ALDOVIA® Chewable Tablets

Spironolactone Chewable Tablets

Potassium-Sparing Aldosterone Antagonist
For Veterinary Use Only

COMPOSITION

ALDOVIA® 25 mg

Each chewable tablet contains:

Spironolactone ......................................... 25 mg
Excipients .................................................. q.s.

PHARMACEUTICAL FORM

Palatable, beige to light-brown, scored chewable tablets for oral administration.

TARGET SPECIES

Dogs

INDICATIONS

ALDOVIA® is indicated, in combination with standard cardiac therapy including diuretic support when required, for the treatment of congestive heart failure caused by valvular regurgitation in dogs.

It may be included in treatment protocols alongside:

• Pimobendan

• Furosemide or another loop diuretic

• An ACE inhibitor such as benazepril

• Other cardiovascular medicines as clinically indicated

PHARMACOLOGICAL PROPERTIES

Spironolactone is a competitive antagonist of aldosterone and a potassium-sparing diuretic.

By blocking aldosterone receptors, it helps reduce:

• Sodium and water retention

• Cardiac remodelling and fibrosis

• Myocardial and vascular damage associated with chronic aldosterone activity

It promotes moderate sodium and water excretion while reducing excessive potassium loss.

DOSAGE AND ADMINISTRATION

For oral administration.

Dogs

2 mg spironolactone/kg body weight once daily.

Administer with food to improve absorption and treatment consistency. The authorised European veterinary dose for spironolactone in canine congestive heart failure is 2 mg/kg once daily.

Treatment is generally long-term and should be adjusted according to the clinical response and veterinary assessment.

PROPOSED DOSING GUIDE

The final dosing guide must correspond to the approved tablet divisibility and registration dossier.

CONTRAINDICATIONS

Do not use in:

• Dogs with hypoadrenocorticism

• Dogs with hyperkalaemia

• Dogs with hyponatraemia

• Animals with known hypersensitivity to spironolactone or any excipient

• Breeding animals or animals intended for breeding

These contraindications are included in authorised veterinary spironolactone product information.

SPECIAL WARNINGS

Renal function and serum potassium should be evaluated before initiating treatment, particularly when ALDOVIA® is administered with an ACE inhibitor.

Use cautiously in animals with:

• Renal insufficiency

• Dehydration

• Hypovolaemia

• Electrolyte disturbances

• Low blood pressure

SPECIAL PRECAUTIONS FOR USE

During prolonged treatment, consider regular monitoring of:

• Serum potassium

• Serum sodium

• Serum creatinine

• Blood urea nitrogen

• Hydration status

• Blood pressure

• Respiratory rate

• Clinical signs of heart failure

The risk of hyperkalaemia may increase when spironolactone is combined with ACE inhibitors, potassium supplements or other potassium-sparing medicines.

ADVERSE REACTIONS

Possible adverse reactions include:

• Vomiting

• Diarrhoea

• Reduced appetite

• Lethargy

• Dehydration

• Electrolyte abnormalities

Reversible prostatic atrophy may occur in intact male dogs because of the anti-androgenic activity of spironolactone.

Discontinue treatment and consult the veterinarian if the dog develops:

• Severe weakness

• Collapse

• Persistent vomiting

• Abnormal heart rhythm

• Markedly reduced urination

USE DURING PREGNANCY, LACTATION AND BREEDING

Do not use in breeding animals or animals intended for breeding.

The safety of spironolactone has not been established during pregnancy or lactation.

DRUG INTERACTIONS

Use cautiously with:

• ACE inhibitors such as benazepril or enalapril

• Potassium supplements

• Other potassium-sparing diuretics

• NSAIDs

• Digoxin

• Antihypertensive agents

• Nephrotoxic medicines

Concurrent administration with ACE inhibitors may increase the risk of hyperkalaemia and renal dysfunction.

OVERDOSE

Overdose may result in:

• Hyperkalaemia

• Hyponatraemia

• Dehydration

• Hypotension

• Vomiting

• Lethargy

• Cardiac rhythm abnormalities

There is no specific antidote.

Treatment should be symptomatic and supportive, including appropriate fluid and electrolyte correction under veterinary supervision.

STORAGE

Store below 25°C.

Protect from moisture and direct sunlight.

Keep tablets in the original blister until administration.

Return divided tablets to the opened blister cavity.

SHELF LIFE

36 months, subject to confirmation by stability studies.

The storage period for divided tablets must be established in the approved registration dossier.

PRESENTATION

Proposed strengths:

• ALDOVIA® 10 mg

• ALDOVIA® 25 mg

• ALDOVIA® 50 mg

• ALDOVIA® 100 mg

Proposed pack sizes:

• 10 chewable tablets

• 30 chewable tablets

• 100 chewable tablets