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Aludex is diluted in water to make a wash. It used to treat the two main types of mange affecting dogs, Demodectic mange and Sarcoptic mange. Where just localised areas are affected it can be applied to these alone, or in generalised cases it is used over the entire animal. Dogs should be washed first with a normal cleansing shampoo, then Aludex solution is applied. It needs to be diluted with water first, at the correct concentration as advised by your vet (or see details below). This process needs to be repeated at weekly intervals for Demodex, or every 2 to 6 weeks for Sarcoptes. Once the skin has been soaked with the resultant solution, the dog should be allowed to stand in a well ventilated area to dry off. The solution should NOT be rinsed off or dried with a towel. Operators using Aludex should wear a protective gown and gloves and should avoid contact with their own skin or eyes.
The active ingredient is called amitraz, which is toxic to horses. It is not recommended for use on cats, pregnant or lactating bitches, or on Chihuahuas. It has been used successfully on Rabbits, Guinea Pigs, Hamsters and Rats, but a more dilute solution is recommended. Some dogs will show side effects due to an alpha-2-adrenoreceptor stimulation effect. This usually shows as sedation or lethargy, but vomiting and salivation can be seen. It is not recommended to use Aludex at the same time as alpha-2-adrenoreceptor sedatives. Dogs showing side effects which last more than 24 hours should be washed in warm, soapy water (not detergent).
Aludex is used to treat the two main types of mange affecting dogs, Demodectic mange and Sarcoptic mange. Where just localised areas are affected it can be applied to these alone, or in generalised cases it is used over the entire animal. Dogs should be washed first with a normal cleansing shampoo, then Aludex solution is applied. Aludex needs to be diluted with water first, at a ration of 1ml Aludex to 25mls water for Demodex treatment, or 1ml Aludex to 50mls water for Sarcoptes treatment. This process needs to be repeated at weekly intervals for Demodex, or every 2 to 6 weeks for Sarcoptes. Once the skin has been soaked with the Aludex solution, the dog should be allowed to stand in a well ventilated area to dry off. Aludex should NOT be rinsed off or dried with a towel. Operators applying Aludex should wear a protective gown and gloves and should avoid contact with their own skin or eyes.
The active ingredient in Aludex is amitraz, which istoxic to horses. It is not recommended for use on cats, pregnant or lactating bitches, or on Chihuahuas. It has been used successfully on Rabbits, Guimea Pigs, Hamsters and Rats, but a more dilute solution is recommended. Some dogs will show side effects due to an alpha-2-adrenoreceptor stimulation effect. This usually shows as sedation or lethargy, but vomiting and salivation can be seen. It is not recommended to use Aludex at the same time as alpha-2-adrenoreceptor sedatives. Dogs showing side effects which last more than 24 hours should be washed in warm, soapy water (not detergent).
Amitraz (as Amitrax technical) 50 g/l.
Stabiliser: Tetraisopropyldiphenylcarboiimide (Stabaxol 1) 10.5 g/l.
For full list of excipients, see section "Pharmaceutical Properties".
Concentrate for cutaneous solution. Clear pale yellow liquid
For the control of demodectic and sarcoptic mange.
Do not use on Chihuahuas. Do not use on dogs suffering from heat stress. Do not use on pregnant or lactating bitches, nor puppies less than 3 months old. Do not use on cats.
For the treatment of demodectic mange, use at 25 ml in 5 litres / 50 ml in 10 litres or 0.025% (half normal rate) for severely debilitated dogs.
For use on dogs only. For external use only. For use only under the supervision of a veterinary surgeon. Dogs should be prevented from licking the fur after treatment. For the treatment of demodectic mange in severely debilitated dogs use 25 ml of Aludex in 10 litres of water (half the normal dose rate).
Flammable. Prepare and use the dilution of the product in a well-ventilated area. Wear waterproof gloves, apron and face shield when handling the product and wash all protective clothing thoroughly after use, including the inside of gloves. May cause sensitisation (allergy) by skin contact. Avoid any contact of the product with the skin or eyes. In case of skin contamination, wash thoroughly with soap and water. In case of eye contamination, rinse with plenty of clean, running water immediately. If irritation persists, seek medical help. Do not eat drink or smoke whilst using the product. When treatment is completed, wash hands thoroughly before eating, drinking or smoking. Do not handle treated animals without use of protective clothing until the treatment has dried thoroughly. Treated animals should not be allowed to sleep or play with people, particularly children, until the animal is dry. If you feel unwell, seek medical advice taking the product leaflet with you.
To the physician: Amitraz is NOT an organophosphorous compound. Do NOT use atropine as an antidote. Do NOT induce vomiting. Treatment should be symptomatic and supportive, paying particular attention to monitoring of respiratory and cardiac function. Recovery, however, is normally spontaneous.
Aludex treatment can lead to known side-effects in a small numbers of dogs. In rare cases neurological disorders (ataxia, lethargy, sedation and CNS depression), skin reactions (erythema, pruritus and dermatitis), digestive tract disorders (diarrhoea and emesis), salivation, anorexia, shallow breathing, dyspnoea, bradypnoea, bradycardia and allergic reactions (oedema) could be observed. Most of these signs are due to alpha-2-adrenoreceptor agonistic effects. Signs are usually transitory and generally resolved without treatment. If symptoms persist, the dogs should be washed in soapy water (not washing-up detergent), dried and warmed. The alpha-2-adrenoreceptor antagonist, atipamezole hydrochloride, may be used at a dose of 0.2 mg/kg body weight by intramuscular injection to reverse these side-effects.
Contra-indicated in the absence of adequate safety trials data.
This product can be used with other dermatological preparations, except those that are water-repellent and with anthelmintics. Concurrent use with other alpha-2-adrenoreceptor agonists is not recommended. Do not use simultaneously with other ectoparasiticide preparations.
For external use only. Shake the container/bottle before use. Make up wash immediately before use.
Use 50 ml Aludex per 5 litres of water for small dogs or 100 ml Aludex per 10 litres of water for large dogs. Whatever the quantity of wash required, it is essential that the initial concentration is not varied from 1 part Aludex to 100 parts water (0.05% amitraz).
Repeat the treatment at intervals of 5-7 days until neither live mites nor viable eggs can be identified microscopically by skin scrapings. Alternatively, continue treatment for at least 3 weeks after all overt clinical symptoms have subsided.
Use 25 ml Aludex per 5 litres of water for small dogs, or 50 ml Aludex per 10 litres of water for large dogs. Do not vary the concentration from 1 part Aludex to 200 parts water (0.025% amitraz).
Repeat treatment at weekly intervals for 2 to 6 weeks.
1.If necessary, shampoo the dog to remove dirt and grease. Long-haired animals can be clipped prior to treatment if required.
2.Prepare the dog wash outdoors or in a very well ventilated area by adding the appropriate amount of Aludex concentrate to the required volume of clean warm water, stirring to ensure complete mixing. Fouled wash becomes unstable after 6 hours and must be discarded. Note that sufficient wash should be prepared to allow complete immersion of the dogs paws and to enable complete wetting of the animal. 5 litres of the wash is normally a minimum requirement and up to 10 litres may be required for larger dogs.
3.In the well ventilated area, stand the dog in a suitable bath or sink and pour the wash over the animal, gently working into the skin and hair with a soft brush or sponge to ensure that the dog is thoroughly wetted to the skin in all areas. Avoid excessive contact with mucosal membranes.
4.DO NOT rinse the dog, but remove it from the bath and allow it to dry naturally in a warm draught-free place. Alternatively, it can be a good idea to take the dog for a short walk after treatment to allow it to start to dry. This also helps to disperse the solvent fumes and stops the dog licking itself and ingesting the wash. Using an Elizabethan collar to prevent licking can also be helpful on some dogs. Do not use a hairdryer.
5.Avoid handling the dog after treatment until the coat is dry.
Even after accidental overdose, adverse effects should not exceed those described under section "Interactions". Refer to this section for recommended actions. Clinical signs of toxicity include:
i) Signs of CNS depression eg. drowsiness.
ii) Reduced body temperature.
iii) Reduced heart rate and blood pressure.
iv) Increased blood sugar levels (alpha-2-adrenergic agonists are known to reduce insulin release, eg. clonidine).
v) Delayed gastro-intestinal transit.
ATC Vet Code: QP53AD01
Acute toxicity (single dose studies)
A) Tecnical material, amitraz
B) Formulated product - Aludex
Male & Female
Toxicity with repeat administration
Technical material, amitraz
No effect level
*males and females in each case.
Mutagenicity, Teratogenicity and Carcinogenicity
Amitraz was inactive in a wide range of laboratory tests for genotoxicity and mutagenicity and is not teratogenic. There was no evidence of tumourogenesis in the rat carcinogenicity study but in a mouse oncogenicity study there were liver tumours in high dose (dietary level of 400 ppm) animals. This was seen in females only, was species specific and of no relevance for humans.
Mode of action and clinical symptomology Amitraz has a variety of pharmacological activities, which are believed to contribute both to its biological efficacy and to the clinical signs of toxicity.
Amitraz is a contact insecticide/acaricide with extended residual activity, functioning as an agonist at octopamine receptors in the nerve synapses. This produces increased nervous activity leading to rapid detachment of parasites and their eventual mortality. This novel mode of action differs from other established insecticides eg. organophosphates, carbamates and pyrethroids.
In mammals, the following activities have been reported:
I) Alpha-2-adrenoreceptor agonist:
This is the main activity responsible for most clinical signs.
II) Weak inhibitor of serotonin receptors
III) Weak H1 receptor agonist.
IV) Mono-amine oxidase inhibitor in vitro but not apparently in vivo.
Dermal absorption of amitraz is relatively slow and achieves peak blood levels 24-72 hours after dosing. Less than 40% of the total applied dose was absorbed in studies on dogs over a period of 10 days following treatment.
Metabolism appears to follow the same route in all mammals observed to date. Initial hydrolysis is to N-(2,4-dimethylphenyl)-N=-methylformamidine (BTS 27271) and 2,4-dimethylformanilide (BTS 27919). The main end products of metabolism are excreted predominantly in the urine and consist of 2-methyl-4-carboxyformanilide (BTS 39098), 4-acetamido- 3-methylbenzoic acid (FBC 31158), their respective conjugates and conjugates of 4-amino-3-methylbenzoic acid (BTS 28369). All these products may be converted to BTS 28369 by acid hydrolysis during extraction and processing. Excretion has been rapid following oral dosing in all species studies, with urine as the major route, accounting for 65-84% of the dose (55-76%) in the first 24 hours.
Tetraisopropydiphenylcarboiimide (Stabaxol 1), Nonoxinol 9, Naphtha 21/99 and Nitrogen.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Dispose of diluted solution immediately after use.
Do not store above 25°C. Store in tightly closed original container in safe place. Store away from food, drink and animal feeding stuffs. Store in a dry place.
50 ml packed in amber coloured glass bottles with white polypropylene/polyethylene (PP/PE) “child-resistant” closure with expanded low density PE/aluminium foil/ PE faced wad.
Harmful to fish and other aquatic life. Do not contaminate ponds, waterways and ditches with concentrate, the diluted wash or used containers.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Unused diluted wash can be discarded through the normal waste disposal system.
1 April 1993
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