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AA-AMILZIDE is a brand name for Hydrochlorothiazide, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AA-AMILZIDE (amiloride hydrochloride and hydrochlorothiazide tablet) is indicated in the maintenance therapy of patients with: ▪ hepatic cirrhosis with ascites and edema. ▪ edema of cardiac origin or with arterial hypertension who are hypokalemic or in whom maintenance of normal potassium levels is considered to be…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 03/2023 7 WARNINGS AND PRECAUTIONS, Driving and Operating Machinery 03/2023 7 WARNINGS AND PRECAUTIONS, Respiratory 03/2023 7 WARNINGS AND PRECAUTIONS, Ophthalmologic 03/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES ....................................................................................... 2 TABLE OF CONTENTS .........................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................. 4 1 INDICATIONS .......................................................................................................... 1 Pediatrics...............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS .............................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................ 5 4 DOSAGE AND ADMINISTRATION............................................................................. 1 Dosing Considerations ..........................................................................................
2 Recommended Dose and Dosage Adjustment ..................................................... 4 Administration ...................................................................................................... 5 Missed Dose ..........................................................................................................
7 5 OVERDOSAGE......................................................................................................... 7
Endocrine and Metabolism Hyperkalemia (See 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Hyperkalemia): 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.
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.
Electrolyte Imbalance and BUN Increases:
Hyponatremia and hypochloremia may occur during the use of AA-AMILZIDE. Hypokalemia may also occur although the incidence is less than with thiazides alone. Any chloride deficit is usually mild and may be corrected by the use of ammonium chloride (except in patients with hepatic disease) and largely prevented by a near normal salt intake.
Increases in BUN levels have been reported and have usually accompanied vigorous fluid elimination, especially when diuretic combinations were used in seriously ill patients, such as those who have hepatic cirrhosis with ascites and metabolic alkalosis, or those with resistant edema.
Therefore, careful monitoring of serum electrolytes and BUN levels is important when using AA-AMILZIDE.
Diabetes Mellitus:
In diabetic patients, hyperkalemia has been commonly reported with the use of amiloride hydrochloride, particularly if they have chronic renal disease or pre-renal azotemia. Some deaths occurred in this last group of patients. Therefore, if therapy with amiloride hydrochloride is considered essential, the drug should be used with caution in diabetic or suspected diabetic patients and only after first determining the status of renal function.
, Driving and Operating Machinery 03/2023 7 WARNINGS AND PRECAUTIONS, Respiratory 03/2023 7 WARNINGS AND PRECAUTIONS, Ophthalmologic 03/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES ....................................................................................... 2 TABLE OF CONTENTS .........................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................. 4 1 INDICATIONS .......................................................................................................... 1 Pediatrics...............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS .............................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................ 5 4 DOSAGE AND ADMINISTRATION............................................................................. 1 Dosing Considerations ..........................................................................................
2 Recommended Dose and Dosage Adjustment ..................................................... 4 Administration ...................................................................................................... 5 Missed Dose ..........................................................................................................
7 5 OVERDOSAGE......................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................. 8 7 WARNINGS AND PRECAUTIONS ..............................................................................
AA-AMILZIDE (amiloride hydrochloride and hydrochlorothiazide) is contraindicated in the following conditions: • Hyperkalemia: AA-AMILZIDE should not be used in the presence of elevated serum potassium levels (See 7 WARNINGS AND PRECAUTIONS, Hyperkalemia).
• Antikaliuretic Therapy or Potassium Salts: Other antikaliuretic agents and potassium supplements are contraindicated in patients receiving AA-AMILZIDE (such combination AA-AMILZIDE (Amiloride Hydrochloride and Hydrochlorothiazide) Page 5 of 43 therapy is commonly associated with rapid increases in plasma potassium levels).
• Impaired Renal Function: Anuria, acute renal failure, severe or progressive renal disease and diabetic nephropathy are contraindications to the use of AA-AMILZIDE (See 7 WARNINGS AND PRECAUTIONS, Renal, Impaired Renal Function). • Patients who are hypersensitive to this drug or to other sulfonamide-derived drugs or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Hydrochlorothiazide in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Careful monitoring of serum potassium levels is required throughout the therapy. One patient with poorly controlled diabetes mellitus who became severely hyperkalemic while on amiloride hydrochloride died following two repeated intravenous glucose tolerance tests.
In diabetic patients, insulin requirements may be increased, decreased or unchanged due to the hydrochlorothiazide component. Diabetes mellitus which has been latent may become AA-AMILZIDE (Amiloride Hydrochloride and Hydrochlorothiazide) Page 10 of 43 manifest during administration of thiazide diuretics.
Other Precautions:
Thiazides may decrease serum PBI levels without signs of thyroid disturbance. Calcium excretion is decreased by hydrochlorothiazide and magnesium excretion is increased. Pathological changes in the parathyroid glands with hypercalcemia and hypophosphatemia have been observed in a few patients on prolonged thiazide therapy.
The common complications of hyperparathyroidism such as renal lithiasis, bone resorption and peptic ulceration have not been seen. Hyperuricemia may occur or gout may be precipitated. Hematologic Patients should be observed regularly for the possible occurrence of idiosyncratic reactions, or blood dyscrasias.
Hepatic/Biliary/Pancreatic Effects Related to Diuresis in Cirrhotic Patients:
Patients with hepatic cirrhosis and ascites are intolerant of acute shifts in electrolyte balance and often have pre-existing hypokalemia as a result of associated secondary hyperaldosteronism. When oral diuretic therapy is used, these patients should be carefully monitored and diuresis should be gradual.
Hepatic encephalopathy, manifested by tremors, confusion, and coma, has been reported in association with amiloride hydrochloride therapy. In cirrhotic patients receiving amiloride hydrochloride alone, jaundice associated with the underlying disease process has deepened in a few instances, but the relationship to the drug is uncertain.
Patients should be observed regularly for the possible occurrence of liver dysfunction. Immune The possibility of exacerbation or activation of systemic lupus erythematosus has been reported with the thiazides. AA-AMILZIDE (Amiloride Hydrochloride and Hydrochlorothiazide) Page 11 of 43 Ophthalmologic Choroidal effusion, Acute Myopia and Secondary Angle-Closure Glaucoma: Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in choroidal effusion, acute transient myopia and/or secondary acute angle-closure glaucoma.
Symptoms include acute onset of decreased visual acuity, blurred vision or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible.
Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulphonamide or penicillin allergy. Peri-Operative Considerations The antihypertensive effect of the drug may be enhanced in the post-sympathectomy patient.
5 mg per 100 mL, or blood urea values over 60 mg per 100 mL should not receive the drug without careful, frequent monitoring of serum electrolytes, creatinine and BUN levels. Potassium retention associated with the use of AA-AMILZIDE is accentuated in the presence of renal impairment and may result in the rapid development of hyperkalemia.
Prolongation of amiloride hydrochloride excretion was observed in patients with renal impairment. In patients with impaired renal function azotemia may be precipitated or increased by […]
1 Special Populations ............................................................................................. 1 Pregnant Women ................................................................................................ 2 Breast-feeding .....................................................................................................
3 Pediatrics............................................................................................................. 4 Geriatrics .............................................................................................................
13 AA-AMILZIDE (Amiloride Hydrochloride and Hydrochlorothiazide) Page 3 of 43 8 ADVERSE REACTIONS............................................................................................ 1 Adverse Reaction Overview ................................................................................
2 Clinical Trials Adverse Reactions ......................................................................... 5 Post-Market Adverse Reactions.......................................................................... 16 9 DRUG INTERACTIONS ...........................................................................................
1 Serious Drug Interactions ................................................................................... 3 Drug-Behavioural Interactions ............................................................................ 4 Drug-Drug Interactions .......................................................................................
5 Drug-Food Interactions ....................................................................................... 6 Drug-Herb Interactions ....................................................................................... 7 Drug-Laboratory Test Interactions......................................................................
22 10 CLINICAL PHARMACOLOGY ................................................................................... 1 Mechanism of Action .......................................................................................... 2 Pharmacodynamics .............................................................................................
3 Pharmacokinetics ................................................................................................ 24 11 STORAGE, STABILITY AND DISPOSAL ..................................................................... 26 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................
26 PART II: SCIENTIFIC INFORMATION .................................................................................. 27 13 PHARMACEUTICAL INFORMATION ....................................................................... 27 14 CLINICAL TRIALS ...................................................................................................
2 Comparative Bioavailability Studies ................................................................... 28 15 MICROBIOLOGY ................................................................................................... 28 16 NON-CLINICAL TOXICOLOGY .................................................................................
28 17 SUPPORTING PRODUCT MONOGRAPHS ................................................................ 31 PATIENT MEDICATION INFORMATION ............................................................................ 32 AA-AMILZIDE (Amiloride Hydrochloride and Hydrochlorothiazide) Page 4 of 43 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS AA-AMILZIDE (amiloride hydrochloride and hydrochlorothiazide tablet) is indicated in the maintenance therapy of patients with: ▪ hepatic cirrhosis with ascites and edema.
▪ edema of cardiac origin or with arterial hypertension who […]
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