metolazone tablet 5 mg
INDICATIONS AND USAGE Metolazone tablets, USP, are 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 tablets, USP, 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 metolazone tablets, USP, in the treatment of hypertension. See package circular for MYKROX Tablets. 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, USP, are indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (see PRECAUTIONS). 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.
bayshore pharmaceuticals llc
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HOW SUPPLIED
METOLAZONE Tablets, USP are available containing 2.5 mg, 5 mg and 10 mg of
METOLAZONE, USP. The 2.5 mg tablets are pink, round tablets, with pink speckles, debossed with "M" on one side and "2 ½" on reverse side. They are available as follows: NDC 76385-136-01 Bottle of 100's The 5 mg tablets are blue, round tablets, with blue speckles, debossed with "M" on one side and "5" on reverse side. They are available as follows: NDC 76385-137-01 Bottle of 100's The 10 mg tablets are yellow, round tablets, with yellow speckles, debossed with "M" on one side and "10" on reverse side. They are available as follows: NDC 76385-138-01 Bottle of 100's Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Keep out of the reach of children. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. For Product Complaints, Medical Inquires or more information on
METOLAZONE Tablets, USP call 888-514-4727. Manufactured by: Centaur Pharmaceuticals Pvt.Ltd, Plot No. 4, International Biotech Park, Phase II, Hinjewadi, Pune – 411 057. INDIA Distributed by: Bayshore Pharmaceuticals LLC Short Hills, NJ 07078 USA All brand names are the trademarks of their respective owners. Issued: 06/2021
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