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The following adverse reactions are discussed elsewhere in labeling:
- Hypotension [see WARNINGS AND PRECAUTIONS]
- Renal Impairment [see WARNINGS AND PRECAUTIONS]
- Electrolytes and Metabolic Disorders [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
MICARDIS HCT has been evaluated for safety in more than 1700 patients, including 716 treated for hypertension for longer than 6 months and 420 for more than 1 year. Adverse reactions have been limited to those that have been previously reported with telmisartan and/or hydrochlorothiazide.
Adverse reactions occurring at an incidence of ≥ 2% in patients treated with telmisartan/hydrochlorothiazide and at a greater rate than in patients treated with placebo, are presented in Table 1 [see Clinical Studies].
Table 1 : Adverse Reactions Occurring at an Incidence
of ≥ 2% in Patients Treated with Telmisartan/Hydrochlorothiazide and at a
Greater Rate Than in Patients Treated with Placebo*
(n = 414)
(n = 74)
(n = 209)
(n = 121)
|Body as a whole|
|Central/Peripheral nervous system|
|Respiratory system disorder|
|Upper respiratory tract infection||8%||7%||7%||10%|
|* includes all doses of telmisartan (20 to 160 mg), hydrochlorothiazide (6.25 to 25 mg), and combinations thereof|
Adverse reactions occurred at approximately the same rates in men and women, older and younger patients, and black and non-black patients.
Other adverse events that have been reported with telmisartan are listed below:
Autonomic Nervous System: impotence, increased sweating, flushing
Body as a Whole: allergy, fever, leg pain, chest pain
Hepato-biliary: elevations of liver enzymes or serum bilirubin
Psychiatric: anxiety, depression, nervousness
Vascular: cerebrovascular disorder
Other adverse events that have been reported with hydrochlorothiazide are listed below:
Body as a Whole: weakness
Hypersensitivity: purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions
Metabolic: hyperglycemia, glycosuria
Musculoskeletal: muscle spasm
Nervous System/Psychiatric: restlessness
Special Senses: transient blurred vision, xanthopsia
Clinical Laboratory Findings
Creatinine, Blood Urea Nitrogen (BUN): Increases in BUN ( ≥ 11.2 mg/dL) and serum creatinine ( ≥ 0.5 mg/dL) were observed in 2.8% and 1.4%, respectively, of patients with essential hypertension treated with MICARDIS HCT tablets in controlled trials. No patient discontinued treatment with MICARDIS HCT tablets because of an increase in BUN or creatinine [see WARNINGS AND PRECAUTIONS].
The following adverse reactions have been identified during post-approval use of MICARDIS HCT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders: eosinophilia
Ear and Labyrinth Disorders: vertigo
General Disorders and Administration Site Conditions: asthenia, edema
Hepato-biliary: Abnormal hepatic function / liver disorder
Immune System Disorders: anaphylactic reaction
Infections and Infestations: urinary tract infection
Investigations: increased CPK
Metabolism and Nutrition Disorders: hypoglycemia (in diabetic patients)
Nervous System Disorders: syncope
Renal and Urinary Disorders: renal failure, renal impairment including acute renal failure
Reproductive System and Breast Disorders: erectile dysfunction
Respiratory, Thoracic and Mediastinal Disorders: coughing
Skin and Subcutaneous Tissue Disorders: drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), angioedema (with fatal outcome)
Vascular Disorder: orthostatic hypotension
Read the Micardis HCT (telmisartan and hydrochlorothiazide tablets) Side Effects Center for a complete guide to possible side effects
Agents Increasing Serum Potassium
Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of thiazide diuretics or angiotensin II receptor antagonists, including telmisartan. Monitor lithium levels in patients receiving MICARDIS HCT and lithium.
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ARBs, including telmisartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. The antihypertensive effect of ARBs may be attenuated by NSAIDs. Therefore, monitor renal function and blood pressure periodically in patients receiving MICARDIS HCT and NSAIDs.
Administration of a non-steroidal anti-inflammatory agent, including a selective COX2 inhibitor, can reduce the diuretic, natriuretic, and antihypertensive effects of diuretics. Therefore, when MICARDIS HCT and non-steroidal anti-inflammatory agents including selective COX2 inhibitors are used concomitantly, observe closely to determine if the desired effect of the diuretic is obtained.
Dual Blockade Of The Renin-Angiotens In-Aldosterone System And Changes In Renal Function
Dual blockade of the renin-angiotensin-aldosterone system with angiotensin blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and renal impairment. The ONTARGET trial enrolled 25,620 patients ≥ 55 years old with atherosclerotic disease or diabetes with end-organ damage, randomizing them to telmisartan (ARB) only, ramipril (ACE inhibitor) only, or the combination, and followed them for a median of 56 months. Patients who received the combination of ARB and ACE inhibitor did not obtain any additional benefit (no additional reduction of risk of cardiovascular death, myocardial infarction, stroke, or hospitalization from heart failure) compared to ARB monotherapy or ACE inhibitor monotherapy, but experienced an increased incidence of renal dysfunction (e.g., acute renal failure) compared with monotherapy groups.
In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on MICARDIS HCT and other agents that affect the RAS (e.g., concomitant use of an ACE inhibitor with an ARB).
Do not co-administer aliskiren with MICARDIS HCT in patients with diabetes. Avoid concomitant use of aliskiren with MICARDIS HCT in patients with renal impairment (GFR < 60 mL/min/1.73 m²).
When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. Monitor digoxin levels in patients taking concomitant MICARDIS HCT and digoxin.
Antidiabetic Drugs (Oral Agents and Ins ulin)
Dosage adjustment of antidiabetic drugs may be required when coadministered with hydrochlorothiazide.
Cholestyramine And Colestipol Resins
Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Stagger the dosage of hydrochlorothiazide and the resin such that hydrochlorothiazide is administered at least 4 hours before or 4 to 6 hours after the administration of the resin.
Read the Micardis HCT Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 2/6/2017
Additional Micardis HCT Information
Micardis HCT - User Reviews
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