Metolazone

Indications

INDICATIONS AND USAGE 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. Mykrox ® tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if Mykrox ® tablets are to be substituted for Zaroxolyn ® tablets and other formulations of metolazone that share its slow and incomplete bioavailability, in the treatment of hypertension. Usage In Pregnancy The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no evidence that they are useful in the treatment of developed toxemia.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION 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.

Contraindications

CONTRAINDICATIONS Anuria, hepatic coma or precoma, known allergy or hypersensitivity to metolazone.

Warnings and precautions

WARNINGS 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.

Pregnancy

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.

Storage and supply

HOW SUPPLIED Metolazone tablets, USP for oral administration are available as: 5 mg: Blue, shallow biconvex, modified oval tablets, debossed “E55” on one side, plain on the other side and supplied as: NDC: 72162-1050-1: 100 Tablets in a BOTTLE Store at 20° to 25°C (68° to 77°F) . Protect from light.

Source: Metolazone (Metolazone) — US FDA prescribing information, 2024-12-24, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.