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Moduretic

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Moduretic

Moduretic

Moduretic Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Modurectic (amiloride HCl-hydrochlorothiazide) is currently available in generic form only. Moduretic is indicated in those patients with hypertension, or with congestive heart failure who develop 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. Some common side effects include but are not limited to: nausea, anorexia, and abdominal pain.

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. 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 nursing 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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Moduretic in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • eye pain, vision problems;
  • numbness or tingly feeling;
  • muscle pain or weakness;
  • slow, fast, or uneven heartbeat;
  • feeling drowsy, restless, or light-headed;
  • urinating less than usual or not at all;
  • dry mouth, increased thirst, tiredness, nausea, vomiting;
  • shallow breathing;
  • tremors, confusion; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild nausea or vomiting;
  • gas, stomach pain; or
  • skin rash.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Moduretic Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Headache, dizziness, nausea, vomiting, loss of appetite, stomach/abdominal pain, gas, or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This product may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor immediately if you have any of these unlikely but serious symptoms of dehydration or mineral loss: very dry mouth, extreme thirst, muscle cramps, weakness, fast heartbeat, severe dizziness, confusion, unusual decrease in the amount of urine, fainting, seizures.

Tell your doctor immediately if this unlikely but serious side effect occurs: joint pain.

Tell your doctor immediately if any of these rare but serious side effects occur: yellowing eyes/skin, dark urine, persistent nausea/vomiting, unusual change in the amount of urine (not including the normal increase in urine when you first start this drug), decrease in vision, eye pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Moduretic (Amiloride and Hydrochlorothiazide)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Moduretic FDA Prescribing Information: Side Effects
(Adverse Reactions)

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) »

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Moduretic - User Reviews

Moduretic User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Moduretic sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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