Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
Dual Blockade of the Renin Angiotensin Aldosterone System
*The following was added:
- …Dual blockade of the RAS with angiotensin-receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy…
- In most patients no benefit has been associated with using two RAS inhibitors concomitantly. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function, and electrolytes in patients on MICARDIS and other agents that affect the RAS.
- Do not co-administer aliskiren with MICARDIS in patients with diabetes. Avoid concomitant use of aliskiren with MICARDIS in patients with renal impairment (GFR <60 mL/min/1.73 m2).
PATIENT PACKAGE INSERT
What is High Blood Pressure (Hypertension)?
- Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. MICARDIS tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack......
- MICARDIS is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or any other component of this product [see Adverse Reactions (6.2)]
6 ADVERSE REACTIONS
6.2 Post-Marketing Experience
- The most frequent spontaneously reported events include: headache, dizziness, asthenia, coughing, nausea, fatigue, weakness, edema, face edema, lower limb edema, angioneurotic edema, urticaria, hypersensitivity, sweating increased, erythema, chest pain, atrial fibrillation, congestive heart failure, myocardial infarction, blood pressure increased, hypertension aggravated, hypotension (including postural hypotension), hyperkalemia, syncope, dyspepsia, diarrhea, pain, urinary tract infection, erectile dysfunction, back pain, abdominal pain, muscle cramps (including leg cramps), myalgia, bradycardia, eosinophilia, thrombocytopenia, uric acid increased, abnormal hepatic function/liver disorder, renal impairment including acute renal failure, anemia, and increased CPK, anaphylactic reaction, tendon pain (including tendonitis, tenosynovitis), drug eruption (e.g. toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), hypoglycemia (in diabetic patients), and angioedema (with fatal outcome).
8 USE IN SPECIFIC POPULATIONS
8.4 Pediatric Use
- Safety and effectiveness in pediatric patients have not been established [see Clinical Pharmacology (12.3)].
Who should not take MICARDIS?
- You should not take MICARDIS tablets if you are allergic (hypersensitive) to the active ingredient (telmisartan) or any of the other ingredients listed at the end of this leaflet.
What are the possible side effects of MICARDIS tablets?
- skin rash
7 DRUG INTERACTIONS
- NSAIDS paragraph added
17 PATIENT COUNSELING INFORMATION
Tell your doctor about the medicines you take
- medicines used to treat pain and arthritis, called non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors