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Telmisartan (Telmisartan)

Trade Name : Telmisartan

West-Ward Pharmaceuticals Corp.

TABLET

Strength 20 mg/1

TELMISARTAN Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]

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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 (Telmisartan) which is also known as Telmisartan and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 20 mg/1 per ml. Read more

Telmisartan (Telmisartan) 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.

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About GNH

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: u00a0FETAL TOXICITY
  • See full prescribing information for complete boxed warning
  • When pregnancy is detected, discontinue Telmisartan as soon as possible (, )
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (, )
  • Telmisartan is an angiotensin II receptor blocker (ARB) indicated for:
  • No data
  • Tablets: 20 mg, 40 mg, 80 mg n n n
  • Telmisartan tablets are contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or any other component of this product [].
  • Do not co-administer aliskiren with telmisartan tablets in patients with diabetes [].
  • No data
  • 5.4n- 5.5
  • The following adverse reaction is described elsewhere in labeling:
  • 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
  • Aliskiren:
  • Digoxin:
  • Lithium:
  • Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors):
  • The antihypertensive effect of angiotensin II receptor antagonists, including telmisartan may be attenuated by NSAIDs including selective COX-2 inhibitors.
  • No data
  • Limited data are available with regard to overdosage in humans. The most likely manifestation of overdosage with telmisartan tablets would be hypotension, dizziness and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.
  • Telmisartan is a non-peptide angiotensin II receptor (type AT1) antagonist.
  • Telmisartan 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.
  • Telmisartan is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of telmisartan. The tablets contain the following inactive ingredients: sodium hydroxide, meglumine, povidone, sorbitol, and magnesium stearate. Telmisartan tablets are hygroscopic and require protection from moisture.
  • No data
  • 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/m 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 (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/m 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).
  • No data
  • Telmisartan 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 company symbol 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. Tablets are provided as follows:
  • Telmisartan tablets 20 mg are round and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0054-0542-18).
  • Telmisartan tablets 40 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0054-0543-18).
  • Telmisartan tablets 80 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0054-0544-18).
  • Storage
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0-30u00b0C (59u00b0-86u00b0F)
  • Advise the patient to read the FDA-approved patient labeling (Patient Information)
  • Pregnancy
  • Advise female patients of childbearing age about the consequences of exposure to telmisartan during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [].
  • Lactation
  • Advise nursing women not to breastfeed during treatment with telmisartan [].
  • 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 [].
  • Potassium Supplements
  • Advise patients not to use potassium supplements or salt substitutes that contain potassium without consulting the prescribing healthcare provider [].
  • Distributed by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724
  • Licensed from: Boehringer Ingelheim International GmbH, Ingelheim, Germany Copyright u00a9 2018 Boehringer Ingelheim International GmbH ALL RIGHTS RESERVED
  • 090340628/4
  • Revised: August 2018
  • IT6874DYF092018
  • Patient Information
  • Telmisartan Tablets USP
  • (tel mi saru2019 tan) Tablets
  • Read this Patient Information before you start taking telmisartan 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 tablets?
  • Telmisartan 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, tell your doctor right away.
  • What is telmisartan?
  • Telmisartan is a prescription medicine used:
  • It is not known if telmisartan is safe and effective in children.
  • Who should not take telmisartan?
  • 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.
  • For patients with diabetes, if you are taking telmisartan you should not take aliskiren.
  • What should I tell my doctor before taking telmisartan tablets?
  • Before you take telmisartan tablets, tell your doctor if you:
  • Tell your doctor about all the medicines you take
  • Telmisartan may affect the way other medicines work, and other medicines may affect how telmisartan works. Especially tell your doctor if you take:
  • 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 tablets?
  • What are the possible side effects of telmisartan tablets?
  • Telmisartan tablets may cause serious side effects, including:
  • Rare, serious allergic reactions may happen. 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. 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 tablets?
  • Keep telmisartan tablets and all medicines out of the reach of children.
  • General information about telmisartan tablets
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use telmisartan tablets for a condition for which it was not prescribed. Do not give telmisartan 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 tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about telmisartan tablets that is written for health professionals.
  • For more information, call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257, or (TTY) 1-800-459-9906.
  • What are the ingredients in telmisartan tablets?
  • Active Ingredient:
  • Inactive Ingredients:
  • 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.u00a0Telmisartan 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.
  • High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to the blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems.
  • What is Cardiovascular Risk?
  • Patients older than 55 years of age who have been diagnosed with blood vessel disease in the heart, legs, or brain (coronary, peripheral, or cerebral vascular disease) or diabetes with end organ damage (for example: kidney, heart, and brain) are at higher risk of cardiovascular events (for example: death from cardiovascular causes, stroke, and/or heart attack).
  • How to open the blister:
  • 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 GmbH, Ingelheim, Germany
  • Revised: August 2018
  • 090340628/4
  • Telmisartan 20 mg 30 Tablets
  • Telmisartan 40 mg 30 Tablets
  • Telmisartan 80 mg 30 Tablets

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