DANTRIUM Capsules Ref.[8167] Active ingredients: Dantrolene

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK

Product name and form

Dantrium Capsules 25 mg.

Pharmaceutical Form

Hard capsule.

Dantrium Capsules 25 mg are presented as white/orange capsules of size 3.

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.

Active Ingredient Description
Dantrolene

The receptor molecule for dantrolene has not been identified. Dantrolene inhibits the binding of ryanodine. Under some conditions, dantrolene will lower intra-sarcoplasmic calcium concentrations in the resting state. This may be more important in diseased muscle (e.g. In malignant hyperthermia in humans and swine stress syndrome) than in muscle with normal function.

List of Excipients

Capsule content:

Maize starch
Talc
Magnesium stearate
Lactose monohydrate

Capsule Shell:

Gelatine
Titanium dioxide (E171)
Sunset yellow (E110)

Pack sizes and marketing

Dantrium capsules are supplied in high density polyethylene (HDPE) bottles with HDPE caps. One bottle contains 100 capsules.

Marketing authorization holder

Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK

Marketing authorization dates and numbers

PL 20011/0032

25 October 1989

Drugs

Drug Countries
DANTRIUM Australia, Canada, Estonia, France, Ireland, Japan, Malta, Netherlands, New Zealand, Romania, United Kingdom, United States, South Africa

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