Country: United States
Language: English
Source: NLM (National Library of Medicine)
METOLAZONE (UNII: TZ7V40X7VX) (METOLAZONE - UNII:TZ7V40X7VX)
Bayshore Pharmaceuticals LLC
ORAL
PRESCRIPTION DRUG
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. 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.
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
Abbreviated New Drug Application
METOLAZONE - METOLAZONE TABLET BAYSHORE PHARMACEUTICALS LLC ---------- METOLAZONE TABLETS, USP RX ONLY DO NOT INTERCHANGE DO NOT INTERCHANGE METOLAZONE TABLETS,USP, ZAROXOLYN TABLETS, AND OTHER FORMULATIONS OF METOLAZONE THAT SHARE THEIR SLOW AND INCOMPLETE BIOAVAILABILITY AND ARE NOT THERAPEUTICALLY EQUIVALENT AT THE SAME DOSES TO MYKROX TABLETS, A MORE RAPIDLY AVAILABLE AND COMPLETELY BIOAVAILABLE METOLAZONE PRODUCT. FORMULATIONS BIOEQUIVALENT TO ZAROXOLYN AND FORMULATIONS BIOEQUIVALENT TO MYKROX SHOULD NOT BE INTERCHANGED FOR ONE ANOTHER. DESCRIPTION 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 H ClN O 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. CLINICAL PHARMACOLOGY Metolazone is a quinazoline diuretic, with properties generally similar to the thiazide diuretics. The actions of metolazone result from interference with the renal tubular ® ® 16 16 3 3 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 fr Read the complete document