Telmisartan 40 mg/1
Telmisartan · TABLET · Alembic Pharmaceuticals Inc.
Telmisartan is a prescription tablet that belongs to a class of medications called angiotensin 2 receptor blockers, which are used to help lower blood pressure. It is taken by mouth and comes in a 40 mg strength.
Key Facts
- Brand Name
- Telmisartan
- Generic Name
- Telmisartan
- NDC Code (Product)
62332-088- Manufacturer
- Alembic Pharmaceuticals Inc.
- Strength
- 40 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA202130
- Drug Class
- Angiotensin 2 Receptor Blocker [EPC]
- Marketing Start
- 06/25/2016
Recall History
Torrent Pharma Inc.
Superpotent; Hydrochlorothiazide
Macleods Pharma Usa Inc
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Macleods Pharma Usa Inc
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Boehringer Ingelheim Pharmaceuticals, Inc.
Subpotent Drug
Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Alembic Pharmaceuticals Limited
Labeling: Label-mixup
Macleods Pharma Usa Inc
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Glenmark Pharmaceuticals Inc., USA
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
AVKARE Inc.
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Torrent Pharmaceuticals Limited
Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Telmisartan tablets, USP are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors ( 1.2 ) 1.1 Hypertension Telmisartan tablets, USP are 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 class to which this drug principally belongs. 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 guidelin…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION May be administered with or without food ( 2.1 ) When used for cardiovascular risk reduction, monitoring of blood pressure is recommended, and if appropriate, adjustment of medications that lower blood pressure may be necessary ( 2.2 ) Indication Starting Dose Dose Range Hypertension ( 2.1 ) 40 mg once daily 40 to 80 mg once daily Cardiovascular Risk Reduction ( 2.2 ) 80 mg once daily 80 mg once daily 2.1 Hypertension Dosage must be individualized. The usual starting dose of telmisartan tablets is 40 mg once a day. Blood pressure response is dose-related over the range of 20 to 80 mg [see Clinical Studies (14.1) ]. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored. Telmisartan tablets may be administered with other antihypertensive agents. Telmisartan tablets may be administered with or without food. 2.2 Cardiovascular Risk Reduction The recommended …
Contraindications
4 CONTRAINDICATIONS Telmisartan is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or any other component of this product [see Adverse Reactions (6.2) ]. Do not co-administer aliskiren with telmisartan in patients with diabetes. [see Drug interactions(7) ]. Known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or any other component of this product ( 4 ) Do not co-administer aliskiren with telmisartan in patients with diabetes ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Aliskiren: Do not co-administer aliskiren with telmisartan in patients with diabetes. Avoid use of aliskiren with telmisartan in patients with renal impairment (GFR <60 mL/min). Digoxin: When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. Therefore, monitor digoxin levels when initiating, adjusting, and discontinuing telmisartan for the purpose of keeping the digoxin level within the therapeutic range. Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists including telmisartan. Therefore, monitor serum lithium levels during concomitant use. 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 fun…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reaction is described elsewhere in labeling: Renal dysfunction upon use with ramipril [see Warnings and Precautions (5.6) ] Hypertension: The most common adverse events (≥1%) reported in hypertension trials are back pain, sinusitis, and diarrhea ( 6.1 ) Cardiovascular risk reduction: The serious adverse events (≥1%) reported in cardiovascular risk reduction trials were intermittent claudication and skin ulcer ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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. Hypertension Telmisartan has been evaluated for safety in more than 3700 patients, including 1900 treated for over 6 months and more than 1300 for over one year. Adverse experiences have generally been mild and transient in nature and have infrequently required discontinuation of therapy. In place…
Frequently Asked Questions
What is Telmisartan used for?
Telmisartan is a prescription tablet that belongs to a class of medications called angiotensin 2 receptor blockers, which are used to help lower blood pressure. It is taken by mouth and comes in a 40 mg strength.
Is Telmisartan a controlled substance?
Telmisartan is not classified as a controlled substance by the DEA.
What is the generic name for Telmisartan?
The generic name for Telmisartan is Telmisartan. There are 8 other brand versions of Telmisartan.
What is the NDC code for Telmisartan 40 mg/1?
The NDC (National Drug Code) for Telmisartan 40 mg/1 is 62332-088, listed by Alembic Pharmaceuticals Inc..