Amiloride Hydrochloride and Hydrochlorothiazide (Page 4 of 5)

Information for Patients

Non-melanoma Skin Cancer

Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.

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% 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 hydrochloride is uncertain and the overall frequency was similar in 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 1%; and (2) incidence 1% 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%
*
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.)
See WARNINGS.
See PRECAUTIONS.

Body as a Whole

Headache *

Malaise

Weakness *

Chest pain

Fatigue/tiredness

Back painSyncope

Cardiovascular

Arrhythmia

TachycardiaDigitalis toxicityOrthostatic hypotensionAngina pectoris

Digestive

Nausea/anorexia *

Constipation

Diarrhea

GI bleeding

Gastrointestinal pain

GI disturbance

Abdominal pain

Appetite changesAbdominal fullnessHiccupsThirstVomitingAnorexiaFlatulence

Metabolic

Elevated serum

Gout

potassium levels

Dehydration

(> 5.5 mEq per liter)

Symptomatic hyponatremia

Musculoskeletal

Leg ache

Muscle cramps/spasmJoint Pain

Nervous

Dizziness *

Paresthesia/numbnessStuporVertigo

Psychiatric

None

InsomniaNervousnessDepressionSleepinessMental confusion

Respiratory

Dyspnea

None

Skin

Rash *

Flushing

Pruritus

DiaphoresisErythema multiforme including Stevens-Johnson SyndromeExfoliative dermatitis including toxic epidermal necrolysisAlopecia

Special Senses

None

Bad tasteVisual disturbanceNasal congestion

Urogenital

None

ImpotenceNocturiaDysuriaIncontinenceRenal dysfunction including renal failureGynecomastia

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 preexisting 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).

Postmarketing Experience

Non-melanoma Skin Cancer

Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥ 50,000 mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.

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