Telmisartan and Amlodipine

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Overview

What is Telmisartan and Amlodipine?

Telmisartan and amlodipine tablet is a fixed dose combination of telmisartan and amlodipine.

Telmisartan and amlodipine tablets contain telmisartan, a non-peptide angiotensin II receptor (type AT) antagonist. 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 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 CHNO and its structural formula is:

Telmisartan and amlodipine tablets contain the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate. Its empirical formula is CHClNO•CHOS and its structural formula is:

Telmisartan and amlodipine tablets are formulated in four strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 40 mg, or 80 mg of telmisartan provided in the following four combinations: 40/5 mg, 40/10 mg, 80/5 mg, and 80/10 mg.

Telmisartan and amlodipine tablets also contain the following inactive ingredients: colloidal silicon dioxide, crosscarmellose sodium, ferric oxide red, ferric oxide yellow, mannitol, magnesium stearate, povidone, sodium hydroxide and sodium starch glycolate.

Telmisartan and amlodipine tablets are hygroscopic and require protection from moisture.

Telmisartan and amlodipine tablets require protection from light.

What does Telmisartan and Amlodipine look like?

What are the available doses of Telmisartan and Amlodipine?

Telmisartan and amlodipine tablets are formulated for oral administration in the following strength combinations:

40 mg/5 mg

Oval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have yellow specks, debossed with 'C54' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.

40 mg/10 mg

Oval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C55' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.

80 mg/5 mg

Capsule shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C56' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.

80 mg/10 mg

Capsule shaped, biconvex, bilayer, uncoated tablet where Amlodipine layer is white but may have yellow specks, debossed with 'C57' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.

What should I talk to my health care provider before I take Telmisartan and Amlodipine?

How should I use Telmisartan and Amlodipine?

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 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 amlodipine tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

Base the choice of telmisartan and amlodipine tablets as initial therapy for hypertension on an assessment of potential benefits and risks including whether the patient is likely to tolerate the starting dose of telmisartan and amlodipine tablets.

Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. Consider the patient's baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy when deciding whether to use telmisartan and amlodipine tablets as initial therapy. Individual blood pressure goals may vary based upon the patient's risk.

Data from an 8-week, placebo-controlled, multidose, factorial trial provide estimates of the probability of reaching a blood pressure goal with telmisartan and amlodipine tablets compared to telmisartan or amlodipine monotherapy and placebo

The figures below provide estimates of the likelihood of achieving systolic and diastolic blood pressure control with telmisartan and amlodipine tablets 80/10 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.

The figures above provide an approximation of the likelihood of reaching a targeted blood pressure goal at 8 weeks. For example, a patient with a baseline blood pressure of 160/110 mmHg has about a 16% likelihood of achieving a goal of <140 mmHg (systolic) and 16% likelihood of achieving <90 mmHg (diastolic) on placebo. The likelihood of achieving these same goals on telmisartan is about 46% (systolic) and 26% (diastolic). The likelihood of achieving these same goals on amlodipine is about 69% (systolic) and 22% (diastolic). These likelihoods rise to 79% for systolic and 55% for diastolic with telmisartan and amlodipine tablets.

Telmisartan is an effective treatment of hypertension in once daily doses of 20 to 80 mg while amlodipine is effective in doses of 2.5 to 10 mg.

Dosage must be individualized and may be increased after at least 2 weeks. Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. The maximum recommended dose of telmisartan and amlodipine tablets is 80/10 mg once daily.

The adverse reactions of telmisartan are uncommon and independent of dose; those of amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter

Telmisartan and amlodipine tablets may be taken with or without food.

What interacts with Telmisartan and Amlodipine?

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What are the warnings of Telmisartan and Amlodipine?

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What are the precautions of Telmisartan and Amlodipine?

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What are the side effects of Telmisartan and Amlodipine?

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What should I look out for while using Telmisartan and Amlodipine?

Known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan, amlodipine or any other component of this product ()

Do not co-administer aliskiren with telmisartan and amlodipine in patients with diabetes ()

What might happen if I take too much Telmisartan and Amlodipine?

Telmisartan

Limited data are available with regard to overdosage in humans. The most likely manifestations 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.

Amlodipine

Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine is limited.

Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/mbasis) caused a marked peripheral vasodilation and hypotension.

If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.

How should I store and handle Telmisartan and Amlodipine?

Vials should be stored refrigerated at 2°-8°C (36°-46°F). Vials may be transferred to room temperature storage for a period not to exceed 2 months. Upon transfer, vial cartons must be marked by the dispensing pharmacist with a "DISCARD BY" date (2 months from the transfer date or the labeled expiration date, whichever comes first). Protect from light until administration.Vials should be stored refrigerated at 2°-8°C (36°-46°F). Vials may be transferred to room temperature storage for a period not to exceed 2 months. Upon transfer, vial cartons must be marked by the dispensing pharmacist with a "DISCARD BY" date (2 months from the transfer date or the labeled expiration date, whichever comes first). Protect from light until administration.Telmisartan and amlodipine tablets are available as 40 mg/5 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have yellow specks, debossed with 'C54' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.40 mg/10 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C55' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/5 mgCapsule shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C56' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/10 mgCapsule shaped, biconvex, bilayer, uncoated tablet where Amlodipine layer is white but may have yellow specks, debossed with 'C57' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.Telmisartan and amlodipine tablets are supplied for oral administration in the following strengths and package configurations:StorageStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Do not remove from blisters until immediately before administration. Protect from moisture and light.Telmisartan and amlodipine tablets are available as 40 mg/5 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have yellow specks, debossed with 'C54' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.40 mg/10 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C55' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/5 mgCapsule shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C56' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/10 mgCapsule shaped, biconvex, bilayer, uncoated tablet where Amlodipine layer is white but may have yellow specks, debossed with 'C57' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.Telmisartan and amlodipine tablets are supplied for oral administration in the following strengths and package configurations:StorageStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Do not remove from blisters until immediately before administration. Protect from moisture and light.Telmisartan and amlodipine tablets are available as 40 mg/5 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have yellow specks, debossed with 'C54' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.40 mg/10 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C55' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/5 mgCapsule shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C56' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/10 mgCapsule shaped, biconvex, bilayer, uncoated tablet where Amlodipine layer is white but may have yellow specks, debossed with 'C57' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.Telmisartan and amlodipine tablets are supplied for oral administration in the following strengths and package configurations:StorageStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Do not remove from blisters until immediately before administration. Protect from moisture and light.Telmisartan and amlodipine tablets are available as 40 mg/5 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have yellow specks, debossed with 'C54' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.40 mg/10 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C55' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/5 mgCapsule shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C56' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/10 mgCapsule shaped, biconvex, bilayer, uncoated tablet where Amlodipine layer is white but may have yellow specks, debossed with 'C57' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.Telmisartan and amlodipine tablets are supplied for oral administration in the following strengths and package configurations:StorageStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Do not remove from blisters until immediately before administration. Protect from moisture and light.Telmisartan and amlodipine tablets are available as 40 mg/5 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have yellow specks, debossed with 'C54' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.40 mg/10 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C55' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/5 mgCapsule shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C56' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/10 mgCapsule shaped, biconvex, bilayer, uncoated tablet where Amlodipine layer is white but may have yellow specks, debossed with 'C57' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.Telmisartan and amlodipine tablets are supplied for oral administration in the following strengths and package configurations:StorageStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Do not remove from blisters until immediately before administration. Protect from moisture and light.Telmisartan and amlodipine tablets are available as 40 mg/5 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have yellow specks, debossed with 'C54' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.40 mg/10 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C55' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/5 mgCapsule shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C56' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/10 mgCapsule shaped, biconvex, bilayer, uncoated tablet where Amlodipine layer is white but may have yellow specks, debossed with 'C57' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.Telmisartan and amlodipine tablets are supplied for oral administration in the following strengths and package configurations:StorageStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Do not remove from blisters until immediately before administration. Protect from moisture and light.Telmisartan and amlodipine tablets are available as 40 mg/5 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have yellow specks, debossed with 'C54' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.40 mg/10 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C55' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/5 mgCapsule shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C56' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/10 mgCapsule shaped, biconvex, bilayer, uncoated tablet where Amlodipine layer is white but may have yellow specks, debossed with 'C57' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.Telmisartan and amlodipine tablets are supplied for oral administration in the following strengths and package configurations:StorageStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Do not remove from blisters until immediately before administration. Protect from moisture and light.Telmisartan and amlodipine tablets are available as 40 mg/5 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have yellow specks, debossed with 'C54' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.40 mg/10 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C55' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/5 mgCapsule shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C56' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/10 mgCapsule shaped, biconvex, bilayer, uncoated tablet where Amlodipine layer is white but may have yellow specks, debossed with 'C57' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.Telmisartan and amlodipine tablets are supplied for oral administration in the following strengths and package configurations:StorageStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Do not remove from blisters until immediately before administration. Protect from moisture and light.Telmisartan and amlodipine tablets are available as 40 mg/5 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have yellow specks, debossed with 'C54' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.40 mg/10 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C55' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/5 mgCapsule shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C56' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/10 mgCapsule shaped, biconvex, bilayer, uncoated tablet where Amlodipine layer is white but may have yellow specks, debossed with 'C57' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.Telmisartan and amlodipine tablets are supplied for oral administration in the following strengths and package configurations:StorageStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Do not remove from blisters until immediately before administration. Protect from moisture and light.Telmisartan and amlodipine tablets are available as 40 mg/5 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have yellow specks, debossed with 'C54' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.40 mg/10 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C55' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/5 mgCapsule shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C56' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/10 mgCapsule shaped, biconvex, bilayer, uncoated tablet where Amlodipine layer is white but may have yellow specks, debossed with 'C57' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.Telmisartan and amlodipine tablets are supplied for oral administration in the following strengths and package configurations:StorageStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Do not remove from blisters until immediately before administration. Protect from moisture and light.Telmisartan and amlodipine tablets are available as 40 mg/5 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have yellow specks, debossed with 'C54' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.40 mg/10 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C55' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/5 mgCapsule shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C56' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/10 mgCapsule shaped, biconvex, bilayer, uncoated tablet where Amlodipine layer is white but may have yellow specks, debossed with 'C57' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.Telmisartan and amlodipine tablets are supplied for oral administration in the following strengths and package configurations:StorageStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Do not remove from blisters until immediately before administration. Protect from moisture and light.Telmisartan and amlodipine tablets are available as 40 mg/5 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have yellow specks, debossed with 'C54' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.40 mg/10 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C55' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/5 mgCapsule shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C56' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/10 mgCapsule shaped, biconvex, bilayer, uncoated tablet where Amlodipine layer is white but may have yellow specks, debossed with 'C57' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.Telmisartan and amlodipine tablets are supplied for oral administration in the following strengths and package configurations:StorageStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Do not remove from blisters until immediately before administration. Protect from moisture and light.Telmisartan and amlodipine tablets are available as 40 mg/5 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have yellow specks, debossed with 'C54' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.40 mg/10 mgOval shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C55' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/5 mgCapsule shaped, biconvex, bilayer, uncoated tablets where Amlodipine layer is white but may have red specks, debossed with 'C56' and Telmisartan layer is red in colour but may have white specks, debossed with 'LU'.80 mg/10 mgCapsule shaped, biconvex, bilayer, uncoated tablet where Amlodipine layer is white but may have yellow specks, debossed with 'C57' and Telmisartan layer is yellow in colour but may have white specks, debossed with 'LU'.Telmisartan and amlodipine tablets are supplied for oral administration in the following strengths and package configurations:StorageStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Do not remove from blisters until immediately before administration. Protect from moisture and light.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Telmisartan

Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). 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. Telmisartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis.

There is also an AT receptor found in many tissues, but AT is not known to be associated with cardiovascular homeostasis. Telmisartan has much greater affinity (>3,000 fold) for the AT receptor than for the AT receptor.

Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is widely used in the treatment of hypertension. ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because telmisartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Whether this difference has clinical relevance is not yet known. Telmisartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of telmisartan on blood pressure.

Amlodipine

Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Negative inotropic effects can be detected but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine. Within the physiologic pH range, amlodipine is an ionized compound (pKa=8.6), and its kinetic interaction with the calcium channel receptor is characterized by a gradual rate of association and dissociation with the receptor binding site, resulting in a gradual onset of effect.

Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

Non-Clinical Toxicology

Known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan, amlodipine or any other component of this product ()

Do not co-administer aliskiren with telmisartan and amlodipine in patients with diabetes ()

The concurrent use of Glycopyrrolate Injection with other anticholinergics or medications with anticholinergic activity, such as phenothiazines, antiparkinson drugs, or tricyclic antidepressants, may intensify the antimuscarinic effects and may result in an increase in anticholinergic side effects.

Concomitant administration of Glycopyrrolate Injection and potassium chloride in a wax matrix may increase the severity of potassium chloride-induced gastrointestinal lesions as a result of a slower gastrointestinal transit time.

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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue telmisartan and amlodipine tablets as soon as possible

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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