Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
METOLAZONE (UNII: TZ7V40X7VX) (METOLAZONE - UNII:TZ7V40X7VX)
Alembic Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
Metolazone tablets 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 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 and other formulations of metolazone 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. Edema during pregnancy may ari
Metolazone tablets, USP are available in three strengths: 2.5 mg: Pink colored, round tablets, debossed with ‘L48’ on one side and plain on other side. Tablets may have speckled appearance. NDC 62332-532-31 Bottle of 100’s tablets NDC 62332-532-91 Bottle of 1000’s tablets 5 mg: Blue colored, round tablets, debossed with ‘L49’ on one side and plain on other side. Tablets may have speckled appearance. NDC 62332-533-31 Bottle of 100’s tablets NDC 62332-533-91 Bottle of 1000’s tablets 10 mg: Yellow colored, round tablets, debossed with ‘L50’ on one side and plain on other side. Tablets may have speckled appearance. NDC 62332-534-31 Bottle of 100’s tablets NDC 62332-534-91 Bottle of 1000’s tablets 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. ZAROXOLYN® and MYKROX® are registered trademarks of UCB Manufacturing, Inc. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revised: 04/2022
Abbreviated New Drug Application
METOLAZONE - METOLAZONE TABLET ALEMBIC PHARMACEUTICALS INC. ---------- 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 2.5, 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 365.83. The structural formula is: Metolazone is very slightly soluble in water, sparingly soluble in methanol, slightly soluble in ethyl acetate, very slightly soluble in methylene chloride. Inactive Ingredients: Microcrystalline cellulose, magnesium stearate and colorants 2.5 mg -D&C Red No. 27 Aluminum Lake, 5 mg - FD&C Blue No. 2 Aluminum Lake and 10 mg - D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Metolazone tablets, USP meets USP _Dissolution Test 3_. ® ® 16 16 3 3 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 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 do not inhibit carbonic anhydrase. A proximal action of metolaz Διαβάστε το πλήρες έγγραφο