METOLAZONE TABLETS USP
Metoz Tablets (Metolazone Tablets USP) for oral administration contain 2.5 or 5mg of Metolazone USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class.
Each uncoated tablet contains:
Metolazone USP 2.5 or 5mg
Metoz (Metolazone) is a quinazoline diuretic, with properties generally similar to the thiazide diuretics. Metoz acts primarily to inhibit sodium reabsorption in the distal convoluted tubule 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.
Diuresis and saluresis usually begin within one hour and may persist for 24 hours or more. For most patients, adjusting the daily dose can vary the duration of effect. High doses may prolong the effect.
INDICATIONS AND USAGE
Metoz is indicated for the treatment of edema accompanying congestive heart failure and renal diseases, including the nephrotic syndrome and states of diminished renal function.
Metoz is also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class.
DOSAGE AND ADMINISTRATION
Dosage of Metoz should be individualized according to indication and patient response.
Usual Single Daily Dosage Schedules:
Edema of cardiac failure: Metoz 5 to 20mg once daily.
Edema of renal disease: Metoz 5 to 20mg once daily.
Mild to moderate essential hypertension: Metoz 2.5 to 5mg once daily.
Anuria, hepatic coma or precoma, known allergy or hypersensitivity to metolazone.
Rapid Onset Hyponatremia and/or Hypokalemia: When symptoms appear, the drug should be discontinued and supportive measures should be initiated immediately.
Lithium: Diuretics should not be given concomitantly because they reduce the renal clearance of lithium and increase the risk of toxicity.
Furosemide: Unusually large or prolonged losses of fluids and electrolytes may result when Metoz is administered concomitantly.
Fluid and Electrolytes: All patients should have serum electrolyte measurements done at appropriate intervals and be observed for clinical signs of fluid and/or electrolyte imbalance.
Glucose Tolerance: Metolazone may raise blood glucose concentrations possibly causing hyperglycemia and glycosuria in patients with diabetes or latent diabetes.
Hyperuricemia: Metolazone may cause an increase in serum uric acid and can occasionally precipitate gouty attacks.
INFORMATION FOR PATIENTS
Patients should be informed of possible adverse effects, advised to take the medication as directed, and promptly report any possible adverse reactions to the treating physician.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Mice and rats administered metolazone 5 days/week for up to 18 and 24 months, respectively, at daily doses of 2, 10, and 50 mg/kg, exhibited no evidence of a tumorigenic effect. Metolazone was not mutagenic in vitro in the in the Ames Test using Salmonella typhimurium strains TA-97, TA-98, TA-100, TA-102, and TA-1535.
Reproductive performance has been evaluated in mice and rats. There is no evidence that metolazone possesses the potential for altering reproductive capacity in mice.
Pregnancy Category B. Reproduction studies performed in mice, rabbits, and rats treated during 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, Metoz Tablets should be used during pregnancy only if clearly needed.
Metolazone appears in breast milk. Because of the potential for serious adverse reactions in nursing infants from metolazone, 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.
Diuretics: Furosemide and probably other loop diuretics given concomitantly with metolazone can cause unusually large or prolonged losses of fluid and electrolytes.
Other Antihypertensives: When Metoz Tablets are used with other antihypertensive drugs, dosage adjustments of the latter may be necessary.
Alcohol, Barbiturates, and Narcotics: The hypotensive effects of these drugs may be potentiated by the volume contraction 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.
Salicylates and Other Non-Steroidal Anti-Inflammatory Drugs: May decrease the antihypertensive effects of Metoz Tablets.
Metolazone is usually well tolerated, and most reported adverse reactions have been mild and transient.
The following adverse reactions have been reported: orthostatic hypotension, excessive volume depletion, venous thrombosis, palpitations, syncope, neuropathy, vertigo, paresthesias, drowsiness, fatigue, weakness, restlessness, headache, dermatitis, urticaria, vomiting, nausea, epigastric distress, diarrhea, constipation, anorexia, abdominal bloating.
Very rarely other adverse reactions seen are: Hypokalemia, hyponatremia, hyperuricemia, hypochloremia, hyperglycemia, glycosuria, hypomagnesemia. hypercalcemia etc.
There is no specific antidote available but immediate evacuation of stomach contents is advised. 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.
Metoz 2.5/5 is available in strips of 10 tablets each. Box of 1 x 10’s /3 x 10’s /10 x 10’s.
Store at temperature between 15-30°C, in a dry and dark place.
Keep medicines out of the reach of children.
CENTAUR PHARMACEUTICALS PVT LTD.
Plant – I, Plot No. 3, Tivim Industrial Estate,
Karaswada, Mapusa, Goa-403 526. INDIA.
Metoz 2.5- NAFDAC Reg. No. A4-5411
AL-TINEZ PHARMACEUTICALS LTD.
18, Jones Street, Ebutte-Metta