake potentially dangerous work until ...
The most frequently reported unwanted effects associated with the use of Dantrium have been drowsiness, ...
There is no known constellation of symptoms with acute overdose. Symptoms that may occur include, but ...
Pharmacotherapeutic group: Muscle relaxants, directly acting agents ATC code: M03CA01 Molecular Pharmacology ...
Absorption Dantrolene sodium is easily and almost completely absorbed from the gastrointestinal tract. ...
Preclinical safety data
Sprague-Dawley female rats fed dantrolene sodium for 18 months at dosage levels of 15, 30 and 60 mg/kg/day ...
List of excipients
Gelatin Maize starch Talc Magnesium stearate Lactose E132 E171 E172
Special precautions for storage
Store below 30°C.
Nature and contents of container
Dantrium Capsules are supplied in high-density polyethylene (HDPE) bottles with HDPE caps and contained ...
Special precautions for disposal and other handling
No special requirements. A patient leaflet is provided for details of use and handling of the product. ...
Marketing authorization holder
SpePharm Holding B.V. Kingsfordweg 151 1043 GR Amsterdam The Netherlands
Marketing authorization number(s)
Date of first authorization / renewal of the authorization
25 October 1989
Date of revision of the text