Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers, including Micardis. Go AS, Bauman MA, Coleman King SM et al. An effective approach to high blood pressure control: a science advisory from the American Heart Association, the American College of Cardiology, and the Centers for Disease Control and Prevention. Hypertension.
Telmisartan is metabolized by conjugation to form a pharmacologically inactive acyl glucuronide; the glucuronide of the parent compound is the only metabolite that has been identified in human plasma and urine. After a single dose, the glucuronide represents approximately 11% of the measured radioactivity in plasma. The cytochrome P450 isoenzymes are not involved in the metabolism of telmisartan. The antihypertensive effect of angiotensin II receptor antagonists, including telmisartan may be attenuated by NSAIDs including selective COX-2 inhibitors. What are the ingredients in Micardis tablets?
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Crosses the placenta and is distributed in the fetus in animals. Of the total number of patients receiving Micardis in hypertension clinical studies, 551 19% were 65 to 74 years of age and 130 4% were 75 years or older. No overall differences in effectiveness and safety were observed in these patients compared to younger patients and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Older adults may be more sensitive to the side effects of this drug, especially dizziness and change in the amount of urine problems. Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of telmisartan on blood pressure. Manufacturers state fixed-combination preparation should not be used for initial antihypertensive therapy.
Salt-Depleted Patients under Dosage and Administration. Special Senses: abnormal vision, conjunctivitis, tinnitus, earache. Aliskiren: Do not co-administer aliskiren with Micardis in patients with diabetes. Plasma concentration of angiotensin II and plasma renin activity PRA increased in a dose-dependent manner after single administration of telmisartan to healthy subjects and repeated administration to hypertensive patients. The once-daily administration of up to 80 mg telmisartan to healthy subjects did not influence plasma aldosterone concentrations. In multiple dose studies with hypertensive patients, there were no clinically significant changes in electrolytes serum potassium or sodium or in metabolic function including serum levels of cholesterol, triglycerides, HDL, LDL, glucose, or uric acid. Some of the side effects that can occur with telmisartan may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. Frohlich ED. Recognition of systolic hypertension for hypertension. Hypertension. Howes LG, Tran D. Can angiotensin receptor antagonists be used safely in patients with previous ACE inhibitor-induced angioedema? Food and Drug Administration. FDA drug safety communication: ongoing safety review of the angiotensin receptor blockers and cancer. Rockville, MD; 2010 Jul 15. From FDA website. Ismail I, Singh R, Sirisinghe RG. Rehydration with sodium-enriched coconut water after exercise-induced dehydration.
Angiotensin II receptor antagonists may be used as an alternative for those patients in whom an ACE inhibitor or ARNI is inappropriate. Micardis is a non-peptide angiotensin II receptor type AT 1 antagonist. What measures are being taken to ensure the safe and effective use of Micardis? Boehringer Ingelheim. Micardis telmisartan tablets prescribing information. Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure JNC. Martineau P, Goulet J. New competition in the realm of renin-angiotensin axis inhibition; the angiotensin II receptor antagonists in congestive heart failure. Ann Pharmacother. There was no evidence of carcinogenicity when telmisartan was administered in the diet to mice and rats for up to 2 years. Because clinical studies are conducted under widely varying conditions, adverse reactions 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. In each study, the women improved. Drinking extra fluids while you are taking Micardis HCT is recommended. Check with your doctor for instructions. Only some of the studies of coenzyme Q10 showed that it helps heart failure symptoms. The onset of antihypertensive activity occurs within 3 hours after administration of a single oral dose. At doses of 20, 40, and 80 mg, the antihypertensive effect of once daily administration of telmisartan is maintained for the full 24-hour dose interval. With automated ambulatory blood pressure monitoring and conventional blood pressure measurements, the 24-hour trough-to-peak ratio for 40 to 80 mg doses of telmisartan was 70 to 100% for both systolic and diastolic blood pressure. Some people take it to help reduce the effects certain medicines can have on the heart, muscles, and other organs. Kirk JK. Therapy with angiotensin II receptor antagonists. Clin Geriatrics.
How should I take Micardis tablets? Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure. American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. Dosage of Micardis is individualized. The usual starting dose is 40 mg once a day. Micardis may interact with water pills or digoxin. Tell your doctor all medications you are taking. Micardis is not recommended for use during pregnancy due to the risk for harm to a fetus. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding. Kidney problems, which may get worse if you already have kidney disease. You may have changes in your kidney test results, and you may need a lower dose of Micardis tablets. 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 angiotensin II receptor antagonists, including telmisartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving telmisartan and NSAID therapy. Read this Patient Information before you start taking Micardis tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. Your doctor may have also prescribed a potassium supplement for you. If so, follow the dosing carefully. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor.
Use with caution. May make these conditions worse. Not to scare anyone I do have an athletic heart normal low heart beatthat I understand can cause false positives. However, the other side effects, dry skin, anxiety, weakness, fatigue etc, in addition to those mentioned above and by other authors is very troubling. I have heard about the cancer issue and suggest follow up with physicians. I asked my cardiologists and he had heard about it and plans to research and discuss the issue with me further. In addition, the medicine has no generic and can therefore, be expensive. I hope to be taken off it soon and hopefully find an alternative effective generic combination that works. The problem is in combination with norvasc and hctz, micardis has been very effective. I run a lot and other drugs were causing me problems in working out. I had to be taken off of those and the above combination was found effective. The thing to remember as I thing most of us that have been dealing with high blood pressure for a while is that there are many different blood pressure medications available. Don't be afraid to work with your doctor and pharmacist in order to find the best combination for you. We must be our own patient advocates. I plan to get off of micardis if I can find a cost effective alternative. Tiredness and may also occur. If any of these effects persist or worsen, tell your doctor or promptly. This may not be a complete list of all interactions that may occur. Ask your health care provider if Micardis HCT may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine. Danish; with English abstract. Studies of telmisartan in this setting do not exclude the possibility that telmisartan may not preserve a meaningful fraction of the effect of the ACE inhibitor to which it was compared. Consider using the ACE inhibitor first, and, if it is stopped for cough only, consider re-trying the ACE inhibitor after the cough resolves. C. 1 2 132 Do not remove tablets from blisters until immediately before administration.
ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension ESH and of the European Society of Cardiology ESC. J Hypertens. You may have very low blood pressure while taking this medication. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick. For the treatment of high blood pressure, it may take up to 4 weeks before you get the full benefit of this drug. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized. This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the dose at the same time each day. Boehringer Ingelheim. Micardis HCT telmisartan and hydrochlorothiazide tablets prescribing information. If you feel faint or dizzy, lie down and call your doctor right away. If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. 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. Can cause fetal and neonatal morbidity and death when administered to a pregnant woman. a See Boxed Warning. 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.
The antihypertensive effect of telmisartan is not influenced by patient age, gender, weight, or body mass index. Blood pressure response in black patients usually a low-renin population is noticeably less than that in Caucasian patients. This has been true for most, but not all, angiotensin II antagonists and ACE inhibitors. Biphasic; terminal half-life is approximately 24 hours. In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. Store Micardis HCT at 77 degrees F 25 degrees C. Brief storage at temperatures between 59 and 86 degrees F 15 and 30 degrees C is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Micardis HCT out of the reach of children and away from pets. Patients with severely reduced kidney function should receive a lower starting dose of 20 mg once a day. Patients with mild or moderately reduced liver function should not receive doses higher than 40 mg a day. How does Micardis work?
In the prevention of cardiovascular problems, Micardis had a similar effect to ramipril, with around 17% of patients dying, being admitted to hospital because of cardiovascular problems, or having a heart attack or stroke. The combination of the two medicines was no more effective than either medicine taken alone and was linked to an increased risk of side effects. What is the risk associated with Micardis? Boehringer Ingelheim Pharmaceuticals, Inc. Telmisartan: Initiate therapy under close medical supervision in patients with obstructive biliary disease or hepatic impairment. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs. What should I tell my doctor before taking Micardis tablets? If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. There are no trials of Micardis demonstrating reductions in cardiovascular risk in patients with hypertension, but at least one pharmacologically similar drug has demonstrated such benefits.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. The incidence of adverse events was not dose-related and did not correlate with gender, age, or race of patients. Coenzymes help work to digest food and perform other body processes, and they help protect the and skeletal muscles. Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Sica DA. Angiotensin receptor blockers and the risk of malignancy: a note of caution. Drug Saf. What is Cardiovascular Risk? Do not co-administer aliskiren with Micardis in patients with diabetes. Keep out of the reach of children.
The information contained in the Truven Health Micromedex products as delivered by Drugs. Our Micardis telmisartan Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. 'Multum' is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist. Telmisartan is also used to lower the risk of heart attacks or stroke in patients 55 years of age and older who have diabetes or heart problems. What are the possible side effects of Micardis tablets? Walser M. Angiotensin-receptor blockers, type 2 diabetes, and renoprotection. N Engl J Med. Store at room temperature away from light and moisture. Do not remove the medication from the blister pack until right before using. If the medication comes in a bottle, keep container tightly closed. Do not store in the bathroom. Keep all medications away from children and pets.
Micardis HCT is to be used only by the patient for whom it is prescribed. Do not share it with other people. Too much sweating, diarrhea, or vomiting may cause you to feel lightheaded. Report prolonged diarrhea or vomiting to your doctor. Food and Drug Administration. WebMD does not endorse any specific product, service, or treatment. Micardis is available as white or off-white, uncoated tablets containing telmisartan 20 mg, 40 mg, or 80 mg. Tablets are marked with the BOEHRINGER INGELHEIM logo on one side, and on the other side, with either 50H, 51H, or 52H for the 20 mg, 40 mg, and 80 mg strengths, respectively. In a controlled study, the addition of telmisartan to hydrochlorothiazide produced an additional dose-related reduction in blood pressure that was similar in magnitude to the reduction achieved with telmisartan monotherapy. Hydrochlorothiazide also had an added blood pressure effect when added to telmisartan. Neutel JM, Smith DHG. Dose response and antihypertensive efficacy of the AT1 receptor antagonist telmisartan in patients with mild to moderate hypertension. Adv Ther. This medication is used to treat high blood pressure hypertension. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Telmisartan belongs to a class of drugs called angiotensin receptor blockers ARBs. It works by relaxing blood vessels so blood can flow more easily.
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Mazzolai L, Burnier M. Comparative safety and tolerability of angiotensin II receptor antagonists. Drug Safety. Sipahi I, Debanne SM, Rowland DY et al. Angiotensin-receptor blockade and risk of cancer: meta-analysis of randomised controlled trials. Lancet Oncol. At first, 40 milligrams mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 80 mg per day.
No dosage adjustment is necessary in patients with decreased renal function. The dosage is based on your medical condition and response to treatment. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Micardis as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.
Genotoxicity assays did not reveal any telmisartan-related effects at either the gene or chromosome level. These assays included bacterial mutagenicity tests with Salmonella and E. coli Ames a gene mutation test with Chinese hamster V79 cells, a cytogenetic test with human lymphocytes, and a mouse micronucleus test. This Patient Information leaflet summarizes the most important information about Micardis tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Micardis tablets that is written for health professionals. This list is not complete. Other drugs may interact with telmisartan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs. No patients discontinued therapy because of anemia. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. American Diabetes Association. Standards of medical care in diabetes--2014. Diabetes Care.