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Telmisartan And Hydrochlorothiazide (Telmisartan And Hydrochlorothiazide)

Trade Name : telmisartan and hydrochlorothiazide

West-Ward Pharmaceuticals Corp.

TABLET

Strength 4012.5 mg/1mg/1

TELMISARTAN; HYDROCHLOROTHIAZIDE Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Telmisartan And Hydrochlorothiazide (Telmisartan And Hydrochlorothiazide) which is also known as telmisartan and hydrochlorothiazide and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 40; 12.5 mg/1; mg/1 per ml. Read more

Telmisartan And Hydrochlorothiazide (Telmisartan And Hydrochlorothiazide) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: FETAL TOXICITY
  • See full prescribing information for complete boxed warningn
  • 5.1n- 8.1
  • 5.1n- 8.1
  • Telmisartan and hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with telmisartan and hydrochlorothiazide.
  • 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. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programu2019s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
  • Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. 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.
  • Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
  • 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). These considerations may guide selection of therapy [].
  • Telmisartan and hydrochlorothiazide is not indicated for initial therapy for the treatment of hypertension [n ].
  • Telmisartan and hydrochlorothiazide may be used alone or in combination with other antihypertensive agents.
  • No data
  • Tablets: 40 mg/12.5 mg, 80 mg/12.5 mg, 80 mg/25 mg ()
  • Telmisartan and hydrochlorothiazide is contraindicated:
  • No data
  • The following adverse reactions are discussed elsewhere in labeling:
  • The most common adverse reactions (u22652% of patients) were upper respiratory tract infection, dizziness, sinusitis, diarrhea, fatigue, influenza-like symptoms, and nausea ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or (800) 459-9906 TTY, or FDA at 1-800-FDA-1088 or n
  • No data
  • No data
  • Telmisartan
  • Hydrochlorothiazide
  • Telmisartan and hydrochlorothiazide tablets are a combination of telmisartan, an orally active angiotensin II antagonist acting on the AT1 receptor subtype, and hydrochlorothiazide, a thiazide diuretic.
  • Telmisartan, a non-peptide molecule, is chemically described as 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is:
  • Telmisartan is a white to slightly yellowish solid. 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.
  • Hydrochlorothiazide is a white, or practically white, practically odorless, crystalline powder with a molecular weight of 297.74. It is slightly soluble in water, and freely soluble in sodium hydroxide solution. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is CHClNOS, and its structural formula is:
  • Telmisartan and hydrochlorothiazide tablets are formulated for oral administration in three combinations of 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg telmisartan and hydrochlorothiazide, respectively. The tablets contain the following inactive ingredients: sodium hydroxide, meglumine, povidone, sorbitol, magnesium stearate, lactose monohydrate, microcrystalline cellulose, maize starch, and sodium starch glycolate. 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. Telmisartan and hydrochlorothiazide tablets are hygroscopic and require protection from moisture.
  • No data
  • Telmisartan and Hydrochlorothiazide
  • Telmisartan
  • There was no evidence of carcinogenicity when telmisartan was administered in the diet to mice and rats for up to 2 years. The highest doses administered to mice (1000 mg/kg/day) and rats (100 mg/kg/day) are, on a mg/m2 basis, about 59 and 13 times, respectively, the maximum recommended human dose (MRHD) of telmisartan. These same doses have been shown to provide average systemic exposures to telmisartan >100 times and >25 times, respectively, the systemic exposure in humans receiving the MRHD of telmisartan (80 mg/day).
  • 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.
  • No drug-related effects on the reproductive performance of male and female rats were noted at 100 mg/kg/day (the highest dose administered), about 13 times, on a mg/m2 basis, the MRHD of telmisartan. 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).
  • Hydrochlorothiazide
  • 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). The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice.
  • Hydrochlorothiazide was not genotoxic in vitro in the Ames mutagenicity assay of 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. 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.
  • Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg, respectively, prior to mating and throughout gestation.
  • Arrayn- Telmisartan and Hydrochlorothiazide
  • 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). These trials included one factorial trial (Study 1) with combinations of telmisartan (20 mg, 40 mg, 80 mg, 160 mg, or placebo) and hydrochlorothiazide (6.25 mg, 12.5 mg, 25 mg, and placebo). The factorial trial randomized 818 patients, including 493 (60%) males; 596 (73%) Non-Black and 222 (27%) Blacks; and 143 (18%) u226565 years of age (median age was 53 years old). The mean supine blood pressure at baseline for the total population was 154/101 mmHg.
  • The combination of telmisartan and hydrochlorothiazide resulted in additive placebo-adjusted decreases in systolic and diastolic blood pressures at trough of 16-21/9-11 mmHg for doses between 40 mg/12.5 mg and 80 mg/25 mg, compared with 9-13/7-8 mmHg for telmisartan 40 mg to 80 mg monotherapy and 4/4 mmHg for hydrochlorothiazide 12.5 mg monotherapy. The antihypertensive effect was independent of age or gender. There was essentially no change in heart rate in patients treated with the combination of telmisartan and hydrochlorothiazide in the placebo-controlled trial.
  • Four other studies of hypertensive patients of at least six monthsu2019 duration allowed add-on of hydrochlorothiazide for patients who either were not adequately controlled on the randomized telmisartan monotherapy dose or had not achieved adequate blood pressure response after completing the up-titration of telmisartan. 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.
  • Telmisartan and hydrochlorothiazide is available in three strengths as biconvex two-layered, oblong-shaped, uncoated tablets containing telmisartan and hydrochlorothiazide:
  • Storagen- Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C-30u00b0C (59u00b0F-86u00b0F)
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Arrayn- Pregnancy
  • Advise female patients of childbearing age about the consequences of exposure to telmisartan and hydrochlorothiazide during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [].
  • Arrayn- Lactation
  • Advise nursing women not to breastfeed during treatment with telmisartan and hydrochlorothiazide [n ].
  • Arrayn- Symptomatic Hypotension and Syncope
  • Advise patients that lightheadedness can occur, especially during the first days of therapy, and to report it to their healthcare provider. Inform patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope. Advise patients to contact their healthcare provider if syncope occurs [].
  • Arrayn- Potassium Supplements
  • Advise patients not to use potassium supplements or salt substitutes that contain potassium without consulting the prescribing healthcare provider [].
  • Arrayn- Acute Myopia and Secondary Angle-Closure Glaucoma
  • Advise patients to discontinue telmisartan and hydrochlorothiazide and seek immediate medical attention if they experience symptoms of Acute Myopia or Secondary Angle-Closure Glaucoma [].
  • Distributed by:
  • West-Ward Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • Licensed from:
  • Boehringer Ingelheim International GmbH
  • Ingelheim, Germany
  • Revised: August 2018
  • IT6875ED092018
  • Telmisartan and Hydrochlorothiazide Tabletsn- telu2019mi saru2019tan and hyeu2019 droe kloru2019 oh thyeu2019 a zide
  • Read this Patient Information before you start taking telmisartan and hydrochlorothiazide 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.
  • What is the most important information I should know about telmisartan and hydrochlorothiazide tablets?
  • Telmisartan and hydrochlorothiazide can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking telmisartan and hydrochlorothiazide, tell your doctor right away.
  • What is telmisartan and hydrochlorothiazide?
  • Telmisartan and hydrochlorothiazide is a prescription medicine used to treat high blood pressure (hypertension).Telmisartan and hydrochlorothiazide contains:
  • Your doctor may prescribe other medicines for you to take along with telmisartan and hydrochlorothiazide to treat your high blood pressure.
  • It is not known if telmisartan and hydrochlorothiazide is safe and effective in children.
  • Do not take telmisartan and hydrochlorothiazide tablets if you:
  • What should I tell my doctor before using telmisartan and hydrochlorothiazide tablets?
  • Before you take telmisartan and hydrochlorothiazide tablets, tell your doctor if you:
  • Tell your doctor about all the medicines you take,
  • Telmisartan and hydrochlorothiazide may affect the way other medicines work, and other medicines may affect how telmisartan and hydrochlorothiazide works. Especially tell your doctor if you take:
  • Ask your doctor if you are not sure if you are taking one of the medicines listed above.
  • Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist when you get a new medicine.
  • How should I take telmisartan and hydrochlorothiazide tablets?
  • What are the possible side effects of telmisartan and hydrochlorothiazide tablets?
  • Telmisartan and hydrochlorothiazide tablets may cause serious side effects,
  • The most common side effects of telmisartan and hydrochlorothiazide tablets include:
  • These are not all the possible side effects with telmisartan and hydrochlorothiazide tablets. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store telmisartan and hydrochlorothiazide tablets?
  • Keep telmisartan and hydrochlorothiazide tablets and all medicines out of the reach of children.
  • General information about telmisartan and hydrochlorothiazide tablets:
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use telmisartan and hydrochlorothiazide tablets for a condition for which it was not prescribed. Do not give telmisartan and hydrochlorothiazide tablets to other people, even if they have the same condition you have. It may harm them.
  • This Patient Information leaflet summarizes the most important information about telmisartan and hydrochlorothiazide tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about telmisartan and hydrochlorothiazide tablets that is written for health professionals.
  • For current prescribing information, call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or (TTY) 1-800-459-9906.
  • What are the ingredients in telmisartan and hydrochlorothiazide tablets?
  • Active Ingredients: telmisartan and hydrochlorothiazide
  • Inactive Ingredients: sodium hydroxide, meglumine, povidone, sorbitol, magnesium stearate, lactose monohydrate, microcrystalline cellulose, maize starch, and sodium starch glycolate
  • The 40 mg/12.5 mg and 80 mg/12.5 mg tablets also contain: ferric oxide red.
  • The 80 mg/25 mg tablets also contain: ferric oxide yellow.
  • 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. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack.
  • High blood pressure makes the heart work harder to pump blood through the body and causes damage to the blood vessels. Telmisartan and hydrochlorothiazide tablets can help your blood vessels relax so your blood pressure is lower.
  • How to open the blister:
  • 1. Tear (You may also use scissors to tear the blister apart)
  • 2. Peel (Peel off the paper layer from the aluminum foil)
  • 3. Push (Push the tablet through the foil)
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Distributed by:West-Ward Pharmaceuticals Corp.Eatontown, NJ 07724
  • Licensed from:Boehringer Ingelheim International GmbHIngelheim, Germany
  • Revised: August 2018
  • 090340629/4
  • Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg
  • 30 Tablets
  • NDC 0054-0547-18
  • Telmisartan and Hydrochlorothiazide Tablets USP, 40 mg/12.5 mg
  • 30 Tablets
  • NDC 0054-0545-18
  • Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg
  • 30 Tablets
  • NDC 0054-0546-18

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