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Date: Wednesday, May 22, 2024 18:51

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Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 7.67
Atopica Soft Capsules for Dogs
Species: Dogs
Therapeutic indication: Pharmaceuticals: Miscellaneous
Active ingredient: Ciclosporin
Product:Atopica 10 mg Soft Capsules for Dogs
Atopica 25 mg Soft Capsules for Dogs
Atopica 50 mg Soft Capsules for Dogs
Atopica 100 mg Soft Capsules for Dogs
Product index: Atopica Soft Capsules for Dogs
Qualitative and quantitative composition
Atopica 100mg soft capsules for dogs:
Active substance: Ciclosporin 100 mg
Excipient(s): α-tocopherol (E-307) 1.00 mg, Iron oxide black (E-172) 0.285 mg, Titanium dioxide (E-171) 5.73 mg, Carminic acid (E-120) <1.00 μg.
Atopica 50mg soft capsules for dogs:
Active substance: Ciclosporin 50 mg
Excipient(s):α-tocopherol (E-307) 0.50 mg, Titanium dioxide (E-171) 4.50 mg, Carminic acid (E-120) < 1.00 μg.
Atopica 25mg soft capsules for dogs:
Active substance: Ciclosporin 25 mg
Excipient(s): α-tocopherol (E-307) 0.25 mg, Iron oxide black (E-172) 0.105 mg, Titanium dioxide (E-171) 2.12 mg, Carminic acid (E-120) < 1.00 μg.
Atopica 10mg soft capsules for dogs:
Active substance: Ciclosporin 10 mg
Excipient(s): α-tocopherol (E-307) 0.10 mg, Titanium dioxide (E-171) 1.13 mg, Carminic acid (E-120) < 1.00 μg.
For a full list of excipients, see section pharmaceutical particulars.
Pharmaceutical form
Soft capsule
Atopica 100mg: Blue-grey oblong soft capsules bearing the following imprint: NVR 100 mg.
Atopica 50mg: Yellow-white oblong soft capsules bearing the following imprint: NVR 50 mg.
Atopica 25mg: Blue-grey oval soft capsules bearing the following imprint: NVR 25 mg.
Atopica 10mg: Yellow-white oval soft capsules bearing the following imprint: NVR 10.
Clinical particulars
Target species
Indications for use, specifying the target species
Treatment of chronic manifestations of atopic dermatitis in dogs.
Do not use in cases of hypersensitivity to ciclosporin or any of the excipients.
For all capsule strengths, do not use in dogs less than six months of age or less than 2 kg in weight.
Do not use in cases with a history of malignant disorders or progressive malignant disorders.
Do not vaccinate with a live vaccine during treatment or within a two-week interval before or after treatment. (see also “Special precautions for use” and “Interaction with other medicinal products and other forms of interaction”).
Special warnings for each target species
Consideration should be given to the use of other measures and/or treatments to control moderate to severe pruritus when initiating therapy with ciclosporin.

Special precautions for use
i) Special precautions for use in animals
Clinical signs of atopic dermatitis such as pruritus and skin inflammation are not specific for this disease and therefore other causes of dermatitis such as ectoparasitic infestations, other allergies which cause dermatological signs (e.g. flea allergic dermatitis or food allergy) or bacterial and fungal infections should be ruled out before treatment is started. It is good practice to treat flea infestations before and during treatment of atopic dermatitis.
It is recommended to clear bacterial and fungal infections before administering The veterinary medicinal product. However, infections occurring during treatment are not necessarily a reason for drug withdrawal, unless the infection is severe.
A complete clinical examination should be performed before treatment. As ciclosporin inhibits T-lymphocytes and though it does not induce tumors, it may lead to increased incidences of clinically apparent malignancy. Lymphadenopathy observed on treatment with ciclosporin should be regularly monitored.
In laboratory animals, ciclosporin is liable to affect the circulating levels of insulin and to cause an increase in glycaemia. In the presence of suggestive signs of diabetes mellitus, the effect of treatment on glycaemia must be monitored. If signs of diabetes mellitus are observed following the use of the product, e.g. polyuria or polydipsia, the dose should be tapered or discontinued and veterinary care sought. The use of ciclosporin is not recommended in diabetic dogs.
Closely monitor creatinine levels in dogs with severe renal insufficiency.
Particular attention must be paid to vaccination. Treatment with the veterinary medicinal product may interfere with vaccination efficacy. In the case of inactivated vaccines, it is not recommended to vaccinate during treatment or within a two-week interval before or after administration of the product. For live vaccines see “Contraindications”.
It is not recommended to use other immunosuppressive agents concomitantly.
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after administration.
In the case of accidental ingestion of the capsule or its contents, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
(1 to 10 animals / 1,000 animals treated):
Digestive tract disorders (Vomiting, Mucous stool, Loose stool, Diarrhoea)1.
Rare (1 to 10 animals / 10,000 animals treated):
Lethargy2 , Anorexia2 ; Hyperactivity2 ; Gingival hyperplasia2,3; Skin reactions (Verruciform lesions, Hair change)2 ; Pinnal reddening2 , Pinnal oedema2 ; Muscle weakness2 , Cramp2 .
Very rare (<1 animal / 10,000 animals treated, including isolated reports):
Diabetes mellitus4.
1generally mild and transient and do not require the cessation of the treatment
2generally resolve spontaneously after treatment is stopped
3mild to moderate
4mainly in West Highland White Terriers
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
In laboratory animals, at doses which induce maternal toxicity (rats at 30 mg/kg bw and rabbits at 100 mg/kg bw) ciclosporin was embryo- and fetotoxic, as indicated by increased pre- and postnatal mortality and reduced foetal weight together with skeletal retardations. In the well-tolerated dose range (rats at up to 17 mg/kg bw and rabbits at up to 30 mg/kg bw) ciclosporin was without embryolethal or teratogenic effects. The safety of the drug has neither been studied in breeding male dogs nor in pregnant or lactating female dogs. In the absence of such studies in the dog, it is recommended to use the drug in breeding dogs only upon a positive risk/benefit assessment by the veterinarian. Ciclosporin passes the placenta barrier and is excreted via milk. Therefore the treatment of lactating bitches is not recommended.
Interactions with other medicinal products and other forms of interaction
Various substances are known to competitively inhibit or induce the enzymes involved in the metabolism of ciclosporin, in particular cytochrome P450 (CYP 3A 4). In certain clinically justified cases, an adjustment of the dosage of the veterinary medicinal product. may be required. Ketoconazole at 5-10 mg/kg is known to increase the blood concentration of ciclosporin in dogs up to fivefold, which is considered to be clinically relevant. During concomitant use of ketoconazole and ciclosporin the veterinarian should consider as a practical measure to double the treatment interval if the dog is on a daily treatment regime.
Macrolides such as erythromycin may increase the plasma levels of ciclosporin up to twofold.
Certain inducers of cytochrome P450, anticonvulsants and antibiotics (e.g. trimethoprim/sulfadimidine) may lower the plasma concentration of ciclosporin.
Ciclosporin is a substrate and an inhibitor of the MDR1 P-glycoprotein transporter. Therefore, the co-administration of ciclosporin with P-glycoprotein substrates such as macrocyclic lactones (e.g. ivermectin and milbemycin) could decrease the efflux of such drugs from blood-brain barrier cells, potentially resulting in signs of CNS toxicity.
Ciclosporin can increase the nephrotoxicity of aminoglycoside antibiotics and trimethoprim. The concomitant use of ciclosporin is not recommended with these active ingredients.
In dogs, no toxicological interactions between ciclosporin and prednisolone (at anti-inflammatory doses) are expected.
Particular attention must be paid to vaccination (see “Contraindications” and “Special precautions for use”).
Amount(s) to be administered and administration route
Oral use.
To ensure a correct dosage, body weight should be determined as accurately as possible.
The mean recommended dose of ciclosporin is 5 mg/kg body weight according to the following scheme.
Number of capsules given to obtain the recommended dose
of the dog
Atopica 10 mg
Atopica 25 mg
Atopica 50 mg
Atopica 100 mg
2 to < 3 kg
1 capsule
3 to < 4 kg
2 capsules
4 to < 7.5 kg
1 capsule
7.5 to < 15 kg
1 capsule
15 to < 29 kg
1 capsule
29 to < 36 kg
3 capsules
36 to < 55 kg
2 capsules
The veterinary medicinal product will initially be given daily until a satisfactory clinical improvement is seen. This will generally be the case within 4 weeks. If no response is obtained within the first 8 weeks, the treatment should be stopped.
Once the clinical signs of atopic dermatitis are satisfactorily controlled, the veterinary medicinal product can then be given every other day as a maintenance dose. The veterinarian should perform a clinical assessment at regular intervals and adjust the frequency of administration to the clinical response obtained.
In some cases where the clinical signs are controlled with every-other-day dosing, the veterinarian can decide to give the veterinary medicinal product every 3 to 4 days.
Adjunct treatment (e.g. medicated shampoos, fatty acids) may be considered before reducing the dosing interval.
Treatment may be stopped when the clinical signs are controlled. Upon recurrence of clinical signs, treatment should be resumed at daily dosing, and in certain cases repeated treatment courses may be required.
The veterinary medicinal product should be given at least 2 hours before or after feeding. Insert the capsule directly into the dog’s mouth.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No undesirable effects beyond those that were seen under recommended treatment have been observed in the dog with a single oral dose of up to 6 times of what is recommended.
In addition to what was seen under recommended dosage, the following adverse reactions were seen in case of overdose for 3 months or more at 4 times the mean recommended dosage: hyperkeratotic areas especially on the pinnae, callous-like lesions of the foot pads, weight loss or reduced weight gain, hypertrichosis, increased erythrocyte sedimentation rate, decreased eosinophil values. Frequency and severity of these signs are dose dependent.
There is no specific antidote and in case of signs of overdose the dog should be treated symptomatically. The signs are reversible within 2 months following cessation of treatment.
Withdrawal period (s)
Not applicable.
Pharmacological particulars
Pharmacotherapeutic group: Selective immunosuppressive agents
ATC Vet Code: QL04AD01.
Pharmacodynamic properties
Ciclosporin (also known as cyclosporin, cyclosporine, cyclosporine A, CsA) is a selective immunosuppressor. It is a cyclic polypeptide consisting of 11 amino acids, has a molecular weight of 1203 daltons and acts specifically and reversibly on T lymphocytes.
Ciclosporin exerts anti-inflammatory and antipruritic effects in the treatment of atopic dermatitis. Ciclosporin has been shown to preferentially inhibit the activation of T-lymphocytes on antigenic stimulation by impairing the production of IL-2 and other T-cell derived cytokines. Ciclosporin also has the capacity to inhibit the antigen-presenting function on the skin immune system. It likewise blocks the recruitment and activation of eosinophils, the production of cytokines by keratinocytes, the functions of Langerhans cells, the degranulation of mast cells and therefore the release of histamine and pro-inflammatory cytokines.
Ciclosporin does not depress haematopoiesis and has no effect on the function of phagocytic cells.
Pharmacokinetic particulars
The bioavailability of ciclosporin is about 35%. The peak plasma concentration is reached within 1 to 2 hours. The bioavailability is better and less subject to individual variations if ciclosporin is administered to fasted animals rather than at mealtimes.
In dogs, the volume of distribution is about 7.8 L/kg. Ciclosporin is widely distributed to all tissues. Following repeated daily administration to dogs ciclosporin concentration in the skin is several times higher than in blood.
Ciclosporin is metabolised mainly in the liver by cytochrome P450 (CYP 3A 4), but also in the intestine. Metabolism takes place essentially in the form of hydroxylation and demethylation, leading to metabolites with little or no activity. Unchanged ciclosporin represents about 25% of circulating blood concentrations in the course of the first 24 hours.
Elimination is mainly via the faeces. Only 10% is excreted in the urine, mostly in the form of metabolites. No significant accumulation was observed in blood of dogs treated for one year.
Pharmaceutical particulars
List of excipients
Carminic acid (E-120)
Corn oil-mono-di-triglycerides
Ethanol (E-1520)
Gelatine (E-441)
Glycerol (E-422)
Iron oxide black (E-172) - Atopica 25mg and 100mg Only.
Macrogolglycerol hydroxystearate
Propylene glycol (E-1520)
Titanium dioxide (E-171)
α-Tocopherol (E-307)
Major Incompatibilities
Not applicable.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Special precautions for storage
Do not store above 25oC.
Keep the veterinary medicinal product in the blister pack. Keep the blister pack in the outer carton.
Nature and composition of immediate packaging
Aluminium/Aluminium blisters containing 5 soft capsules.
Cardboard box containing 15 soft capsules in 3 blister packs
Cardboard box containing 30 soft capsules in 6 blister packs
Cardboard box containing 60 soft capsules in 12 lister packs
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with national requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
Atopica 10mg soft capsules for dogs:
UK (Great Britain): Vm 00879/5014; UK (Northern Ireland): Vm 00879/3011
Atopica 25mg soft capsules for dogs:
UK (Great Britain): Vm 00879/5016; UK (Northern Ireland): Vm 00879/3013
Atopica 50mg soft capsules for dogs:
UK (Great Britain): Vm 00879/5017; UK (Northern Ireland): Vm 00879/3014
Atopica 100mg soft capsules for dogs:
UK (Great Britain): Vm 00879/5015; UK (Northern Ireland): Vm 00879/3012
Significant changes
Date of the first authorisation or date of renewal
06 October 2003
Date of revision of the text
June 2023
Any other information
Veterinary medicinal product subject to prescription.
Legal category
Legal category: POM-V
GTIN description:Atopica 100mg
GTIN description:Atopica 50mg
GTIN description:Atopica 25mg
GTIN description:Atopica 10mg