Patient Medication Information: uses, side effects, how to take - Mylan-Amilazide
ABOUT THIS MEDICATION
What the medication is used for:
maintenance therapy for patients with chronic
inflammation of the liver with accumulation of fluid (hepatic cirrhosis with ascites and edema)
maintenance therapy for patients with accumulation of
fluid (edema) of cardiac origin or with arterial hypertension who have low potassium concentration in the blood, (hypokalemic) or in who, maintenance of normal potassium levels is considered to be important such as digitalized patients, patients in whom adequate dietary intake of potassium is not possible or in patients with abnormalities in the heart rate or heart rhythm (cardiac arrhythmias.)
What it does:
MYLAN-AMILAZIDE (Amiloride Hydrochloride and Hydrochlorothiazide Tablets) is a diuretic/antihypertensive therapy which combines natriuretic action (the elimination of extra sodium in urine) of hydrochlorothiazide with the potassium-conserving property of amiloride hydrochloride. The mild diuretic and antihypertensive actions of amiloride hydrochloride are additive to the natriuretic, diuretic and antihypertensive activity of the thiazide while decreasing the loss of potassium and bicarbonate. MYLAN-AMILAZIDE begins to work within 1 to 2 hours and remains active for approximately 24 hours.
When it should not be used:
if you have elevated serum potassium levels
(hyperkalemia).
if you are taking other antikaliuretic agents that decrease
urinary excretion of potassium and potassium supplements
if you have complete suppression of urinary secretion by
the kidneys (anuria), sudden decline in kidney’s function (acute renal failure), severe or progressive kidney disease, and kidney failure due to prolonged diabetes (diabetic nephropathy).
if you ever had a reaction to Mylan-Amilazide or any of
its ingredients or to other sulfonamide –derived drugs
What the medicinal ingredient is:
Amiloride Hydrochloride and Hydrochlorothiazide Tablets, USP
What the important nonmedicinal ingredients are:
Lactose, dibasic calcium phosphate, guar gum, starch, magnesium stearate and sunset yellow FCF.
What dosage forms it comes in:
Each tablet contains 5mg of amiloride hydrochloride and 50 mg of hydrochlorothiazide.
WARNINGS AND PRECAUTIONS
BEFORE you use Mylan-Amilazide talk to your doctor or pharmacist if:
- You have hyperkalemia ( increased blood potassium level)
- You are diabetic
- If your blood pH is low (i.e. respiratory or metabolic acidosis)
- Have liver dysfunction
- Impaired kidney function
- Have history of allergy or bronchial asthma
If you are pregnant or if you are planning on becoming pregnant.
- You are breast-feeding (nursing)
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with Mylan-Amilazide include:
lithium, non steroidal anti-inflammatory drugs, other antihypertensive drugs, skeletal muscle relaxants, pressor amines (such as norepinephrine), antidiabetic drugs, cholestyramine and colestipol resins and corticosteroids, ACTH
Alcohol, barbiturates and narcotics may also interact with Mylan-Amilazide.
PROPER USE OF THIS MEDICATION
Usual dose:
Optimal dosage should be established by individual titration of the components.
Mylan-Amilazide supplies a fixed dose of hydrochlorothiazide and amiloride hydrochloride. This combination product may be used for maintenance therapy.
Hepatic Cirrhosis with Ascites and Edema
The usual maintenance dose of Mylan-Amilazide is 1 tablet given once a day. The dosage should not exceed 4 tablets a day in single or divided doses
Edema of cardiac origin
The usual maintenance dose is 1 or 2 tablets given once a day or in divided doses. The dosage should not exceed 4 tablets a day. Therapy may be on intermittent basis.
| IMPORTANT: PLEASE READ |
Page 29 of 29 Hypertension
The usual maintenance dosage is 1 or 2 tablets given once a day or in divided doses. The dosage should not exceed 4 tablets a day
Overdose:
No data is available in regard to overdose with Mylan-Amilazide. The most common signs and symptoms expected from overdose include dehydration and electrolyte imbalance.
No specific information is available on the treatment nor is an antidote available. Mylan-Amilazide should be discontinued and the patient observed closely.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
You may experience some common side effects such as nausea, anorexia, headache, dizziness, weakness and rash. Some patients have reported other less common side effects such as constipation, thirst, vomiting, sleepiness, flushing, chest pain, nasal congestion, impotence, dehydration and fatigue
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Uncommon | hyperkalemia hypokalemia (decreased potassium level in blood) hypochloremia (low levels of chloride ions in blood) | √ √ √ | √ √ √ | |
This is not a complete list of side effects. For any unexpected effects while taking Mylan-Amilazide, contact your doctor or pharmacist.
HOW TO STORE IT
Store between 15 º C and 30 º C in a tightly closed container
Keep out of reach of children
REPORTING SUSPECTED SIDE EFFECTS To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by: toll-free telephone: 866-234-2345 toll-free fax 866-678-6789 By email: cadrmp@hc-sc.gc.ca By regular mail: National AR Centre Marketed Health Products Safety and Effectiveness Information Division Marketed Health Products Directorate Tunney’s Pasture, AL 0701C Ottawa ON K1A 0K9 NOTE: Before contacting Health Canada, you should contact your physician or pharmacist. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.website.document
or by contacting the sponsor, Mylan Pharmaceuticals ULC
at: 1-800-575-1379 or at: customerservice@mylan.ca