Amiloride Hydrochloride 5 mg Tablet, 1,000-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Potassium-sparing Diuretic class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Amiloride is usually used in combination with other diuretics ('water pills') to treat high blood pressure and heart failure in patients who have low amounts of potassium in their bodies or for whom low potassium levels in the body could be dangerous. Amiloride is in a class of medications called diuretics. It works by causing the kidneys to get rid of unneeded water and salt from the body into the urine, but reduces the loss of potassium. High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys, and other parts of the body...
Read the full MedlinePlus article ↗- Great question. The diuretic you were already taking — likely a thiazide — works well at removing extra fluid and lowering blood pressure, but it also flushes potassium out of your...
- Why has my doctor added amiloride to my other water pill instead of just giving me more of the first one?
- Potassium is critical for your heart and muscles to work properly. Too little causes problems — that's why amiloride is added in the first place. But amiloride itself can push pota...
- What's the big deal about potassium — why does my doctor keep checking my blood levels?
Patient education
Supplement & herbal interactions
Amiloride may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.2193 | $219.30 / 1000 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| amiloride hydrochloride 5 mg 00574-0292-01 | Padagis | 100 tablets | $0.190 | AB | Availability likely | — |
| Amiloride Hydrochloride 5 mg 42794-0005-02 | Sigmapharm | 100 tablets | $0.190 | AB | Availability likely | — |
| Amiloride Hydrochloride 5 mg 49884-0117-01 | Par | 100 tablets | $0.190 | AB | Availability likely | — |
| Amiloride Hydrochloride 5 mgthis 63629-2114-01 | Bryant | 1000 tablets | — | AB | Discontinued | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63629-2114-01 You're viewing this | 1000 TABLET in 1 BOTTLE (63629-2114-1) | 1986-05-12 | Discontinued by firm |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliureticdiuretic agents in congestive heart failure or hypertension to: help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic. prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet.
Amiloride HCl has little additive diuretic or antihypertensive effect when added to a thiazide diuretic. Amiloride HCl should rarely be used alone. It has weak (compared with thiazides) diuretic and antihypertensive effects.
Used as single agents, potassium sparing diuretics, including amiloride HCl, result in an increased risk of hyperkalemia (approximately 10% with amiloride). Amiloride HCl should be used alone only when persistent hypokalemia has been documented and only with careful titration of the dose and close monitoring of serum electrolytes.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Amiloride HCl should be administered with food. Amiloride HCl, one 5 mg tablet daily, should be added to the usual antihypertensive or diuretic dosage of a kaliuretic diuretic. The dosage may be increased to 10 mg per day, if necessary.
More than two 5 mg tablets of amiloride HCl daily usually are not needed, and there is little controlled experience with such doses. If persistent hypokalemia is documented with 10 mg, the dose can be increased to 15 mg, then 20 mg, with careful monitoring of electrolytes. In treating patients with congestive heart failure after an initial diuresis has been achieved, potassium loss may also decrease and the need for amiloride HCl should be re-evaluated.
Dosage adjustment may be necessary. Maintenance therapy may be on an intermittent basis. If it is necessary to use amiloride HCl alone (see INDICATIONS), the starting dosage should be one 5 mg tablet daily.
This dosage may be increased to 10 mg per day, if necessary. More than two 5 mg tablets usually are not needed, and there is little controlled experience with such doses. If persistent hypokalemia is documented with 10 mg, the dose can be increased to 15 mg, then 20 mg, with careful monitoring of electrolytes.
⛔ Contraindications ▾
CONTRAINDICATIONS Hyperkalemia Amiloride HCl should not be used in the presence of elevated serum potassium levels (greater than 5.5 mEq per liter). Antikaliuretic Therapy or Potassium Supplementation Amiloride HCl should not be given to patients receiving other potassium-conserving agents, such as spironolactone or triamterene. Potassium supplementation in the form of medication, potassium-containing salt substitutes or a potassium-rich diet should not be used with amiloride HCl except in severe and/or refractory cases of hypokalemia.
Such concomitant therapy can be associated with rapid increases in serum potassium levels. If potassium supplementation is used, careful monitoring of the serum potassium level is necessary. Impaired Renal Function Anuria, acute or chronic renal insufficiency, and evidence of diabetic nephropathy are contraindications to the use of amiloride HCl.
Patients with evidence of renal functional impairment (blood urea nitrogen [BUN] levels over 30 mg per 100 mL or serum creatinine levels over 1.5 mg per 100 mL) or diabetes mellitus should not receive the drug without careful, frequent and continuing monitoring of serum electrolytes, creatinine, and BUN levels. Potassium retention associated with the use of an antikaliuretic agent is accentuated in the presence of renal impairment and may result in the rapid development of hyperkalemia. Hypersensitivity Amiloride HCl is contraindicated in patients who are hypersensitive to this product.
⚠️ Warnings ▾
WARNINGS Hyperkalemia Like other potassium-conserving agents, amiloride may cause hyperkalemia (serum potassium levels greater than 5.5 mEq per liter) which, if uncorrected, is potentially fatal. Hyperkalemia occurs commonly (about 10%) when amiloride is used without a kaliuretic diuretic. This incidence is greater in patients with renal impairment, diabetes mellitus (with or without recognized renal insufficiency), and in the elderly.
When amiloride is used concomitantly with a thiazide diuretic in patients without these complications, the risk of hyperkalemia is reduced to about 1-2%. It is thus essential to monitor serum potassium levels carefully in any patient receiving amiloride, particularly when it is first introduced, at the time of diuretic dosage adjustments, and during any illness that could affect renal function. The risk of hyperkalemia may be increased when potassium-conserving agents, including amiloride HCl, are administered concomitantly with an angiotensin-converting enzyme inhibitor, an angiotensin II receptor antagonist, cyclosporine or tacrolimus.
(See PRECAUTIONS , Drug Interactions. ) Warning signs or symptoms of hyperkalemia include paresthesias, muscular weakness, fatigue, flaccid paralysis of the extremities, bradycardia, shock, and ECG abnormalities. Monitoring of the serum potassium level is essential because mild hyperkalemia is not usually associated with an abnormal ECG. When abnormal, the ECG in hyperkalemia is characterized primarily by tall, peaked T waves or elevations from previous tracings.
There may also be lowering of the R wave and increased depth of the S wave, widening and even disappearance of the P wave, progressive widening of the QRS complex, prolongation of the PR interval, and ST depression. Treatment of hyperkalemia: If hyperkalemia occurs in patients taking amiloride HCl, the drug should be discontinued immediately. If the serum potassium level exceeds 6.5 mEq per liter, active measures should be taken to reduce it.
Such measures include the intravenous administration of sodium bicarbonate solution or oral or parenteral glucose with a rapid-acting insulin preparation. If needed, a cation exchange resin such as sodium polystyrene sulfonate may be given orally or by enema. Patients with persistent hyperkalemia may require dialysis.
Diabetes Mellitus In diabetic patients, hyperkalemia has been reported with the use of all potassium-conserving diuretics, including amiloride HCl, even in patients without evidence of diabetic nephropathy. Therefore, amiloride HCl should be avoided, if possible, in diabetic patients and, if it is used, serum electrolytes and renal function must be monitored frequently. Amiloride HCl should be discontinued at least 3 days before glucose tolerance testing.
Metabolic or Respiratory Acidosis Antikaliuretic therapy should be instituted only with caution in severely ill patients in whom respiratory or metabolic acidosis may occur, such as patients with cardiopulmonary disease or poorly controlled diabetes. If amiloride HCl is given to these patients, frequent monitoring of acid-base balance is necessary. Shifts in acid-base balance alter the ratio of extracellular/intracellular potassium, and the development of acidosis may be associated with rapid increases in serum potassium levels.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Amiloride HCl is usually well tolerated and, except for hyperkalemia (serum potassium levels greater than 5.5 mEq liter - see WARNINGS), significant adverse effects have been reported infrequently. Minor adverse reactions were reported relatively frequently (about 20%) but the relationship of many of the reports to amiloride HCl is uncertain and the overall frequency was similar in hydrochlorothiazide treated groups. Nausea/anorexia, abdominal pain, flatulence, and mild skin rash have been reported and probably are related to amiloride.
Other adverse experiences that have been reported with amiloride are generally those known to be associated with diuresis, or with the underlying disease being treated. The adverse reactions for amiloride HCl listed in the following table have been arranged into two groups: (1) incidence greater than one percent; and (2) incidence one percent or less. The incidence for group (1) was determined from clinical studies conducted in the United States (837 patients treated with amiloride HCl).
The adverse effects listed in group (2) include reports from the same clinical studies and voluntary reports since marketing. The probability of a causal relationship exists between amiloride HCl and these adverse reactions, some of which have been reported only rarely. *Reactions occurring in 3% to 8% of patients treated with amiloride HCl. (Those reactions occurring in less than 3% of the patients are unmarked.) **See WARNINGS.
Incidence > 1% Incidence ≤ 1% Body as a Whole Headache* Back pain Weakness Chest pain Fatigability Neck/shoulder ache Pain, extremities Cardiovascular None Angina pectoris Orthostatic hypotension Arrhythmia Palpitation Digestive Nausea/anorexia* Jaundice Diarrhea* GI bleeding Vomiting* Abdominal fullness Abdominal pain GI disturbance Gas pain Thirst Appetite changes Heartburn Constipation Flatulence Dyspepsia Metabolic Elevated serum potassium levels (>5.5 mEq per liter)** None Skin None Skin rash Itching Dryness of mouth Pruritus Alopecia Musculoskeletal Muscle cramps Joint pain Leg ache Nervous Dizziness Paresthesia Encephalopathy Tremors Vertigo Psychiatric None Nervousness Mental confusion Insomnia Decreased libido Depression Somnolence Respiratory Cough Shortness of Breath Dyspnea Special Senses None Visual disturbances Nasal congestion Tinnitus Increased intraocular pressure Urogenital Impotence Polyuria Dysuria Urinary frequency Bladder spasms Gynecomastia Causal Relationship Unknown Other reactions have been reported but occurred under circumstances where a causal relationship could not be established.
However, in these rarely reported events, that possibility cannot be excluded. Therefore, these observations are listed to serve as alerting information to physicians. Activation of probable pre-existing peptic ulcer Aplastic anemia Neutropenia Abnormal liver function
🔄 Drug Interactions ▾
Drug Interactions When amiloride HCl is administered concomitantly with an angiotensin-converting enzyme inhibitor, an angiotensin II receptor antagonist, cyclosporine or tacrolimus, the risk of hyperkalemia may be increased. Therefore, if concomitant use of these agents is indicated because of demonstrated hypokalemia, they should be used with caution and with frequent monitoring of serum potassium. (See WARNINGS ).
Lithium generally should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity. Read circulars for lithium preparations before use of such concomitant therapy. In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics.
Therefore, when amiloride HCl and non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained. Since indomethacin and potassium-sparing diuretics, including amiloride HCl, may each be associated with increased serum potassium levels, the potential effects on potassium kinetics and renal function should be considered when these agents are administered concurrently.
🤰 Pregnancy ▾
Pregnancy Pregnancy Category B . Teratogenicity studies with amiloride HCl in rabbits and mice given 20 and 25 times the maximum human dose, respectively, revealed no evidence of harm to the fetus, although studies showed that the drug crossed the placenta in modest amounts. Reproduction studies in rats at 20 times the expected maximum daily dose for humans showed no evidence of impaired fertility.
At approximately 5 or more times the expected maximum daily dose for humans, some toxicity was seen in adult rats and rabbits and a decrease in rat pup growth and survival occurred. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of amiloride HCI did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CONTRAINDICATIONS , Impaired Renal Function. )
🆘 Overdosage ▾
OVERDOSAGE No data are available in regard to overdosage in humans. The oral LD 50 of amiloride HCl (calculated as the base) is 56 mg/kg in mice and 36 to 85 mg/kg in rats, depending on the strain. It is not known whether the drug is dialyzable.
The most likely signs and symptoms to be expected with overdosage are dehydration and electrolyte imbalance. These can be treated by established procedures. Therapy with amiloride HCl should be discontinued and the patient observed closely.
There is no specific antidote.Emesis should be induced or gastric lavage performed.Treatment is symptomatic and supportive. If hyperkalemia occurs, active measures should be taken to reduce the serum potassium levels.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Amiloride HCl is a potassium-conserving (antikaliuretic) drug that possesses weak (compared with thiazide diuretics) natriuretic, diuretic, and antihypertensive activity. These effects have been partially additive to the effects of thiazide diuretics in some clinical studies. When administered with a thiazide or loop diuretic, amiloride has been shown to decrease the enhanced urinary excretion of magnesium which occurs when a thiazide or loop diuretic is used alone.
Amiloride has potassium-conserving activity in patients receiving kaliureticdiuretic agents. Amiloride HCl is not an aldosterone antagonist and its effects are seen even in the absence of aldosterone. Amiloride exerts its potassium sparing effect through the inhibition of sodium reabsorption at the distal convoluted tubule, cortical collecting tubule and collecting duct; this decreases the net negative potential of the tubular lumen and reduces both potassium and hydrogen secretion and their subsequent excretion.
This mechanism accounts in large part for the potassium sparing action of amiloride. Amiloride usually begins to act within 2 hours after an oral dose. Its effect on electrolyte excretion reaches a peak between 6 and 10 hours and lasts about 24 hours.
Peak plasma levels are obtained in 3 to 4 hours and the plasma half-life varies from 6 to 9 hours. Effects on electrolytes increase with single doses of amiloride HCl up to approximately 15 mg. Amiloride HCl is not metabolized by the liver but is excreted unchanged by the kidneys.
About 50 percent of a 20 mg dose of amiloride HCl is excreted in the urine and 40 percent in the stool within 72 hours. Amiloride has little effect on glomerular filtration rate or renal blood flow. Because amiloride HCl is not metabolized by the liver, drug accumulation is not anticipated in patients with hepatic dysfunction, but accumulation can occur if the hepatorenal syndrome develops.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Each yellow compressed tablet contains 5 mg of anhydrous Amiloride HCl and is debossed “Par 117”. Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container as defined in the USP. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
📋 Description ▾
DESCRIPTION Amiloride HCl, an antikaliuretic-diuretic agent, is a pyrazine-carbonyl-guanidine that is unrelated chemically to other known antikaliuretic or diuretic agents. It is the salt of a moderately strong base (pKa 8.7). It is designated chemically as 3,5-diamino-6-chloro-N-(diaminomethylene) pyrazinecarboxamide monohydrochloride, dihydrate and has a molecular weight of 302.12.
Its empirical formula is C 6 H 8 CIN 7 O•HCl•2H 2 O and its structural formula is: Each tablet for oral administration contains 5 mg of Amiloride HCI, calculated on the anhydrous basis. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 lake, dibasic calcium phosphate dihydrate, FD&C yellow #6 lake, magnesium stearate, microcrystalline cellulose and silicon dioxide.