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MAVIK is a brand name for Trandolapril, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions ● When used in pregnancy, angiotensin converting enzyme (ACE) inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected or if the patient is planning to become pregnant, MAVIK® (trandolapril) should be discontinued as soon as possible (see WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women).
General Ability to Operate Machinery Depending on individual susceptibility, the patients’ ability to drive a vehicle or operate machinery may be impaired, especially in the initial stages of treatment. Cardiovascular Hypotension Symptomatic hypotension has occurred after administration of MAVIK® usually after the first or second dose or when the dose was increased.
It is more likely to occur in patients who are volume and salt depleted as a result of diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting. In patients with ischemic heart disease or cerebrovascular disease, an excessive fall in blood pressure (BP) could result in a myocardial infarction or cerebrovascular accident (see ADVERSE REACTIONS).
Because of the potential fall in BP in these patients, therapy with MAVIK® should be started under close medical supervision. Such patients should be followed closely for the first weeks of treatment and whenever the dose of MAVIK® is increased.
In patients with severe congestive heart failure, with or without associated renal insufficiency, ACE inhibitor therapy may cause excessive hypotension and has been associated with oliguria, and/or progressive azotemia, and rarely, with acute renal failure and/or death.
9% sodium chloride. A transient hypotensive response is not a contraindication to further doses which can be given, usually without difficulty, once BP has increased after volume expansion. However, lower doses of MAVIK® and/or reduced concomitant diuretic therapy should be considered.
If hypotension develops in patients receiving treatment following acute myocardial infarction, consideration should be given to discontinuation of MAVIK® (see ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions, Treatment Following Acute Myocardial Infarction, and DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment, Treatment Following Acute Myocardial Infarction).
MAVIK® Product Monograph Page 6 of 43 Date of Revision:
MAVIK® (trandolapril) is contraindicated in: ● Patients who are pregnant, planning to become pregnant or of childbearing potential who are not using adequate contraception (see WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women).
● Nursing women (see WARNINGS AND PRECAUTIONS, Special Populations, Nursing Women). ● Patients who are hypersensitive to this drug, to any other Angiotensin Converting Enzyme (ACE) inhibitor, or to any ingredient in the formulation or component of the container.
For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING. ● Patients with a history of angioedema associated with administration of an ACE inhibitor. ● Patients with hereditary/ idiopathic angioedema. ● Combination with sacubitril/valsartan due to an increased risk of angioedema.
Do not initiate MAVIK® until at least 36 hours have elapsed following the last dose of sacubitril/valsartan. In the case of a switch from MAVIK® to sacubitril/valsartan, do not start sacubitril/valsartan until at least 36 hours have elapsed following the last dose of MAVIK®.
(see WARNINGS AND PRECAUTIONS, Immune, Angioedema and DRUG INTERACTIONS, Drug-Drug Interactions). 73m2) ○ hyperkalemia (> 5mMol/L) or ○ congestive heart failure who are hypotensive (see WARNINGS AND PRECAUTIONS, Dual Blockade of the Renin-Angiotensin- Aldosterone System (RAAS); WARNINGS AND PRECAUTIONS, Renal, Renal Impairment; WARNINGS AND PRECAUTIONS, Cardiovascular, Hypotension; and DRUG INTERACTIONS, Table 3).
● Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (see WARNINGS AND PRECAUTIONS, Other, Lactose). ● Patients with hypotensive or hemodynamically unstable states.
● Patients with hemodynamically significant bilateral artery stenosis, or severe stenosis of the artery of a solitary functioning kidney (see WARNINGS AND PRECAUTIONS, Renal).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Trandolapril in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
August 19, 2019 and Control No. 227932 Aortic Stenosis There is concern, on theoretical grounds, that patients with aortic stenosis might be at particular risk of decreased coronary perfusion when treated with vasodilators. 73m2); hyperkalemia (> 5 mMol/L) and/or congestive heart failure who are hypotensive.
Therefore, the use of MAVIK® in combination with aliskiren- containing drugs is contraindicated in these patients (see CONTRAINDICATIONS). Further, co-administration of ACE inhibitors, including MAVIK®, with other agents blocking the RAAS, such as ARBs or aliskiren-containing drugs, is generally not recommended in any patients, since such treatment has been associated with an increased incidence of severe hypotension, renal failure, and hyperkalemia.
See CONTRAINDICATIONS, DRUG INTERACTIONS. If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
The concomitant use of ACE inhibitors and angiotensin II receptor blockers (ARBs) in patients with diabetic nephropathy is contraindicated (see CONTRAINDICATIONS). For additional information, see DRUG INTERACTIONS. Ear/Nose/Throat As with other ACE inhibitors, dry, persistent cough, which usually disappears only after withdrawal or lowering of the dose of MAVIK®, has been reported.
Such possibility should be considered as part of the differential diagnosis of cough. Endocrine and Metabolism Hyperkalemia and Potassium-Sparing Diuretics Elevated serum potassium has been observed in hypertensive patients, especially those with renal dysfunction.
2% of patients treated with MAVIK®; in most cases these resolved despite continued therapy. Hyperkalemia was not a cause of discontinuation of therapy in any hypertensive patient. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, the concomitant use of agents to treat hypokalemia or other drugs associated with increases in serum potassium (potassium-sparing diuretics, potassium MAVIK® Product Monograph Page 7 of 43 Date of Revision: August 19, 2019 and Control No.
g. co-trimoxazole also known as trimethoprim/sulfamethoxazole). (see DRUG INTERACTIONS, Drug-Drug Interactions). Hematologic Neutropenia/agranulocytosis Agranulocytosis and bone marrow depression have been caused by ACE inhibitors. The risk of neutropenia appears to be dose- and type-related and is dependent on the patient’s clinical status.
These reactions are more frequent in patients with renal impairment, especially those with a collagen vascular disease. Current experience with MAVIK® shows the incidence […]
MAVIK® Product Monograph Page 5 of 43 Date of Revision:
August 19, 2019 and Control No. 227932 WARNINGS AND PRECAUTIONS Serious Warnings and Precautions ● When used in pregnancy, angiotensin converting enzyme (ACE) inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected or if the patient is planning to become pregnant, MAVIK® (trandolapril) should be discontinued as soon as possible (see WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women).
General Ability to Operate Machinery Depending on individual susceptibility, the patients’ ability to drive a vehicle or operate machinery may be impaired, especially in the initial stages of treatment. Cardiovascular Hypotension Symptomatic hypotension has occurred after administration of MAVIK® usually after the first or second dose or when the dose was increased.
It is more likely to occur in patients who are volume and salt depleted as a result of diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting. In patients with ischemic heart disease or cerebrovascular disease, an excessive fall in blood pressure (BP) could result in a myocardial infarction or cerebrovascular accident (see ADVERSE REACTIONS).
Because of the potential fall in BP in these patients, therapy with MAVIK® should be started under close medical supervision. Such patients should be followed closely for the first weeks of treatment and whenever the dose of MAVIK® is increased.
In patients with severe congestive heart failure, with or without associated renal insufficiency, ACE inhibitor therapy may cause excessive hypotension and has been associated with oliguria, and/or progressive azotemia, and rarely, with acute renal failure and/or death.
9% sodium chloride. A transient hypotensive response is not a contraindication to further doses which can be given, usually without difficulty, once BP has increased after volume expansion. However, lower doses of MAVIK® and/or reduced concomitant diuretic therapy should be considered.
If hypotension develops in patients receiving treatment following acute myocardial infarction, consideration should be given to discontinuation of MAVIK® (see ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions, Treatment Following Acute Myocardial Infarction, and DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment, Treatment Following Acute Myocardial Infarction).
MAVIK® Product Monograph Page 6 of 43 Date of Revision:
August 19, 2019 and Control No. 227932 Aortic Stenosis There is concern, on theoretical grounds, that patients with aortic stenosis might be at particular risk of decreased coronary perfusion when treated with vasodilators. 73m2); hyperkalemia (> 5 mMol/L) and/or congestive heart failure who are hypotensive.
Therefore, the use of MAVIK® in combination with aliskiren- containing drugs is contraindicated in these patients (see CONTRAINDICATIONS). Further, co-administration of ACE inhibitors, including MAVIK®, with other agents blocking the RAAS, such as ARBs or aliskiren-containing drugs, is generally not recommended in any patients, since such treatment has been associated with an increased incidence of severe hypotension, renal failure, and hyperkalemia.
See CONTRAINDICATIONS, DRUG […]