Frumil 5 mg + 40 mg Tablets

Brand Name

This medication is marketed under the trade name Frumil, a label well-regarded among healthcare providers for its diuretic effects.

International Nonproprietary Name (INN)

The active ingredients are known globally as amiloride hydrochloride and furosemide, ensuring consistent identification across medical frameworks.

Form of Release

The drug is available as tablets, formulated for oral use with a fixed combination of its active components to streamline dosing. These tablets are designed for convenience and stability under typical storage conditions.

Composition

Amiloride hydrochloride and furosemide form the primary active substances, working together to regulate fluid and electrolyte levels. Supporting ingredients include lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate, which maintain tablet structure and aid disintegration. A coloring agent may be added for visual distinction. These components enhance the combined effects of amiloride and furosemide without altering their potency.

Pharmacologic Properties

Pharmacodynamics

This medication combines a potassium-sparing diuretic, amiloride, with a loop diuretic, furosemide, for a dual-action approach. Amiloride blocks sodium reabsorption in the distal tubules and collecting ducts, increasing sodium and water loss while preserving potassium. Furosemide inhibits the sodium-potassium-chloride cotransporter in the loop of Henle, boosting urine output and reducing fluid volume. Together, they decrease edema and blood pressure while limiting potassium depletion, suiting conditions with fluid overload. Effects start within an hour, peaking at two to three hours, with sustained benefits from regular use. This synergy ensures effective fluid control with electrolyte balance.

Pharmacokinetics

After oral administration, the drug’s components absorb variably from the digestive tract. Furosemide’s bioavailability ranges from 50% to 70%, affected by food and pH, peaking in plasma within one to two hours. Amiloride absorbs more steadily, with about 50% bioavailability, peaking at three to four hours. Furosemide binds 95% to plasma proteins and distributes widely, while amiloride binds less at 23%. Furosemide is minimally metabolized, excreted mostly unchanged in urine, and amiloride exits unmetabolized via urine. Furosemide’s half-life is around two hours, and amiloride’s is six to nine hours, both extended by renal issues, needing oversight. Elimination is mainly renal, with minor fecal clearance.

Indications for Use

The medication addresses conditions needing robust fluid and electrolyte management. It treats edema linked to congestive heart failure, reducing tissue fluid and easing heart strain. It’s also used for edema from liver cirrhosis or nephrotic syndrome, decreasing ascites or swelling. In hypertension, it lowers blood pressure by reducing plasma volume, especially when potassium retention matters. Its dual mechanism suits patients requiring diuresis without significant potassium loss, often part of broader chronic condition strategies.

Contraindications

Certain conditions bar the use of this drug to avoid severe risks. Hypersensitivity to amiloride, furosemide, or tablet ingredients prohibits it, as reactions might range from rashes to anaphylaxis. Severe kidney impairment, including anuria, rules it out, as both components depend on renal excretion, risking buildup. Hyperkalemia or severe hypokalemia contraindicates it due to its potassium effects. The medication is avoided in Addison’s disease or untreated electrolyte imbalances, where it could worsen disturbances. Significant dehydration or low blood volume needs correction first to prevent collapse.

Method of Administration and Dosage

How to Take

Tablets are taken orally, ideally in the morning to avoid nighttime urination, with or without food. Swallowing them whole with water ensures proper stomach delivery. A regular schedule supports steady effects.

Dosage for Adults and Children

Adults with edema or hypertension typically start with one tablet daily, delivering 5 mg amiloride and 40 mg furosemide, adjustable to two tablets based on fluid response. Higher doses are rare and need close oversight. Pediatric use is uncommon, but when prescribed, dosing begins at 0.1 mg per kilogram of amiloride and 1 mg per kilogram of furosemide daily, split if needed, under expert guidance. Adjustments hinge on response and electrolyte levels for safety.

Dose Adjustment in Specific Conditions

Renal impairment calls for lower doses or avoidance if clearance drops below 30 mL/min, as slower excretion raises toxicity risks. Liver dysfunction, particularly with cirrhosis, suggests cautious dosing, often half a tablet daily, due to fluid and potassium shifts. Elderly or renally compromised patients may also start lower to avoid dehydration or imbalance. Dosing should be tailored with frequent lab checks to maintain balance.

Side Effects

The medication may cause various unintended effects, differing in occurrence and intensity. Dehydration or thirst from excessive fluid loss is common, especially if intake isn’t adjusted. Electrolyte shifts, like hypokalemia from furosemide or hyperkalemia from amiloride, might lead to cramps, weakness, or heart rhythm changes. Nausea, vomiting, or diarrhea can affect some but often fade. Dizziness or lightheadedness may stem from pressure drops, particularly early on. Rare severe issues, like ototoxicity—ear ringing—or allergic reactions such as rash or jaundice, need urgent care. Monitoring reduces these risks effectively.

Overdose

Symptoms of Overdose

Taking too much can cause severe dehydration, showing as dry mouth, intense thirst, or confusion from rapid fluid loss. Low blood pressure might lead to dizziness, fainting, or shock from reduced volume. Electrolyte issues, like extreme hypokalemia or hyperkalemia, could cause muscle paralysis or heart arrhythmias, risking serious outcomes. Symptoms emerge within hours and worsen without action, reflecting potent diuretic effects.

First Aid Measures

Stop the drug immediately in an overdose and seek urgent medical help. Recent ingestion may warrant gastric lavage or charcoal under supervision to curb uptake. IV fluids restore hydration and pressure, while electrolyte replacement fixes imbalances like potassium or sodium. Heart and kidney monitoring stabilizes the patient until recovery, aiming to reverse diuretic overload quickly.

Drug Interactions

Effects on Other Medications

This drug can alter other medications’ effects when combined. It may boost antihypertensive actions, risking steep pressure drops, needing dose tweaks. NSAIDs might lessen its diuretic effect and stress kidneys, a concern over time. Potassium-sparing agents or supplements increase hyperkalemia odds with amiloride, while lithium levels may rise from reduced clearance, needing plasma checks. Furosemide with digoxin can raise toxicity risks, requiring cardiac oversight. Adjustments minimize these interactions.

Compatibility with Alcohol and Food

Alcohol might worsen dehydration or low pressure with the medication, raising dizziness risks, so moderation is wise. Food doesn’t notably affect uptake, though high-sodium diets could counter fluid loss, suggesting balance. Potassium-rich foods like bananas need watching to avoid excess with amiloride.

Special Precautions

Use During Pregnancy and Breastfeeding

The drug is generally avoided in pregnancy unless critical, as furosemide crosses the placenta and may affect fetal fluids, while amiloride data are limited. Both appear in breast milk, so nursing mothers should consult their doctor, possibly choosing alternatives to limit infant exposure.

Impact on Driving and Machinery Operation

Dizziness or fatigue, especially at start or dose shifts, may hinder driving or machinery use. Patients should gauge their response before such tasks, ensuring safety.

Considerations for Elderly and Pediatric Populations

Older adults may need lower doses due to renal decline, with checks for dehydration or electrolyte shifts. In children, use is rare and specialist-guided, with weight-based dosing adjusted cautiously for growth safety. Tailored care optimizes outcomes.