Moduretic
- Generic Name: amiloride and hydrochlorothiazide
- Brand Name: Moduretic
Moduretic (Amiloride and Hydrochlorothiazide) side effects drug center
Moduretic Side Effects Center
Modurectic (amiloride HCl-hydrochlorothiazide) is a combination of a potassium-conserving (antikaliuretic) drug and a diuretic indicated in those patients with hypertension, or with congestive heart failure who develop low blood potassium (hypokalemia) when thiazides or other kaliuretic diuretics are used, or in whom maintenance of normal serum potassium levels is considered to be clinically important, e.g., digitalized patients, or patients with significant cardiac arrhythmias. Modurectic is currently available in generic form only. Common side effects of Modurectic include:
Modurectic may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor if you have unlikely but serious symptoms of dehydration or mineral loss including:
- very dry mouth,
- extreme thirst,
- muscle cramps,
- weakness,
- fast heartbeat,
- severe dizziness,
- confusion,
- unusual decrease in the amount of urine,
- fainting, or
- seizures.
Moduretic contains 5 mg of amiloride HCl and 50 mg of hydrochlorothiazide. The usual starting dosage is 1 tablet a day. The dosage may be increased to 2 tablets a day. Modurectic may interact with other medicines that make you light-headed (such as cold medicines, pain medications, muscle relaxers, and medicines for seizures, depression or anxiety), cyclosporine, tacrolimus, lithium, digoxin, steroids, blood thinners, insulin or oral diabetes medications, other blood pressure medications, ACE inhibitors, angiotensin 2 receptor blockers (ARBs), and indomethacin or other nonsteroidal anti-inflammatory drugs (NSAIDs). Tell your doctor all medications and supplements you use. Moduretic should be used during pregnancy only if clearly needed. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.
Our Modurectic (amiloride HCl-hydrochlorothiazide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Moduretic Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- a light-headed feeling, like you might pass out;
- high sodium--headache, confusion, slurred speech, hallucinations, vomiting, severe weakness, muscle cramps, loss of coordination, feeling unsteady, shallow breathing; or
- high potassium--slow heart rate, weak pulse, muscle weakness, tingly feeling.
Common side effects may include:
- diarrhea, constipation;
- mild stomach pain; or
- tired feeling.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Moduretic (Amiloride and Hydrochlorothiazide)
Moduretic Professional Information
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 entire FDA prescribing information for Moduretic (Amiloride and Hydrochlorothiazide)
&Copy; Moduretic Patient Information is supplied by Cerner Multum, Inc. and Moduretic Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.