These highlights do not include all the information needed to use COZAAR safely and effectively. Hemoglobin: A greater than 2 g/dL decrease in hemoglobin was observed in 0.8% Telmisartan patients compared with 0.3% placebo patients. Other Drugs: Co-administration of Telmisartan did not result in a clinically significant interaction with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. 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). NDC 62332-211-30 bottle of 30 units, NDC 62332-211-91 bottle of 1000 units, NDC 62332-211-10 100 Tablets (i.e. In active-controlled studies, the addition of 12.5 mg hydrochlorothiazide to titrated doses of telmisartan in patients who did not achieve or maintain adequate response with telmisartan monotherapy further reduced systolic and diastolic blood pressures. Hydrochlorothiazide also had an added blood pressure effect when added to Telmisartan. 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. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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 volume of distribution for telmisartan is approximately 500 liters, indicating additional tissue binding. These are not all the possible side effects with telmisartan and hydrochlorothiazide tablets. Tablets should not be removed from the bottle until immediately before administration. Call your doctor right away if you get any of the symptoms listed above. See full prescribing information for complete boxed warning. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems. Studies in rats and rabbits with telmisartan showed fetotoxicity only at maternally toxic doses (see Data). Advise the patient to read the FDA-approved patient labeling (Patient Information). This dose in the rat resulted in an average systemic exposure (telmisartan AUC as determined on day 6 of pregnancy) at least 50 times the average systemic exposure in humans at the MRHD (80 mg/day). If oliguria or hypotension occurs, support blood pressure and renal perfusion. Following once-daily administration of telmisartan, the magnitude of blood pressure reduction from baseline after placebo subtraction was approximately (SBP/DBP) 6 to 8/6 mmHg for 20 mg, 9 to 13/6 to 8 mmHg for 40 mg, and 12 to 13/7 to 8 mmHg for 80 mg. You should not take Telmisartan tablets if you are allergic (hypersensitive) to the active ingredient (Telmisartan) or any of the other ingredients listed at the end of this leaflet. Monitor digoxin levels in patients taking concomitant telmisartan and hydrochlorothiazide tablets and digoxin. In rats, maternally toxic (reduction in body weight gain and food consumption) Telmisartan doses of 15 mg/kg/day (about 1.9 times the MRHD on a mg/m 2 basis), administered during late gestation and lactation, were observed to produce adverse effects in neonates, including reduced viability, low birth weight, delayed maturation, and decreased weight gain. Talk with your doctor about the best way to feed your baby if you take Telmisartan tablets. In placebo-controlled clinical trials, clinically relevant changes in standard laboratory test parameters were rarely associated with administration of Telmisartan tablets. What is the most important information I should know about telmisartan and hydrochlorothiazide tablets?, Tell your doctor about all the medicines you take. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. NDC 62332-209-30 Telmisartan and Hydrochlorothiazide Tablets, USP 40 mg/12.5 mg There may be new information. The antihypertensive effect was independent of age or gender. 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. High blood pressure makes the heart work harder to pump blood through the body and causes damage to the blood vessels. Advise patients to discontinue telmisartan and hydrochlorothiazide tablets and seek immediate medical attention if they experience symptoms of Acute Myopia or Secondary Angle-Closure Glaucoma [see Warnings and Precautions (5.6]. The onset of antihypertensive activity occurs within 3 hours after administration of a single oral dose. Telmisartan and hydrochlorothiazide can pass into your breast milk and may harm your baby. Blood pressure response is dose-related over the range of 20 to 80 mg [see Clinical Studies ( 14.1)] . 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. Initial U.S. Approval: 1995 . Pediatric Patients Aliskiren: Do not co-administer aliskiren with Telmisartan tablets in patients with diabetes. In case of emergency/overdose In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant diseases or other drug therapy. Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. 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 (see Clinical Considerations). Tell your doctor right away if you get any of these symptoms: The most common side effects of Telmisartan tablets include: These are not all the possible side effects with Telmisartan tablets. 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. What are the ingredients in Telmisartan tablets? 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. 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). Gender White to off white color layer may contains yellow color specks. Liver Enzymes: Occasional elevations of liver chemistries occurred in patients treated with Telmisartan; all marked elevations occurred at a higher frequency with placebo. Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists including Telmisartan tablets. Lowering blood pressure may lower your risk of a stroke or heart attack. Genotoxicity assays did not reveal any telmisartan-related effects at either the gene or chromosome level. When co-administering telmisartan and ramipril, the response may be greater because of the possibly additive pharmacodynamic effects of the combined drugs, and also because of the increased exposure to ramipril and ramiprilat in the presence of telmisartan. You have high blood pressure when the force is too much. Approved as a pharmacy medicine, Sanofi will launch Cialis Together in the second half of the year. have been told that you have abnormal body salt (electrolytes) levels in your blood have liver problems have asthma or history of asthma have lupus have diabetes have kidney problems have any other medical conditions. Keep telmisartan and hydrochlorothiazide tablets and all medicines out of the reach of children. Events, (What 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. Advise patients that lightheadedness can occur, especially during the first days of therapy, and to report it to their healthcare provider. View NDC Code(s)NEW! NDC 62332-210-30 bottle of 30 units, NDC 62332-210-91 bottle of 1000 units, NDC 62332-210-10 100 Tablets (i.e. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Telmisartan + Amlodipine besilate (Twynsta) Important Safety Information. Telmisartan is present in the milk of lactating rats (see Data). Total plasma clearance of Telmisartan is > 800 mL/min. Take as directed Important considerations Alternatives Highlights for telmisartan Telmisartan oral tablet is available as both a generic and brand-name drug. For further details, please refer to the full prescribing information. In contrast, Cmax and AUC of telmisartan decrease by 31% and 16%, respectively. Safety and effectiveness in pediatric patients have not been established [see Clinical Pharmacology ( 12.3)] . There is also an AT2 receptor found in many tissues, but AT2 is not known to be associated with cardiovascular homeostasis. You should not do both. This Patient Information leaflet summarizes the most important information about telmisartan and hydrochlorothiazide tablets. Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F) [see USP Controlled Room Temperature]. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. Report Adverse Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Drug Info Cozaar (losartan) alternatives: What can I take instead of losartan? Digoxin: When Telmisartan tablets were co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. Advise patients that lightheadedness can occur, especially during the first days of therapy, and to report it to their healthcare provider. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium salt and chloride in approximately equivalent amounts. Therefore, monitor renal function and blood pressure periodically in patients receiving telmisartan and hydrochlorothiazide tablets and NSAIDs. Store Telmisartan tablets at room temperature 68F to 77F (20C to 25C). The antihypertensive effects of Telmisartan tablets have been demonstrated in six principal placebo-controlled clinical trials, studying a range of 20 to 160 mg; one of these examined the antihypertensive effects of Telmisartan and hydrochlorothiazide in combination. Telmisartan tablets can cause harm or death to an unborn baby. General information about telmisartan and hydrochlorothiazide tablets: As a consequence of inhibiting the renin-angiotensin-aldosterone system, anticipate changes in renal function in susceptible individuals. If you take too much telmisartan and hydrochlorothiazide tablets, call your doctor, or go to the nearest hospital emergency room right away. If you miss a dose, take it as soon as you remember. This Patient Information leaflet summarizes the most important information about Telmisartan tablets. 62332-211-91. Discuss treatment options with women planning to become pregnant. There may be an increased chance of low blood pressure. Call your doctor right away if you have: Skin Cancer. The antihypertensive effect of angiotensin II receptor antagonists, including Telmisartan may be attenuated by NSAIDs including selective COX-2 inhibitors. Symptomatic Hypotension and Syncope Alembic, NDC 62332-210-30 Telmisartan and Hydrochlorothiazide Tablets, USP 80 mg/12.5 mg These effects are usually reversible. Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program (NTP) uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female mice (at doses of up to approximately 600 mg/kg/day) or in male and female rats (at doses of up to approximately 100 mg/kg/day). 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). Telmisartan tablets are a prescription medicine used: It is not known if Telmisartan tablets are safe and effective in children. Telmisartan has an accumulation index in plasma of 1.5 to 2 upon repeated once-daily dosing. Take telmisartan and hydrochlorothiazide tablet once each day. Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. No carcinogenicity, mutagenicity, or fertility studies have been conducted with the combination of telmisartan and hydrochlorothiazide. Advise female patients of childbearing age about the consequences of exposure to Telmisartan during pregnancy. 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. FULL PRESCRIBING INFORMATION WARNING: FETAL TOXICITY 1 INDICATIONS AND USAGE 1.1 Hypertension Telmisartan tablets are indicated for the treatment of hypertension, to lower blood pressure. The most likely manifestations of overdosage with telmisartan are hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Exchange transfusions or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function. In controlled clinical trials with more than 2500 hypertensive patients, 1017 patients were exposed to telmisartan (20 mg to 160 mg) and concomitant hydrochlorothiazide (6.25 mg to 25 mg). Monitor carefully and uptitrate slowly in patients with biliary obstructive disorders or hepatic insufficiency [see Warnings and Precautions ( 5.4)] . How should I store telmisartan and hydrochlorothiazide tablets? Twynsta is used to treat high blood pressure (hypertension). Telmisartan tablets can cause fetal harm when administered to a pregnant woman. Clinical particulars 5. 2 DOSAGE AND ADMINISTRATION 2.1 Hypertension - Dosage must be individualized. Drug class: Angiotensin receptor blockers. The usual starting dose of Telmisartan tablets is 40 mg once a day. Telmisartan has much greater affinity (>3,000 fold) for the AT 1 receptor than for the AT 2 receptor. Storage 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 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. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not remove Telmisartan tablets from the bottle until right before you take them. Ramipril: Co-administration of telmisartan 80 mg once daily and ramipril 10 mg once daily to healthy subjects increases steady-state Cmax and AUC of ramipril 2.3- and 2.1-fold, respectively, and Cmax and AUC of ramiprilat 2.4- and 1.5-fold, respectively. Terminal half-life and total clearance appear to be independent of dose. Chartwell RX, LLC. Take Telmisartan tablets exactly as your doctor tells you to take it. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. Telmisartan Tablets USP are a non-peptide angiotensin II receptor (type AT 1) antagonist. Studies in rats and rabbits with Telmisartan showed fetotoxicity only at maternally toxic doses (see Data) . 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