| Composition |
Each tablet of Crandozix 20 contains: Furosemide 20mg.
Each tablet of Crandozix 40 contains: Furosemide 40mg.
Each tablet of Crandozix 80 contains: Furosemide 80mg. |
| Properties |
It has been demonstrated that furosemide inhibits primarily the absorption of sodium and chloride not only in the proximal and distal tubules but also in the loop of Henle.
The high degree of efficacy is largely due to the unique site of action on the distal tubule.
The onset of diuresis following oral administration is within 1 hour.
The peak effect occurs within the first or second hour. The duration of diuretic effect is 6 to 8 hours. |
| Pharmacodynamics properties |
gastrointestinal System Reactions:
Hepatic encephalopathy in patients with hepatocellular insufficiency, pancreatitis, jaundice (intrahepatic cholestatic jaundice), increased liver enzymes, anorexia, nausea, vomiting.
Systemic Hypersensitivity Reactions:
Severe anaphylactic or anaphylactoid reactions (e.g. with shock), systemic vasculitis and interstitial nephritis.
Central Nervous System Reactions:
Tinnitus, hearing loss, paresthesias, vertigo, dizziness, headache and blurred vision.
Hematologic Reactions:
Aplastic anemia, thrombocytopenia, agranulocytosis, hemolytic anemia, leucopenia, eosinophilia.
Dermatologic-Hypersensitivity Reactions:
Toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, purpura, photosensitivity, rash, pruritus, urticaria.
Cardiovascular Reaction:
- Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics.
- Increase in cholesterol and triglyceride serum levels |
| Therapeutic indications |
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.
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. |
| Warnings and precautions |
WARNINGS:
In patients with hepatic cirrhosis and ascites, Furosemide therapy is best initiated in the hospital.
In hepatic coma and in states of electrolyte depletion, therapy should not be instituted until the basic condition is improved. Supplemental potassium chloride and, if required, an aldosterone antagonist are helpful in preventing hypokalemia and metabolic alkalosis.
If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, Furosemide should be discontinued.
PRECAUTIONS:
Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients.
As with any effective diuretic, electrolyte depletion may occur during Furosemide therapy, especially in patients receiving higher doses and a restricted salt intake. Hypokalemia may develop with Furosemide when cirrhosis is present, or during concomitant use of corticosteroids, ACTH, licorice in large amounts, or prolonged use of laxatives.
Digitalis therapy may exaggerate metabolic effects of hypokalemia, especially myocardial effects. |
| Contraindication |
| Furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide. |
| Pregnancy and lactation |
Pregnancy Category C: Furosemide should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Treatment during pregnancy requires monitoring of fetal growth because of the potential for higher
birth weights.
Nursing mothers: Because it appears in breast milk, caution should be exercised when Furosemide is administered to a nursing mother. Furosemide may inhibit lactation. |
| Drug interactions |
- Furosemide may increase the ototoxic potential of aminoglycoside antibiotics, especially in the
presence of impaired renal function.
- Furosemide should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity.
Patients receiving high doses of salicylates concomitantly with Furosemide, as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites.
- There is a risk of ototoxic effects if cisplatin and Furosemide are given concomitantly.
- Furosemide has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and
may potentiate the action of succinylcholine.
- Furosemide combined with angiotensin converting enzyme inhibitors or angiotensin II receptor
blockers may lead to hypotension and deterioration in renal function.
- An interruption or reduction in the dosage of Furosemide, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers may be necessary.
- Concomitant use of cyclosporine and Furosemide is associated with increased risk of gouty arthritis secondary to Furosemide -induced hyperurecemia. |
| DOSAGE & ADMINISTRATION |
1. 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 given as a single dose.
Ordinarily a prompt diuresis ensues.
If needed, the same dose can be administered 6 to 8 hours later or the dose may be increased. The dose may be raised by 20 or 40 mg and given not sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained.
The individually determined single dose should then be given once or twice daily (eg, at 8 am and 2 pm).
The dose of Furosemide may be carefully titrated up to 600 mg/day in patients with clinically severe edematous states.
Geriatric patients:
In general, dose selection for the elderly patient should be cautious, usually starting at the low of the dosing range.
Pediatric patients:
The usual initial dose of oral Furosemide in pediatric patients is 2 mg/kg body weight, given as a single dose.
If the diuretic response is not satisfactory after the initial dose, dosage may be increased by 1
or 2 mg/kg no sooner than 6 to 8 hours after the previous dose.
Doses greater than 6 mg/kg body weight are not recommended.
For maintenance therapy in pediatric patients, the dose should be adjusted to the minimum effective level.
2. Hypertension:
Therapy should be individualized according to the patient's response to gain maximal therapeutic response and to determine the minimal dose needed to maintain the therapeutic response.
Adults:
The usual initial dose of Furosemide for hypertension is 80 mg, usually divided into 40 mg twice a day.
Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.
Geriatric patients:
In general, dose selection and dose adjustment for the elderly patient should be cautious, usually starting at the low of the dosing range. |
| Overdose |
The principal signs and symptoms of overdose with Furosemide are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia and hypochloremic alkalosis and are extensions of its diuretic action.
Treatment of overdosage is supportive and consists of replacement of excessive fluid and electrolyte losses.
Serum electrolytes, carbon dioxide level and blood pressure should be determined frequently.
Adequate drainage must be assured in patients with urinary bladder outlet obstruction (such as prostatic hypertrophy).
Hemodialysis does not accelerate furosemide elimination. |
| Package |
| 20 tablets in tow blisters inside a carton box with a leaflet. |
| Storage |
| Store at 25 C°, excursions permitted to (15 – 30) C°, keep away from children. |
