Drugplain

Telmisartan and Amlodipine 5 mg/1

Telmisartan and Amlodipine · TABLET · Alembic Pharmaceuticals Limited

2 Recalls on Record
Plain English

Telmisartan and Amlodipine is a tablet containing telmisartan and amlodipine at 5 mg/1, taken oral. Manufactured by Alembic Pharmaceuticals Limited.

Key Facts

Brand Name
Telmisartan and Amlodipine
Generic Name
Telmisartan and Amlodipine
NDC Code (Product)
46708-184
Manufacturer
Alembic Pharmaceuticals Limited
Strength
5 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA205234
Drug Class
Angiotensin 2 Receptor Blocker [EPC]
Marketing Start
11/22/2016

Recall History

2 Recalls on Record
Class III04/01/2019

Lupin Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications; 18 month long term stability study.

TerminatedVoluntary: Firm initiated
Class III04/03/2019

AVKARE Inc.

Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea10 reports
constipation9 reports
toxicity to various agents8 reports
hypotension7 reports
blood pressure increased6 reports
diarrhoea6 reports
fall6 reports
rash6 reports
angioedema5 reports
cough5 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Telmisartan and amlodipine tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents 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 angiotensin II receptor blockers and dihydropyridine calcium channel blockers. There are no controlled trials demonstrating risk reduction with telmisartan and amlodipine tablets. 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 Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antih…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Substitute telmisartan and amlodipine tablets for its individually titrated components for patients on amlodipine and telmisartan. Telmisartan and amlodipine tablets may also be given with increased amounts of amlodipine, telmisartan, or both, as needed. (2.2, 2.3) Use telmisartan and amlodipine tablets to provide additional blood pressure lowering for patients not adequately controlled with amlodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone (2.3) Dosage may be increased after at least 2 weeks to a maximum dose of 80/10 mg once daily, usually by increasing one component at a time but both components can be raised to achieve more rapid control (2.1, 2.2) Majority of antihypertensive effect is attained within 2 weeks (2.1) Initiate with 40/5 mg or 80/5 mg once daily (2.4) Switch patients who experience dose-limiting adverse reactions on amlodipine to telmisartan and amlodipine tablets containing a lower dose of that component (2.3) 2.1 General Considerations Telmisartan is an effective treatment of hypertension in once daily doses of 20 to 80 mg while amlodipine is effec…

Contraindications

4 CONTRAINDICATIONS Telmisartan and amlodipine tablets are contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan, amlodipine, or any other component of this product [see Adverse Reactions (6.2)]. Do not co-administer aliskiren with telmisartan and amlodipine tablets in patients with diabetes [see Drug Interactions (7.2)]. Known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan, amlodipine or any other component of this product (4) Do not co-administer aliskiren with telmisartan and amlodipine tablets in patients with diabetes (4)

Drug Interactions

7 DRUG INTERACTIONS NSAIDS: Increased risk of renal impairment and loss of antihypertensive effect (7) If simvastatin is co-administered with amlodipine, do not exceed doses greater than 20 mg daily of simvastatin (7) Do not co-administer aliskiren with telmisartan and amlodipine tablets in patients with diabetes (7.2) 7.1 Drug Interactions with Telmisartan and Amlodipine Tablets The pharmacokinetics of amlodipine and telmisartan are not altered when the drugs are co-administered. No drug interaction studies have been conducted with telmisartan and amlodipine tablets and other drugs, although studies have been conducted with the individual amlodipine and telmisartan components of telmisartan and amlodipine tablets, as described below: 7.2 Drug Interactions with Telmisartan Aliskiren: Do not co-administer aliskiren with telmisartan and amlodipine tablets in patients with diabetes. Avoid use of aliskiren with telmisartan and amlodipine tablets 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 digo…

Adverse Reactions

6 ADVERSE REACTIONS In the placebo-controlled factorial design study, the most common reasons for discontinuation of therapy with telmisartan and amlodipine tablets were peripheral edema, dizziness, and hypotension, each leading to discontinuation of ≤0.5% of telmisartan and amlodipine tablets-treated patients. Adverse reactions that occurred at a ≥2% higher incidence on telmisartan and amlodipine tablets than placebo were peripheral edema (4.8% vs 0%), dizziness (3.0% vs 2.2%), and back pain (2.2% vs 0%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact 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. Telmisartan and amlodipine tablets The concomitant use of telmisartan and amlodipine has been evaluated for safety in more than 3700 patients with hypertension; approximately 1900 of these patients were exposed for at least 6 months and over 160 of these patients were exposed for at least…

Frequently Asked Questions

What is Telmisartan and Amlodipine used for?

Telmisartan and Amlodipine contains Telmisartan and Amlodipine. It is a tablet taken oral. Consult your doctor for specific uses.

Is Telmisartan and Amlodipine a controlled substance?

Telmisartan and Amlodipine is not classified as a controlled substance by the DEA.

What is the generic name for Telmisartan and Amlodipine?

The generic name for Telmisartan and Amlodipine is Telmisartan and Amlodipine. There are no other listed brand versions of Telmisartan and Amlodipine.

What is the NDC code for Telmisartan and Amlodipine 5 mg/1?

The NDC (National Drug Code) for Telmisartan and Amlodipine 5 mg/1 is 46708-184, listed by Alembic Pharmaceuticals Limited.

Product NDC

46708-184

Package NDC

46708-184-08

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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