Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
METOLAZONE (UNII: TZ7V40X7VX) (METOLAZONE - UNII:TZ7V40X7VX)
Mylan Pharmaceuticals Inc.
METOLAZONE
METOLAZONE 2.5 mg
ORAL
PRESCRIPTION DRUG
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. 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
Metolazone Tablets, USP are available containing 2.5 mg, 5 mg and 10 mg of metolazone, USP. 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 0378-6172-01 bottles of 100 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 0378-6173-01 bottles of 100 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 0378-6174-01 bottles of 100 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. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India 75069724 Revised: 10/2019 MX:MTLZ:R1
Abbreviated New Drug Application
METOLAZONE- METOLAZONE TABLET MYLAN PHARMACEUTICALS INC. ---------- DO NOT INTERCHANGE: DO NOT INTERCHANGE ZAROXOLYN TABLETS AND OTHER FORMULATIONS OF METOLAZONE THAT SHARE ITS 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. 1 2 DESCRIPTION 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 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 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. _Meets USP Dissolution Test 2._ 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 does not inhibit carbonic anhydrase. A proximal action of metolazone has been shown in humans by increased excretion of phosphate and magnesium ®1 ®2 ® ® ZAROXOLYN IS A REG ISTERED TRADEMARK OF CELLTECH PHARMACEUTICALS, Læs hele dokumentet