Details for: AA-AMILZIDE
Company: AA PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00784400 | AA-AMILZIDE | HYDROCHLOROTHIAZIDE; AMILORIDE HYDROCHLORIDE | 50 MG; 5 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
AA-AMILZIDE is used in adults for:
- Swelling of the hands, ankles or feet in patients with hepatic cirrhosis (a liver disease).
- Patients with swelling of the hands, ankles or feet caused by heart problems or patients with high blood pressure (hypertension) who have low levels of potassium in their blood (hypokalemia) or who need to maintain normal levels of potassium.
What it does
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. This lowers blood pressure.
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.
When it should not be used
Do not take AA-AMILZIDE if you:
- Are allergic to amiloride hydrochloride or hydrochlorothiazide, or to any non-medicinal ingredient in the formulation.
- Are allergic to any sulfonamide-derived drugs (sulfa drugs); most of them have a medicinal ingredient that ends in “-MIDE”.
- Have difficulty urinating or produce no urine.
- Have high potassium levels (hyperkalemia).
- Have kidney failure, severe or worsening kidney disease or problems with your kidneys because of diabetes (diabetic nephropathy).
- Are using any form of potassium supplementation.
- Are taking any other potassium-conserving medications or “water pills”.
- Are breastfeeding. AA-AMILZIDE passes into breast milk.
- 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.
What the medicinal ingredient is
amiloride hydrochloride and hydrochlorothiazide.
What the non-medicinal ingredients are
Colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and sunset yellow aluminium lake 40 %
What dosage form it comes in
Tablet; amiloride hydrochloride 5 mg and hydrochlorothiazide 50 mg.
Warnings and precautions
Serious Warnings and Precautions
BEFORE you use AA-AMILZIDE talk to your doctor, nurse, or pharmacist if you:
- Are allergic to penicillin.
- Have diabetes, liver, heart or kidney disease.
- Have cardiopulmonary disease (disease involving both the lungs and heart).
- Had a sympathectomy (a surgery to remove part of a nerve from your spinal cord).
- Have lupus or gout.
- Have a stomach (peptic) ulcer.
- Are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
- Are pregnant or thinking of becoming pregnant.
- Are less than 18 or over 65 years of age.
- 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.
Risk of skin cancer:
AA-AMILZIDE contains hydrochlorothiazide. Treatment with
hydrochlorothiazide may increase the risk of developing nonmelanoma skin cancer.
The risk is higher if you have been taking AAAMILZIDE 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.
- 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 doctor 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) during the treatment.
Hydrochlorothiazide in AA-AMILZIDE can cause Sudden Eye Disorders:
- Myopia: sudden nearsightedness or blurred vision.
- Glaucoma: an increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss.
These eye disorders are related and can develop within hours to weeks
of starting AA-AMILZIDE.
You may become sensitive to the sun while taking AA-AMILZIDE.
Exposure to sunlight should be minimized until you know how you
respond.
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 especially occur after the first dose and when the dose is increased.
Interactions with this medication
As with most medicines, interactions with other drugs are possible.
Tell your doctor, nurse, or pharmacist about all the medicines you
take, including drugs prescribed by other doctors, vitamins, minerals,
natural supplements, or alternative medicines.
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, an antifungal drug.
- Anticancer drugs, including cyclophosphamide and methotrexate.
- Antidepressants, in particular selective serotonin reuptake inhibitors (SSRIs), including citalopram, escitalopram, and sertraline.
- Antidiabetic drugs, including insulin and oral medicines.
- Bile acid resins used to lower cholesterol.
- Calcium or vitamin D supplements.
- Corticosteroids used to treat joint pain and swelling.
- Digoxin, a heart medication.
- Drugs that slow down or speed up bowel function, including atropine, metoclopramide, and domperidone.
- Drugs used to treat epilepsy, including carbamazepine and topiramate.
- Gout medications, including allopurinol and probenecid.
- Lithium used to treat bipolar disease.
- Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
- Other blood pressure lowering drugs. When taken in combination with AA-AMILZIDE, they may cause excessively low blood pressure.
- Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.
Proper use of this medication
Take AA-AMILZIDE exactly as prescribed. It is recommended to
take your dose at about the same time every day.
AA-AMILZIDE can be taken with or without food. If AAAMILZIDE causes upset stomach, take it with food or milk.
Usual Dose
Usual Adult dose: For Swelling of the hands, ankles or feet in Patients with Hepatic Cirrhosis: 1 tablet given once a day. The dosage should not exceed 4 tablets a day in single or divided doses.
For Swelling of the hands, ankles or feet caused by Heart Problems: 1
or 2 tablets given once a day or in divided doses. The dosage should
not exceed 4 tablets a day.
For High Blood Pressure (Hypertension): 1 or 2 tablets given once a
day or in divided doses. The dosage should not exceed 4 tablets a day.
Overdose
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.
Side effects and what to do about them
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 glands in your mouth, stomach pain, hiccups, thirst, gas, bad taste, dry mouth
- reduced libido
- bleeding under the skin, rash, red patches on the skin, itching, flushing
- stuffy nose
If any of these affects you severely, tell your doctor, nurse or pharmacist.
AA-AMILZIDE can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and seek immediate medical help |
|---|---|---|---|
| Common | |||
| Low Blood Pressure: dizziness, fainting, lightheadedness. May occur when you go from lying or sitting to standing up | ✔ | ||
| Decreased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell | ✔ | ||
| 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. | ✔ | ||
| Uncommon | |||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
| Kidney Disorder: change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue | ✔ | ||
| Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✔ | ||
| Increased blood sugar: frequent urination, thirst, and hunger | ✔ | ||
| Electrolyte Imbalance: weakness, drowsiness, muscle pain or cramps, irregular heartbeat | ✔ | ||
| Gastrointestina l bleeding: black stool or blood in stool | ✔ | ||
| Depression: feeling sad, not interested in usual activities, weight change and sleep disruptions | ✔ | ||
| Mental confusion: Inability to know the date, where and who you are | ✔ | ||
| Angina: Chest pain | ✔ | ||
| Rare | |||
| Decreased Platelets: bruising, bleeding, fatigue and weakness | ✔ | ||
| Decreased White Blood Cells: infections, fatigue, fever, aches, pains, and flu-like symptoms | ✔ | ||
| Very rare | |||
| Toxic Epidermal Necrolysis: severe skin peeling, especially in mouth and eyes | ✔ | ||
| Unknown | |||
Eye Disorders:
|
✔ | ||
| Anemia: fatigue, loss of energy, weakness, shortness of breath. | ✔ | ||
| Inflammation of the Pancreas: abdominal pain that lasts and gets worse when you lie down, nausea, vomiting | ✔ | ||
| Hepatic encephalopathy: forgetfulness, confusion, irritability, sleeping during the day and being awake at night | ✔ | ||
| Necrotizing angiitis: fever, stomach pain, numbness and tingling in the hands and feet, swelling in the hands, ankles or feet, changes in frequency of urination | ✔ | ||
| Respiratory distress: trouble breathing, shortness of breath, skin turning blue around the mouth, lips and fingernails | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking AA-AMILZIDE, contact your doctor, nurse, or pharmacist.
How to store
Store at room temperature (15°C to 30°C).
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting www.canada.ca/en/health-canada/services/drugshealth-products/medeffect-canada/adverse-reactionreporting.html for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
Read this carefully before you start taking AA-AMILZIDE and each time you get a refill. This leaflet is a summary and will not tell you everything about AA-AMILZIDE. Talk to your doctor, nurse, or pharmacist about your medical condition and treatment and ask if there is any new information about AA-AMILZIDE.
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 consumer information by visiting the Health Canada website health-products.canada.ca/dpd-bdpp/index-eng.jsp; the manufacturer’s website www.aapharma.ca/en/, or by calling 1-877-998-9097.
This leaflet was prepared by AA Pharma Inc.
Last revised: June 6, 2019