metolazone
Pharmaranks rates Metolazone 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Metolazone is a thiazide-like diuretic used to treat Edema, Heart Failure, Hypertension, Nephrotic Syndrome.
Thiazide-Like Diuretic · by Unichem
Generic of Diulo
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Metolazone
- Drug class
- Thiazide-Like Diuretic
- Form
- Tablet
- Strength
- Metolazone 10MG · Metolazone 2.5MG · Metolazone 5MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- edema, heart failure, hypertension
- Manufacturer
- Unichem
- What the pharmacy pays
- ~$8.76 for 30 — not your price
- FDA application
- ANDA214799
What is Metolazone?
From the FDA label:Metolazone tablets, USP, for oral administration contain 2½, 5, or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16 H 16 ClN 3 O 3 S, the chemical name 7-chloro-1, 2, 3, 4-tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide, and a molecular weight of 365.83. The structural formula is: Metolazone is very slightly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide and dye: 2.5 mg - D&C Red No. 30 lake; 5 mg - FD&C Blue No. 2 lake; 10 mg - D&C Yellow No. 10 lake and FD&C Yellow No. 6 lake. Image
How to use
Effective dosage of metolazone tablets, USP, should be individualized according to indication and patient response. A single daily dose is recommended. Therapy with metolazone tablets, USP, 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, USP, 5 to 20 mg once daily. Edema of renal disease: Metolazone tablets, USP, 5 to 20 mg once daily. Mild to moderate essential hypertension: Metolazone tablets, USP, 2½ to 5 mg once daily. New patients – MYKROX Tablets (metolazone tablets, USP) (see MYKROX package circular). If considered desirable to switch patients currently on metolazone tablets, USP, to MYKROX, the dose should be determined by titration starting at one tablet (½ 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…
Side effects
Metolazone tablets, USP, are usually well tolerated, and most reported adverse reactions have been mild and transient. Many of metolazone tablets, USP, 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.…
Warnings
Important safety information
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 tablets, USP, are administered concomitantly to patients receiving furosemide (see PRECAUTIONS , Drug Interactions ). Other Antihypertensive Drugs When metolazone tablets, USP, are used with other antihypertensive drugs, particular care must be taken to avoid excessive reduction of blood pressure, especially during initial therapy. Cross –Allergy Cross-allergy may occur when metolazone tablets, USP, are given to patients known to be allergic to sulfonamide-derived drugs, thiazides, or quinethazone. Sensitivity Reactions Sensitivity reactions (e.g., angioedema, bronchospasm) may occur with or without a history of allergy or bronchial asthma and may occur with the first dose of metolazone tablets, USP.
Who should not take Metolazone
Anuria, hepatic coma or precoma, known allergy or hypersensitivity to metolazone.
Overdose — what happens if you take too much
Intentional overdosage has been reported rarely with metolazone and similar diuretic drugs. Signs And Symptoms Orthostatic hypotension, dizziness, drowsiness, syncope, electrolyte abnormalities, hemoconcentration and hemodynamic changes due to plasma volume depletion may occur. In some instances depressed respiration may be observed. At high doses, lethargy of varying degree may progress to coma within a few hours. The mechanism of CNS depression with thiazide overdosage is unknown. Also, GI irritation and hypermotility may occur. Temporary elevation of BUN has been reported, especially in patients with impairment of renal function. Serum electrolyte changes and cardiovascular and renal function should be closely monitored. Treatment There is no specific antidote available but immediate evacuation of stomach contents is advised. Dialysis is not likely to be effective. Care should be taken when evacuating the gastric contents to prevent aspiration, especially in the stuporous or comatose patient. Supportive measures should be initiated as required to maintain hydration, electrolyte balance, respiration, and cardiovascular and renal function.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Diuretics Furosemide and probably other loop diuretics given concomitantly with metolazone can cause unusually large or prolonged losses of fluid and electrolytes (see WARNINGS). Other Antihypertensives When metolazone tablets, USP, are used with other antihypertensive drugs, care must be taken, especially during initial therapy. Dosage adjustments of other antihypertensives may be necessary. Alcohol, Barbiturates, And Narcotics The hypotensive effects of these drugs may be potentiated by the volume contraction that may be associated with metolazone therapy. Digitalis Glycosides Diuretic-induced hypokalemia can increase the sensitivity of the myocardium to digitalis. Serious arrhythmias can result. Corticosteroids Or ACTH May increase the risk of hypokalemia and increase salt and water retention. Lithium Serum lithium levels may increase (see WARNINGS). Curariform Drugs Diuretic-induced hypokalemia may enhance neuromuscular blocking effects of curariform drugs (such as tubocurarine) – the most serious effect would be respiratory depression which could proceed to apnea. Accordingly, it may be advisable to discontinue metolazone tablets, USP, three days before elective surgery. Salicylates And Other Non-Steroidal Anti-Inflammatory Drugs May decrease the antihypertensive effects of metolazone tablets USP. Sympathomimetics Metolazone may decrease arterial responsiveness to norepinephrine, but this diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use. Insulin And Oral Antidiabetic Agents See Glucose Tolerance under PRECAUTIONS, General. Methenamine Efficacy may be decreased due to urinary alkalizing effect of metolazone. Anticoagulants Metolazone, as well as other thiazide-like diuretics, may affect the hypoprothrombinemic response to anticoagulants; dosage adjustments may be necessary.
Drug class
May treat (source: NIH RxClass)
See how Metolazone ranks — best-rated thiazide-like diuretic for:
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Metolazone treat?
- Metolazone (Metolazone) may be used to treat edema, heart failure, hypertension, nephrotic syndrome, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Metolazone rated?
- pharmaranks gives Metolazone a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Metolazone cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $8.76 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Hemiclor — about $2.67 on the same basis.
- Is there a coupon or discount for Metolazone?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Metolazone. To pay less, Metolazone is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Metolazone?
- Metolazone is marketed by Unichem. You can see Unichem's full profile, rating, and other products on pharmaranks.
- Is Metolazone a brand-name or generic drug?
- Metolazone is a generic medication; its active ingredient is Metolazone. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Metolazone available over the counter?
- No. Metolazone is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Metolazone come in?
- Metolazone is currently marketed as tablet, per the FDA's National Drug Code Directory.
- What class of drug is Metolazone?
- Metolazone is classified as thiazide-like diuretic, per the FDA's Established Pharmacologic Class.
- Is Metolazone FDA-registered?
- Metolazone is on record with the U.S. FDA under application number ANDA214799. You can verify this on its official FDA label.
- Has Metolazone been recalled by the FDA?
- Metolazone has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Metolazone safe?
- There's no single safe-or-not verdict. pharmaranks gives Metolazone a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Metolazone?
- Metolazone's side effects are taken directly from its FDA label. From the label: Metolazone tablets, USP, are usually well tolerated, and most reported adverse reactions have been mild and transient. Many of metolazone tablets, USP, related adverse reactions represent extensions of its expected pharmacologic activity and can be attributed to either its antihypertensive action or… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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metolazone
72/100