Patient Medication Information: uses, side effects, how to take - AA-Amilzide
What is AA-AMILZIDE used for?
AA-AMILZIDE is used to treat adults who have:
- scarring of the liver (liver cirrhosis) with fluid in the abdomen and swelling of the hands, ankles, or feet (edema).
- swelling of the hands, ankles, or feet caused by heart problems.
- high blood pressure (hypertension) and have low levels of potassium in their blood (hyperkalemia) or who need to maintain normal levels of potassium.
How does AA-AMILZIDE work?
AA-AMILZIDE contains a combination of 2 drugs, amiloride hydrochloride and hydrochlorothiazide:
- amiloride hydrochloride helps the body lose excess salt but keep a normal amount of potassium (an electrolyte) in the blood.
- hydrochlorothiazide is a diuretic or “water pill” that increases urination. It works by causing the kidneys to get rid of unneeded water and salt from the body into the urine. It also helps lower blood pressure.
Serious Warnings and Precautions
AA-AMILZIDE may cause high levels of potassium in your blood (hyperkalemia). If you are 65 years of age or older, diabetic, have liver disease, heart disease, kidney problems, are very ill, or are taking other diuretic medicines, you are more likely to develop hyperkalemia. Your healthcare professional may do blood tests to monitor the potassium levels in your blood. Talk to your healthcare professional right away if you have an irregular heartbeat, nausea or vomiting, chest pain, numbness or tingling in the hands, feet or lips, shortness of breath, or weakness or heaviness of the arms or legs.
This medicine does not cure high blood pressure. It helps to control it. Therefore, it is important to continue taking AA-AMILZIDE regularly even if you feel fine. Do not stop taking AA-AMILZIDE without talking to your healthcare professional.
What are the ingredients in AA-AMILZIDE?
Medicinal ingredients: amiloride hydrochloride and hydrochlorothiazide.
Non-medicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and sunset yellow aluminium lake 40 %.
AA-AMILZIDE comes in the following dosage forms:
Tablet; 5 mg / 50 mg.
Do not use AA-AMILZIDE if:
- you are allergic to amiloride hydrochloride or hydrochlorothiazide, or to any non-medicinal ingredient in AA-AMILZIDE.
- you are allergic to any sulfonamide-derived drugs (sulfa drugs); most of them have a medicinal ingredient that ends in “-MIDE”.
- you have difficulty urinating or produce no urine.
- you have high levels of potassium in your blood (hyperkalemia).
- you have kidney failure, severe or worsening kidney disease or problems with your kidneys because of diabetes (diabetic nephropathy).
- you are taking any form of potassium supplements.
- you are taking any other potassium sparing diuretics (a specific kind of “water pill” that makes your body keep potassium).
you have one of the following rare hereditary diseases:
- Galactose intolerance
- Lapp lactase deficiency
- Glucose-galactose malabsorption
Because lactose is a non-medicinal ingredient in AA-AMILZIDE.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AA-AMILZIDE. Talk about any health conditions or problems you may have, including if you:
- are allergic to penicillin.
- have liver, heart or kidney disease.
- have high blood sugar or diabetes. AA-AMILZIDE may affect your blood sugar levels and accelerate the development of diabetes.
- have a disease involving both the lungs and heart (cardiopulmonary disease).
- had or plan to have a sympathectomy (a surgery to remove part of a nerve from your spinal cord).
- have lupus.
- have high levels of uric acid in the blood or have gout. AA-AMILZIDE may make a gout attack more likely.
- have a stomach (peptic) ulcer.
- are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
- are 65 years of age or older.
- have had skin cancer or have a family history of skin cancer.
- have a greater chance of developing skin cancer because you have light-coloured skin, get sunburned easily, or are taking drugs to suppress your immune system.
- have had breathing or lung problems (including inflammation or fluid in the lungs) in the past following the use of medication containing hydrochlorothiazide.
- have problems with your thyroid or parathyroid glands.
Other warnings you should know about:
Risk of skin cancer:
- AA-AMILZIDE contains hydrochlorothiazide. Taking hydrochlorothiazide may increase your risk of developing non-melanoma skin cancer. The risk is higher if you have been taking AA-AMILZIDE for many years (more than 3) or at a high dose.
While taking AA-AMILZIDE:
- Make sure to regularly check your skin for any new lesions. Check areas that are most exposed to the sun, such as the face, ears, hands, shoulders, upper chest and back.
- You may become more sensitive to the sun while taking AA-AMILZIDE. Limit your exposure to the sun and to indoor tanning. Always use sunscreen (SPF-30 or higher) and wear protective clothing when going outside.
- Talk to your healthcare professional immediately if you get more sensitive to the sun or UV light or if you develop an unexpected skin lesion (such as a lump, bump, sore, or patch) while you are taking AA-AMILZIDE.
Sudden eye problems:
- AA-AMILZIDE contains hydrochlorothiazide. Taking hydrochlorothiazide can cause serious eye problems. These eye problems are related and can happen within hours to weeks of starting AA-AMILZIDE.
These eye problems include:
- Choroidal effusion: An abnormal buildup of liquid in your eye that may result in vision changes.
- Myopia: Sudden nearsightedness or blurred vision.
- Glaucoma: An increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss.
- If your vision changes, stop taking AA-AMILZIDE and get immediate medical help.
Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to AA-AMILZIDE. Dizziness, lightheadedness, or fainting can occur.
Acute Respiratory Distress Syndrome: Hydrochlorothiazide in AA-AMILZIDE can cause sudden respiratory toxicity, called Acute Respiratory Distress Syndrome (ARDS)
- Treatment with hydrochlorothiazide can lead to pulmonary edema, buildup of fluid in lungs, within minutes to hours after taking the medicine.
- Talk to your healthcare professional immediately if you experience sudden onset in difficulty or labored breathing, fever, and low blood pressure (e.g. dizziness or lightheadedness). Stop taking AA-AMILZIDE and seek immediate medical help.
Pregnancy: It is not known if AA-AMILZIDE can harm an unborn baby. AA-AMILZIDE is not recommended during pregnancy unless your healthcare professional decides the benefits outweigh the potential risks to your baby. If you discover that you are pregnant while taking AA-AMILZIDE tell your healthcare professional right away.
Breast-feeding: AA-AMILZIDE passes into breast milk and may harm your baby. Do not breast-feed while you are taking AA-AMILZIDE. Talk to your healthcare professional about other ways to feed your baby during this time.
Blood tests and monitoring: During your treatment with AA-AMILZIDE, your healthcare professional may monitor:
- your kidney function
- your blood pressure
- the amount of electrolytes in your blood (such as potassium, sodium, calcium)
- your liver function
Your healthcare professional will decide when to perform tests and will interpret the results.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions The following drugs may interact with AA-AMILZIDE:
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The following may interact with AA-AMILZIDE:
- Adrenocorticotropic hormone (ACTH), used to treat West Syndrome.
- Alcohol, barbiturates (sleeping pills), or narcotics (strong pain medications). They may cause low blood pressure and dizziness when you go from lying or sitting to standing up.
- Amphotericin B, used to treat fungal infections.
- Anticancer medications, including cyclophosphamide and methotrexate.
- Antidepressants, in particular selective serotonin reuptake inhibitors (SSRIs), including citalopram, escitalopram, and sertraline.
- Antidiabetic medications, including insulin and oral medicines.
- Bile acid resins used to lower cholesterol, including cholestyramine.
- Calcium or vitamin D supplements.
- Corticosteroids, used to treat joint pain and swelling.
- Medicines used to suppress the immune system, including cyclosporin and tacrolimus.
- Medicines that slow down or speed up bowel function, including atropine, metoclopramide, and domperidone.
- Medicines used to treat epilepsy, including carbamazepine and topiramate.
- Medicines used to treat gout, including allopurinol and probenecid.
- Lithium, used to treat bipolar disease.
- Other blood pressure lowering drugs, including angiotensin-converting enzyme (ACE) Inhibitors and Angiotensin II receptor antagonist. When taken in combination with AA-AMILZIDE, they may cause excessively low blood pressure.
- Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.
How to take AA-AMILZIDE:
- AA-AMILZIDE is not for initial therapy. You must first be stabilized on the individual components of AA-AMILZIDE (i.e., amiloride hydrochloride and hydrochlorothiazide).
- Take AA-AMILZIDE exactly as prescribed by your healthcare professional. It is recommended to take your dose at about the same time every day.
AA-AMILZIDE can be taken with or without food. If AA-AMILZIDE causes upset stomach, take it with food or milk.
Usual dose:
Scarring of the liver (liver cirrhosis) with fluid in the abdomen and swelling of the hands, ankles or feet: 1 tablet once a day. The maximum daily dose is 4 tablets a day.
Swelling of the hands, ankles or feet caused by heart problems: 1 or 2 tablets once a day or in divided doses. The maximum daily dose is 4 tablets a day.
High blood pressure (Hypertension): 1 or 2 tablets once a day or in divided doses. The maximum daily dose is 4 tablets a day.
Overdose:
Signs of an overdose may include:
- dehydration
- low electrolyte levels in the blood, which may cause you to feel weak, dizzy, confused, tired, have cramps or vomit.
- rapid, slow or irregular heartbeat
| If you think you, or a person you are caring for, have taken too much AA-AMILZIDE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you have forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double dose.
What are possible side effects from using AA-AMILZIDE?
These are not all the possible side effects you may have when taking AA-AMILZIDE. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- muscle cramps, spasms, and pain, weakness, restlessness
- dizziness, pins and needles in your fingers, headache, being in a daze, trouble sleeping, nervousness, sleepiness, fatigue, tiredness
- constipation, diarrhea, nausea, vomiting, decreased appetite, upset stomach, enlargement of the salivary glands (glands that product saliva) in your mouth, stomach pain, hiccups, thirst, gas, bad taste, dry mouth
- reduced libido
- bleeding under the skin (bruising), rash, red patches on the skin, itching, flushing
- stuffy nose
- fever
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Urticarial reaction: skin with red spots which burn, itch or sting | √ | ||
| UNCOMMON | |||
| Allergic Reaction: difficulty swallowing or breathing, | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| wheezing, drop in blood pressure, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat. | |||
| Angina (not enough oxygen to the heart muscle): discomfort in the shoulder, arm, back, throat, jaw or teeth; pain or pressure in the chest | √ | ||
| Dehydration (dry mouth, excessive thirst): thirst, headache, loss of appetite, feel tired and weak, lack of sweating, decreased blood pressure and urine, dark yellow urine | √ | ||
| Depression (sad mood that won’t go away): difficulty sleeping or sleeping too much, changes in appetite or weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family, gatherings and activities with friends, reduced libido (sex drive) and thoughts of death or suicide. If you have a history of depression, your depression may become worse | √ | ||
| Dysuria: difficulty and pain when passing urine | √ | ||
| Gastrointestinal (GI) bleeding (bleeding anywhere along the GI tract between mouth and anus): blood in vomit, black tarry stool, bright red blood in your stool or coming from | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| rectum, rapid pulse, low blood pressure, low urine flow, confusion, weakness, dizziness | |||
| Gout: Sudden, severe attacks of pain, swelling, redness and tenderness in one or more joints, most often in the big toe | √ | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up) | √ | ||
| Impotence: inability to have or maintain an erection | √ | ||
| Kidney disorder: nausea, vomiting, fever, swelling of extremities, fatigue, thirst, dry skin, irritability, dark urine, increased or decreased urine output, blood in the urine, rash, weight gain (from retaining fluid), loss of appetite, abnormal blood test results, mental status changes (drowsiness, confusion, coma) | √ | ||
| Malaise: Feeling of discomfort | √ | ||
| Mental confusion: problems with short-term memory, difficulty carrying out tasks, poor attention span, difficulty following a conversation | √ | ||
| Tachycardia (abnormally fast heartbeat): dizziness, light headedness, shortness of breath, racing heart | √ | ||
| Vertigo (a sense of spinning dizziness) | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| RARE | |||
Electrolyte Imbalance: Hypokalemia (low level of potassium in the blood): muscle weakness, muscle spasms, cramping, constipation, feeling of skipped heart beats or palpitations, fatigue, tingling or numbness Hyperkalemia (high levels of potassium in the blood): feeling of skipped heart beats or palpitations, shortness of breath, chest pain, nausea, vomiting, numbness or tingling in the hands, feet or lips, shortness of breath, or weakness or heaviness of the arms or legs Hypochloremia (low levels of chloride in the blood): dry mouth, thirst, nausea, vomiting, weakness, drowsiness, restlessness, seizures or fits, confusion, headache, muscle pains or cramps, dizziness, lightheadedness or fainting | √ | ||
| VERY RARE | |||
| Acute Respiratory Distress Syndrome (ARDS): severe difficulty breathing, including shortness of breath at rest or with activity, rapid breathing, wheezing or cough | √ | ||
| UNKNOWN | |||
| Agranulocytosis (decrease in white blood cells): frequent infection with fever, chills, sore throat | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Anemia (decreased number of red blood cells): fatigue, loss of energy, looking pale, shortness of breath, weakness | √ | ||
| Blood and lymphatic system disorder: bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness, infections, fever, aches, pains, and flu-like symptoms. | √ | ||
Eye problems: Choroidal effusion: blind spots, eye pain, blurred vision. Myopia: sudden near sightedness or blurred vision. Glaucoma: increased pressure in your eyes, eye pain. | √ | ||
| Glycosuria (sugar in urine) | √ | ||
| Hepatic encephalopathy (a nervous system disorder): forgetfulness, confusion, irritability, sleeping during the day and being awake at night, tremors | √ | ||
| Hyperglycemia: (high blood sugar): increased thirst, frequent urination, dry skin, headache, blurred vision and fatigue | √ | ||
| Hyperuricemia (high blood levels of uric acid, gout): severe joint pain, stiffness, redness and swelling | √ | ||
| Jaundice (build up of bilirubin in the blood): yellowing of the skin and eyes, dark urine, light coloured stool, itching all over your body | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Necrotizing angiitis (inflammation of the blood vessels): fever, stomach pain, numbness and tingling in the hands and feet, swelling in the hands, ankles or feet, changes in frequency of urination | √ | ||
| Non-melanoma skin cancer: lump or discoloured patch on the skin that stays after a few weeks and slowly changes. Cancerous lumps are red/pink and firm and sometimes turn into ulcers. Cancerous patches are usually flat and scaly | √ | ||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid heart beat, nausea, vomiting, tenderness when touching the abdomen | √ | ||
| Photosensitivity (sensitivity to sunlight): itchy, red skin when exposed to sunlight | √ | ||
| Pneumonitis (inflammation of the lung tissue): shortness of breath, cough, fatigue, loss of appetite, unintentional weight loss | √ | ||
| Stomach ulcer: heartburn, long lasting stomach pain, loss of appetite and weight loss | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store at room temperature (15°C to 30°C).
Keep out of reach and sight of children.
If you want more information about AA-AMILZIDE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html). Find the Patient Medication Information on the manufacturer’s website (https://www.aapharma.ca/en/), or by calling 1-877-998-9097.