pharmacopeia
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/api/v1/drug/metolazone

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Sodium Chloride Symporter Inhibitors.

Sodium Chloride Symporter

Indications

Sourced from openFDA
  • Metolazone is indicated for the treatment of salt and water retention including: • edema accompanying congestive heart failure; • edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. Metolazone is also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class.ICD-10: I10, I50.9, R60.9

Contraindications

Sourced from openFDA
  • Anuria, hepatic coma or precoma, known allergy or hypersensitivity to metolazone.contraindicated

Dosage & administration

Sourced from openFDA

Effective dosage of metolazone tablets should be individualized according to indication and patient response. A single daily dose is recommended. Therapy with metolazone tablets should be titrated to gain an initial therapeutic response and to determine the minimal dose possible to maintain the desired therapeutic response. Usual Single Daily Dosage Schedules Suitable initial dosages will usually fall in the ranges given. Edema of cardiac failure: Metolazone tablets, 5 mg to 20 mg once daily. Edema of renal disease: Metolazone tablets, 5 mg to 20 mg once daily. Mild to moderate essential hypertension: Metolazone tablets, 2.5 mg to 5 mg once daily. New patients - If considered desirable to switch patients currently on Zaroxolyn ® tablets and other formulations of metolazone that share its slow and incomplete bioavailability to Mykrox ® , the dose should be determined by titration starting at one tablet (0.5 mg) once daily and increasing to two tablets (1 mg) once daily if needed. Treatment of Edematous States The time interval required for the initial dosage to produce an effect may vary. Diuresis and saluresis usually begin within one hour and persist for 24 hours or longer. When a desired therapeutic effect has been obtained, it may be advisable to reduce the dose if possible. The daily dose depends on the severity of the patient's condition, sodium intake, and responsiveness. A decision to change the daily dose should be based on the results of thorough clinical and laboratory evaluations.

Warnings & precautions

Sourced from openFDA

Rapid Onset Hyponatremia and/or Hypokalemia Rarely, the rapid onset of severe hyponatremia and/or hypokalemia has been reported following initial doses of thiazide and non-thiazide diuretics. When symptoms consistent with severe electrolyte imbalance appear rapidly, drug should be discontinued and supportive measures should be initiated immediately. Parenteral electrolytes may be required. Appropriateness of therapy with this class of drugs should be carefully reevaluated. Hypokalemia Hypokalemia may occur with consequent weakness, cramps and cardiac dysrhythmias. Serum potassium should be determined at regular and appropriate intervals and dose reduction, potassium supplementation or addition of a potassium-sparing diuretic instituted whenever indicated. Hypokalemia is a particular hazard in patients who are digitalized or who have or have had a ventricular arrhythmia; dangerous or fatal arrhythmias may be precipitated. Hypokalemia is dose related. Concomitant Therapy Lithium In general, diuretics should not be given concomitantly with lithium because they reduce its renal clearance and add a high risk of lithium toxicity. Read prescribing information for lithium preparations before use of such concomitant therapy. Furosemide Unusually large or prolonged losses of fluids and electrolytes may result when metolazone is administered concomitantly to patients receiving furosemide (see PRECAUTIONS, Drug Interactions ).

Adverse reactions

Sourced from openFDA

Metolazone is usually well tolerated and most reported adverse reactions have been mild and transient. Many metolazone related adverse reactions represent extensions of its expected pharmacologic activity and can be attributed to either its antihypertensive action or its renal/metabolic actions. The following adverse reactions have been reported. Several are single or comparably rare occurrences. Adverse reactions are listed in decreasing order of severity within body systems. Cardiovascular Chest pain/discomfort, orthostatic hypotension, excessive volume depletion, hemoconcentration, venous thrombosis, palpitations. Central and Peripheral Nervous System Syncope, neuropathy, vertigo, paresthesias, psychotic depression, impotence, dizziness/lightheadedness, drowsiness, fatigue, weakness, restlessness (sometimes resulting in insomnia), headache. Dermatologic/Hypersensitivity Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, necrotizing angiitis (cutaneous vasculitis), skin necrosis, purpura, petechiae, dermatitis (photosensitivity), urticaria, pruritus, skin rashes. Gastrointestinal Hepatitis, intrahepatic cholestatic jaundice, pancreatitis, vomiting, nausea, epigastric distress, diarrhea, constipation, anorexia, abdominal bloating, abdominal pain. Hematologic Aplastic/hypoplastic anemia, agranulocytosis, leukopenia, thrombocytopenia. Metabolic Hypokalemia, hyponatremia, hyperuricemia, hypochloremia, hypochloremic alkalosis, hyperglycemia, glycosuria, increase in serum urea nitrogen (BUN) or creatinine, hypophosphatemia, hypomagnesemia, hypercalcemia.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects Reproduction studies performed in mice, rabbits and rats treated during the appropriate period of gestation at doses up to 50 mg/kg/day have revealed no evidence of harm to the fetus due to metolazone. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, metolazone tablets should be used during pregnancy only if clearly needed. Metolazone crosses the placental barrier and appears in cord blood. Non-Teratogenic Effects The use of metolazone tablets in pregnant women requires that the anticipated benefit be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, thrombocytopenia and possibly other adverse reactions which have occurred in the adult. It is not known what effect the use of the drug during pregnancy has on the later growth, development and functional maturation of the child. No such effects have been reported with metolazone.

Approval history

Sourced from openFDA
  • Dec 19, 2003ANDAANDA076732Sandoz
  • Dec 19, 2003ANDAANDA076466Sandoz
  • Dec 23, 2003ANDAANDA076698Mylan
  • Dec 2, 2020ANDAANDA213251Alembic
  • Mar 30, 2021ANDAANDA213827Innogenix
  • Mar 30, 2021ANDAANDA214799Unichem
  • Aug 20, 2021ANDAANDA215184Rubicon Research
  • Oct 24, 2022ANDAANDA215616Renata

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
11,038 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Dyspnoea1,22311%
  2. 2Death8767.9%
  3. 3Acute Kidney Injury7947.2%
  4. 4Nausea7496.8%
  5. 5Renal Failure7146.5%
  6. 6Cardiac Failure Congestive6786.1%
  7. 7Fatigue6565.9%
  8. 8Diarrhoea6495.9%
  9. 9Dizziness6105.5%
  10. 10Chronic Kidney Disease5905.3%
  11. 11Hypotension5805.3%
  12. 12Asthenia5775.2%
  13. 13Headache5515.0%
  14. 14Oedema Peripheral5294.8%
  15. 15Fall5134.6%

Literature

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Recent PubMed references pinned to Metolazone as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 36 ClinicalTrials.gov registrations naming Metolazone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Metolazone work?
Mechanism-of-action class: Sodium Chloride Symporter Inhibitors.
What is Metolazone used for?
According to FDA labeling, Metolazone carries indications including: Metolazone is indicated for the treatment of salt and water retention including: • edema accompanying congestive heart failure; • edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. Metolazone is also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Metolazone?
Metolazone is classified as Sulfonamides, plain, Thiazide-like Diuretic, Sodium Chloride Symporter Inhibitors, Decreased Blood Pressure, Decreased Intravascular Volume, Increased Distal Tubule Cl- Excretion, Increased Distal Tubule H+ Excretion, Increased Distal Tubule K+ Excretion, Increased Distal Tubule Na+ Excretion, Increased Diuresis.
What are the contraindications for Metolazone?
Metolazone labeling lists contraindications including: Anuria, hepatic coma or precoma, known allergy or hypersensitivity to metolazone.. Always consult the full prescribing information and a clinician.
Note. Data for metolazone is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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