1. Name Of The Medicinal Product
SCOPODERM® TTS®
2. Qualitative And Quantitative Composition
Each patch contains 1.5mg hyoscine U.S.P.
3. Pharmaceutical Form
Scopoderm TTS is a transdermal therapeutic system. Each patch is a flat system of laminates, sealed around the edge, containing a clear oily filling. The system is a thin circular disc, tan coloured and fitted with a transparent, hexagonal protective liner which projects over the edge of the disc. Viewed through the liner, the system appears silver in colour. Each system has a contact surface area measuring 2.5cm2 and hyoscine content of 1.5mg. The average amount of hyoscine absorbed from each system in 72 hours is 1mg.
4. Clinical Particulars
4.1 Therapeutic Indications
For the prevention of symptoms of motion sickness such as nausea, vomiting and vertigo.
4.2 Posology And Method Of Administration
Route of Administration
Transdermal
Dosage and Administration
Adults
To achieve the optimum protective effect, one system should be applied about 5-6 hours before embarking on a journey (or on the evening before). The system should be placed onto a clean, dry, hairless area of skin behind the ear, taking care to avoid any cuts or irritation. One system can provide protection for up to 72 hours. Should protection be required for longer periods of time, a fresh system should be placed behind the other ear after 72 hours. (No more than one system should be used at a time). Conversely, if protection is only required for shorter periods of time, the system should be removed at the end of the journey.
Patients should wash their hands thoroughly after handling the system. In addition, after removal of the system, the site of application should also be washed. These precautions are necessary to minimise any chance of hyoscine accidentally being transferred to the eyes (see side-effects).
Limited contact with water (i.e. during bathing or swimming), should not affect the system, although it should be kept as dry as possible.
If the Scopoderm TTS becomes accidentally detached, it should be replaced by a fresh system.
Use in Elderly
Scopoderm TTS may be used in the elderly (see dosage recommendations for adults) although the elderly may be more prone to suffer from the side-effects of hyoscine (see precautions).
Use in Children
Scopoderm TTS can be used in children age 10 years or over (see dosage recommendations for adults). Insufficient data are available to recommend the use of Scopoderm TTS for younger children.
4.3 Contraindications
Scopoderm TTS is contra-indicated in patients with glaucoma or with a history of the condition, and in patients with known hypersensitivity to hyoscine.
4.4 Special Warnings And Precautions For Use
Scopoderm TTS should be used with caution in patients with pyloric stenosis, those who have bladder outflow obstruction, or in patients with intestinal obstruction.
Patients should not consume alcohol whilst using Scopoderm TTS.
Scopoderm TTS should also be used with caution in elderly patients, and in patients with impaired hepatic or renal function.
In rare cases, confusional states and visual hallucinations may occur. In such cases, Scopoderm TTS should be removed immediately. If severe symptoms persist, appropriate therapeutic measures should be taken (see overdosage section).
Idiosyncratic reactions may occur with ordinary therapeutic doses of hyoscine.
In isolated cases an increase in seizure frequency in epileptic patients has been reported.
Care should be taken after removal of the system as side-effects may persist for up to 24 hours or longer.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Scopoderm TTS should be used with caution in patients being treated with drugs that act on the central nervous system (including alcohol) or drugs with anticholinergic properties.
4.6 Pregnancy And Lactation
Teratogenic studies have been performed in pregnant rats and rabbits with hyoscine administered by daily intravenous injection. No adverse effects were noted in rats. In rabbits, the drug had a marginal embryotoxic effect at a high dose (at drug plasma levels approximately 100 times those observed in humans using Scopoderm TTS).
Scopoderm TTS should only be used during pregnancy if the expected benefits to the mother outweigh the potential risks to the foetus.
It is not known if hyoscine passes into the breast milk. Therefore nursing mothers should refrain from breast feeding their infants whilst using Scopoderm TTS.
4.7 Effects On Ability To Drive And Use Machines
Scopoderm TTS may cause drowsiness, dizziness, confusion or visual disturbance in certain individuals. Patients using the system must not drive, operate machinery, pilot an aircraft, dive or engage in any other activities in which such symptoms could be dangerous (see side-effects).
4.8 Undesirable Effects
The following side-effects may occur:
Eyes
In isolated cases pupillary dilatation may precipitate acute glaucoma, particularly narrow angle glaucoma
(see Contra-Indications).
Occasional: Irritation of the eyelids
If traces of hyoscine on the hands enter the eyes, transient cycloplegia and pupillary dilatation (occasionally unilateral) frequently occur.
Mouth
Frequent: Transient dryness of the mouth.
Central Nervous System
Occasional: Drowsiness.
Rare: Impairment of memory and concentration, restlessness, dizziness, disorientation, confusion and visual hallucinations. (see precautions).
Skin
Occasional: Local irritation
In isolated cases: A generalised skin rash
Urogenital system
Rare: Disturbances of micturition (i.e. urine retention)
Side-effects after removal of Scopoderm TTS
Rare: Unwanted effects, including headache, nausea, vomiting and disturbance of balance, occurring after removal of the system. These symptoms have occurred most often in patients who have used the system for several days. In such cases, patients should not drive or engage in other activities requiring concentration
(see warnings).
4.9 Overdose
Symptoms
Initially, restlessness, excitation and confusion may be observed. In response to higher doses, delirium, hallucinations and convulsions set in. At very high doses, coma and respiratory paralysis may occur.
Treatment
If symptoms of overdosage occur, the system(s) should be removed immediately. Physostigmine is the most effective antidote. Depending on the severity of poisoning, physostigmine should be given by slow intravenous injection in doses of 1-4mg (0.5mg in children). Repeated injections may be necessary since physostigmine is rapidly metabolised. Diazepam may be used to counter excitation and convulsions although at higher doses it may cause respiratory depression. In severe cases, artificial respiration may be necessary. If hyperthermia occurs, immediate action should be taken to dissipate heat.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
The transdermal therapeutic system (TTS) is a novel form of drug delivery designed to achieve a continuous release of hyoscine through the intact skin to the systemic circulation for up to 72 hours.
Hyoscine has anticholinergic properties. It acts as a competitive antagonist to acetylchloline and other parasympathomimetic agents. Its mechanism of action in the central nervous system in preventing motion sickness has yet to be elucidated. Hyoscine produces classical symptoms of parasympathetic blockade.
5.2 Pharmacokinetic Properties
Following Scopoderm TTS administration, measurement of the urinary excretion has shown the equilibrium between absorption and elimination to be reached within about 6 hours. Steady plasma concentrations of hyoscine in the range of 0.17-0.33nmol/litre are produced. Provided the system is not removed, this equilibrium is maintained and plasma hyoscine levels are within this therapeutic range for up to 72 hours.
After removal of Scopoderm TTS, the plasma concentration diminishes slowly to approximately one third over the following 24 hours because hyoscine in the skin continues to enter the blood stream.
5.3 Preclinical Safety Data
None stated
6. Pharmaceutical Particulars
6.1 List Of Excipients
Drug Reservoir
Light mineral oil
Polyisobutylene (1.200.000)
Polyisobutylene (35.000)
Backing Film
Pigmented MDPE/AL/PET/HS Film (vapour coated aluminised polyester with outer coating of pigmented medium density polyethylene (MDPE) and a heat sealable inner coating. Thickness 0.0686mm.
Release Controlling Membrane
Polypropylene Film. Thickness 0.0254mm.
Adhesive (to skin)
Light mineral oil
Polyisobutylene (1.200.000)
Polyisobutylene (35.000)
Release Liner (discarded before use)
Silicone/Polyester Film
Thickness 0.0762mm
6.2 Incompatibilities
None stated
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
Store below 25oC. Do not freeze.
6.5 Nature And Contents Of Container
Scopoderm TTS - Individually packed into sealed paper laminated aluminium foil pouches. Outer cardboard carton containing two patches.
6.6 Special Precautions For Disposal And Other Handling
Patients should wash their hands thoroughly after handling the system. In addition, after removal of the system, the site of application should also be washed. These precautions are necessary to minimise any chance of hyoscine accidentally being transferred to the eyes (see side-effects).
7. Marketing Authorisation Holder
Novartis Consumer Health UK Limited
Trading as: Novartis Consumer Health
Wimblehurst Road
Horsham
West Sussex
RH12 5AB
UK
8. Marketing Authorisation Number(S)
00030/0180
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of first authorisation: 30 March 2001
Date of last renewal: 5 December 2008
10. Date Of Revision Of The Text
5 December 2008.
Legal category: POM
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