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Oral formulations of furosemide and amiloride hydrochloride

Drugs List

  • co-amilofruse (amiloride 10mg and furosemide 80mg) tablets
  • co-amilofruse (amiloride 2.5mg and furosemide 20mg) tablets
  • co-amilofruse (amiloride 5mg and furosemide 40mg) tablets
  • FRUMIL 5mg+40mg tablets
  • FRUMIL LS 2.5mg+20mg tablets
  • Therapeutic Indications


    Ascites and oedema associated with hepatic cirrhosis
    Congestive cardiac failure
    Diuresis (potassium sparing) in nephrosis
    Diuresis (potassium sparing) required due to corticosteroid therapy
    Diuresis (potassium sparing) required due to oestrogen therapy
    Prompt diuresis especially where potassium conservation is important



    Starting dose: 5mg amiloride + 40mg furosemide.
    Maintenance doses (all tablet strengths): 1 to 2 tablets in the morning.


    Acute renal failure
    Addison's disease
    Electrolyte imbalance
    Long QT syndrome
    Pre-coma associated with hepatic cirrhosis
    Renal damage secondary to nephrotoxic agents
    Renal impairment - creatinine clearance below 30ml/minute/1.73m sq
    Renal impairment associated with hepatic coma
    Renal impairment secondary to hepatotoxic agents
    Severe hypokalaemia
    Severe hyponatraemia
    Torsade de pointes

    Precautions and Warnings

    Children under 18 years
    Family history of long QT syndrome
    Predisposition to hypotension
    Predisposition towards electrolyte imbalance
    Benign prostatic hyperplasia
    Diabetes mellitus
    Glucose-galactose malabsorption syndrome
    Hepato-renal syndrome
    History of torsade de pointes
    Lactose intolerance
    Systemic lupus erythematosus
    Urinary obstruction

    Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
    Correct electrolyte disorders before treatment
    Correct hypotension before initiating treatment
    May exacerbate or activate systemic lupus erythematosus
    Advise ability to drive/operate machinery may be affected by side effects
    Correct hypovolaemia prior to administration
    Contains lactose
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor blood urea
    Monitor fluid and electrolyte status
    Monitor haematological parameters regularly throughout treatment
    Monitor serum potassium regularly
    Excess consumption of liquorice may increase the risk of hypokalaemia
    Increased risk of hyperkalaemia with K+ suppl. and K+ sparing diuretic
    May precipitate diabetes mellitus
    May precipitate gout
    Discontinue treatment before glucose tolerance test
    Discontinue if evidence of significant bone marrow depression
    Withdraw drug if skin rash or pruritus occur
    Advise patient not to take NSAIDs unless advised by clinician
    Hypotensive effects may be potentiated by alcohol
    Advise on problems of salt substitutes/high intake of potassium-rich food

    Pregnancy and Lactation


    Co-amilofruse is contraindicated in pregnancy.

    Furosemide should be used with caution during pregnancy as animal studies in rats and rabbits have reported teratogenicity. Furosemide crosses the placenta, and can stimulate foetal urine production for a short time. Briggs (2011) states that furosemide does not significantly increase amniotic fluid volume. Furosemide inhibits physiological closure of the ductus arteriosus in premature babies. Briggs (2011) and Schaefer(2007) suggest that furosemide can be used when treatment of heart or renal failure requires a diuretic. However, if treatment is continued throughout pregnancy, there is a risk of neonatal hypoglycaemia.

    No reports of amiloride passing to the foetus in humans have been found. However, due to it's low molecular weight and the fact that it crosses the placenta in mice and rabbits, amiloride is expected to pass through the placenta in humans. There is a lack of human data for amiloride use during pregnancy. However, in one study where 28 newborns had been exposed to amiloride in the first trimester two major birth defects where seen (one expected), one of these was a hypospadias. No anomalies where seen in the other five categories (cardiovascular, oral clefts, spina bifida, polydactyly and limb reduction defects) for which specific data were available. Briggs (2011) states that there is limited human data, but due to animal data there is a low risk to the foetus. Schaefer (2007) concludes that amiloride should not be used during pregnancy. However, use with any of the diuretics is not an indication for termination of the pregnancy.

    Diuretics are no longer used as part of the standard therapy for hypertension and oedema during pregnancy, due to the maternal, hypovolaemic character of the disease. Many sources contraindicate the use of diuretics during pregnancy, except for patients with heart disease, mainly because they do not prevent or alter the course of toxaemia and they may decrease placental perfusion. If long term treatment is necessary the mother's electrolytes and haematocrit should be measured and the development of oligohydramnios should be ruled out. Hypoglycaemia in the newborn should also be monitored.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Co-amilofruse is contraindicated in breastfeeding.

    Furosemide has been found in breast milk. It is frequently used in paediatric units (Hale, 2014) and because of the extremely poor bioavailability exhibited by furosemide in newborns very high doses are required. The amounts transferred into human milk would be very unlikely to produce any effects in infants, although theoretical suppression of lactation could occur. Schaefer (2007) state that if furosemide is indicated then it may be prescribed.

    It is not known whether amiloride is excreted in human milk. Due to its low molecular weight and the fact that amiloride is excreted in the milk of lactating rats at concentrations higher than that measured in blood, passage into human milk is expected. There is a lack of human data with amiloride during breastfeeding and the effects on the nursing infant are unknown. Schaefer (2007) concludes that due to insufficient information amiloride should not be used during breastfeeding. However, single doses do not require limitation of breastfeeding, but therapy should be changed.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal pain
    Acute generalised exanthematous pustulosis
    Allergic reaction
    Altered liver function tests
    Anaphylactoid reaction
    Aplastic anaemia
    Bone marrow depression
    Bullous pemphigoid
    Cardiac arrhythmias
    Cholestatic jaundice
    Decreased glucose tolerance
    Delayed reactions
    Drug rash with eosinophilia and systemic symptoms (DRESS)
    Dry mouth
    Erythema multiforme
    Exacerbation of systemic lupus erythematosus
    Exfoliative dermatitis
    Fluid and electrolyte disturbances
    Gastric upset
    Gastro-intestinal symptoms
    Haemolytic anaemia
    Hepatic encephalopathy
    Hypersensitivity reactions
    Impaired concentration
    Increase in blood urea nitrogen
    Increase in plasma cholesterol
    Increase in plasma triglyceride concentration
    Increased calcium excretion
    Increased intra-ocular pressure
    Interstitial nephritis
    Metabolic acidosis
    Metabolic alkalosis
    Minor psychiatric disturbances
    Muscle cramps
    Orthostatic hypotension
    Precipitation of diabetes
    Sensation of pressure
    Serum creatinine increased
    Sexual dysfunction
    Skin reactions
    Stevens-Johnson syndrome
    Systemic lupus erythematosus
    Toxic epidermal necrolysis
    Urinary retention
    Visual disturbances


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: June 2015

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Martindale: The Complete Drug Reference. 39th Edition. London: Brayfield A (ed). Pharmaceutical Press; 2017.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

    Summary of Product Characteristics: Co-Amilofruse 20mg/2.5mg Tablets. Aurobino Pharma - Milpharm Ltd. Revised May 2012.
    Summary of Product Characteristics: Co-Amilofruse 40mg/5mg Tablets. Aurobino Pharma - Milpharm Ltd. Revised May 2012.
    Summary of Product Characteristics: Co-Amilofruse 80mg/10mg Tablets. Aurobino - Milpharm Ltd. Revised May 2012.

    Summary of Product Characteristics: Frumil. Sanofi. Revised May 2015.
    Summary of Product Characteristics: Frumil LS. Sanofi. Revised May 2015.
    Summary of Product Characteristics: Frumil, Frumil LS. Sanofi. Revised September 2010.

    NICE Evidence Services Available at: Last accessed: 23 June 2017

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