Drug Availability

HPS Pharmacies wish to give notice that Pfizer Australia is experiencing a supply interruption for Dantrium® capsules as follows:

Dantrium® Capsules
Dantrolene Sodium 25mg
ARTG 42975

Dantrium® Capsules
Dantrolene Sodium 50mg
ARTG 42976

This supply interruption is due to an unexpected third party manufacturing issue. Normal supplies are expected to resume in late April 2019.

In the interim, Pfizer has arranged the temporary supply of an alternative product, Dantrium® 25mg capsules (Norgine). This product is registered and marketed in the United Kingdom, but is not registered for use in Australia. It is currently available in Australia due to an exemption granted by the Therapeutic Goods Administration (TGA) under section 19A of the Therapeutic Goods Act 1989.

The following table details some of the differences between the two formulations. Further information on the alternative product can be accessed in the summary of product characteristics (SmPC) available on the electronic Medicines Compendium.

Product Characteristic

Dantrium® 25mg Capsules

Dantrium® 25mg Capsules (Norgine)

Active Ingredient

Dantrolene sodium 25mg

Dantrolene sodium 25mg

Excipients

Gelatin, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, maize starch, Sunset yellow FCF, purified talc, TekPrint SW-9008 black ink, TekPrint SW-9010 black ink, titanium dioxide

Maize starch, talc, magnesium stearate, lactose monohydrate, gelatine, titanium dioxide (E171), Sunset yellow (E110)

Approved Indication

Clinical spasticity resulting from serious chronic disorders (refer to full product information for further details). Precaution in paediatric use. Chronic, severe spasticity of skeletal muscle in adults. Not recommended in paediatric use.

Contraindications

Active hepatic disease (refer to full product information for further details)

Hepatic dysfunction, acute skeletal muscle spasms, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, hypersensitivity to the active substance or to any of the excipients (refer to SmPC for further details)

Special Warnings/Precaution

Contains lactose

The colouring agent E110 can cause allergic-type reactions including asthma. Allergy is more common in people who are allergic to aspirin.

Contains lactose.

Storage Conditions

Store below 25°C

Store below 30°C

Capsule Description

Orange and tan, opaque, coded “DANTRIUM 25mg”, “0149” and “0030” with a single line all in black

Hard capsule. White/orange capsules of size 3.

 

Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Pfizer Australia on 1800 999 543.

Information regarding expected dates for supply may vary subject to delays which are out of our control. HPS Pharmacies does not accept responsibility for such changes but will endeavour to keep our clients updated as information is made available from drug manufacturers or wholesalers.

Subscribe Knowledge Centre Updates

Enter your details to receive Knowledge Centre updates