Sedastop 5 mg/ml Solution for Injection for Cats and Dogs
Active ingredient: Atipamezole Hydrochloride
Form
Injection
Species
Manufacturer
Le Vet B.V.
VMD MA No.
19994/4014
What it's used for
Atipamezole is indicated for the reversal of the sedative & analgesic effects of medetomidine or dexmedetomidine in dogs and cats. It also reverses all oth...
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Sedastop 5 mg/ml Solution for Injection for Cats and Dogs — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
medetomidine or dexmedetomidine in dogs and cats. It also reverses all other effects
of medetomidine or dexmedetomidine, such as cardiovascular and respiratory
effects.
dexmedetomidine hydrochloride administration.
To ensure a correct dosage, body weight should be determined as accurately as
possible.
Dogs: The intramuscular atipamezole hydrochloride dose [in µg] is five times that of
the previous medetomidine hydrochloride dose or ten times that of the
dexmedetomidine hydrochloride dose. Due to the 5-fold higher concentration
of the active ingredient (atipamezole hydrochloride) in this veterinary medicinal
product compared to that of preparations containing 1 mg medetomidine
hydrochloride per ml and the 10-fold higher concentration compared to that of
preparations containing 0.5 mg dexmedetomidine hydrochloride, an equal volume of
each preparation is required.
Dosage example Dogs:
Medetomidine 1 mg/ml solution
for injection dosage
Narcostop 5 mg/ml solution for
injection for dogs dosage
0.04 ml/kg body weight (bw), 0.04 ml/kg bw,
AN: 00606/2024 & 00608/2024
i.e. 40 µg/kg bwi.e. 200 µg/kg bwDexmedetomidine 0.5 mg/ml
solution for injection dosage
Narcostop 5 mg/ml solution for
injection for dogs dosage
0.04 ml/kg body weight (bw),
i.e. 20 µg/kg bw
0.04 ml/kg bw,
i.e. 200 µg/kg bw
Cats: The intramuscular atipamezole hydrochloride dose [in µg] is two-and-a-half
times that of the previous medetomidine hydrochloride dose or five times that of the
dexmedetomidine hydrochloride dose. Due to the 5-fold higher concentration of the
active ingredient (atipamezole hydrochloride) in this veterinary medicinal product
compared to that of preparations containing 1 mg medetomidine hydrochloride per ml
and the 10-fold higher concentration compared to that of preparations containing 0.5
mg dexmedetomidine hydrochloride, half the volume of the veterinary medicinal
product to that of the previously administered medetomidine or dexmedetomidine
should be given.
Dosage example Cats:
Medetomidine 1 mg/ml solution
for injection dosage
Narcostop 5 mg/ml solution for
injection for cats dosage
0.08 ml/kg body weight (bw),
i.e. 80 µg/kg bw
0.04 ml/kg bw,
i.e. 200 µg/kg bw
Dexmedetomidine 0.5 mg/ml
solution for injection dosage
Narcostop 5 mg/ml solution for
injection for cats dosage
0.08 ml/kg body weight (bw),
i.e. 40 µg/kg bw
0.04 ml/kg bw,
i.e. 200 µg/kg bw
The recovery time is shortened to approximately 5 minutes. The animal becomes
mobile after approximately 10 minutes after administration of the veterinary medicinal
product.
- Breeding animals
- Animals suffering from liver, renal or cardiac diseases
See also section 3.7
AN: 00606/2024 & 00608/2024
Rare
(1 to 10 animals / 10,000
animals treated):
Hyperactivity, Vocalisation
a
, Inappropriate
urination, Inappropriate defecation
Tachycardia
Increased salivation, Vomiting
Muscle tremor
Increased respiratory rate
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Hypotension
b
Sedation
c
, Recovery prolonged
d
Hypothermia
e
a
Atypical.
AN: 00606/2024 & 00608/2024
b
Transient effect that has been observed during the first 10 minutes post-injection of
atipamezole hydrochloride.
c
Recurrence.
d
The recovery time may not be shortened after administration of atipamezole.
e
Only in cats, when using low doses to partially reverse the effects of medetomidine
or dexmedetomidine. Should be guarded against, even when aroused from sedation.
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 its local representative or the national
competent authority via the national reporting system. See also the package leaflet
for respective contact details.
drink is offered.
Special precautions for safe use in the target species:
After administration of the veterinary medicinal product, the animals should be
allowed to rest in a quiet place. During recovery time animals should not be left
unattended.
Due to different dosing recommendations caution should be taken if using the
veterinary medicinal product off-label in animals other than the target species.
If other sedatives than medetomidine are given it must be kept in mind that the
effects of those other agents may persist after reversal of (dex)medetomidine.
Atipamezole does not reverse the effect of ketamine, which may cause seizures in
dogs and elicit cramps in cats when used alone. Do not use atipamezole earlier than
30-40 minutes after concomitant administration of ketamine.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Due to the potent pharmacological activity of atipamezole, skin-, eye- and mucous
membrane-contact with this veterinary medicinal product should be avoided. In case
of accidental spillage wash the affected area immediately with clean running water.
Seek medical attention if irritation persists. Remove contaminated clothes that are in
direct contact with the skin.
Care should be taken to avoid accidental ingestion or self-injection. In case of
accidental ingestion or self-injection occurs, seek medical advice immediately and
show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
products such as diazepam, acepromazine or opiates is not recommended.
Keep the vial in the outer carton in order to protect from light.
AN: 00606/2024 & 00608/2024
Excipients:
Qualitative
and other constituents
Quantitative
information is essential
administration of the veterinary
medicinal product
Methyl parahydroxybenzoate (E 218)1.0 mgSodium chlorideHydrochloric acid (for pH-adjustment)Sodium hydroxide (for pH-adjustment)Water for injections
A clear colourless, sterile aqueous solution.
3. CLINICAL INFORMATION
3.1 Target species
Dogs and cats.
3.2 Indications for use for each target species
Atipamezole hydrochloride is indicated for reversal of the sedative effects and
cardiovascular effects after use of alpha-2-agonists like medetomidine and
dexmedetomidine in dogs and cats.
3.3 Contraindications
Do not use in:
- Breeding animals
- Animals suffering from liver, renal or cardiac diseases
See also section 3.7
AN: 00606/2024 & 00608/2024
3.4 Special warnings
Make sure the animal has regained a normal swallowing reflex before any food or
drink is offered.
3.5 Special precautions for use
Special precautions for safe use in the target species:
After administration of the veterinary medicinal product, the animals should be
allowed to rest in a quiet place. During recovery time animals should not be left
unattended.
Due to different dosing recommendations caution should be taken if using the
veterinary medicinal product off-label in animals other than the target species.
If other sedatives than medetomidine are given it must be kept in mind that the
effects of those other agents may persist after reversal of (dex)medetomidine.
Atipamezole does not reverse the effect of ketamine, which may cause seizures in
dogs and elicit cramps in cats when used alone. Do not use atipamezole earlier than
30-40 minutes after concomitant administration of ketamine.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Due to the potent
This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.
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