Amiloride

What is Amiloride?

• Amiloride (Midamor), is a potassium-conserving (antikaliuretic) drug that possesses weak (compared with thiazide diuretics) natriuretic, diuretic, and antihypertensive activity.

Amiloride structure

Amiloride3D

What are the uses of this medicine?

• Amiloride (Midamor), is 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.

How does this medicine work?

• The hydrochloride salt of amiloride, a synthetic pyrazine derivative with antikaliuretic and diuretic properties.
• Amiloride inhibits sodium channels located in the distal tubules and collecting ducts of the kidney, thereby preventing the absorption of sodium and increasing its excretion along with water, to produce naturesis.
• In response to the hypernatremic conditions in the kidney, the plasma membrane becomes hyperpolarized and electrochemical forces are reduced, which then prevents the excretion of potassium and hydrogen into the lumen.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Hyperkalemia
• Antikaliuretic Therapy or Potassium Supplementation
• Impaired Renal Function
• Hypersensitivity

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril (Capoten), fosinopril, lisinopril (in Prinzide, in Zestoretic), moexipril (Univasc, in Uniretic), perindopril (Aceon), quinapril (Accupril, in Accuretic), ramipril (Altace), and trandolapril (Mavik, in Tarka)
• angiotensin II receptor antagonists (ARB) such as azilsartan (Edarbi, Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten, in Teveten HCT), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, Benicar HCT), telmisartan (Micardis, in Micardis HCT), and valsartan (Diovan, in Diovan HCT, Exforge)
• cyclosporine (Gengraf, Neoral, Sandimmune)
• lithium (Lithobid)
• nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others), indomethacin (Indocin), and naproxen (Aleve, Naprosyn, others)
• tacrolimus (Astagraf XL, Prograf)

Is this medicine FDA approved?

• Amiloride was approved by the U.S. Food and Drug Administration (FDA) on October 5, 1981.

How should this medicine be used?

Recommended dosage:

• 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.
• If persistent hypokalemia is documented with 10 mg, the dose can be increased to 15 mg, then 20 mg, with careful monitoring of electrolytes.

• If it is necessary to use amiloride HCl alone, the starting dosage should be one 5 mg tablet daily.
• This dosage may be increased to 10 mg per day, if necessary.
• If persistent hypokalemia is documented with 10 mg, the dose can be increased to 15 mg, then 20 mg, with careful monitoring of electrolytes.

Administration:

• Amiloride comes as a tablet to take by mouth.
• Amiloride HCl should be administered with food.
• To help you remember to take amiloride, take it around the same time every day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As tablet for oral administration contains 5 mg of Amiloride HCI

This medicine is available in fallowing brand namesː

• Midamor

What side effects can this medication cause?

The most common side effects of this medicine may include:

• Headache
• Back pain
• Weakness
• Chest pain
• Fatigability
• Neck/shoulder ache
• Pain, extremities
• Angina pectoris
• Orthostatic hypotension
• Arrhythmia
• Palpitation
• 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)
• Skin rash
• Itching
• Dryness of mouth
• Pruritus
• Alopecia
• Muscle cramps
• Joint pain
• Leg ache
• Dizziness
• Paresthesia
• Encephalopathy
• Tremors
• Vertigo
• Nervousness
• Mental confusion
• Insomnia
• Decreased libido
• Depression
• Somnolence
• Cough
• Shortness of Breath
• Dyspnea
• Visual disturbances
• Nasal congestion
• Tinnitus
• Increased intraocular pressure
• Impotence
• Polyuria
• Dysuria
• Urinary frequency
• Bladder spasms
• Gynecomastia

Less common, but serious side effects may include:

• dry mouth
• thirst
• numbness and tingling
• confusion
• muscle weakness
• stomach pain, or cramps
• fast heartbeat and other signs of dehydration and electrolyte imbalance
• yellowing of the skin or eyes
• chest pain
• rash
• itching
• hives
• difficulty breathing or swallowing

What special precautions should I follow?

• Hyponatremia and hypochloremia may occur when amiloride HCl is used with other diuretics and increases in BUN levels have been reported. Therefore, when amiloride HCl is given with other diuretics to such patients, careful monitoring of serum electrolytes and BUN levels is important.
• Amiloride may cause hyperkalemia (serum potassium levels greater than 5.5 mEq per liter) which, if uncorrected, is potentially fatal. If hyperkalemia occurs in patients taking amiloride HCl, the drug should be discontinued immediately.
• In diabetic patients, hyperkalemia has been reported with the use of all potassium-conserving diuretics, including amiloride HCl. 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.
• 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.
• Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from amiloride HCl, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• dehydration and electrolyte imbalance

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• It is not known whether the drug is dialyzable.
• 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.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• 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.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Amiloride HCL

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.

Who manufactures and distributes this medicine?

Dist. by:

• Par Pharmaceutical
• Chestnut Ridge, NY U.S.A.

Mfg. by:

• Par Formulations Private Limited,
• Pudupakkam, Kelambakkam
• Made in India

What should I know about storage and disposal of this medication?

• Store at controlled room temperature 15°-30°C (59°-86°F).
• Dispense in a tight, light-resistant container as defined in the USP.

• Dailymed label info on Amiloride
• FDA Amiloride