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Moduretic

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Moduretic

Moduretic

SIDE EFFECTS

MODURETIC (amiloride 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 MODURETIC (amiloride and hydrochlorothiazide) is about 1-2 percent in patients without renal impairment or diabetes mellitus (see WARNINGS). Minor adverse reactions to amiloride HCl 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 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 MODURETIC (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 MODURETIC (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 MODURETIC (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 MODURETIC (amiloride and hydrochlorothiazide) and these adverse reactions, some of which have been reported only rarely.

Incidence > 1% Incidence ≤ 1%
Body as a Whole
   Headache**
   Weakness**
   Fatigue/tiredness
Malaise
Chest pain
Back pain
Syncope
Cardiovascular
Arrhythmia
Tachycardia
Digitalis toxicity
Orthostatic hypotension
Angina pectoris
Digestive
   Nausea/anorexia**
   Diarrhea
   Gastrointestinal pain
   Abdominal pain
Constipation
GI bleeding
GI disturbance
Appetite changes
Abdominal fullness
Hiccups
Thirst
Vomiting
Anorexia
Flatulence
Metabolic
   Elevated serum potassium levels ( > 5.5 mEq per liter)***
Gout
Dehydration
Symptomatic hyponatremiat
Musculoskeletal
   Leg ache
Muscle cramps/spasm
Joint pain
   Nervous
   Dizziness**
Paresthesia/numbness
Stupor
Vertigo
Psychiatric
   None
Insomnia
Nervousness
Depression Sleepiness
Mental confusion
Respiratory
   Dyspnea
None
Skin
   Rash**
   Pruritus
Flushing
Diaphoresis
Erythema multiforme including
Stevens-Johnson syndrome
Exfoliative dermatitis including toxic epidermal necrolysis
Alopecia
Special Senses
   None
Bad taste
Visual disturbance
Nasal congestion
Urogenital
   None
Impotence Nocturia Dysuria Incontinence
Renal dysfunction including renal failure Gynecomastia
** Reactions occurring in 3% to 8% of patients treated with MODURETIC (amiloride and hydrochlorothiazide) . (Those reactions occurring in less than 3% of the patients are unmarked.)
***See WARNINGS.
†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).

Read the Moduretic (amiloride and hydrochlorothiazide) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when MODURETIC (amiloride and hydrochlorothiazide) and non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained. Since indomethacin and potassium-sparing diuretics, including MODURETIC (amiloride and hydrochlorothiazide) , may each be associated with increased serum potassium levels, the potential effects on potassium kinetics and renal function should be considered when these agents are administered concurrently.

Amiloride HCl

When amiloride HCl is administered concomitantly with an angiotensin-converting enzyme inhibitor, an angiotensin II receptor antagonist, cyclosporine or tacrolimus, the risk of hyperkalemia may be increased. Therefore, if concomitant use of these agents is indicated because of demonstrated hypokalemia, they should be used with caution and with frequent monitoring of serum potassium. (See WARNINGS.)

Hydrochlorothiazide

When given concurrently the following drugs may interact with thiazide diuretics. Alcohol, barbiturates, or narcotics — potentiation of orthostatic hypotension may occur. Antidiabetic drugs (oral agents and insulin) — dosage adjustment of the antidiabetic drug may be required.

Other antihypertensive drugs — additive effect or potentiation.

Cholestyramine and colestipol resins — Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively.

Corticosteroids, ACTH — intensified electrolyte depletion, particularly hypokalemia.

Pressor amines (e.g., norepinephrine) — possible decreased response to pressor amines but not sufficient to preclude their use.

Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine) — possible increased responsiveness to the muscle relaxant.

Lithium — generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such preparations with MODURETIC (amiloride and hydrochlorothiazide) .

Metabolic and Endocrine Effects

In diabetic patients, insulin requirements may be increased, decreased, or unchanged due to the hydrochlorothiazide component. Diabetes mellitus that has been latent may become manifest during administration of thiazide diuretics.

Because calcium excretion is decreased by thiazides, MODURETIC (amiloride and hydrochlorothiazide) should be discontinued before carrying out tests for parathyroid function. Pathologic changes in the parathyroid glands, with hypercalcemia and hypophosphatemia have been observed in a few patients on prolonged thiazide therapy; however, the common complications of hyperparathyroidism such as renal lithiasis, bone resorption, and peptic ulceration have not been seen.

Hyperuricemia may occur or acute gout may be precipitated in certain patients receiving thiazide therapy.

Other Precautions

In patients receiving thiazides, sensitivity reactions may occur with or without a history of allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazides.

Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.

Read the Moduretic Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 4/24/2009
This monograph has been modified to include the generic and brand name in many instances.

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