Amiloride Hydrochloride and Hydrochlorothiazide (Page 4 of 5)

Geriatric Use

Clinical studies of amiloride hydrochloride and hydrochlorothiazide tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and the comitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see CONTRAINDICATIONS, Impaired Renal Function).

ADVERSE REACTIONS

Amiloride hydrochloride and hydrochlorothiazide is usually well tolerated and significant clinical adverse effects have been reported infrequently. The risk of hyperkalemia (serum potassium levels greater than 5.5 mEq per liter) with amiloride hydrochloride and hydrochlorothiazide is about 1 to 2 percent in patients without renal impairment or diabetes mellitus (see WARNINGS). Minor adverse reactions to amiloride hydrochloride have been reported relatively frequently (about 20%) but the relationship of many of the reports to amiloride HCl is uncertain and the overall frequency was similar to hydrochlorothiazide treated groups. Nausea/anorexia, abdominal pain, flatulence, and mild skin rash have been reported and probably are related to amiloride. Other adverse experiences that have been reported with amiloride and hydrochlorothiazide are generally those known to be associated with diuresis, thiazide therapy, or with the underlying disease being treated. Clinical trials have not demonstrated that combining amiloride and hydrochlorothiazide increases the risk of adverse reactions over those seen with the individual components.

The adverse reactions for amiloride and hydrochlorothiazide listed in the following table have been arranged into two groups: (1) incidence greater than one percent; and (2) incidence one percent or less. The incidence for group (1) was determined from clinical studies conducted in the United States (607 patients treated with amiloride and hydrochlorothiazide). The adverse effects listed in group (2) include reports from the same clinical studies and voluntary reports since marketing. The probability of a causal relationship exists between amiloride and hydrochlorothiazide and these adverse reactions, some of which have been reported only rarely.

Incidence > 1%

Incidence ≤ 1%

Body as a Whole

Headache 1 Weakness 1

Fatigue/tiredness

MalaiseChest painBack painSyncope

Cardiovascular

Arrhythmia

TachycardiaDigitalis toxicityOrthostatic hypotensionAngina pectoris

Digestive

Nausea/anorexia 1 Diarrhea Gastrointestinal pain Abdominal pain

ConstipationGI bleedingGI disturbanceAppetite changesAbdominal fullnessHiccupsThirstVomitingAnorexiaFlatulence

Metabolic

Elevated serum potassium levels (> 5.5 mEq per liter)2

GoutDehydrationSymptomatic hyponatremia 3

Musculoskeletal

Leg ache

Muscle cramps/spasmJoint pain

Nervous

Dizziness 1

Paresthesia/numbnessStuporVertigo

Psychiatric None

InsomniaNervousnessDepressionSleepinessMental confusion

Respiratory

Dyspnea

None

Skin

Rash 1 Pruritus

FlushingDiaphoresisErythema multiforme including Stevens- Johnson syndromeExfoliative dermatitis including toxic epidermal necrolysisAlopecia

Special Senses

None

Bad tasteVisual disturbanceNasal congestion

Urogenital

None

ImpotenceNocturiaDysuriaIncontinenceRenal dysfunction including renal failureGynecomastia

1. Reactions occurring in 3% to 8% of patients treated with amiloride hydrochloride and hydrochlorothiazide. (Those reactions occurring in less than 3% of the patients are unmarked.)

2. See WARNINGS

3. See PRECAUTIONS

Other adverse reactions that have been reported with the individual components and within each category are listed in order of decreasing severity:

Amiloride

Body as a Whole: Painful extremities, neck/shoulder ache, fatigability.

Cardiovascular: Palpitation.

Digestive: Activation of probable pre-existing peptic ulcer, abnormal liver function, jaundice, dyspepsia, heartburn.

Hematologic: Aplastic anemia, neutropenia.

Integumentary: Alopecia, itching, dry mouth.

Nervous System/Psychiatric: Encephalopathy, tremors, decreased libido.

Respiratory: Shortness of breath, cough.

Special Senses: Increased intraocular pressure, tinnitus.

Urogenital: Bladder spasms, polyuria, urinary frequency.

Hydrochlorothiazide

Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation.

Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia.

Hypersensitivity: Anaphylactic reactions, necrotizing angiitis (vasculitis, cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, purpura.

Metabolic: Electrolyte imbalance (see PRECAUTIONS), hyperglycemia, glycosuria, hyperuricemia.

Nervous System/Psychiatric: Restlessness.

Special Senses: Transient blurred vision, xanthopsia.

Urogenital: Interstitial nephritis (see WARNINGS).

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