- Risk of hyperkalemia (serum potassium levels >5.5 mEq/liter), if left uncorrected potentially fatal cases may occur. Risk of 1-2% in patients without renal impairment or diabetes mellitus exists. Risk increases in patients with renal impairment or diabetes mellitus (even without recognized diabetic nephropathy (FDA Black Box Warning)
- Carefully monitor serum potassium levels particularly during initiation, dose modification, and during any illness affecting renal function (FDA Black Box Warning)
- Avoid concomitant use with an ACE inhibitor, cyclosporine or tacrolimus as increased risk of hyperkalemia have occurred
- Monitor serum potassium levels as mild hyperkalemia is not usually associated with an abnormal ECG
- Immediately discontinue the drug on occurrence of hyperkalemia
- Administer IV sodium bicarbonate solution or oral or parenteral glucose with a rapid-acting insulin preparation if serum potassium level exceeds 6.5 mEq/liter; cation exchange resin such as sodium polystyrene sulfonate may be given orally or by enema if needed. Dialysis may be required for patients with persistent hyperkalemia
- If possible avoid use in diabetic patients; if used frequently monitor serum electrolytes and renal function
- Discontinue drug at least three days before glucose tolerance testing
- Observe for clinical signs of fluid or electrolyte imbalance; determine serum electrolytes at appropriate intervals; monitor for serum or urine electrolytes if patient is vomiting excessively on receiving parenteral fluids
- Dilutional hyponatremia has occurred in edematous patients in hot weather; appropriately restrict water; administer salts on rare instances of fatal hyponatremia. Appropriately replace therapy in case of actual salt depletion
- Risk of hypokalemia exists if presence of severe cirrhosis, during concurrent use of corticosteroids or ACTH, or after prolonged therapy; interference with adequate oral electrolyte intake is also the contributing factor
- Carefully monitor serum electrolyte and BUN levels in seriously ill patients, those who had hepatic cirrhosis with ascites and metabolic alkalosis, or those with resistant edema
- Hypokalemia may cause cardiac arrhythmia and may sensitize/exaggerate the response to the toxic effects of digitalis; monitoring important
- Monitor BUN/Cr at baseline, then periodically, or more frequently if renal impairment, diabetes, in elderly, or seriously ill patients; discontinue the drug in patients with renal disease
- Frequently monitor acid-base balance in patients with cardiopulmonary disease or poorly controlled diabetes
- Monitor electrolytes at baseline, when changing treatment and when illness alters renal function
Cautions: Use cautiously in:
- Renal impairment
- Hepatic impairment
- Hepatic disease
- Cardiopulmonary disease
- Electrolyte abnormalities
- Volume depletion
- Seizure disorder
- Arrhythmias
- Post-sympathectomy
- Diabetes mellitus
- SLE
- History of gout
- History of pancreatitis
- Pregnancy near-term
- Gestational hypertension
- Geriatrics
Pregnancy Category:B
Breastfeeding: Hydrochlorothiazide doses of 50 mg/day or less are acceptable during lactation. Intense diuresis with large doses may decrease breastmilk production. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 8 December 2010). Unknown whether amiloride is excreted in human milk. Thiazides are excreted in breast milk. Has a potential for serious adverse reactions in nursing infants. Discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
US Trade Name(s)
US Availability
amiloride/hydrochlorothiazide (generic)
Canadian Trade Name(s)
- Hydro tab
- Apo-amilzide
- Nu-amilzide
- Novamilor tab
- Amilzide
Canadian Availability
Hydro tab (amiloride/hydrochlorothiazide)
Apo-amilzide (amiloride/hydrochlorothiazide)
Nu-amilazide (amiloride/hydrochlorothiazide)
Novamilor tab (amiloride/hydrochlorothiazide)
Amilzide (amiloride/hydrochlorothiazide)
UK Trade Name(s)
- Co-amilozide
- Moduret 25
- Moduretic
UK Availability
Co-amilozide (amiloride/hydrochlorothiazide)
Moduret 25 (amiloride/hydrochlorothiazide)
Moduretic (amiloride/hydrochlorothiazide)
Australian Trade Name(s)
Australian Availability
Amizide, Moduretic (amiloride/hydrochlorothiazide)
[Outline]
Drug Name: Amiloride hydrochloride 5 MG / HCTZ 50 MG Oral Tablet
Pill Image:
[
See full size image]
Ingredient(s): Amiloride mixture with Hydrochlorothiazide
Imprint: M;577
Color(s): Orange
Shape: Round
Size (mm): 9.00
Score: 2
Inactive Ingredient(s): croscarmellose sodium / lactose (hydrous) / magnesium stearate / pregelatinized starch / sodium lauryl sulfate / fd&c yellow #6 aluminum lake
Drug Label Author:
Mylan Pharmaceuticals Inc
DEA Schedule:
Non-Scheduled
