Common use of CLINICAL INFORMATION Clause in Contracts

CLINICAL INFORMATION. i. Prescribed indications Riluzole is licensed to extend life for individuals with the amyotrophic lateral sclerosis (ALS) form of motor neurone disease (MND) ii. Therapeutic summary Motor neurone disease is the term used to describe progressive muscular atrophy (PMA) and amyotrophic lateral sclerosis (ALS) which includes Progressive Bulbar Palsy. ALS, which is characterised by both upper and lower motor neurone signs, is the most common form of MND, accounting for 65% to 85% of all cases. Adult-onset MND is characterised by progressive degeneration of the motor neurones of the brain, brain stem or spinal cord, starting insidiously with symptoms and signs including stumbling, foot drop, weakened grip, slurred speech, cramp, muscle wasting, twitching and tiredness. Other symptoms of MND include muscle stiffness, paralysis, incoordination and impaired speech, swallowing and breathing. Most individuals die from ventilatory failure, resulting from progressive weakness and wasting of limb, respiratory and bulbarmuscles within approximately 3 years of the onset of symptoms. iii. Dose & Route of administration 50mg every 12 hours; Use tablets 1st line Administration - swallowing difficulties: The tablets can be crushed and mixed with soft food e.g. yoghurt or puree to aid swallowing. Tablets crushed onto food should be eaten within 15 minutes as there is no stability data available for this method of administration. Use crushed tablets with care as they may have a local anaesthetic effect in the mouth. Administration – enteral tubes: The tablets can be crushed and dispersed in water for enteral tube administration. Give immediately. Riluzole may block enteral feeding tubes, so ensure that the tube is flushed well after each dose. A licensed oral suspension is available however this is significantly more expensive. The MND specialists may recommend suspension in exceptional circumstances in patients with severe dysphagia causing coughing and aspiration, or in patients using enteral feeding where there is a risk of crushed riluzole tablets blocking feeding tubes.