Nerve Agent Pre-Treatment Tablet Set L1a1 (Naps L1a1)
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nerve Agent Pre-treatment Tablet Set L1A1 (NAPS L1A1)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains the active constituent:
Pyridostigmine bromide BP 31.5mg
For excipients see 6.1
3 PHARMACEUTICAL FORM
Round, biconvex, white to off-white tablets, one side inscribed with “L1Al”
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
NAPS is indicated for the pre-treatment of service personnel and MoD sponsored civilian personnel at risk of poisoning by organophosphorus cholinesterase inhibitors.
4.2 Posology and method of administration
For oral use only.
Adults: One tablet every 8 hours in anticipation of nerve agent exposure. Dosage is not applicable to children and the elderly.
4.3 Contraindications
NAPS is contra-indicated in subjects with mechanical gastro-intestinal or urinary obstruction, and in subjects with hypersensitivity to bromides.
4.4 Special warnings and precautions for use
Although there is a theoretical risk of worsening asthma with NAPS this has not been observed in clinical practice.
Care should be taken with in patients with hypotension, bradycardia, vagotonia and recent coronary artery occlusion.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
The effects of pyridostigmine are antagonised by procainamide, propefanone (possibly), quinidine, aminoglycosides, clindamycin, lithium, propranolol, polymixins.
Pyridostigmine antagonises the effects of non-depolarising muscle relaxants. Pyridostigmine may enhance the effects of suxamethonium.
The effects of parasympathomimetics, such as pyridostigmine, are antagonised by anti-muscarinics.
4.6 Fertility, pregnancy and lactation
The safety of NAPS has not been established during pregnancy and lactation.
4.7 Effects on ability to drive and use machines
The recommended dosage does not affect the ability to drive or use machines.
4.8 Undesirable effects
Nervous system Disorders:
Common (>1/100, <1/10): Headache;
Uncommon (>1/1000, <1/100) Paraesthesia.
Gastro-Intestinal System:
Common (>1/100, <1/10): Nausea, flatus, loose stool, abdominal cramps, salivation.
Genitourinary System:
Common (>1/100, <1/10): Urinary frequency, urgency.
Respiratory, thoracic and mediastinal disorders:
Common (>1/100, <1/10): Rhinorrhoea;
Uncommon (>1/1000, <1/100): Exacerbation of acute asthma.
Side effects are generally tolerable and do not interfere with physical or mental performance of military tasks in the great majority of cases. In a few cases, intractable nausea and diarrhoea may warrant discontinuation of NAPS.
4.9 Overdose
Signs of overdosage may include abdominal cramps, diarrhoea, nausea and vomiting, increased peristalsis, salivation, increased bronchial secretions, sweating and miosis (due to muscarinic effects), muscular cramps, fasciculations, general weakness, bradycardia and hypotension (nicotinic effects).
If respiratory depression is severe, artificial ventilation should be attempted. Atropine sulphate may be given to counter muscarinic effects.
5.1 Pharmacodynamic properties
Pyridostigmine bromide causes reversible inhibition of cholinesterases. NAPS at the recommended dosage will reversibly inhibit approximately 20% of red blood cell cholinesterase by carbamoylation, protecting this proportion of the enzyme. Thus, in the event of poisoning, the individual has a reserve of enzyme to counteract the effects of the nerve agent.
5.2 Pharmacokinetic properties
Following oral administration, about 16% of the dose is absorbed, with some intersubject variability. Peak levels of pyridostigmine in the blood are reached approximately 1.7 hours after oral dosing and the elimination half-life is about
4 hours.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that in other sections of the Summary of Product Characteristics.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Starch pregelatinised, maize starch, lactose monohydrate, silica colloidal, anhydrous talc, magnesium stearate.
6.2 Incompatibilities
None known.
6.3 Shelf life
5 years.
6.4 Special precautions for storage
Do not store above 25°C. Keep the plastic sleeve in the outer foil in order to protect from moisture.
6.5 Nature and contents of container
A plastic sleeve containing 21 A1/PVC/PVDC blister packed tablets. Each sleeve is sealed in a polyethylene/polyester/aluminium foil sachet. For dispensing purposes 10 sachets are packed in a cardboard carton.
6.6 Special precautions for disposal
Do not incinerate.
7 MARKETING AUTHORISATION HOLDER
Secretary of State for Defence
Ministry of Defence
Main Building
Whitehall
LONDON
SW1 2HB
8 MARKETING AUTHORISATION NUMBER(S)
PL 04537/0003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
11/08/1993 / 13/11/2006
10 DATE OF REVISION OF THE TEXT
03/10/2012