Positive test results were obtained in the in vitro CHO Sister Chromatid Exchange (clastogenicity) assay, in the Mouse Lymphoma Cell (mutagenicity) assay, and in the Aspergillus nidulans non-disjunction assay. These considerations may guide selection of therapy. 5705185. Its empirical formula is C33H30 N4O2, its molecular weight is 514.63, and its structural formula is: Telmisartan is a white to slightly yellowish solid. Dosage adjustment of antidiabetic drugs may be required when co-administered with hydrochlorothiazide. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. The once-daily administration of up to 80 mg Telmisartan to healthy subjects did not influence plasma aldosterone concentrations. Keep a list of them and show it to your doctor or pharmacist when you get a new medicine. Following once daily administration of Telmisartan, the magnitude of blood pressure reduction from baseline after placebo subtraction was approximately (SBP/DBP) 6-8/6 mmHg for 20 mg, 9-13/6-8 mmHg for 40 mg, and 12-13/7-8 mmHg for 80 mg. Inactive Ingredients: magnesium stearate, mannitol, meglumine and sodium hydroxide. Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It may harm them. You should not do both. 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. In 30 hypertensive patients with normal renal function treated for 8 weeks with telmisartan 80 mg or telmisartan 80 mg in combination with hydrochlorothiazide 12.5 mg, there were no clinically significant changes from baseline in renal blood flow, glomerular filtration rate, filtration fraction, renovascular resistance, or creatinine clearance. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored. 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. Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. The volume of distribution for telmisartan is approximately 500 liters, indicating additional tissue binding. The tablets contain the following inactive ingredients: mannitol, sodium hydroxide, meglumine, povidone, sodium stearyl fumarate, lactose monohydrate, magnesium stearate. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F) [see USP Controlled Room Temperature]. Files, Presentations Geriatric Patients: The pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years of age. Especially tell your doctor if you take: Know the medicines you take. Biochemical Data Summary. Push (Push the tablet through the aluminum foil). Telmisartan + HCTZ (Micardis Plus) Important Safety Information The overall incidence of adverse events reported with Telmisartan + HCTZ (Micardis Plus) was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients . This Patient Information has been approved by the U.S. Food and Drug Administration. If symptomatic hypotension should occur, supportive treatment should be instituted. Do not take telmisartan and hydrochlorothiazide tablets if you: Drug Interaction Studies The following adverse reaction is described elsewhere in labeling: 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. As coloring agents, the 40 mg/12.5 mg and 80 mg/12.5 mg tablets contain ferric oxide red, and the 80 mg/25 mg tablets contain ferric oxide yellow. The antihypertensive effect of ARBs may be attenuated by NSAIDs. The cytochrome P450 isoenzymes are not involved in the metabolism of telmisartan. 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. Rx only 30 Tablets Telmisartan Tablets USP are a non-peptide angiotensin II receptor (type AT 1) antagonist. Telmisartan is not expected to interact with drugs that inhibit cytochrome P450 enzymes; it is also not expected to interact with drugs metabolized by cytochrome P450 enzymes, except for possible inhibition of the metabolism of drugs metabolized by CYP2C19. Telmisartan tablets can help your blood vessels relax so your blood pressure is lower. With cessation of treatment with Telmisartan tablets, blood pressure gradually returned to baseline values over a period of several days to one week. No patients discontinued therapy because of anemia. If you miss a dose, take it as soon as you remember. Studies in which hydrochlorothiazide was administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3000 and 1000 mg/kg/day, respectively (about 600 and 400 times the MRHD), provided no evidence of harm to the fetus. Other uses for this medicine What special precautions should I follow? The pharmacokinetics of telmisartan with orally administered telmisartan tablets are nonlinear over the dose range 20 mg to 160 mg, with greater than proportional increases of plasma concentrations (Cmax and AUC) with increasing doses. Eye problems. These highlights do not include all the information needed to use TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. Studies in rats and rabbits with Telmisartan showed fetotoxicity only at maternally toxic doses (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. Telmisartan and hydrochlorothiazide tablet contains: telmisartan, an angiotensin receptor blocker (ARB) hydrochlorothiazide, a water pill or diuretic Your doctor may prescribe other medicines for you to take along with telmisartan and hydrochlorothiazide tablets to treat your high blood pressure. 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. Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Drug class: angiotensin receptor blockers, 20 mg, white to off-white colored, circular, biconvex, uncoated tablets debossed with , 40 mg, white to off-white colored, capsule shaped, uncoated tablets debossed with , 80 mg, white to off-white colored, capsule shaped, uncoated tablets debossed with , to treat high blood pressure (hypertension), are pregnant or are planning to become pregnant. Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. Therefore, monitor renal function and blood pressure periodically in patients receiving telmisartan and hydrochlorothiazide tablets and NSAIDs. Get Label RSS Feed, NDC 62135-537-30 HDPE bottle of 30 tablets with a child resistant closure and desiccant. Table of Contents Table of Contents BOXED WARNING (What is this?) These effects are usually reversible. Name of the medicinal product 2. Tell your doctor if you have any side effect that bothers you or that does not go away. Telmisartan is not removed by hemofiltration and is not dialyzable. When plasma levels have been followed for at least 24 hours, the plasma half-life has been observed to vary between 5.6 and 14.8 hours. Fetal/Neonatal adverse reactions Following oral administration, peak concentrations (Cmax) of telmisartan are reached in 0.5 to 1 hour after dosing. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Terminal half-life and total clearance appear to be independent of dose. In patients with severe renal impairment, telmisartan and hydrochlorothiazide tablets are not recommended. . The no-observed-effect doses for developmental toxicity in rats and rabbits, 5 and 15 mg/kg/day, respectively, are approximately 0.64 and 3.7 times, respectively, on a mg/m2 basis, the MRHD of telmisartan (80 mg/day). Onset: 1-2 hours. When pregnancy is detected, discontinue Telmisartan tablets as soon as possible. For more information call Alembic Pharmaceuticals Limited at 1-866-210-9797. Manufactured In India By: Pediatric Patients In normal volunteers, a dose of Telmisartan 80 mg inhibited the pressor response to an intravenous infusion of angiotensin II by about 90% at peak plasma concentrations with approximately 40% inhibition persisting for 24 hours. This is not a complete list of telmisartan side effects. In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure or renal dysfunction), treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Call your doctor right away if you get any of the symptoms listed above. Genotoxicity assays did not reveal any Telmisartan-related effects at either the gene or chromosome level. Genotoxicity assays did not reveal any telmisartan-related effects at either the gene or chromosome level. Total plasma clearance of Telmisartan is > 800 mL/min. Drug Info Cozaar (losartan) alternatives: What can I take instead of losartan? Change in body salts (electrolytes) level in your blood and fluid problems. Symptoms of eye problems can happen within hours to weeks of starting telmisartan and hydrochlorothiazide tablets. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. NDC 62332-209-30 Telmisartan and Hydrochlorothiazide Tablets, USP 40 mg/12.5 mg If you would like more information, talk with your doctor. The factorial trial randomized 818 patients, including 493 (60%) males; 596 (73%) Non-Black and 222 (27%) Blacks; and 143 (18%) 65 years of age (median age was 53 years old). Tear (You may also use scissors to tear the blister apart) Take Telmisartan tablets with or without food. Tablets should not be removed from the bottle until immediately before administration. Call your doctor for medical advice about side effects. 62332-211-30, The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. To report SUSPECTED ADVERSE REACTIONS, contact, When pregnancy is detected, discontinue telmisartan and hydrochlorothiazide as soon as possible. Telmisartan was present in the milk of lactating rats at concentrations 1.5 to 2 times those found in plasma from 4 to 8 hours after administration. 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). One of the medicines in telmisartan and hydrochlorothiazide tablets can cause eye problems that may lead to vision loss. If you feel faint or dizzy, lie down and call your doctor right away. Cialis Together 10mg Tablets - Tadalafil - 4 Tablets. If you take too much telmisartan and hydrochlorothiazide tablets, call your doctor, or go to the nearest hospital emergency room right away. Telmisartan shows bi-exponential decay kinetics with a terminal elimination half-life of approximately 24 hours. Warnings Do not use Twynsta if you are pregnant. 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). Telmisartan tablets comes in a child-resistant package. In clinical trials, however, no significant increases in blood pressure response or in the incidence of orthostatic hypotension were found in women. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack. What should I know about storage and disposal of this medication? Blood and Lymphatic System Disorders: Eosinophilia, General Disorders and Administration Site Conditions: Asthenia, edema, Hepato-biliary: Abnormal hepatic function /liver disorder, Immune System Disorders: Anaphylactic reaction, Metabolism and Nutrition Disorders: Hypoglycemia (in diabetic patients), hyponatremia, Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis, Nervous System Disorders: Headache, 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: Angioedema (with fatal outcome), drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), Vascular Disorder: Orthostatic hypotension. Telmisartan has much greater affinity (>3,000-fold) for the AT1 receptor than for the AT2 receptor. During initial clinical studies, a single case of angioedema was reported (among a total of 3781 patients treated). Monitor digoxin levels in patients taking concomitant telmisartan and hydrochlorothiazide tablets and digoxin. 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. See What is the most important information I should know about telmisartan and hydrochlorothiazide tablets? Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. Cipla Ltd. Drug Summary What Is Twynsta? The pharmacokinetics of orally administered Telmisartan are nonlinear over the dose range 20 mg to 160 mg, with greater than proportional increases of plasma concentrations (C max and AUC) with increasing doses. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Renal Insufficiency: Telmisartan is not removed from blood by hemofiltration and is not dialyzable[see Warnings and Precautions (5.3) and Use in Specific Populations (8.7)]. RxNorm, Neonates with a history of in utero exposure to Telmisartan tablets: In the controlled clinical trials (n=1017), approximately 20% of patients treated with telmisartan/hydrochlorothiazide were 65 years of age or older, and 5% were 75 years of age or older. The most common side effects of telmisartan and hydrochlorothiazide tablets include: How should I store telmisartan and hydrochlorothiazide tablets? There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Call your doctor right away if you have: Skin Cancer. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Especially tell your doctor if you take: aliskiren digoxin (Lanoxin) lithium (Lithobid,lithium carbonate, lithium citrate) other medicines used to treat your high blood pressure or a heart problem water pills (diuretic) aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) potassium supplements or a salt substitute containing potassium medicine used to treat diabetes, including insulin narcotic pain medicines sleeping pills steroid medicine or Adrenocorticotrophic Hormone (ACTH) barbiturates certain cholesterol lowering medicines (resins that are used for cholesterol reduction, e.g.,cholestyramine and colestipol resins ). Common side effects of Twynsta include: dizziness or lightheadedness as your body adjusts to the medication. No teratogenic effects were observed when Telmisartan was administered to pregnant rats at oral doses of up to 50 mg/kg/day and to pregnant rabbits at oral doses up to 45 mg/kg/day. Telmisartan tablets may affect the way other medicines work, and other medicines may affect how Telmisartan tablets work. In general, avoid combined use of RAS inhibitors. Call your doctor if you get: swelling in your feet, ankles, or hands unexplained weight gain Hydrochlorothiazide crosses the placental but not the blood-brain barrier and is excreted in breast milk. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular . ; 10 blister cards of 10 tablets each). Advise patients not to use potassium supplements or salt substitutes that contain potassium without consulting the prescribing healthcare provider [see Warnings and Precautions (5.4) and Drug Interactions (7.1)]. Hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidney. The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice. We comply with the HONcode standard for trustworthy health information. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. Telmisartan tablets can cause fetal harm when administered to a pregnant woman. Discuss treatment options with women planning to become pregnant. What should I do if I forget a dose? Hydrochlorothiazide was not genotoxic in vitro in the Ames mutagenicity assay of Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 and in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations, or in vivo in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene. What are telmisartan and hydrochlorothiazide tablets? Change in body salts (electrolytes) level in your blood and fluid problems. In normal volunteers, a dose of telmisartan 80 mg inhibited the pressor response to an intravenous infusion of angiotensin II by approximately 90% at peak plasma concentrations with approximately 40% inhibition persisting for 24 hours. There are no trials of Telmisartan tablets demonstrating reductions in cardiovascular risk in patients with hypertension, but at least one pharmacologically similar drug has demonstrated such benefits. Alembic, NDC 62332-211-30 Telmisartan and Hydrochlorothiazide Tablets, USP 80 mg/25 mg At 40 mg and 160 mg, the bioavailability was 42% and 58%, respectively. What is the most important information I should know about telmisartan and hydrochlorothiazide tablets? Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia. The incidence of symptomatic orthostasis after the first dose in all controlled trials was low (0.04%). [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. If oliguria or hypotension occurs, support blood pressure and renal perfusion. Use of drugs that act on the RAS in the second and third trimesters of pregnancy can result in the following: oligohydramnios, reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Telmisartan has an accumulation index in plasma of 1.5 to 2.0 upon repeated once daily dosing. Low blood pressure (hypotension) is most likely to happen if you also: take water pills (diuretics) are on a low-salt diet get dialysis treatments have heart problems get sick with vomiting or diarrhea do not drink enough fluids sweat a lot In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Hydrochlorothiazide also had an added blood pressure effect when added to Telmisartan. Do not co-administer aliskiren with Telmisartan tablets in patients with diabetes [see Drug Interactions ( 7)]. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Metabolism and Elimination Cialis will compete against Viatris' sildenafil-based Viagra Connect in the men's sexual health and wellness category, which has seen a proliferation of . What are the possible side effects of telmisartan and hydrochlorothiazide tablets? Telmisartan and hydrochlorothiazide tablets may cause serious side effects, including: Injury or death to your unborn baby. 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 (14)]. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. TELMISARTAN tablets USP, for oral use Initial U.S. Approval: 1998 See needed to use full prescribing. Mean decreases in trough systolic and diastolic blood pressure with telmisartan (40, 80, and 160 mg) and lisinopril (10, 20, and 40 mg) were similar. In placebo-controlled clinical trials, clinically relevant changes in standard laboratory test parameters were rarely associated with administration of Telmisartan tablets. Important: Moisture sensitive tablets - do not remove from bottle until immediately before administration. upper respiratory tract infections, including sinus pain/congestion and sore throat dizziness feeling tired flu-like symptoms back pain diarrhea nausea. Rx only 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. Following either intravenous or oral administration of 14C-labeled telmisartan, most of the administered dose (>97%) was eliminated unchanged in feces via biliary excretion; only minute amounts were found in the urine (0.91% and 0.49% of total radioactivity, respectively). Creatinine: A 0.5 mg/dL rise or greater in creatinine was observed in 0.4% Telmisartan patients compared with 0.3% placebo patients. Important: Moisture sensitive tablets - do not remove from bottle until immediately before administration. Take as directed Important considerations Alternatives Highlights for telmisartan Telmisartan oral tablet is available as both a generic and brand-name drug. Telmisartan is an angiotensin II receptor antagonist. Advise the patient to read the FDA-approved patient labeling (Patient Information). No dose adjustment is required in patients with mild (CrCl 60 to 90 mL/min) or moderate (CrCl 30 to 60 mL/min) renal impairment. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Take Telmisartan tablets one time each day at the same time. Telmisartan is not expected to interact with drugs that inhibit cytochrome P450 enzymes; it is also not expected to interact with drugs metabolized by cytochrome P450 enzymes, except for possible inhibition of the metabolism of drugs metabolized by CYP2C19. The highest doses administered to mice (1000 mg/kg/day) and rats (100 mg/kg/day) are, on a mg/m2basis, about 59 and 13 times, respectively, the maximum recommended human dose (MRHD) of telmisartan. Telmisartan shows bi-exponential decay kinetics with a terminal elimination half-life of approximately 24 hours. You can ask your pharmacist or doctor for information about Telmisartan tablets that is written for health professionals. Kidney problems, which may get worse if you already have kidney disease. Twynsta (telmisartan/amlodipine) is a combination of an angiotensin receptor blocker and a calcium channel blocker used to treat high blood pressure ( hypertension ). You may report side effects to FDA at 1-800-FDA-1088. Telmisartan is not removed by hemodialysis. Before you take Telmisartan tablets, tell your doctor if you: Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Advise patients to contact their healthcare provider if syncope occurs [see Warnings and Precautions (5.2)]. Rare, serious allergic reactions may happen. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base. Plasma protein binding is constant over the concentration range achieved with recommended doses. Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). You may have changes in your kidney test results, and you may need a lower dose of telmisartan and hydrochlorothiazide tablets. Monitor carefully and uptitrate slowly in patients with biliary obstructive disorders or hepatic insufficiency [see Warnings and Precautions ( 5.4)] . Use of RAS inhibitors beats and when your heart rests 62135-537-30 HDPE bottle of 30 tablets telmisartan tablets cause. 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