Medine.co.uk

Out of date information, search another

Nerve Agent Pre-Treatment Tablet Set L1a1 (Naps L1a1)

Out of date information, search another
Informations for option: Nerve Agent Pre-Treatment Tablet Set L1a1 (Naps L1a1), show other option

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”

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    Special 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    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 reconmiended 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) Parasethsia 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): Rhinorrhea; 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 muscarmnic effects.

5.    PHARMACOLOGICAL PROPERTIES

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 precliical data of relevance to the prescriber which are additional to that in other sections of the Summary of Product Characteristics.

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 25C. 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

PL 04537/0003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

13/11/2006

10 DATE OF REVISION OF THE TEXT

03/10/2012