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Metabolism and nutrition disorders

Increased excretion of sodium and chloride and consequently water. Increased excretion of other electrolytes (in particular calcium and magnesium). The two active ingredients exert opposing influences on potassium excretion. The serum potassium concentration may decrease, especially at the commencement of treatment, although, particularly as treatment is continued, the potassium concentration may increase (owing to the later onset of action of amiloride) especially in patients with impairment of renal function.

Symptomatic electrolyte disturbances, metabolic alkalosis due to furosemide, metabolic acidosis due to amiloride, dehydration and hypovolaemia especially in elderly patients, transitory increases in blood creatinine and urea levels, increase in cholesterol and triglyceride serum levels, increase in uric acid serum levels and attacks of gout. Decrease of glucose tolerance. Latent diabetes mellitus may become manifest Pseudo-Bartter syndrome in the context of misuse and/or long-term use of furosemide has been reported.

Vascular disorders

Hypotension including or thostatic hypotension, tendency for thromboses, vascultis. Cases of thrombosis have been reported.

Renal and urinary disorders

Acute retention of urine in patients with a partial obstruction of urinary outflow, interstitial nephritis, nephrocalcinosis/nephrolithiasis in premature infants. Rare cases of tubulointerstitial nephritis have been reported.

Gastrointestinal disorders

Nausea, vomiting, diarrhoea, acute pancreatitis.

Hepato-bilary disorders

Intrahepatic cholestasis, increase in liver transaminases.

Ear and labyrinth disorders

Hearing disorders and tinnitus, although usually transitory, particularly in patients with renal failure, hypoproteinaemia (e.g. in nephritic syndrome). Cases of Deafness, sometimes irreversible have been reported after administration of furosemide.

Skin and subcutaneous tissue disorders

Itching, urticaria, other rashes or bulbous lesions, erythema multiforme, bulbous pemphigoid, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, purpura, photosensitivity. AGEP (acute generalized exanthematous pustulosis) and DRESS (Drug rash with eosinophilia and systemic symptoms) has been reported with the use of products containing furosemide.

Immune system disorders

Severe anaphylactic or anaphylactoid reactions (e.g. with shock). Cases of exacerbation or activation of systemic lupus erythematosus have been reported.

Nervous system disorders

Paraesthesiae, hepatic encephalopathy in patients with hepatocellular insufficiency.

Headache, dizziness, fainting or loss of consciousness have been reported.

Musculoskeletal and connective tissue disorders

Cases of rhabdomyolysis have been reported, often in the context of severe hypokalaemia.

Blood and the lymphatic system disorders

Thrombocytopenia, agranulocytosis, leucopenia, aplastic anaemia or haemolytic anaemia, eosinophilia, haemoconcentration.

General disorders and administration site conditions


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