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Prilactone

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Summary for the public


What is PRILACTONE?

PRILACTONE tablets contain the active substance spironolactone (10 mg, 40 mg or 80 mg). The tablets are scored to make them easier to break if smaller doses are needed.


What is PRILACTONE used for?

PRILACTONE is used to treat dogs that have congestive heart failure because of faulty heart valves. When the heart valves are faulty, the heart is not able to pump blood as efficiently as before. As a result, blood can accumulate in the veins and fluid can leak out into the tissues, leading to the heart being unable to deliver oxygen-rich blood to the body adequately. PRILACTONE is used in combination with ‘standard therapy’ (other heart medicines, including diuretic support where necessary).

PRILACTONE is given to the dog once daily, with food (either mixed in the food, or immediately after feeding). The dose to use is 2 mg per kilogram of the dog’s body weight. The appropriate number of tablets, half tablets or quarter tablets to give according to the dog’s size is given in the Package Leaflet.


How does PRILACTONE work?

The active substance in PRILACTONE, spironolactone, blocks the actions of a hormone called aldosterone in the kidneys, heart and blood vessels. By blocking aldosterone, spironolactone causes the kidneys to excrete salt and fluids, but retain potassium, and hence it improves heart function. It is accepted there are also other ways in which spironolactone works on the heart and blood vessels in congestive heart failure (although these mechanisms of action have not yet been fully demonstrated in dogs).


How has PRILACTONE been studied?

PRILACTONE has been studied in the laboratory, as well as in three studies in dogs with heart valve diseases, which were treated in various veterinary practices or clinics across Europe (‘clinical studies‘). In these clinical studies, the animal owners gave either PRILACTONE tablets or placebo (dummy tablets without any active ingredient) to their dogs, once daily, at a dose of 2 mg/kg with food. PRILACTONE tablets were given with food because this results in more of the active substance being absorbed from the tablets. All dogs also received ‘standard therapy’ (generally another medicine belonging to the group called ‘ACE-inhibitors’ and if needed a diuretic). Treatment continued for up to 15 months.


What benefit has PRILACTONE shown during the studies?

The results of the studies showed that dogs with congestive heart failure caused by faulty heart valves that were given PRILACTONE tablets in addition to another heart medicine (‘standard therapy’), had a longer survival time than the dogs that received the standard therapy plus placebo tablets. In a long term study, the dogs treated with PRILACTONE also showed less deterioration of their heart disease compared to the dogs which were treated only with ‘standard therapy’.


What is the risk associated with PRILACTONE?

PRILACTONE was generally well tolerated when administered daily at the recommended dose for up to 15 months in dogs with heart failure.

As spironolactone can reduce the levels of some male hormones, male dogs which have not been neutered may show a shrinking of the prostate gland. However, this is reversible. For the same reasons, PRILACTONE tablets should not be used in growing dogs. They should also not be given to animals with high blood potassium levels (hyperkalaemia) or low blood sodium levels (hyponatraemia), or to animals with hypoadrenocorticism (a disease that results from the reduction in corticosteroid secretion from the adrenal gland). PRILACTONE tablets should not be given to dogs with poor kidney function that are being given medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). As spironolactone is broken down in the liver, the tablets should be used with caution in dogs with liver disease.

PRILACTONE tablets should not be used in dogs used for, or intended for use in breeding, as it has been demonstrated that spironolactone might cause harm to newborn or young laboratory animals. For a full list of all side effects reported with PRILACTONE, and for a list of all interactions with other medicines, see the Package Leaflet.


What are the precautions for the person who gives the medicine or comes into contact with the animal?

Anyone handling PRILACTONE should wash their hands afterwards. PRILACTONE may cause skin sensitisation, so people who know that they are allergic to spironolactone should not handle the product. In case someone accidentally swallows PRILACTONE tablets, medical advice should be sought immediately and the Package Leaflet or the label should be shown to the physician.


Why has PRILACTONE been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of PRILACTONE outweigh its risks for use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs, and recommended that PRILACTONE be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about PRILACTONE

The European Commission granted a marketing authorisation valid throughout the European Union for PRILACTONE to CEVA SANTE ANIMALE on 20 June 2007. Information on the prescription status of this product may be found on the outer package.

Authorisation details
Name: Prilactone
EMEA Product number: EMEA/V/C/000105
Active substance: spironolactone
INN or common name: Spironolactone
Species: Dogs
ATCvet Code: QC03DA01
Marketing Authorisation Holder: Ceva Sante Animale
Revision: 2
Date of issue of Market Authorisation valid throughout the European Union: 10/06/2007
Contact address:
CEVA SANTE ANIMALE
10 avenue de la Ballastière
33500 Libourne
France



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    PRILACTONE 10 mg tablets for dogs
    PRILACTONE 40 mg tablets for dogs
    PRILACTONE 80 mg tablets for dogs
    2.
    QUALITATIVE AND QUANTITATIVE COMPOSITION
    Active substance:
    Each tablet contains:
    PRILACTONE 10 mg
    spironolactone 10 mg
    PRILACTONE 40 mg
    spironolactone 40 mg
    PRILACTONE 80 mg
    spironolactone 80 mg
    For a full list of excipients, see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Tablets.
    PRILACTONE 10 mg: White, with a slight brownish mottling, bisected oval tablet of 10 mm length.
    PRILACTONE 40 mg: White, with a slight brownish mottling, oval tablet of 17 mm length with three
    parallel break-lines.
    PRILACTONE 80 mg: White, with a slight brownish mottling, oval tablet of 20 mm length with three
    parallel break-lines.
    4.
    CLINICAL PARTICULARS
    4.1
    Target species
    Dogs.
    4.2
    Indications for use, specifying the target species
    For use in combination with standard therapy (including diuretic support, where necessary) for the
    treatment of congestive heart failure caused by valvular regurgitation in dogs.
    4.3
    Contraindications
    Do not use in animals used for, or intended for use in breeding.
    Do not use the product in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia.
    Do not administer spironolactone in conjunction with NSAIDs to dogs with renal insufficiency.
    4.4
    Special warnings for each target species
    None
    2/25
    4.5
    Special precautions for use
    Special precautions for use in animals
    Kidney function and serum potassium levels should be evaluated before initiating combined treatment
    with spironolactone and ACE inhibitors. Unlike in humans, an increased incidence of hyperkalaemia
    was not observed in clinical trials performed in dogs with this combination. However, in dogs with
    renal impairment regular monitoring of renal function and serum potassium levels is recommended as
    there may be an increased risk of hyperkalaemia.
    Dogs treated concomitantly with spironolactone and NSAIDs should be correctly hydrated.
    Monitoring of their renal function and plasma potassium levels is recommended before initiation and
    during treatment with combined therapy (see 4.3).
    As spironolactone has an antiandrogenic effect, it is not recommended to administer the product to
    growing dogs.
    As spironolactone undergoes extensive hepatic biotransformation, care should be taken when using the
    product to treat dogs with hepatic dysfunction.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    May cause skin sensitisation: persons known to be allergic to spironolactone should not handle the
    product. Wash hands after use.
    In the event of accidental ingestion, seek medical advice immediately and show the package leaflet or
    the label to the physician.
    4.6 Adverse reactions (frequency and seriousness)
    A reversible prostatic atrophy is often observed in entire male dogs.
    4.7 Use during pregnancy, lactation or lay
    Do not use during pregnancy and lactation because developmental toxicity has been observed in
    laboratory species.
    4.8 Interaction with other medicinal products and other forms of interaction
    In clinical studies, PRILACTONE was co-administered with furosemide and pimobendan without
    evidence of associated adverse reactions.
    Spironolactone decreases digoxin elimination and hence raises digoxin plasma concentration. As the
    therapeutic index for digoxin is very narrow, it is advisable to monitor closely dogs receiving both
    digoxin and spironolactone.
    The administration of either deoxycorticosterone or NSAIDs with spironolactone may lead to a
    moderate reduction of the natriuretic effects (reduction of urinary sodium excretion) of spironolactone.
    Concomitant administration of spironolactone with ACE-inhibitors and other potassium-sparing drugs
    (as angiotensin receptor blockers, ß-blockers, calcium channels blockers, etc..) may potentially lead to
    hyperkalaemia (see 4.5).
    Spironolactone may cause both induction and inhibition of cytochrome P450 enzymes and could
    therefore affect the metabolism of other drugs utilizing these metabolic pathways.
    3/25
    4.9
    Amounts to be administered and administration route
    Oral use.
    2 mg of spironolactone per kg of body weight once daily. The product should be administered with
    food. The tablet can either be mixed with a small amount of food offered prior to the main meal, or
    administered directly into the mouth after feeding.
    Number of Tablets
    B ODYWEIGHT
    PRILACTONE
    10 mg Tablets
    PRILACTONE
    40 mg Tablets
    PRILACTONE
    80 mg Tablets
    1 to 2.5 kg
    ½
    2.5 to 5 kg
    1
    5 to 10 kg
    2
    10 to 15 kg
    3
    15 to 20 kg
    1
    20 to 30 kg
    1 + ½
    30 to 40 kg
    1
    40 to 50 kg
    1 + ¼
    50 to 60 kg
    1 + ½
    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
    After administration of up to 10 times the recommended dose (20 mg/kg) to healthy dogs, dose-
    dependent adverse effects were noted, see section 4.6.
    In case of an accidental massive ingestion by a dog, there is no specific antidote or treatment. It is
    therefore recommended to induce vomiting, lavage the stomach (depending on risk assessment) and
    monitor electrolytes. Symptomatic treatment, e.g., fluid therapy, should be provided.
    4.11 Withdrawalperiod(s)
    Not applicable.
    5.
    PHARMACOLOGICAL PROPERTIES
    Pharmacotherapeutic group: Aldosterone antagonist.
    ATCvet code: QC03DA01.
    5.1
    Pharmacodynamic properties
    Spironolactone and its active metabolites (including 7α-thiomethyl-spironolactone and canrenone) act
    as specific antagonists of aldosterone, and exert their effects by binding competitively to the
    mineralocorticoid receptor located in the kidneys, heart and blood vessels.
    Spironolactone is a natriuretic drug (historically described as a soft diuretic). In the kidney,
    spironolactone inhibits the aldosterone-induced sodium retention leading to increase in sodium and
    subsequently water excretion, and potassium retention.
    4/25
     
    The renal effects of spironolactone and its metabolites lead to a decrease in extracellular volume and
    consequently in a decrease of cardiac preload and left atrial pressure. The result is an improvement in
    heart function.
    In the cardiovascular system, spironolactone prevents the detrimental effects of aldosterone. Although
    the precise mechanism of action is not yet clearly defined, aldosterone promotes myocardial fibrosis,
    myocardial and vascular remodelling and endothelial dysfunction.
    In experimental models in dogs, it was shown that long term therapy with an aldosterone antagonist
    prevents progressive left ventricle dysfunction and attenuates left ventricle remodelling in dogs with
    chronic heart failure.
    In a clinical study investigating the survival time in dogs with congestive heart failure, there was a
    65% reduction in the relative risk of mortality at 15 months in dogs treated with spironolactone in
    combination with standard therapy compared to dogs treated with standard therapy alone. (Mortality
    was classified as death or euthanasia due to heart failure).
    When used in combination with ACE-inhibitors, spironolactone may counteract the effects of
    “aldosterone escape”.
    A slight increase in aldosterone blood levels may be observed in animals on treatment. This is thought
    to be due to activation of feedback mechanisms without adverse clinical consequence. There may be a
    dose related hypertrophy of the adrenal zona glomerulosa at high dose rates.
    5.2
    Pharmacokinetic particulars
    The pharmacokinetics of spironolactone are based on its metabolites, as the parent compound is
    unstable at assay.
    Absorption
    After oral administration of spironolactone to dogs, it was demonstrated that the three metabolites
    achieved levels of 32 to 49% of the administered dose. Food increases the bioavailability to 80 to
    90 %. Following oral administration of 2 to 4 mg/kg, absorption increases linearly over the range.
    After multiple oral doses of 2 mg spironolactone per kg for 10 consecutive days, no accumulation is
    observed. Mean C max of 382 μg/l and 94 μg/l are achieved for the primary metabolites, 7α-thiomethyl-
    spironolactone and canrenone, after 2 and 4 hours, respectively. Steady-state conditions are reached by
    day 2.
    Distribution
    The mean volumes of distribution (Vss) of 7α-thiomethyl-spironolactone and canrenone are
    approximately 153 litres and 177 litres respectively.
    The mean residence time of the metabolites ranges from 9 to 14 hours and they are preferentially
    distributed to the gastro-intestinal tract, kidney, liver and adrenal glands.
    Metabolism
    Spironolactone is rapidly and completely metabolised by the liver into its active metabolites, 7α-
    thiomethyl-spironolactone and canrenone, which are the primary metabolites in the dog.
    Elimination
    Spironolactone is mainly excreted via its metabolites. Plasma clearance of canrenone is
    1.45±0.39 l/h/kg and 7α-thiomethyl-spironolactone is 0.89±0.44 l/h/kg. After oral administration of
    radiolabelled spironolactone to the dog, 70 % of the dose is recovered in faeces and 20 % in the urine.
    5/25
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Beef flavouring
    Mannitol
    Sodium laurilsulfate
    Microcrystalline cellulose
    Povidone
    Sorbitol
    Talc
    Magnesium stearate
    6.2 Incompatibilities
    Not applicable.
    6.3 Shelf life
    3 years as packaged for sale.
    6.4. Special precautions for storage
    This veterinary medicinal product does not require any special storage conditions.
    Partially used tablets should be stored in the original blister pack.
    6.5 Nature and composition of immediate packaging
    Material of the primary container
    Blister packs (polyamide/aluminium/polyvinyl chloride//aluminium) in a cardboard box.
    Pack sizes
    Box containing 3 blisters of 10 tablets
    Box containing 18 blisters of 10 tablets
    6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
    materials derived from the use of such products, if appropriate
    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
    products should be disposed of in accordance with local requirements.
    7.
    MARKETING AUTHORISATION HOLDER
    CEVA SANTE ANIMALE
    10 avenue de la Ballastière
    33500 Libourne
    France
    8.
    MARKETING AUTHORISATION NUMBER(S)
    EU/2/07/074/001 – 002 (10 mg tablets)
    EU/2/07/074/003 – 004 (40 mg tablets)
    EU/2/07/074/005 – 006 (80 mg tablets)
    6/25
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    20 June 2007
    10.
    DATE OF REVISION OF THE TEXT
    20 July 2009
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    Detailed information on this product is available on the website of the European Medicines Agency
    7/25
    ANNEX II
    A.
    MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
    BATCH RELEASE
    B.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING
    AUTHORISATION REGARDING SUPPLY OR USE
    C.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING
    AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
    D.
    STATEMENT OF THE MRLs
    8/25
    A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer responsible for batch release
    CEVA SANTE ANIMALE
    Z.I. Très le Bois
    F-22600 Loudeac
    France
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    Veterinary medicinal product subject to prescription.
    The holder of this marketing authorisation must inform the European Commission about the marketing
    plans for the medicinal product authorised by this decision.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
    Not applicable.
    D.
    STATEMENT OF THE MRLs
    Not applicable.
    9/25
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    10/25
    A. LABELLING
    11/25
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    Carton box labelling – 10 mg tablets
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    PRILACTONE 10 mg tablets for dogs
    Spironolactone.
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Each tablet contains 10 mg spironolactone.
    3.
    PHARMACEUTICAL FORM
    Tablets
    4.
    PACKAGE SIZE
    30 tablets
    180 tablets
    5.
    TARGET SPECIES
    Dogs
    6.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Oral use.
    Read the package leaflet before use.
    7.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    8.
    EXPIRY DATE
    EXP: {month/year}
    9.
    SPECIAL STORAGE CONDITIONS
    Store partially used tablets in the original blister pack.
    12/25
     
    10. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Disposal: read package leaflet.
    11. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only – to be supplied only on veterinary prescription.
    12. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    13. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    CEVA SANTE ANIMALE
    10 avenue de la Ballastière
    33500 Libourne
    France
    14. MARKETING AUTHORISATION NUMBER(S)
    EU/2/07/074/001 (3 blisters of 10 tablets)
    EU/2/07/074/002 (18 blisters of 10 tablets)
    15. MANUFACTURER’S BATCH NUMBER
    Lot:
    13/25
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    Carton box labelling – 40 mg tablets
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    PRILACTONE 40 mg tablets for dogs
    Spironolactone.
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Each tablet contains 40 mg spironolactone.
    3.
    PHARMACEUTICAL FORM
    Tablets
    4.
    PACKAGE SIZE
    30 tablets
    180 tablets
    5.
    TARGET SPECIES
    Dogs
    6.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Oral use.
    Read the package leaflet before use.
    7.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    8.
    EXPIRY DATE
    EXP: {month/year}
    9.
    SPECIAL STORAGE CONDITIONS
    Store partially used tablets in the original blister pack.
    14/25
     
    10. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Disposal: read package leaflet.
    11. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only – to be supplied only on veterinary prescription.
    12. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    13. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    CEVA SANTE ANIMALE
    10 avenue de la Ballastière
    33500 Libourne
    France
    14. MARKETING AUTHORISATION NUMBER(S)
    EU/2/07/074/003 (3 blisters of 10 tablets)
    EU/2/07/074/004 (18 blisters of 10 tablets)
    15. MANUFACTURER’S BATCH NUMBER
    Lot:
    15/25
     
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    Carton box labelling – 80 mg tablets
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    PRILACTONE 80 mg tablets for dogs
    Spironolactone.
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Each tablet contains 80 mg spironolactone.
    3.
    PHARMACEUTICAL FORM
    Tablets
    4.
    PACKAGE SIZE
    30 tablets
    180 tablets
    5.
    TARGET SPECIES
    Dogs
    6.
    METHOD AND ROUTE(S) OF ADMINISTRATION
    Oral use.
    Read the package leaflet before use.
    7.
    SPECIAL WARNING(S), IF NECESSARY
    Read the package leaflet before use.
    8.
    EXPIRY DATE
    EXP: {month/year}
    9.
    SPECIAL STORAGE CONDITIONS
    Store partially used tablets in the original blister pack.
    16/25
     
    10. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
    WASTE MATERIALS, IF ANY
    Disposal: read package leaflet.
    11. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only - to be supplied only on veterinary prescription.
    12. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    13. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    CEVA SANTE ANIMALE
    10 avenue de la Ballastière
    33500 Libourne
    France
    14. MARKETING AUTHORISATION NUMBER(S)
    EU/2/07/074/005 (3 blisters of 10 tablets)
    EU/2/07/074/006 (18 blisters of 10 tablets)
    15. MANUFACTURER’S BATCH NUMBER
    Lot:
    17/25
     
    MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
    Blister foil of 10 tablets
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    PRILACTONE 10 mg tablets
    Spironolactone
    2.
    NAME OF THE MARKETING AUTHORISATION HOLDER
    CEVA
    3.
    EXPIRY DATE
    EXP: {month/year}
    4.
    BATCH NUMBER
    Lot:
    5.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    18/25
     
    MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
    Blister foil of 10 tablets
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    PRILACTONE 40 mg tablets
    Spironolactone
    2.
    NAME OF THE MARKETING AUTHORISATION HOLDER
    CEVA
    3.
    EXPIRY DATE
    EXP: {month/year}
    4.
    BATCH NUMBER
    Lot:
    5.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    19/25
     
    MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
    Blister foil of 10 tablets
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    PRILACTONE 80 mg tablets
    Spironolactone
    2.
    NAME OF THE MARKETING AUTHORISATION HOLDER
    CEVA
    3.
    EXPIRY DATE
    EXP: {month/year}
    4.
    BATCH NUMBER
    Lot:
    5.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    20/25
     
    B. PACKAGE LEAFLET
    21/25
    PACKAGE LEAFLET
    PRILACTONE 10 mg tablets for dogs
    PRILACTONE 40 mg tablets for dogs
    PRILACTONE 80 mg tablets for dogs
    1.
    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
    THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
    RELEASE, IF DIFFERENT
    Marketing authorisation holder:
    CEVA SANTE ANIMALE
    10 avenue de la Ballastière
    33500 Libourne
    France
    Tel: + 33 (0) 5 57 55 40 40
    e-mail: contact@ceva.com
    Manufacturer for batch release:
    CEVA SANTE ANIMALE
    Z.I. Très le Bois
    22600 Loudéac
    France
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    PRILACTONE 10 mg tablets for dogs
    PRILACTONE 40 mg tablets for dogs
    PRILACTONE 80 mg tablets for dogs
    Spironolactone
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
    Each tablet contains:
    PRILACTONE 10 mg
    spironolactone 10 mg
    PRILACTONE 80 mg
    spironolactone 80 mg
    Excipients include beef flavouring.
    4.
    INDICATION(S)
    PRILACTONE tablets are used in combination with standard therapy (including diuretic support,
    where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs.
    5.
    CONTRAINDICATIONS
    Do not use in pregnant or lactating animals or in animals used for, or intended for use in breeding.
    Do not use in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia.
    Do not use in conjunction with non-steroidal anti-inflammatory drugs (NSAIDs) in dogs with renal
    insufficiency (kidney impairment/dysfunction).
    22/25
    PRILACTONE 40 mg
    spironolactone 40 mg
    6.
    ADVERSE REACTIONS
    A reversible prostatic atrophy (reduction in size) is often observed in entire male dogs.
    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
    veterinary surgeon.
    7.
    TARGET SPECIES
    Dogs.
    8.
    DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
    Oral use.
    2 mg of spironolactone per kg of body weight once daily.
    Number of Tablets
    B ODYWEIGHT
    PRILACTONE
    10 mg Tablets
    PRILACTONE
    40 mg Tablets
    PRILACTONE
    80 mg Tablets
    1 to 2.5 kg
    ½
    2.5 to 5 kg
    1
    5 to 10 kg
    2
    10 to 15 kg
    3
    15 to 20 kg
    1
    20 to 30 kg
    1 + ½
    30 to 40 kg
    1
    40 to 50 kg
    1 + ¼
    50 to 60 kg
    1 + ½
    9.
    ADVICE ON CORRECT ADMINISTRATION
    The product should be administered with food. The tablet can either be mixed with a small amount of
    food offered prior to the main meal, or administered directly into the mouth after feeding.
    10. SPECIAL STORAGE PRECAUTIONS
    Keep out of the reach and sight of children.
    This veterinary medicinal product does not require any special storage conditions.
    Partially used tablets should be stored in the original blister pack.
    Do not use after the expiry date (EXP) which is stated on the carton and blister label.
    23/25
     
    11.
    SPECIAL WARNING(S)
    Special precautions for use in animals
    Kidney function and serum potassium levels should be evaluated before initiating combined treatment
    with spironolactone and ACE inhibitors. Unlike in humans, an increased incidence of hyperkalaemia
    (raised blood potassium levels) was not observed in studies in dogs with this combination. However,
    in dogs with renal impairment regular monitoring of renal function and serum potassium levels is
    recommended as there may be an increased risk of hyperkalaemia.
    Dogs treated concomitantly with spironolactone and NSAIDs should be correctly hydrated.
    Monitoring of their renal function and plasma potassium levels is recommended before initiation and
    during treatment with combined therapy (see Contraindications).
    As spironolactone has an antiandrogenic effect (acts against male hormones), it is not recommended to
    administer the product to growing dogs.
    As spironolactone undergoes extensive hepatic (liver) biotransformation, care should be taken when
    using the product in dogs with liver dysfunction.
    Special precautions to be taken by the person administering the veterinary medicinal product to
    animals
    May cause skin sensitisation: persons known to be allergic to spironolactone should not handle the
    product. Wash hands after use.
    In the event of accidental ingestion, seek medical advice immediately and show the package leaflet or
    the label to the physician.
    Interactions
    In clinical studies, PRILACTONE was co-administered with furosemide and pimobendan without
    evidence of associated adverse reactions.
    Spironolactone decreases digoxin elimination and hence raises digoxin plasma concentration. As the
    therapeutic index for digoxin is very narrow, it is advisable to monitor closely dogs receiving both
    digoxin and spironolactone.
    The administration of either deoxycorticosterone or NSAIDs with spironolactone may lead to a
    moderate reduction of the natriuretic effects (reduction of urinary sodium excretion) of spironolactone.
    Concomitant administration of spironolactone with ACE-inhibitors and other potassium-sparing drugs
    (as angiotensin receptor blockers, ß-blockers, calcium channels blockers, etc) may potentially lead to
    hyperkalaemia. (See Special precautions for use in animals).
    Spironolactone may cause both induction and inhibition of cytochrome P450 enzymes and could
    therefore affect the metabolism of other drugs utilizing these metabolic pathways.
    Overdose
    After administration of up to 10 times the recommended dose (20 mg/kg) to healthy dogs, dose-
    dependent adverse effects were noted (see Adverse Reactions).
    In case of an accidental massive ingestion by the dog, there is no specific antidote or treatment. It is
    therefore recommended to induce vomiting, lavage the stomach (depending on risk assessment) and
    monitor electrolytes. Symptomatic treatment, e.g., fluid therapy, should be provided.
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    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
    MATERIALS, IF ANY
    Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should
    help to protect the environment.
    13. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
    20 July 2009
    14. OTHER INFORMATION
    Pack sizes:
    PRILACTONE tablets are supplied in blister packs with 30 or 180 tablets per pack. Not all pack sizes
    may be marketed.
    Pharmacodynamic properties
    Spironolactone and its active metabolites (including 7α-thiomethyl-spironolactone and canrenone) act
    as specific antagonists of aldosterone, and exert their effects by binding competitively to the
    mineralocorticoid receptor located in the kidneys, heart and blood vessels.
    Spironolactone is a natriuretic drug (historically described as a soft diuretic). In the kidney,
    spironolactone inhibits the aldosterone-induced sodium retention leading to increase in sodium and
    subsequently water excretion, and potassium retention.
    The renal effects of spironolactone and its metabolites lead to a decrease in extracellular volume and
    consequently in a decrease of cardiac preload and left atrial pressure. The result is an improvement in
    heart function.
    In the cardiovascular system, spironolactone prevents the detrimental effects of aldosterone. Although
    the precise mechanism of action is not yet clearly defined, aldosterone promotes myocardial fibrosis,
    myocardial and vascular remodelling and endothelial dysfunction.
    In experimental models in dogs, it was shown that long term therapy with an aldosterone antagonist
    prevents progressive left ventricle dysfunction and attenuates left ventricle remodelling in dogs with
    chronic heart failure.
    In a clinical study investigating the survival time in dogs with congestive heart failure, there was a
    65% reduction in the relative risk of mortality at 15 months in dogs treated with spironolactone in
    combination with standard therapy compared to dogs treated with standard therapy alone. (Mortality
    was classified as death or euthanasia due to heart failure).
    When used in combination with ACE-inhibitors, spironolactone may counteract the effects of
    “aldosterone escape”.
    A slight increase in aldosterone blood levels may be observed in animals on treatment. This is thought
    to be due to activation of feedback mechanisms without adverse clinical consequence.
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    Source: European Medicines Agency


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