Zaroxolyn (Page 3 of 3)
Adverse Reactions to Zaroxolyn
ZAROXOLYN is usually well tolerated, and most reported adverse reactions have been mild and transient. Many ZAROXOLYN related adverse reactions represent extensions of its expected pharmacologic activity and can be attributed to either its antihypertensive action or its renal/metabolic actions. The following adverse reactions have been reported. Several are single or comparably rare occurrences. Adverse reactions are listed in decreasing order of severity within body systems.
Cardiovascular
Chest pain/discomfort, orthostatic hypotension, excessive volume depletion, hemoconcentration, venous thrombosis, palpitations.
Central And Peripheral Nervous System
Syncope, neuropathy, vertigo, paresthesias, psychotic depression, impotence, dizziness/lightheadedness, drowsiness, fatigue, weakness, restlessness (sometimes resulting in insomnia), headache.
Dermatologic/Hypersensitivity
Toxic epidermal necrolysis (TEN), Stevens-Johnson Syndrome, necrotizing angiitis (cutaneous vasculitis), skin necrosis, purpura, petechiae, dermatitis (photosensitivity), urticaria, pruritus, skin rashes.
Gastrointestinal
Hepatitis, intrahepatic cholestatic jaundice, pancreatitis, vomiting, nausea, epigastric distress, diarrhea, constipation, anorexia, abdominal bloating, abdominal pain.
Hematologic
Aplastic/hypoplastic anemia, agranulocytosis, leukopenia, thrombocytopenia.
Metabolic
Hypokalemia, hyponatremia, hyperuricemia, hypochloremia, hypochloremic alkalosis, hyperglycemia, glycosuria, increase in serum urea nitrogen (BUN) or creatinine, hypophosphatemia, hypomagnesemia, hypercalcemia.
Musculoskeletal
Joint pain, acute gouty attacks, muscle cramps or spasm.
Other
Transient blurred vision, chills, dry mouth.
In addition, adverse reactions reported with similar antihypertensive-diuretics, but which have not been reported to date for ZAROXOLYN include: bitter taste, sialadenitis, xanthopsia, respiratory distress (including pneumonitis), and anaphylactic reactions. These reactions should be considered as possible occurrences with clinical usage of ZAROXOLYN.
Whenever adverse reactions are moderate or severe, ZAROXOLYN dosage should be reduced or therapy withdrawn.
OVERDOSAGE
Intentional overdosage has been reported rarely with metolazone and similar diuretic drugs.
Signs And Symptoms
Orthostatic hypotension, dizziness, drowsiness, syncope, electrolyte abnormalities, hemoconcentration and hemodynamic changes due to plasma volume depletion may occur. In some instances depressed respiration may be observed. At high doses, lethargy of varying degree may progress to coma within a few hours. The mechanism of CNS depression with thiazide overdosage is unknown. Also, GI irritation and hypermotility may occur. Temporary elevation of BUN has been reported, especially in patients with impairment of renal function. Serum electrolyte changes and cardiovascular and renal function should be closely monitored.
Treatment
There is no specific antidote available but immediate evacuation of stomach contents is advised. Dialysis is not likely to be effective. 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.
DOSAGE AND ADMINISTRATION
Effective dosage of ZAROXOLYN should be individualized according to indication and patient response. A single daily dose is recommended. Therapy with ZAROXOLYN should be titrated to gain an initial therapeutic response and to determine the minimal dose possible to maintain the desired therapeutic response.
Usual Single Daily Dosage Schedules
Suitable initial dosages will usually fall in the ranges given.
Edema of cardiac failure: ZAROXOLYN 5 to 20 mg once daily.
Edema of renal disease: ZAROXOLYN 5 to 20 mg once daily.
Mild to moderate essential hypertension: ZAROXOLYN 2½ to 5 mg once daily.
New patients – MYKROX Tablets (metolazone tablets, USP) (see MYKROX package circular). If considered desirable to switch patients currently on ZAROXOLYN to MYKROX, the dose should be determined by titration starting at one tablet (1/2 mg) once daily and increasing to two tablets (1 mg) once daily if needed.
Treatment Of Edematous States
The time interval required for the initial dosage to produce an effect may vary. Diuresis and saluresis usually begin within one hour and persist for 24 hours or longer. When a desired therapeutic effect has been obtained, it may be advisable to reduce the dose if possible. The daily dose depends on the severity of the patient’s condition, sodium intake, and responsiveness. A decision to change the daily dose should be based on the results of thorough clinical and laboratory evaluations. If antihypertensive drugs or diuretics are given concurrently with ZAROXOLYN, more careful dosage adjustment may be necessary. For patients who tend to experience paroxysmal nocturnal dyspnea, it may be advisable to employ a larger dose to ensure prolongation of diuresis and saluresis for a full 24-hour period.
Treatment Of Hypertension
The time interval required for the initial dosage regimen to show effect may vary from three or four days to three to six weeks in the treatment of elevated blood pressure. Doses should be adjusted at appropriate intervals to achieve maximum therapeutic effect.
HOW SUPPLIED
NDC:68151-2943-7 in a PACKAGE of 1 TABLETS
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.
For Medical Information
Contact: Medical Affairs Department Phone: (866) 822-0068 Fax: (770) 970-8859
UCB, Inc. Smyrna, GA 30080
ZAROXOLYN is a registered trademark of UCB Manufacturing, Inc. © 2014, UCB, Inc., Smyrna, GA 30080 All rights reserved.
Rev. 01/2014
Metolazone 2.5 mg tablet
Label Image ZAROXOLYN metolazone tablet | ||||||||||||||||||
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Labeler — Carilion Materials Management (079239644) |
Registrant — Carilion Materials Management (079239644) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Carilion Materials Management | 079239644 | REPACK (68151-2943) |
Revised: 08/2016 Carilion Materials Management
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