Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1567
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Metolazone (Tablet)
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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.<br/>Usual Single Daily Dosage Schedules: Suitable initial dosages will usually fall in the ranges given. Edema of cardiac failure: Edema of renal disease: Mild to moderate essential hypertension:<br/>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. If antihypertensive drugs or diuretics are given concurrently with metolazone tablets, more careful dosage adjustment may be necessary. For patients who tend to experience paroxysmal nocturnal dyspnea, it may be advisable to employ a larger dose to ensure prolongation of diuresis and saluresis for a full 24-hour period.
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Metolazone Tablets, USP for oral administration contain 2.5 mg, 5 mg or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula CHClNOS, 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 only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: colloidal silicon dioxide, FD&C Yellow #6 Lake HT, magnesium stearate and microcrystalline cellulose. In addition, the 10 mg strength contains D&C Yellow #10 Lake HT and FD&C Blue #2 Lake HT.
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Metolazone is a quinazoline diuretic, with properties generally similar to the thiazide diuretics. The actions of metolazone result from interference with the renal tubular mechanism of electrolyte reabsorption. Metolazone acts primarily to inhibit sodium reabsorption at the cortical diluting site and to a lesser extent in the proximal convoluted tubule. Sodium and chloride ions are excreted in approximately equivalent amounts. The increased delivery of sodium to the distal tubular exchange site results in increased potassium excretion. Metolazone does not inhibit carbonic anhydrase. A proximal action of metolazone has been shown in humans by increased excretion of phosphate and magnesium ions and by a markedly increased fractional excretion of sodium in patients with severely compromised glomerular filtration. This action has been demonstrated in animals by micropuncture studies. When metolazone tablets are given, diuresis and saluresis usually begin within one hour and may persist for 24 hours or more. For most patients, the duration of effect can be varied by adjusting the daily dose. High doses may prolong the effect. A single daily dose is recommended. When a desired therapeutic effect has been obtained, it may be possible to reduce dosage to a lower maintenance level. The diuretic potency of metolazone at maximum therapeutic dosage is approximately equal to thiazide diuretics. However, unlike thiazides, metolazone may produce diuresis in patients with glomerular filtration rates below 20 mL/min. Metolazone and furosemide administered concurrently have produced marked diuresis in some patients where edema or ascites was refractory to treatment with maximum recommended doses of these or other diuretics administered alone. The mechanism of this interaction is unknown . Maximum blood levels of metolazone are found approximately eight hours after dosing. A small fraction of metolazone is metabolized. Most of the drug is excreted in the unconverted form in the urine.
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Metolazone Tablets, USP are available containing 2.5 mg, 5 mg and 10 mg of metolazone. The 2.5 mg tablets are peach, round, biconvex, unscored tablets debossed with M on one side of the tablet and 172 on the other side.They are available as follows: NDC 0378-6172-01bottles of 100 tablets NDC 0378-6172-10bottles of 1000 tablets The 5 mg tablets are orange, round, biconvex, unscored tablets debossed with M on one side of the tablet and 173 on the other side.They are available as follows: NDC 0378-6173-01bottles of 100 tablets NDC 0378-6173-10bottles of 1000 tablets The 10 mg tablets are light green, round, biconvex, unscored tablets debossed with M on one side of the tablet and 174 on the other side.They are available as follows: NDC 0378-6174-01bottles of 100 tablets NDC 0378-6174-10bottles of 1000 tablets Store at 20��to 25��C (68��to 77��F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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| dailymed-instance:overdosag... |
Intentional overdosage has been reported rarely with metolazone and similar diuretic drugs.<br/>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.<br/>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.
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Metolazone
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Metolazone (Tablet)
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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. Musculoskeletal: Joint pain, acute gouty attacks, muscle cramps or spasm. Other: Transient blurred vision, chills, dry mouth. In addition, adverse reactions reported with similar antihypertensive-diuretics, but which have not been reported to date for metolazone include: bitter taste, sialadenitis, xanthopsia, respiratory distress (including pneumonitis), and anaphylactic
reactions. These reactions should be considered as
possible occurrences with clinical usage of metolazone. Whenever adverse reactions are moderate or severe, metolazone dosage should be reduced or therapy withdrawn.
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Metolazone tablets are indicated for the treatment of salt and water retention including: Metolazone tablets are 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.<br/>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. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Metolazone tablets are indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy . Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may be appropriate.
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Metolazone
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