DIUMIDE

COMPOSITION:

Diumide-20: 

Each tablet contains: Furosemide IP 20 mg                

Diumide-40: 

Each tablet contains: Furosemide IP 40 mg                

CLINICAL PHARMACOLOGY:

Mechanism of action:

Furosemide is a powerful diuretic that inhibits sodium and chloride absorption in the proximal and distal tubules, as well as in the loop of Henle, independently of carbonic anhydrase and aldosterone.

Pharmacokinetics:

Absorption: Furosemide is rapidly absorbed orally, with variable bioavailability (50–70%).

Distribution: It has high plasma protein binding (~95%) and distributes into extracellular fluid.

Metabolism: Minimal metabolism occurs in the liver.

Excretion: Primarily excreted unchanged via the kidneys; a small amount is eliminated in bile.

INDICATIONS AND USAGE: 

Edema 

Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.

Hypertension 

Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone.

DOSAGE AND ADMINISTRATION:

Edema 

Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response.  

Adults -- The usual initial dose of furosemide is 20 to 80 mg as a single dose. If needed, the same dose can be repeated after 6 to 8 hours or increased by 20 or 40 mg, not sooner than 6 to 8 hours after the previous dose, until the desired effect is achieved. The dose should then be given once or twice daily (e.g., at 8 am and 2 pm). In severe cases, the dose may be titrated up to 600 mg/day.

WARNINGS AND PRECAUTIONS:

Warning:

Furosemide requires careful dosing to avoid excessive diuresis and electrolyte imbalance. In patients with hepatic cirrhosis, therapy should start in a hospital to prevent complications, and it should be discontinued if renal issues or tinnitus occur. Caution is needed in patients with hypoproteinemia, sulfonamide allergies, and those at risk of ototoxicity.

Precautions: 

Excessive diuresis from furosemide can cause dehydration, circulatory collapse, and electrolyte imbalances like hypokalemia. Patients should be monitored for weakness, muscle cramps, hypotension, and gastrointestinal issues.

ADVERSE REACTIONS:

Common adverse effects of furosemide include low blood pressure, dehydration, electrolyte depletion, jaundice, and tinnitus.

DRUG INTERACTIONS:

Furosemide may enhance ototoxicity with aminoglycosides, interact with drugs like ethacrynic acid, cisplatin, and lithium, and reduce the effectiveness of phenytoin and methotrexate. It also increases nephrotoxicity risk with cephalosporins.

USE IN SPECIAL POPULATION:

Pregnancy: Furosemide is a pregnancy category C drug, used only when the benefits outweigh potential fetal risks.

Nursing Mothers: Furosemide appears in breast milk and may inhibit lactation, so caution is advised when administering it to nursing mothers.

Pediatric Use: In premature infants, furosemide can cause nephrocalcinosis or nephrolithiasis and may increase the risk of persistent patent ductus arteriosus.

Geriatric Use: Elderly patients, especially those with impaired renal function, are at greater risk for toxic reactions, requiring careful dose selection and renal function monitoring.

CONTRAINDICATIONS:

Furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

OVERDOSAGE: 

Furosemide overdose can cause dehydration, hypotension, electrolyte imbalances, and hypochloremic alkalosis. Treatment is supportive, focusing on fluid and electrolyte replacement and monitoring blood pressure and serum levels.

STORAGE: 

Store between 15-30°C protected from light and moisture. 

PRESENTATION: 

Diumide-20/40: Each box containing 10 blister strips of 10 tablets.