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MICARDIS PLUS is a brand name for Telmisartan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MICARDIS PLUS (80 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated for: • treatment of mild to moderate essential hypertension in patients in whom combination therapy with telmisartan and hydrochlorothiazide is considered appropriate. MICARDIS PLUS (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated…
Verbatim from this product's HC label. Tap a section to expand.
). 1 Pediatrics • Pediatrics (<18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of MICARDIS PLUS in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics • Geriatrics (> 65 years of age): No dosage adjustment is necessary. It should be recognized, however, that greater sensitivity in some older individuals cannot be ruled out. 4 Drug-Drug Interactions, Dual Blockade of the Renin-Angiotensin System (RAS) with ARBs, ACEIs or aliskiren-containing drugs).
• Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the
5 mg). A dose-relationship of undesirable effects was not established, and they showed no correlation with gender, age, or race of the patients. The combination of telmisartan and hydrochlorothiazide has been evaluated for safety in 1725 patients including 716 treated for over six months and 420 for over one year.
In clinical trials with the individual components used in combination, no unexpected adverse events have been observed. Adverse experiences have been limited to those that have been previously reported with telmisartan and hydrochlorothiazide monotherapy.
In general, treatment with the combination was well tolerated; most adverse experiences were mild and transient in nature and did not require discontinuation of therapy. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
5 mg telmisartan/hydrochlorothiazide combination, irrespective of their causal relationship, are presented in the following table. This table includes the results of two pivotal studies. One study, a factorial design, compared the use of various doses of telmisartan tablets and hydrochlorothiazide tablets in combination to telmisartan alone, hydrochlorothiazide alone and placebo.
5 mg of telmisartan/hydrochlorothiazide to telmisartan 80 mg alone. 8 HCTZ = hydrochlorothiazide Note: Telmisartan 80 mg open label treatment is not included in the Telmisartan 80 mg column Additional adverse reactions reported in clinical trials with telmisartan plus hydrochlorothiazide are listed below according to system organ class: Body as a Whole: Allergy, leg pain.
4 Drug-Drug Interactions, Dual Blockade of the Renin-Angiotensin System (RAS) with ARBs, ACEIs or aliskiren-containing drugs). • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.
For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph. 1 Pregnant Women). 2 Breast-feeding women). • Patients with anuria due to the presence of hydrochlorothiazide. Product Monograph MICARDIS PLUS (telmisartan/ hydrochlorothiazide) Page 5 of 61 Unclassified / Non classifié • Patients with the rare hereditary condition of fructose intolerance (HFI).
• Sorbitol: MICARDIS PLUS tablets contain 338 mg of sorbitol per maximum recommended daily dose. o Sorbitol is a source of fructose. , galactosaemia, the Lapp Lactase deficiency or glucose-galactose malabsorption. 5 mg or 99 mg of lactose monohydrate in the dose strength of 80 mg/25 mg.
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions When used in pregnancy, angiotensin II receptor (AT1) blockers (ARB) can cause injury or even death of the developing fetus. 1 Special Populations). 5 mg components as described below.
2 Recommended Dose and Dosage Adjustment • MICARDIS PLUS (telmisartan/hydrochlorothiazide) is not for initial therapy. 5 mg) once daily. 5 mg), may be switched to MICARDIS PLUS (telmisartan 80 mg/hydrochlorothiazide 25 mg) once daily.
Telmisartan Monotherapy The recommended dose of telmisartan is 80 mg once daily. The antihypertensive effect is present within 2 weeks and maximal reduction is generally attained after four weeks. If additional blood pressure reduction is required, a thiazide diuretic may be added.
No initial dosing adjustment is necessary for elderly patients or for patients with renal impairment but greater sensitivity in some older individuals cannot be ruled out. Markedly reduced telmisartan plasma levels were observed in patients on hemodialysis.
4 Drug-Drug Interactions, Dual Blockade of the Renin-Angiotensin System (RAS) with ARBs, ACEIs or aliskiren-containing drugs). • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.
For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph. 1 Pregnant Women). 2 Breast-feeding women). • Patients with anuria due to the presence of hydrochlorothiazide. Product Monograph MICARDIS PLUS (telmisartan/ hydrochlorothiazide) Page 5 of 61 Unclassified / Non classifié • Patients with the rare hereditary condition of fructose intolerance (HFI).
• Sorbitol: MICARDIS PLUS tablets contain 338 mg of sorbitol per maximum recommended daily dose. o Sorbitol is a source of fructose. , galactosaemia, the Lapp Lactase deficiency or glucose-galactose malabsorption. 5 mg or 99 mg of lactose monohydrate in the dose strength of 80 mg/25 mg.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Telmisartan 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.
Central and Peripheral Nervous System:
Vertigo.
Gastro-intestinal System:
Dyspepsia, gastritis, gastro-intestinal disorder.
Metabolic and Nutritional System:
Hypokalaemia, loss of diabetic control, hyperuricemia. Product Monograph MICARDIS PLUS (telmisartan/ hydrochlorothiazide) Page 18 of 61 Unclassified / Non classifié Musculo-Skeletal System: Myalgia, arthralgia.
Nervous System Disorders:
Sleep disorder.
Psychiatric System:
Anxiety.
Respiratory System:
Bronchitis, sinusitis, respiratory distress, pneumonitis. Reproductive system and breast disorders: erectile dysfunction.
Skin and Appendages System:
Eczema, skin disorder.
Urinary System:
Urinary tract infection. 5 mg) used in combination discontinued due to hypotension. Adverse events occurred at approximately the same rates in men and women, older and younger patients and black and non-black patients. Abnormal Hematologic and Clinical Chemistry Findings In controlled trials, clinically relevant changes in standard laboratory test parameters were rarely associated with administration of telmisartan and hydrochlorothiazide in combination.
8% No patient discontinued treatment due to an increase in BUN. 4% No patient discontinued treatment due to an increase in creatinine. 2% Changes in hemoglobin were not considered clinically significant and there were no discontinuations due to anemia.
6% Changes in hematocrit were not considered clinically significant and there were no discontinuations due to anemia.
Liver function Tests:
Occasional elevations of liver enzymes and/or serum bilirubin have occurred. No telmisartan/hydrochlorothiazide treated patients discontinued therapy due to abnormal liver function. Serum Electrolytes: see 7 WARNINGS AND PRECAUTIONS.
Telmisartan Additional side effects were reported in clinical trials with telmisartan in the indication hypertension or in patients 50 years or older at high risk of cardiovascular events. Telmisartan has been evaluated for safety in 27 clinical trials involving 7968 patients.
Of these 7968 patients, 5788 patients were treated with telmisartan monotherapy including 1058 patients treated for > 1 year and 1395 patients treated in placebo-controlled trials. The following […]
Product Monograph MICARDIS PLUS (telmisartan/ hydrochlorothiazide) Page 6 of 61 Unclassified / Non classifié Diuretic Treated Patients In patients receiving diuretics, telmisartan therapy should be initiated with caution, since these patients may be volume depleted and thus more likely to experience hypotension following initiation of additional antihypertensive therapy.
Whenever possible, all diuretics should be discontinued two to three days prior to the administration of telmisartan to reduce the likelihood of hypotension (see 7 WARNINGS AND PRECAUTIONS, Hypotension). If this is not possible because of the patient’s condition, telmisartan should be administered with caution and the blood pressure monitored closely.
Thereafter, the dosage should be adjusted according to the individual response of the patient. Considerations for Special Populations Patients with Renal Impairment The usual regimens of therapy with MICARDIS PLUS may be followed as long as the patient's creatinine clearance is > 30 mL/min.
In patients with more severe renal impairment, loop diuretics are preferred to thiazides; in this instance, MICARDIS PLUS is not recommended. Patients with Hepatic Impairment For patients with hepatic impairment, a starting dose of 40 mg of telmisartan is recommended.
MICARDIS PLUS is not recommended for patients with severe hepatic impairment.
Pediatrics (<18 years of age):
Based on the data submitted and reviewed by Health Canada, the safety and efficacy of MICARDIS PLUS in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
Geriatrics (> 65 years of age):
No dose adjustment is necessary. It should be recognized, however, that greater sensitivity in some older individuals cannot be ruled out. Drug Discontinuation If diagnosis of Acute Respiratory Distress Syndrome (ARDS) is suspected, MICARDIS PLUS should be withdrawn and appropriate treatment given (see 7 WARNINGS AND PRECAUTIONS, Respiratory).
If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, the diuretic should be discontinued (see 7 WARNINGS AND PRECAUTIONS, Renal, Azotemia). If photosensitivity reactions occur during treatment with hydrochlorothiazide-containing drugs, treatment should be stopped (see 7 WARNINGS AND PRECAUTIONS, Skin).
In the event of significant hypercalcemia, MICARDIS PLUS should be discontinued followed by assessment of parathyroid function (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Hydrochlorothiazide). If laryngeal stridor or angioedema of the face, extremities, lips, tongue, or glottis occurs, MICARDIS PLUS should be discontinued immediately, the patient treated appropriately in Product Monograph MICARDIS PLUS (telmisartan/ hydrochlorothiazide) Page 7 of 61 Unclassified / Non classifié accordance with accepted medical care, and carefully observed until the swelling disappears (see 7 WARNINGS AND PRECAUTIONS, Immune, Systemic Lupus Erythematosus).
1 Pregnant […]