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Edemex

To the Medical and Pharmaceutical Professions.

Composition:
Each 1 ml ampoule contains:
Bumetanide                            0.25 mg

Properties:
Edemex is a loop diuretic with rapid onset and short duration of action. It inhibits sodium reabsorption in the ascending limb of the loop of Henle.
Excretion of potassium, chloride and phosphate is increased by Edemex.
Edemex decreases uric acid excretion.

Pharmacokinetics:
- Following an intravenous injection, diuresis starts within minutes and reaches its maximum levels within 15 to 30 minutes.
- Edemex is eliminated rapidly with a half life between 1 and 1½ hours.
- Plasma protein binding is in the range of 94% - 96%.

Indications & usage:
Edemex is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease including the nephrotic syndrome.
Edemex is used alone or as an adjunct in the treatment of hypertension

Contraindications:
Edemex is contraindicated in anuria, any marked increase in blood urea nitrogen (BUN) or creatinine during therapy of patients with progressive renal disease.
Edemex is contraindicated in hepatic coma and in patients with hypersensitivity to the drug.

Side effects:
The most frequent clinical side effects are muscle cramps, hypotension, dizziness, headache, nausea, hyperuricemia, hyperglycemia, gout, hypochloramic alkalosis, hyponatreamia, hypokalemia, hypomagnesemia, and skin rash (rarely).

Drug Interactions:
- Lithium should generally not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity.
- Edemex potentiates the effect of various antihypertensive drugs.
- Indomethacin blunts the increases in urine volume and sodium excretion thus concurrent therapy with Edemex is not recommended.

Warnings & precautions:
- Dehydration, electrolyte depletion, reduction in blood volume and hypokalemia.
- Serum potassium should be measured periodically.
- Potassium supplements or K-sparing diuretics should be added if necessary.
- Edemex may increase urinary calcium excretion with resultant hypocalcemia.
 
Pregnancy:
There are no adequate and well controlled studies in pregnant women.

Nursing mothers:
Nursing should not be undertaken while the patient is on Edemex since it may be excreted in human milk.

Overdosage:
Overdosage can lead to acute water loss, electrolyte depletion, dehydration, reduction of blood volume, pancreatitis, tinnitus and deafness.

Treatment:
Replacement of fluids, electrolyte losses by careful monitoring of the urine and electrolyte output and serum electrolyte level.

Dosage and administration:
The usual initial dose is 0.5 to 1 mg intravenously or intramuscularly.
Intravenous administration should not be given over a period of 1 to 2 minutes.
If the response to an initial dose is insufficient, a second or third dose may be given at intervals of 2 to 3 hours but should not exceed a daily dosage of 10 mg.

Therapeutic category:
Diuretic.

Legal category: Prescription only medicine.

Package:
Each box contains 3 sterile 2 ml ampoules.

Storage:
Store at a temperature below 30° C, protect from light.
 

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.