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OUR PRODUCTS

torsemide ,  spirolactone
Commercial name
UREREST
Category
Antihypertensive drugs
Chemical composition

Each film coated tablet contains:

5 mg torsemide (anhydrous form) + 50 mg spirolactone

10 mg torsemide (anhydrous form) + 50 mg spirolactone

20 mg torsemide (anhydrous form) + 50 mg spirolactone

10 mg torsemide (anhydrous form) + 25 mg spirolactone

Dosage Form
film - coated tablets
Pharmaceutical group
DIURETICS DRUGS
Contraindications
  • Hypersensitivity to torsemide, sulfonylureas, spironolactone or any of the components of the product
  • Anuria patients
  • Acute renal failure
  • Significant impairment of renal excretory function
  • Hepatic coma and pre-coma
Drug interactions

- Probenecid: Coadministration of probenecid reduces the secretion of torsemide in the proximal tubules and thus reduces the diuretic activity of torsemide.

- Lithium: Lithium should generally not be given with diuretics. Diuretics are known to decrease renal clearance of lithium and add a significant risk of lithium toxicity.

- Angiotensin-converting enzyme (ACE) inhibitors: Sequential or combined treatment, or initiation of a new combination with an ACE inhibitor, may cause temporary hypotension. This can be reduced by decreasing the starting dose of the ACE inhibitor and/or reducing or temporarily stopping the dose of torsemide.

- Alcohol, barbiturates, or narcotics: Orthostatic hypotension may occur when any of these agents are used with spironolactone.

- Corticosteroids, adrenocorticotropic hormone (ACTH): Severe electrolyte depletion, especially hypokalemia, may occur when any of these agents are taken with spironolactone. Pressor amines (eg, norepinephrine): Spironolactone reduces the vascular response to norepinephrine.

- Muscle relaxants, other than depolarizing (eg, tubocurarine): May result in an increased response potential to muscle relaxant when co-administered with spironolactone. Muscle relaxants containing curare and theophylline may be enhanced when used with Torsemide.

- Non-steroidal anti-inflammatory drugs (NSAIDs): In some patients, taking NSAIDs can reduce the diuretic effect.

- Salicylates: Since torsemide and salicylate compete for renal tubular secretion, patients receiving high doses of salicylate may experience salicylate toxicity when administered concomitantly.

- Cardiac glycosides: When torsemide is used simultaneously with cardiac glycosides, a deficiency of potassium and / or magnesium may increase the sensitivity of the myocardium to such drugs.

- Carbinoxolone: ​​Since carbinoxolone may cause sodium retention and thus reduce the effectiveness of spironolactone, concomitant use of the two components should be avoided.

- Angiotensin II antagonists, aldosterone blockers, heparin, low molecular weight heparin, and other drugs known to cause hyperkalemia: Coadministration of these agents with spironolactone may result in severe hyperkalemia.

- Antihypertensive agents: As with diuretics, the effect of antihypertensive drugs given concomitantly with torsemide or spironolactone may be increased.

- Antidiabetics: The effect of antidiabetic drugs may be reduced when used with torsemide.

- Trimethoprim/Sulfamethoxazole: Concomitant use of trimethoprim/sulfamethoxazole (cotrimoxazole) with spironolactone may result in clinically relevant hyperkalemia

Dosage and usage

 

Edema associated with secondary hyperaldosteronism in:

Cirrhosis, congestive heart failure, nephrotic syndrome, High blood pressure with hyperaldosteronism

Dosage

Dosage must be individual.

Ascites cirrhosis:

The usual recommended initial dose is two tablets of the preparation. If an adequate response is not obtained, the dose may be increased to four tablets of the preparation Further, in cases of severe edema, where a greater amount of the loop diuretic is desired, the patient may be switched to four 10 mg tablets of this preparation

Congestive heart failure:

The usual recommended starting dose is one 10 mg tablet or two 5 mg tablets. If an adequate response is not obtained, the dose may be increased to up to four tablets of the 5 mg preparation or of the 10 mg preparation. Furthermore, in severe cases of edema, where a greater amount of the loop diuretic is required, the patient may be switched to four 20 mg tablets in case of nephrotic syndrome

The usual recommended initial dose is two 10 mg tablets. If an adequate response is not obtained, the dose may be increased to four 10 mg tablets. Furthermore, in cases of severe edema, a larger amount of the loop diuretic is desired. The patient may be switched to four 20 mg tablets.

Hypertension:

Patients who do not show an adequate response to Torsemide 10 mg may be switched to one 10 mg tablet. If an adequate response is not obtained, the patient may be switched to two 5 mg tablets. The dose should not be increased to more than these

Side Effect

Dizziness, headache, nausea, weakness, vomiting, hyperglycemia, excessive urination, hyperuricemia, hypokalemia, excessive thirst, hypovolemia, impotence, esophageal bleeding, dyspepsia, urinary retention, increased certain liver enzymes Allergic reaction, photosensitivity.

Marketing authorization number(s)

UREREST 5/50 F.C.TABLETS.................( 494 /2020 ).

UREREST 10/50 F.C.TABLETS.................( 495 /2020 ).

UREREST20/50 F.C.TABLETS.................( 496 /2020 ).

UREREST 10/25 F.C.TABLETS.................( 493/2020 ).

The nature and content of the packaging

A carton box containing 1 or 3 blisters, each one contains 10 f.c.tablets.