DANTRIUM Capsules (2018)
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Περιεχόμενα
Name of the medicinal product
Dantrium Capsules 25 mg.
Qualitative and quantitative composition
Each capsule contains 25 mg dantrolene sodium. Excipient with known effect: 161.0 mg of lactose monohydrate per capsule. For a full list of excipients, see section 6.1.
Pharmaceutical form
Hard capsule. Dantrium Capsules 25 mg are presented as white/orange capsules of size 3.
Therapeutic indications
Dantrium Capsules are indicated for the treatment of chronic, severe spasticity of skeletal muscle in adults.
Posology and method of administration
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<sup> ...
Contraindications
Dantrium is contraindicated where spasticity is utilised to sustain upright posture and balance in locomotion or whenever spasticity is utilised to obtain or maintain increased function. Dantrium is contraindicated ...
Special warnings and precautions for use
Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with Dantrium therapy. Patients should be instructed to contact their physician should signs or symptoms of hepatotoxicity ...
Interaction with other medicinal products and other forms of interaction
Hyperkalaemia and myocardial depression have been observed in malignant hyperthermia-susceptible patients receiving intravenous dantrolene sodium and concomitant calcium channel blockers. The effects of ...
Fertility, pregnancy and lactation
Pregnancy Although teratological studies in animals have proved satisfactory, Dantrolene sodium does cross the placenta and therefore the use of Dantrium is not advised during pregnancy. Breast-feeding ...
Effects on ability to drive and use machines
Patients should be advised not to drive a motor vehicle or undertake potentially dangerous work until Dantrium therapy has been stabilised, because some patients experience drowsiness and dizziness.
Undesirable effects
Summary of the safety profile The most frequently reported unwanted effects associated with the use of Dantrium have been drowsiness, dizziness, weakness, general malaise, fatigue and diarrhoea. These ...
Overdose
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), ...
Pharmacodynamic properties
Pharmacotherapeutic group: Muscle relaxants, directly acting agents ATC code: M03CA01 Mechanism of action The receptor molecule for dantrolene sodium has not been identified. Radiolabelled dantrolene sodium ...
Pharmacokinetic properties
Absorption Dantrolene sodium is easily and almost completely absorbed from the gastrointestinal tract. After dosing on an empty stomach, plasma dantrolene sodium levels peak within three hours in most ...
Preclinical safety data
Carcinogenicity Dantrolene sodium showed some evidence of tumourgenicity at high dose levels in Sprague-Dawley female rats. However, these effects were not seen in other studies in Fischer 344 rats or ...
List of excipients
Capsule content: Maize starch Talc Magnesium stearate Lactose monohydrate Capsule Shell: Gelatine Titanium dioxide (E171) Sunset yellow (E110)
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
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. One bottle contains 100 capsules.
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
Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK
Marketing authorization number(s)
PL 20011/0032
Date of first authorization / renewal of the authorization
25 October 1989
Date of revision of the text
07/09/2018
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