Classes
DEA Class; Rx
Common Brand Names; Moduretic
- Thiazide Combos
Description
Oral combination product; potassium-sparing diuretic and thiazide diuretic; amiloride counteracts potassium loss due to HCTZ; useful in patients requiring thiazide diuretics with hypokalemia unresponsive to potassium supplements.
Indications
Indicated for the treatment of hypertension, peripheral edema, or edema associated with heart failure in patients who develop hypokalemia when thiazides (or other kaliuretic diuretics) are used alone, or in patients with significant risks for hypokalemia (e.g., digitalized, cardiac arrhythmias).
Contraindications
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
Anuria
Hyperkalemia (potassium levels ≥ 5.5 mEq/L)
Adverse Effects
Amiloride
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%)
Hydrochlorothiazide
Anorexia
Epigastric distress
Hypotension
Orthostatic hypotension
Photosensitivity
Anaphylaxis
Anemia
Confusion
Erythema multiforme
Stevens-Johnson syndrome
Exfoliative dermatitis including toxic epidermal necrolysis
Dizziness
Hypokalemia and/or hypomagnesemia
Hyperuricemia
Headache
Warnings
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 and 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.
Maximum Dosage
10 mg/day PO amiloride and 100 mg/day PO hydrochlorothiazide.
10 mg/day PO amiloride and 100 mg/day PO hydrochlorothiazide.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Amiloride hydrochloride/hydrochlorothiazide
tablet
- 5mg/50mg