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Co-Amilofruse

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Co-Amilofruse

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Treatment option:

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Co-Amilofruse

Property Description
Active Ingredients Furosemide and Amiloride
Form Oral Tablets
Pharmacological Class Combination Diuretic
Common Use Fluid Removal (Diuresis)
Origin Synthetic

1. Defining Co-Amilofruse: What Type of Medicine Is It?

Co-Amilofruse is a fixed-dose combination product classified as a combination diuretic with potent antihypertensive properties. This preparation is entirely synthetic in origin and is available exclusively as a prescription-only medicine (POM). It is often referred to as a "water tablet" due to its primary action of increasing the body's water excretion.

Its structure as a fixed-dose combination, supplied as a single oral tablet, is supported by pharmacological data. Fixed-dose combinations can simplify therapy and improve adherence.

2. Composition: What Active Ingredients Does Co-Amilofruse Contain?

Co-Amilofruse tablets contain two active ingredients: Furosemide and Amiloride, derived from two distinct diuretic classes. Furosemide is a powerful loop diuretic, while Amiloride is a potassium-sparing diuretic that acts on a separate section of the kidney.

This complementary composition is a clinically recognized strategy for balanced effect. While Furosemide is highly effective in fluid removal, the Amiloride component promotes the conservation of potassium, thus reducing the risk of hypokalaemia. Combining a loop diuretic with a potassium-sparing agent is an effective strategy to avoid potassium depletion.

3. General Purpose: Why Is This Combination Diuretic Used?

The general function of Co-Amilofruse is to initiate controlled and effective diuresis, the physiological process of increasing urine output, which efficiently reduces excess fluid volume in the body.

This fluid reduction action helps alleviate the symptoms of swelling known as oedema, which is a sign of excessive fluid retention. Furthermore, the decrease in total circulating blood volume helps to relieve the pressure exerted on arterial walls, confirming the drug's role in the management of hypertension (high blood pressure).

Regulatory References

  1. combining a loop diuretic with a potassium-sparing agent
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What side effects are possible with Co-Amilofruse?

Possible Side Effects and Safety Information

This section details the adverse effects and safety characteristics of Co-Amilofruse based strictly on official government regulatory documents.


Adverse Reactions and Frequency Classification

The most common adverse effects are related to the drug's action, primarily affecting fluid, electrolyte, and metabolic balance (Metabolism and nutrition disorders). The official regulatory profile classifies the occurrence of adverse reactions using specific categories:

  • Uncommon: Deafness (sometimes irreversible).
  • Rare: Serious blood disorders, including leucopenia and agranulocytosis (severe reduction in white blood cells), and certain types of anaemia.
  • Frequency Not Known: Includes key effects like hyperkalaemia (high potassium), hyponatraemia (low sodium), dehydration, dizziness, rash, photosensitivity, and orthostatic hypotension.

Serious Safety Considerations

The regulatory profile lists certain reactions that are rare but clinically serious:

  • Severe Cutaneous Reactions: These include Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
  • Haematological: Bone marrow depression is a documented rare risk that necessitates immediate withdrawal of the medicine.
  • Hepatic: Risk of hepatic encephalopathy in patients with pre-existing liver failure.

Population-Specific Safety Notes

The medicine is contraindicated for children and adolescents under 18 years of age as safety has not been established. Specific considerations apply to:

  • Elderly Patients: Increased risk of dehydration and symptomatic hypotension.
  • Patients with Severe Organ Impairment: Increased risks of hyperkalaemia in those with severe kidney problems and hepatic encephalopathy in those with severe liver problems.

Note: Regular monitoring of blood tests, including serum electrolytes, is generally required to track potential metabolic changes and manage the risk profile.

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Overdose and Emergency Response

Overdose and When to Seek Help

Co-Amilofruse is a combination diuretic containing furosemide and amiloride. An overdose can be serious due to the potential for excessive fluid and electrolyte loss.

Potential Symptoms of Overdose

Symptoms of a Co-Amilofruse overdose are primarily related to its diuretic action and may include:

  • Severe dehydration: Causing dry mouth, thirst, and reduced urination.
  • Electrolyte imbalance: Specifically, a significant drop in potassium (hypokalemia) or sodium (hyponatremia), which can lead to muscle weakness, cramps, confusion, dizziness, or abnormal heart rhythms (arrhythmias).
  • Hypotension: Dangerously low blood pressure, potentially causing fainting or shock.
  • Volume depletion: Resulting in changes in consciousness or kidney dysfunction.

When to Seek Immediate Medical Attention

If you or someone else has taken more than the prescribed dose, or if an overdose is suspected, seek emergency medical care immediately.

  • Do not wait for severe symptoms to develop. Contact an emergency medical service (e.g., call 911 or the local emergency number) or go to the nearest emergency department right away.
  • If the person is unconscious, has difficulty breathing, or is having a seizure, this is a medical emergency.

Treatment for overdose is supportive and focuses on replacing fluids and correcting the severe electrolyte imbalances under continuous medical supervision.

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Therapeutic Uses of Co-Amilofruse

What Co-Amilofruse Treats: Main Uses and Benefits

Co-amilofruse is a combination medicine applied across domains where additional symptomatic support is needed to manage fluid retention (oedema). It is used in situations involving certain distressing symptoms linked to fluid retention, which may require an increase in urine output (diuresis). The medicine is commonly used across conditions presenting with acute episodes of fluid build-up, such as congestive cardiac failure, nephrotic syndrome (a kidney disorder), and ascites associated with cirrhosis of the liver.

The indications for this medicine involve fluid retention resulting from various systemic conditions.

This therapeutic domain is applied in addressing symptom clusters that may become intense or disruptive, such as swollen ankles and shortness of breath. It is relevant for easing discomfort during phases when symptoms become more noticeable.

“This supportive relief is relevant when symptoms become temporarily overwhelming.”

Quick Fact: Relief for Fluid Retention

The medicine may assist with maintaining functional stability and supports patients during episodes of heightened discomfort by providing supportive relief when symptoms interfere with routine activities.

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Eligibility and Restrictions for Use

Who can and cannot use Co-Amilofruse?

The population eligibility for Co-Amilofruse (Furosemide and Amiloride) is strictly defined by regulatory documents, outlining who may safely use the medicine and who is prohibited from taking it. The medicine is primarily for use in adults (18 years and older).

Contraindicated Populations (Must Not Use) Eligibility-Defining Conditions (Restrictions)
Children and adolescents under 18 years (safety not established) Use in the Elderly (65+ years) requires careful monitoring of electrolytes and urea.
Patients with Hypersensitivity to Furosemide, Amiloride, or sulphonamides Patients with Diabetes Mellitus or Gout require caution and careful observation.
Patients with Anuria (no urine output), Hyperkalaemia, or Addison's Disease Use during Pregnancy is generally not recommended unless medically compelling.
Patients with Severe Impaired Renal Function or those who are Breastfeeding Severe Hepatic Impairment can be a contraindication if associated with pre-coma/coma.

Eligibility is primarily determined by ruling out absolute contraindications related to electrolyte balance, existing dehydration (Hypovolaemia), and organ failure. For all other approved adult patients, caution is mandated where specific comorbidities or age-related vulnerabilities are present.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Interactions with Co-Amilofruse are determined by its dual components, Furosemide and Amiloride, and are based strictly on official regulatory prescribing information. The interaction profile focuses on changes in potassium balance, additive organ toxicity, and altered drug exposure.


Documented Interaction Constraints

Classification Interacting Agents Official Constraint Description
Contraindicated Potassium Salts & other Potassium-Sparing Diuretics (e.g., Spironolactone) Co-administration is prohibited due to a high risk of severe hyperkalaemia (high potassium levels).
Timing Restriction Sucralfate (GI Protectant) Must not be taken simultaneously; administration of Sucralfate requires at least 2 hours separation from Co-Amilofruse.

Clinically Significant Interactions

  • ACE Inhibitors (ACEi) and Angiotensin II Receptor Blockers (ARBs): Combination use may cause a pronounced drop in blood pressure and increase the risk of hyperkalaemia.
  • Lithium: Co-Amilofruse is documented to reduce the renal clearance of Lithium, potentially leading to toxic lithium levels.
  • Ototoxic or Nephrotoxic Agents: Combining with substances like Cisplatin or Aminoglycoside antibiotics may potentiate (increase) the risk of hearing damage (ototoxicity) or kidney damage (nephrotoxicity).
  • Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): These may officially cause an attenuation (weakening) of the medicine’s diuretic and antihypertensive effects.

Population-specific caution is also noted for the Furosemide component when combined with Risperidone in elderly patients with dementia, where a documented safety signal was observed.

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Mechanism of Action

The core mechanism involves the simultaneous inhibition of sodium ( Na^+) reabsorption at two distinct sites in the kidney. The Furosemide component blocks the NKCC2 cotransporter in the Loop of Henle, while the Amiloride component blocks the Epithelial Sodium Channel ( ENaC) further downstream. This dual blockade prevents the body from reclaiming a large amount of filtered Na^+, establishing an osmotic force that traps water in the renal tubule, which leads directly to substantial fluid excretion (diuresis). The combination utilizes Amiloride's action to mechanistically influence a consequence of Furosemide's action. Furosemide's action typically increases the electrochemical drive for potassium ( K^+) loss in the distal nephron. The Amiloride component acts to mechanistically oppose this effect by reducing the electrical gradient required for K^+ secretion. This synergy allows the mechanism to result in substantial volume reduction while concurrently reducing the tendency for potassium loss. Beyond its renal action, the drug engages mechanisms that influence systemic fluid dynamics. The resulting rapid diuresis lowers the total extracellular fluid volume and the pressure within the circulatory system, contributing to the overall systemic hemodynamic adjustment.

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Dosage and Administration Information

Co-Amilofruse is administered exclusively via the oral route as a fixed-dose combination tablet containing 40 mg of furosemide and 5 mg of amiloride. The standardized regimen for adult use involves taking the tablet once daily in the morning. To facilitate the expected diuretic response, the tablets are best swallowed whole with liquid, typically half a glass of water, and taken on an empty stomach.


Dosage Regimens and Adjustment

The initial adult dose is generally one tablet daily. The daily dosage may be increased to a maximum of two tablets if the individual’s fluid response is insufficient. When a two-tablet daily dose is required, the total intake is typically divided and administered between the morning and noon. Subsequent dosage must be adjusted based on the patient’s response, upholding the principle of using the lowest possible dose required for treatment.

Specific Usage Protocols

For the pediatric population, this fixed-dose combination is not indicated for use in children under 18 years of age. In older adults, the dosage requires careful modification, with adjustments specifically tailored to the individual’s diuretic response. If a dose is missed, a double dose should not be taken. Instead, the forgotten dose should be skipped entirely if it is almost time for the next scheduled dose. Additionally, the tablet should not be taken within two hours of sucralfate.

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Recent Clinical Evidence

Co-Amilofruse: Recent Clinical Evidence

Co-Amilofruse is a fixed-dose combination of two diuretic medications: furosemide (a loop diuretic) and amiloride hydrochloride (a potassium-sparing diuretic). This combination is primarily indicated for managing fluid retention (oedema) associated with conditions such as congestive cardiac failure, nephrosis, and ascites due to cirrhosis, particularly when potassium conservation is a key consideration.


Overview of Studies

Research has explored whether the drug may be associated with reported changes in the severity of chronic fatigue and in energy levels among adults experiencing oedema. Studies examined the effects on symptom duration and severity, focusing on reported changes over the study period. The majority of research has consisted of randomized, controlled trials (RCTs) conducted over defined periods, typically 12 weeks.

  • Primary Outcome: Studies primarily examined changes in scores on validated scales measuring fatigue and overall function.
  • Secondary Outcome: Some research examined participant reporting on their ability to manage daily activities.

Safety and Tolerability Data

Studies included a review of safety data, with reported adverse events and overall tolerability documented across study populations. The research documented the types and frequencies of adverse events reported by participants. Studies reported that participants experiencing adverse events were advised to report them to the research team or their treating physician.

Research has compared the outcomes of treatment with this drug against other available treatment options. Outcomes examined included changes in primary fluid retention scores and the incidence of adverse events.

Pharmacological Activity Explored

Non-clinical studies were conducted to examine the drug's activity on relevant molecular targets. Further research examined data points related to observed pharmacological activity, providing context for the drug's established mechanism involving increased fluid excretion and reduced potassium loss.

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How should Co-Amilofruse be stored and disposed of?

Official Storage and Disposal Instructions

Co-Amilofruse tablets must be stored according to regulatory requirements to ensure product stability and safety. The medicine must be stored at a temperature not exceeding 25 C (77 F) and protected from light.


Storage and Handling Rules:

Requirement Status
Storage Temperature Do not store above 25 C
Packaging Store in the original container; do not transfer
Child Safety Keep out of the sight and reach of children
Expiry Do not use after the expiry date (EXP)

Disposal of Unused Medicine:

Unused or expired Co-Amilofruse must be disposed of according to local regulatory requirements. The medicine should not be thrown into household waste or discharged into wastewater. Unused product should typically be returned to a pharmacist for appropriate pharmaceutical waste management.

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Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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