Edemex


Composition:
Each tablet contains:
Bumetanide                1 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 oral administration of Edemex, the onset of diuresis occurs in 30-60 minutes and peak activity is reached between one and two hours.
Edemex is eliminated rapidly with a t½ of 1-1½ hours. Plasma protein binding is in the range of 94% to 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& 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.

Warnings & Precautions:
- Dehydration, electrolyte depletion and reduction in blood volume.
- 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 fluid, electrolyte losses by careful monitoring of the urine and electrolyte output and serum electrolyte level.
 
Dosage and Administration:
0.5 mg (½ tablet) – 2 mg (two tablets) is given as a single dose.
If the diuretic response is not adequate, a second or a third dose may be given at 4-5 hours intervals up to 10 mg (maximum daily dose).
- An intermittent dose schedule where Edemex is given on alternative days or for 3-4 days with rest periods of 1-2 days is recommended for the safest & most effective method for the continued control of edema. In patients with hepatic failure the dosage is increased very carefully.

Therapeutic category: Diuretic.

Legal category: Prescription only medicine.

Package:
Each box contains 20 tablets.

Storage: Store in a dry place at a temperature below 30ºC, 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.