DIUMIDE S

COMPOSITION:

Diumide S :

Each film coated tablet contains: Furosemide IP 20 mg and Spironolactone IP 50 mg 

CLINICAL PHARMACOLOGY:

Mechanism of Action:

Furosemide: A loop diuretic that treats hypertension and edema by inhibiting sodium and water reabsorption in the kidneys.

Spironolactone: A potassium-sparing diuretic and antihypertensive that blocks aldosterone receptors to promote sodium excretion and potassium retention.

Pharmacokinetics:

Furosemide: A loop diuretic with 50% bioavailability, peak levels in 1–2 hours, high protein binding (~95%), and primarily renal excretion with a 1–2 hour half-life.

Spironolactone: A potassium-sparing diuretic metabolized into active forms, with peak levels in 2–4 hours, a 13–24 hour half-life, and excretion via urine and feces.

INDICATIONS AND USAGE:

Diumide S is a combination of a short-acting diuretic and a long-acting aldosterone antagonist, used for resistant edema associated with secondary hyperaldosteronism, such as in chronic heart failure and hepatic cirrhosis. It is reserved for cases unresponsive to standard diuretics and should only be used after separate titration of the components. Its use for managing essential hypertension is limited to patients with proven hyperaldosteronism.

DOSAGE AND ADMINISTRATION:

For oral use, the dose should be the lowest necessary to achieve the desired effect. Adults: 1–4 tablets daily.

Children: Not suitable for use in children.

Elderly: Excretion of Frusemide and Spironolactone may be slower in the elderly.

Administration Instructions: Tablets should be taken at breakfast and/or lunch with plenty of liquid. An evening dose is not recommended, particularly during initial treatment, to avoid increased nocturnal urine output.

WARNINGS AND PRECAUTIONS:

Warning:

Treatment with Diumide S requires regular monitoring of serum sodium, potassium, and creatinine, especially in patients with renal impairment or when combined with certain drugs that increase potassium levels. 

Precautions:

Spironolactone may cause tumor progression in metastatic castration-resistant prostate cancer, increase prostate-specific antigen (PSA) levels, and cause vocal changes. Frusemide may exacerbate or activate systemic lupus erythematosus.

ADVERSE REACTIONS:

Diumide S may cause hyponatremia, renal failure, hepatic enzyme elevation, and side effects like headache, nausea, and vomiting. Frusemide can lead to hematological disorders, electrolyte imbalances, gastrointestinal issues, tinnitus, hypotension, and allergic skin reactions.

DRUG INTERACTIONS:

Concomitant use of antihypertensives, diuretics, or blood-pressure-lowering drugs with Diumide S may cause a greater drop in blood pressure. NSAIDs, including acetylsalicylic acid, can reduce Diumide S efficacy and may lead to acute renal failure or increased salicylate toxicity in dehydrated or hypovolemic patients

USE IN SPECIFIC POPULATION:

Pregnancy: Diumide S must not be given during pregnancy. Frusemide crosses the placental barrier. Animal studies conducted with spironolactone have shown genital feminization in male offspring. Anti-androgenic effects have been reported in human under risk of external genital ambiguity in new-born males

Nursing Mother: Use of Diumide S is contraindicated during lactation. Frusemide passes into the breast milk and inhibits lactation.

Pediatric: Regular checks for electrolytes, hydration, renal function, and growth are essential.

Geriatric: Diumide S requires careful monitoring for renal function and electrolyte imbalance.

CONTRAINDICATIONS:

Diumide S should not be used in patients with hypovolaemia, severe electrolyte imbalances (hyperkalemia, severe hypokalemia, and severe hyponatremia), impaired renal function, or hepatic encephalopathy. It is contraindicated in cases of acute renal failure, anuria, or creatinine clearance below 30 ml/min.

OVERDOSAGE:

The clinical picture in acute or chronic overdose depends primarily on the extent and consequences of electrolyte and fluid loss, e.g. hypovolaemia, dehydration, haemoconcentration, cardiac arrhythmias due to excessive diuresis. Symptoms of these disturbances include severe hypotension (progressing to shock), acute renal failure, thrombosis, delirious states, flaccid paralysis, apathy and confusion.

STORAGE:

Store protected from light and moisture, at a temperature not exceeding 30°C

PRESENTATION:

Diumide S: Carton containing 10 Aluminium strips each containing 10 tablets (10 x 10’s strips).