DIUREVIA® Tablets

Furosemide Tablets

Loop Diuretic for Dogs and Cats
For Veterinary Use Only

COMPOSITION

DIUREVIA® 20 mg

Each tablet contains:

Furosemide ............................................... 20 mg
Excipients .................................................. q.s.

DIUREVIA® 40 mg

Each tablet contains:

Furosemide ............................................... 40 mg
Excipients .................................................. q.s.

PHARMACEUTICAL FORM

White to off-white, scored oral tablets.

TARGET SPECIES

Dogs and cats.

Furosemide veterinary tablets are authorised in several markets for both species.

INDICATIONS

DIUREVIA® is indicated for the treatment of oedema and abnormal fluid accumulation associated with:

• Congestive heart failure

• Pulmonary oedema and pulmonary congestion

• Ascites associated with cardiac insufficiency

• Peripheral oedema

• Acute non-inflammatory tissue oedema

• Other conditions requiring diuretic therapy, as determined by the veterinarian

The approved indication for veterinary furosemide tablets includes pulmonary congestion, ascites and oedema associated with cardiac insufficiency.

PHARMACOLOGICAL PROPERTIES

Furosemide is a potent loop diuretic.

It inhibits the reabsorption of sodium and chloride in the ascending limb of the loop of Henle, resulting in increased urinary excretion of:

• Water

• Sodium

• Chloride

• Potassium

• Other electrolytes

The resulting diuresis reduces circulating fluid volume, pulmonary congestion, oedema and cardiac preload. Excessive administration can cause profound diuresis, dehydration and electrolyte depletion.

DOSAGE AND ADMINISTRATION

For oral administration.

Dogs and cats

Initial proposed dosage:

1–2 mg furosemide/kg body weight, administered once or twice daily.

The dose and frequency should be individually adjusted according to:

• Clinical severity

• Respiratory condition

• Urine output

• Renal function

• Hydration status

• Response to treatment

For acute or severe congestive heart failure, a veterinarian may adjust the dosage or use injectable therapy.

Use the lowest effective dose capable of controlling clinical signs.

The definitive dose schedule must correspond to the approved registration dossier and local label.

METHOD OF ADMINISTRATION

Administer directly into the mouth or with a small quantity of food.

Ensure continuous access to fresh drinking water unless the veterinarian instructs otherwise.

Do not alter or discontinue long-term cardiac treatment without veterinary supervision.

CONTRAINDICATIONS

Do not use in animals with:

• Anuria or inability to produce urine

• Severe dehydration

• Hypovolaemia

• Severe electrolyte depletion

• Known hypersensitivity to furosemide, sulfonamides or any excipient

• Hepatic coma

Do not use where increased urine production could worsen the animal’s clinical condition.

SPECIAL WARNINGS

Furosemide is a potent diuretic. Excessive dosage or prolonged use without monitoring may cause:

• Dehydration

• Hypovolaemia

• Hyponatraemia

• Hypokalaemia

• Hypochloraemia

• Metabolic alkalosis

• Renal impairment

• Hypotension

Careful veterinary supervision and individual dose adjustment are therefore required.

SPECIAL PRECAUTIONS FOR USE

Before and during prolonged treatment, consideration should be given to monitoring:

• Hydration status

• Body weight

• Renal function

• Serum electrolytes

• Blood pressure

• Respiratory rate

• Clinical signs of congestive heart failure

Use cautiously in animals with:

• Renal impairment

• Hepatic dysfunction

• Diabetes mellitus

• Electrolyte abnormalities

• Low blood pressure

ADVERSE REACTIONS

Dose-related adverse reactions may include:

• Increased urination

• Increased thirst

• Dehydration

• Weakness or lethargy

• Reduced appetite

• Vomiting or diarrhoea

• Electrolyte imbalance

• Hypotension

• Deterioration of renal function

Prolonged or excessive diuresis may lead to significant water and electrolyte depletion.

Discontinue treatment and contact the veterinarian if the animal develops:

• Collapse

• Severe weakness

• Reduced urine production

• Persistent vomiting

• Marked loss of appetite

• Neurological abnormalities

USE DURING PREGNANCY AND LACTATION

Use only according to the benefit-risk assessment performed by the attending veterinarian.

Furosemide may cross the placenta and may be excreted in milk.

DRUG INTERACTIONS

Use cautiously with:

• ACE inhibitors

• Other diuretics

• Aminoglycoside antibiotics

• Corticosteroids

• Digoxin

• NSAIDs

• Nephrotoxic medicines

• Antihypertensive medicines

Concurrent administration with other diuretics or cardiovascular medicines may increase the risks of dehydration, electrolyte abnormalities, hypotension or renal dysfunction.

Furosemide is commonly used as part of combination treatment for canine congestive heart failure, including alongside pimobendan and other cardiac medicines when clinically appropriate.

OVERDOSE

Overdose may cause:

• Excessive diuresis

• Severe dehydration

• Electrolyte depletion

• Hypotension

• Circulatory collapse

• Renal dysfunction

There is no specific antidote.

Treatment should include discontinuation or reduction of the dose and appropriate fluid and electrolyte replacement under veterinary supervision.

STORAGE

Store below 25°C.

Protect from moisture and direct sunlight.

Keep tablets in the original blister until administration.

Keep out of the sight and reach of children.

SHELF LIFE

36 months, subject to confirmation by stability studies.

Divided tablets should be returned to the opened blister and used within the period established in the approved dossier.

PRESENTATION

Available strengths:

• DIUREVIA® 20 mg

• DIUREVIA® 40 mg

Proposed pack sizes:

• 10 tablets

• 30 tablets

• 100 tablets