Dosing & Uses
Dosage Forms & Strengths
5-10 mg/50-100 mg (amiloride/HCTZ)/day PO
Use cautioni in patients with diabetes mellitus or serum creatinine >1.5 mg/dL; contraindicated in anuria, acute or chronic renal insufficiency or signs of diabetic nephropathy
Dose adjustment not necessary; use caution
Safety & efficacy not established
½ tablet to 1 tablet/day initially
Serious - Use Alternative
Significant - Monitor Closely
- Hyperkalemia (10%)
- Impotence (<3%)
- Diarrhea (3-8%)
- Headache (3-8%)
- Nausea (3-8%)
- Vomiting (3-8%)
- Abdominal pain (<3%), Muscle cramps (<3%)
- Appetite changes (<3%)
- Constipation (<3%)
- Cough (<3%)
- Dizziness (<3%)
- Dyspnea (<3%)
- Encephalopathy (<3%)
- Fatigue (<3%), Weakness (<3%)
- Gas pain (<3%)
Frequency Not Defined
- AnorexiaEpigastric distress
- Orthostatic hypotension
- Erythema multiforme
- Stevens-Johnson syndrome
- Exfoliative dermatitis including toxic epidermal necrolysis
- Hypokalemia and/or hypomagnesemia
Black Box Warning
Monitor serum potassium levels in patients receiving amiloride and hydrochlorothiazide especially when initiating therapy, adjusting the dose or with an illness that may cause renal dysfunction; hyperkalemia (potassium levels ≥ 5.5 mEq/L) if uncorrected is potentially fatal and may occur in patients without renal impairment or diabetes mellitus (risk of hyperkalemia is 1-2%); risk of hyperkalemia is higher in patients with renal impairment or diabetes mellitus even in the absence of diabetic nephropathy
Hypersensitivity to amiloride, HCTZ or sulfonamides
Concomitant use with potassium-sparing agents (eg, spironolactone, triamterene)
Concomitant administration with any form of potassium supplementation
Acute renal failure or evidence of diabetic nephropathy
Hyperkalemia (potassium levels ≥ 5.5 mEq/L)
Avoid use in patients with diabetes; may require adjustments in insulin or oral hypoglycemic treatment; hyperglycemia may occur during administration
Electrolyte imbalance (hypokalemia, hypophosphatemia, hyperkalemia, hypercalcemia, hypomagnesemia, hyponatremia, or hypochloremic alkalosis) may occur
Triglyceride and cholesterol levels may increase
May experience increase in serum urea nitrogen (BUN), or serum creatinine
Symptoms of lupus erythematosus may exacerbate
Hydrochlorothiazide may cause acute transient myopia and acute angle closure glaucoma within hours or weeks of initiating therapy
Gout symptoms may be precipitated
Hypersensitivity reactions may occur with or without history of allergy or bronchial asthma
Not for administration in patients with acute or chronic renal insufficiency (cumulative drug effects may be observed); diuretics may precipitate azotemia in renal disease
Use caution in patients in whom respiratory or metabolic acidosis may occur
Use caution in patients with hepatic impairment; minor alterations of fluid and electrolyte imbalance may precipitate hepatic coma
The risk of hydrochlorothiazide toxicity may be greater in renal impairment
Antihypertensive effects of this therapy may be enhanced in postsympathectomy patients
Pregnancy & Lactation
Pregnancy Category: B
Lactation: Excretion in breast milk is unknown. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.