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Telmisartan and Amlodipine 40 mg; 5 mg Tablet, 30-count — NDC 68180-0196-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Telmisartan and Amlodipine 40 mg; 5 mg Tablet, 30-count — NDC 68180-196-06 (Billing 68180-0196-06)

by Lupin Pharmaceuticals, Inc. · 30 TABLET in 1 BOTTLE

This is a package of 30 tablets of Telmisartan and Amlodipine 40 mg; 5 mg Tablet from Lupin Pharmaceuticals, Inc., no longer marketed (first marketed Jan 2014), no longer in the FDA NDC Directory; retail pharmacies pay about $2.67 per tablet (NADAC). It is the main listing for this product, which comes in 3 package sizes.

NDC 68180-0196-06
🏷️ FDA NDC (as labeled) 68180-196-06 billing pads the product segment with a zero
This package
Contains30-count Cost per ea$2.67 NADAC Per package$80.03 / 30 tablets Pack sizes3 compare ↓
Main listing for product 68180-196 · Also comes in: 10 tablets 68180-196-12 90 tablets 68180-196-09
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 68180-196-06 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68180 labeler · 196 product · 06 package
Listing certified through
Dec 31, 2026
Billing quantity
30 EA per package
Barcode (UPC)
0368180196068
FDA record last changed
Sep 10, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68180-196-06
Product NDC 68180-196
11-digit billing NDC 68180019606
NCPDP billing unit EA — each (per item)
RxCUI 876514, 876519, 876524, 876529
UNII 864V2Q084H, U5SYW473RQ
UPC 0368180196068
Application # ANDA201586
SPL Set ID a97fefa6-99e6-4eb7-9393-ab2252a2c7d8
Established class (EPC) Angiotensin 2 Receptor Blocker
Mechanism of action Angiotensin 2 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2014-01-08
Route ORAL
Dosage form TABLET
Substance TELMISARTAN; AMLODIPINE BESYLATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 36993002700320
GPI class Telmisartan-amLODIPine
GCN Seq No 065746
GCN 27783
HICL code 036697
Ingredient (HICL) Telmisartan/Amlodipine
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A4
Therapeutic class — intermediate (HIC2) Antihypertensives
HIC3 code A4H
Therapeutic class — specific (HIC3) Angiotensin Receptor Blockr-Calcium Channel Blockr
AHFS code 24:28.08.00
AHFS class Dihydropyridines
FDB label name TELMISARTAN-AMLODIPINE 40-5 MG
FDB brand name Telmisartan-Amlodipine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 065746
  • GCN: 27783
  • GPI-14 (Medi-Span): 36993002700320
  • HICL (First Databank): 036697
  • AHFS class code: 24:28.08.00
  • RxCUI (RxNorm): 876514
Why two NDCs? The FDA registers this code as 68180-196-06 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68180-0196-06. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Dihydropyridine Calcium Channel Blocker class.

Pharmacologic class Dihydropyridine Calcium Channel Blocker, Calcium Channel Blocker
Drug family (ATC) Renin-inhibitors, ACE inhibitors and calcium channel blockers, Dihydropyridine derivatives
How it works Calcium Channel Antagonists, Cytochrome P450 3A Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name TELMISARTAN-AMLODIPINE 40-5 MG Ingredient Telmisartan/Amlodipine

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $2.668 $80.03 / 30 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Jan 2024 $3.395 $2.668
▼ Down 21% over the last 2 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
68180-0196-06 You're viewing this Main listing 30 TABLET in 1 BOTTLE $2.67 / ea $80.03 2014-01-08 — Discontinued by firm
68180-0196-09 68180-196-09 90 TABLET in 1 BOTTLE — — 2014-01-08 — Active
68180-0196-12 68180-196-12 10 TABLET in 1 BLISTER PACK — — 2014-01-08 — Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 tablet in 1 bottle.
How does this package differ from NDC 68180-0196-12?
Both are Telmisartan and Amlodipine 40 mg; 5 mg Tablet — the drug itself is identical. This page's package is the 30-count one, while NDC 68180-0196-12 is the 10 tablets package.
What NDC number is used to bill for this package of Telmisartan and Amlodipine 40 mg; 5 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Telmisartan and Amlodipine 40 mg/1; 5 mgthis 68180-0196-06 Lupin 30 tablets $2.668 — Discontinued —
Telmisartan and Amlodipine 40 mg/1; 5 mg 00378-1075-93 Mylan 30 tablets $3.191 — Availability likely +20%
Telmisartan and Amlodipine 40 mg/1; 5 mg 46708-0184-08 Alembic 640 tablets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Yellow / Red
ShapeCapsule
ImprintLU;C57
Size8 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerLupin Pharmaceuticals, Inc.
Application holderLUPIN LTD
FDA applicationANDA201586 (ANDA)
Labeler code68180
First marketedJan 2014
Product typeHuman Prescription Drug
Portfolio404 products on file

More NDCs from Lupin Pharmaceuticals, Inc. labeler code 68180

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 115 words ▾

WARNING: FETAL TOXICITY WARNING: FATAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue telmisartan and amlodipine tablets as soon as possible ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 ) When pregnancy is detected, discontinue telmisartan and amlodipine tablets as soon as possible [see WARNING AND PRECAUTIONS ( 5.1 ) and USE IN SPECIFIC POPULATIONS ( 8.1 )]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see WARNING AND PRECAUTIONS ( 5.1 ) and USE IN SPECIFIC POPULATIONS ( 8.1 )] .

🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE Telmisartan and amlodipine tablet is an angiotensin II receptor blocker (ARB) and a dihydropyridine calcium channel blocker (DHP-CCB) combination product 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. ( 1 ) Telmisartan and amlodipine tablets are indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals ( 1 ) 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 like… [Excerpted — this section continues on DailyMed.]

⏱️ Dosage and Administration ~3 min read ▾

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 )

2.1General Considerations 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 [see ADVERSE REACTIONS ( 6.1 )]. Telmisartan and amlodipine tablets may be taken with or without food.

2.2Replacement Therapy Patients receiving amlodipine and telmisartan from separate tablets may instead receive telmisartan and amlodipine tablets containing the same component doses once daily. When substituting for individual components, increase the dose of telmisartan and amlodipine tablets if blood pressure control has not been satisfactory.

2.3Add-on Therapy for Patients with Hypertension Not Adequately Controlled on Antihypertensive Monotherapy Telmisartan and amlodipine tablets may be used 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. Patients treated with 10 mg amlodipine who experience any dose-limiting adverse reactions such as edema, may be switched to telmisartan and amlodipine tablets 40/5 mg once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response [see ADVERSE REACTIONS ( 6.1 )].

2.4Initial Therapy A patient may be initiated on telmisartan and amlodipine tablets if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose of telmisartan and amlodipine tablet is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started on telmisartan and amlodipine tablet 80/5 mg once daily.

Initial therapy with telmisartan and amlodipine tablet is not recommended in patients ≥75 years old or with hepatic impairment [see DOSAGE AND ADMINISTRATION ( 2.5 ), WARNINGS AND PRECAUTIONS ( 5.4 ) , and USE IN SPECIFIC POPULATIONS ( 8.5 , 8.6 )]. Correct imbalances of intravascular volume- or salt-depletion, before initiating therapy with telmisartan and amlodipine tablets [see WARNINGS AND PRECAUTIONS ( 5.2 )].

2.5Dosing in Specific Populations Renal Impairment No initial dosage adjustment is required for patients with mild or moderate renal impairment. Titrate slowly in patients with severe renal impairment. Hepatic Impairment In most patients, initiate amlodipine therapy at 2.5 mg. Ti… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 180 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 40/5 mg, 40/10 mg, 80/5 mg, 80/10 mg ( 3 ) Telmisartan and amlodipine tablets USP 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'.

⛔ Contraindications 86 words ▾

4 CONTRAINDICATIONS 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 in patients with diabetes ( 4 ) 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 )].

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Avoid fetal or neonatal exposure ( 5.1 ) Hypotension: Correct any volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension. Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis ( 5.2 ) Titrate slowly in patients with hepatic ( 5.4 ) or severe renal impairment ( 5.5 ) Heart failure: Monitor for worsening ( 5.8 ) Avoid concomitant use with an ACE inhibitor ( 5.6 ) Myocardial infarction: Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of telmisartan and amlodipine, particularly in patients with severe obstructive coronary artery disease ( 5.7 )

5.1Fetal Toxicity 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 [see USE IN SPECIFIC POPULATIONS ( 8.1 )].

5.2Hypotension Telmisartan In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of therapy with telmisartan and amlodipine tablets. Either correct this condition prior to administration of telmisartan and amlodipine tablets, or start treatment under close medical supervision with a reduced dose. If hypotension does occur, place the patient in the supine position and, if necessary, give an intravenous infusion of normal saline.

A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized. Amlodipine Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.

5.3Hyperkalemia Telmisartan Hyperkalemia may occur in patients on ARBs, particularly in patients with advanced renal impairment, heart failure, on renal replacement therapy, or on potassium supplements, potassium-sparing diuretics, potassium-containing salt substitutes or other drugs that increase potassium levels. Consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances, particularly in patients at risk.

5.4Patients with Impaired Hepatic Function Telmisartan As the majority of telmisartan is eliminated by biliary excretion, patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. Initiate telmisartan at low doses and titrate slowly in these patients [see DOSAGE AND ADMINISTRATION ( 2.5 ), USE IN SPECIFIC POPULATIONS ( 8.6 ), and CLINICAL PHARMACOLOGY ( 12.3 ) ]. Amlodipine Amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t 1/2 ) is 56 hours in patients with impaired hepatic function.

Since patients with hepatic impairment have decreased clearance of amlodipine, start amlodipine or add amlodipine at 2.5 mg in patients with hepatic impairment. The lowest dose of telmisartan and amlodipine tablet is 40/5 mg; therefore, initial therapy with telmisartan and amlodipine tablet is not recommended in hepatically impaired patients [see USE IN SPECIFIC POPULATIONS ( 8.6 )].

5.5Renal Function Impairment Telmisartan As a consequence of inhibiting the renin-angiotensin-aldosterone system, anticipate changes in renal function in susceptible individuals. In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure or renal dysfunction), treatment with angiotensin-conve… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

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% vs 2.2%), and back pain (2.2% vs 0%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 one year.

Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. In the placebo-controlled factorial design study, the population treated with a telmisartan and amlodipine combination had a mean age of 53 years and included approximately 50% males, 79% were Caucasian, 17% Blacks, and 4% Asians. Patients received doses ranging from 20/2.5 mg to 80/10 mg orally, once daily.

The frequency of adverse reactions was not related to gender, age, or race. The adverse reactions that occurred in the placebo-controlled factorial design trial in ≥2% of patients treated with telmisartan and amlodipine and at a higher incidence in telmisartan and amlodipine-treated patients (n=789) than placebo-treated patients (n=46) were peripheral edema (4.8% vs 0%), dizziness (3% vs 2.2%), and back pain (2.2% vs 0%). Edema (other than peripheral edema), hypotension, and syncope were reported in <2% of patients treated with telmisartan and amlodipine tablets.

In the placebo-controlled factorial design trial, discontinuation due to adverse events occurred in 2.2% of all treatment cells of patients in the telmisartan/amlodipine-treated patients and in 4.3% in the placebo-treated group. The most common reasons for discontinuation of therapy with telmisartan and amlodipine tablets were peripheral edema, dizziness, and hypotension (each ≤0.5%). Peripheral edema is a known, dose-dependent adverse reaction of amlodipine, but not of telmisartan.

In the factorial design study, the incidence of peripheral edema during the 8 week, randomized, double-blind treatment period was highest with amlodipine 10 mg monotherapy. The incidence was notably lower when telmisartan was used in combination with amlodipine 10 mg. Table 1: Incidence of Peripheral Edema During the 8 Week Treatment Period Telmisartan Placebo 40 mg 80 mg Amlodipine Placebo 5 mg 10 mg 0% 0.7% 17.8% 0.8% 1.4% 6.2% 0.7% 2.1% 11.3% Telmisartan 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 only infrequently required discontinuation of therapy. In placebo-controlled trials involving 1041 patients treated with various doses of telmisartan (20 to 160 mg) monotherapy for up to 12 weeks, an overall incidence of adverse events was similar to the patients treated with placebo. Adverse events occurring at an incidence of ≥1% in patients treated with telmisartan and at a greater rate than in patients treated with placebo, irrespective of their causal association, are presented in Table 2.

Table 2: Adverse Events Occurring at an Incidence o… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

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 in patients with diabetes ( 7.2 )

7.1Drug 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:

7.2Drug 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 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 function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving telmisartan and NSAID therapy.

The antihypertensive effect of angiotensin II receptor antagonists, including telmisartan may be attenuated by NSAIDs including selective COX-2 inhibitors.

7.3Drug Interactions with Amlodipine In clinical trials, amlodipine has been safely administered with thiazide diuretics, beta-blockers, angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs. Simvastatin Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.

Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring of trough blood levels of cyclosporin and tacrolimus and dose adjustment when appropriate is recommended. The following have no clinically relevant effects on the pharmacokinetics of amlodipine: cimetidine, grapefruit juice, magnesium and aluminum hydroxide antacid, sildenafil.

Amlodipine has no clinically relevant effects on the pharmacokinetics or pharmacodynamics of the following: atorvastatin, digoxin, warfarin. CYP3A4 Inhibitors Co-administration of a 180 mg daily dose of diltiazem with 5 mg amlodipine in elderly hypertensive patients resulted in a 60% increase in amlodipine systemic exposure. Erythromycin co-administration in healthy volunteers did not significantly change amlodipine systemic exposure.

However, strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of amlodipine to a greater extent. Monitor for symptoms of hypotension and edema when amlodipine is co-adminis… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Patients ≥75 years of age or hepatically impaired patients: Start with amlodipine or add amlodipine 2.5 mg to telmisartan ( 2.5 , 8.5 , 8.6 ) Lactation: Do not breastfeed during treatment with telmisartan and amlodipine tablets ( 8.2 )

8.1Pregnancy Risk Summary Telmisartan and amlodipine tablets can cause fetal harm when administered to a pregnant woman. 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 (see Clinical Considerations) . Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.

Studies in rats and rabbits with telmisartan showed fetotoxicity only at maternally toxic doses (see Data) . In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine maleate during organogenesis at doses approximately 10 and 20-times the maximum recommended human dose (MRHD), respectively. However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold).

Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose ( see Data ). When pregnancy is detected, discontinue telmisartan and amlodipine tablets as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major malformations and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk: Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage).

Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal adverse reactions: Use of drugs that act on the RAS in the second and third trimesters of pregnancy can result in the following: oligohydramnios, reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death.

In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. In patients taking telmisartan and amlodipine tablets during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation.

If oligohydramnios is observed, discontinue telmisartan and amlodipine tablets, unless it is considered lifesaving for the mother. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to telmisartan and amlodipine tablets for hypotension, oliguria, and hyperkalemia.

If oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function [see USE IN SPECIFIC POPULATIONS ( 8.4 )] . Data Animal Data: No reproductive toxicity studies have been conducted with the combination of telmisartan and amlodipine besylate.

Ho… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Telmisartan and amlodipine tablets can cause fetal harm when administered to a pregnant woman. 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 (see Clinical Considerations) . Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.

Studies in rats and rabbits with telmisartan showed fetotoxicity only at maternally toxic doses (see Data) . In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine maleate during organogenesis at doses approximately 10 and 20-times the maximum recommended human dose (MRHD), respectively. However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold).

Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose ( see Data ). When pregnancy is detected, discontinue telmisartan and amlodipine tablets as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major malformations and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk: Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage).

Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal adverse reactions: Use of drugs that act on the RAS in the second and third trimesters of pregnancy can result in the following: oligohydramnios, reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death.

In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. In patients taking telmisartan and amlodipine tablets during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation.

If oligohydramnios is observed, discontinue telmisartan and amlodipine tablets, unless it is considered lifesaving for the mother. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to telmisartan and amlodipine tablets for hypotension, oliguria, and hyperkalemia.

If oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function [see USE IN SPECIFIC POPULATIONS ( 8.4 )] . Data Animal Data: No reproductive toxicity studies have been conducted with the combination of telmisartan and amlodipine besylate.

However, these studies have been conducted for telmisartan and amlodipine besylate alone. Telmisartan: No teratogenic effects were observed when telmisartan was administered to pregnant rats at oral doses of up to 50 mg/kg/day and to pregnant rabbits at oral doses up… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 60 words ▾

8.4Pediatric Use Safety and effectiveness of telmisartan and amlodipine tablets in pediatric patients have not been established. Neonates with a history of in utero exposure to telmisartan and amlodipine If oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use Telmisartan and Amlodipine Tablets Of the total number of 3282 hypertensive patients receiving a telmisartan/amlodipine combination in clinical studies, 605 (18%) patients were 65 years of age or older and of these, 88 (3%) patients were 75 years and older. No overall differences in efficacy or safety of telmisartan and amlodipine tablets were observed in this patient population. Telmisartan Of the total number of patients receiving telmisartan in clinical studies, 551 (18.6%) were 65 to 74 years of age and 130 (4.4%) were 75 years and older.

No overall differences in effectiveness and safety were observed in these patients compared to younger patients and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Amlodipine Clinical studies of amlodipine besylate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approximately 40% to 60%, and a lower initial dose may be required. Since patients age 75 and older have decreased clearance of amlodipine, start amlodipine or add amlodipine 2.5 mg to telmisartan.

The lowest dose of telmisartan and amlodipine tablet is 40/5 mg; therefore, initial therapy with telmisartan and amlodipine tablets is not recommended in patients 75 years of age and older [see DOSAGE AND ADMINISTRATION ( 2.5 )].

🆘 Overdosage 209 words ▾

10 OVERDOSAGE 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/m 2 basis) 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.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action 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 1 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 2 receptor found in many tissues, but AT 2 is not known to be associated with cardiovascular homeostasis. Telmisartan has much greater affinity (>3,000 fold) for the AT 1 receptor than for the AT 2 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 in vitro 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.

12.2Pharmacodynamics Telmisartan and Amlodipine Tablets Telmisartan and amlodipine tablets have been shown to be effective in lowering blood pressure. Telmisartan and amlodipine tablet is a combination of two drugs with antihypertensive properties: a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker), amlodipine besylate, and an angiotensin II receptor blocker, telmisartan. Both telmisartan and amlodipine lower blood pressure by reducing peripheral resistance but through complementary mechanisms.

Telmisartan In normal volunteers, a dose of telmisartan 80 mg inhibited the pressor response to an intravenous infusion of angiotensin II by about 90% at peak plasma concentrations with approximately 40% inhibition persisting for 24 hours. Plasma concentration of angiotensin II and plasma renin activity (PRA) increased in a dose-dependent manner after single administration of telmisartan to hea… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action ~2 min read ▾

12.1Mechanism of Action 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 1 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 2 receptor found in many tissues, but AT 2 is not known to be associated with cardiovascular homeostasis. Telmisartan has much greater affinity (>3,000 fold) for the AT 1 receptor than for the AT 2 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 in vitro 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.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Telmisartan and amlodipine tablets USP are available as 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'. Telmisartan and amlodipine tablets USP are supplied for oral administration in the following strengths and package configurations: Tablet strength ( telmisartan / amlodipine besylate equivalent to amlodipine ) mg Package Configuration NDC # 40 mg/5 mg Bottles of 30 Bottles of 90 A box containing 100 Tablets (10 X 10 unit-dose) 68180-196-06 68180-196-09 68180-196-13 40 mg/10 mg Bottles of 30 Bottles of 90 A box containing 100 Tablets (10 X 10 unit-dose) 68180-197-06 68180-197-09 68180-197-13 80 mg/5 mg Bottles of 30 Bottles of 90 A box containing 100 Tablets (10 X 10 unit-dose) 68180-198-06 68180-198-09 68180-198-13 80 mg/10 mg Bottles of 30 Bottles of 90 A box containing 100 Tablets (10 X 10 unit-dose) 68180-199-06 68180-199-09 68180-199-13 Storage Store 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.

📋 Description ~1 min read ▾

11 DESCRIPTION Telmisartan and amlodipine tablet USP is a fixed dose combination of telmisartan and amlodipine. Telmisartan and amlodipine tablets USP contain telmisartan, a non-peptide angiotensin II receptor (type AT 1 ) 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 C 33 H 30 N 4 O 2 and its structural formula is: Telmisartan and amlodipine tablets USP 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 C 20 H 25 ClN 2 O 5 •C 6 H 6 O 3 S and its structural formula is: Telmisartan and amlodipine tablets USP 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 USP 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 USP are hygroscopic and require protection from moisture. Telmisartan and amlodipine tablets USP require protection from light. t am

💬 Information for Patients 163 words ▾

17 PATIENT COUNSELING INFORMATION 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 and amlodipine tablets during pregnancy. Discuss treatment options with women planning to become pregnant.

Tell patients should be asked to report pregnancies to their physicians as soon as possible [see WARNINGS AND PRECAUTIONS ( 5.1 ) and USE IN SPECIFIC POPULATIONS ( 8.1 )]. Lactation Advise nursing women not to breastfeed during treatment with telmisartan and amlodipine tablets [see USE IN SPECIFIC POPULATIONS ( 8.2 )]. Symptomatic Hypotension 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 [see WARNINGS AND PRECAUTIONS ( 5.2 )] .

🍼 Nursing Mothers 143 words ▾

8.2Lactation Risk Summary There is no information regarding the presence of telmisartan and amlodipine tablets or telmisartan in human milk, the effects on the breastfed infant, or the effects on milk production. Limited published studies report that amlodipine is present in human milk. However, there is insufficient information to determine the effects of amlodipine on the breastfed infant.

There is no available information on the effects of amlodipine on milk production. Telmisartan is present in the milk of lactating rats (see Data) . Because of the potential for serious adverse reactions in the breastfed infant including hypotension, hyperkalemia and renal impairment, advise a nursing woman not to breastfeed during treatment with telmisartan and amlodipine tablets.

Data: Telmisartan was present in the milk of lactating rats at concentrations 1.5 to 2 times those found in plasma from 4 to 8 hours after administration.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Telmisartan and Amlodipine Tablets The pharmacokinetics of amlodipine and telmisartan when combined are similar to the pharmacokinetics of amlodipine and telmisartan when administered separately. After administering telmisartan and amlodipine tablets 80/10 mg with a high-fat meal, the total area under the plasma concentration-time curve (AUC) and C max for telmisartan decreased by about 24% and 60%, respectively. For amlodipine, AUC and C max were not altered [see DOSAGE AND ADMINISTRATION ( 2.1 )].

Telmisartan Following oral administration, peak concentrations (C max ) of telmisartan are reached in 0.5 to 1 hour after dosing. Food slightly reduces the bioavailability of telmisartan, with a reduction in the area under the plasma concentration-time curve (AUC) of about 6% with the 40 mg tablet and about 20% after a 160 mg dose. The absolute bioavailability of telmisartan is dose dependent.

At 40 and 160 mg the bioavailability was 42% and 58%, respectively. The pharmacokinetics of orally administered telmisartan are nonlinear over the dose range 20 to 160 mg, with greater than proportional increases of plasma concentrations (C max and AUC) with increasing doses. Telmisartan shows bi-exponential decay kinetics with a terminal elimination half life of approximately 24 hours.

Trough plasma concentrations of telmisartan with once daily dosing are about 10% to 25% of peak plasma concentrations. Telmisartan has an accumulation index in plasma of 1.5 to 2.0 upon repeated once daily dosing. Amlodipine Peak plasma concentrations of amlodipine are reached 6 to 12 hours after administration of amlodipine alone.

Absolute bioavailability has been estimated to be between 64% and 90%. The bioavailability of amlodipine is not altered by the presence of food. Elimination of amlodipine from the plasma is biphasic with a terminal elimination half-life of about 30 to 50 hours.

Steady state plasma levels of amlodipine are reached after 7 to 8 days of consecutive daily dosing. Distribution Telmisartan: Telmisartan is highly bound to plasma proteins (>99.5%), mainly albumin and α 1 - acid glycoprotein. Plasma protein binding is constant over the concentration range achieved with recommended doses.

The volume of distribution for telmisartan is approximately 500 liters indicating additional tissue binding. Amlodipine: The apparent volume of distribution of amlodipine is 21 L/kg. Approximately 93% of circulating amlodipine is bound to plasma proteins in hypertensive patients.

Metabolism and Elimination Telmisartan: Following either intravenous or oral administration of 14 C-labeled telmisartan, most of the administered dose (>97%) was eliminated unchanged in feces via biliary excretion; only minute amounts were found in the urine (0.91% and 0.49% of total radioactivity, respectively). Telmisartan is metabolized by conjugation to form a pharmacologically inactive acylglucuronide; the glucuronide of the parent compound is the only metabolite that has been identified in human plasma and urine.

After a single dose, the glucuronide represents approximately 11% of the measured radioactivity in plasma. The cytochrome P450 isoenzymes are not involved in the metabolism of telmisartan. Total plasma clearance of telmisartan is >800 mL/min.

Terminal half-life and total clearance appear to be independent of dose. Amlodipine: Amlodipine is extensively (about 90%) converted to inactive metabolites via hepatic metabolism with 10% of the parent compound and 60% of the metabolites excreted in the urine. Specific Populations Renal Insufficiency: Telmisartan No dosage adjustment is necessary in patients with decreased renal function.

Telmisartan is not removed from blood by hemofiltration [see WARNINGS AND PRECAUTIONS ( 5.5 )]. Amlodipine The pharmacokinetics of amlodipine are not significantly influenced by renal impairment. Patients with renal failure may therefore receive the usual initial dose.

Hepatic Insufficiency: Telmisartan In patients with he… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~3 min read ▾

12.2Pharmacodynamics Telmisartan and Amlodipine Tablets Telmisartan and amlodipine tablets have been shown to be effective in lowering blood pressure. Telmisartan and amlodipine tablet is a combination of two drugs with antihypertensive properties: a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker), amlodipine besylate, and an angiotensin II receptor blocker, telmisartan. Both telmisartan and amlodipine lower blood pressure by reducing peripheral resistance but through complementary mechanisms.

Telmisartan In normal volunteers, a dose of telmisartan 80 mg inhibited the pressor response to an intravenous infusion of angiotensin II by about 90% at peak plasma concentrations with approximately 40% inhibition persisting for 24 hours. Plasma concentration of angiotensin II and plasma renin activity (PRA) increased in a dose-dependent manner after single administration of telmisartan to healthy subjects and repeated administration to hypertensive patients. The once-daily administration of up to 80 mg telmisartan to healthy subjects did not influence plasma aldosterone concentrations.

In multiple dose studies with hypertensive patients, there were no clinically significant changes in electrolytes (serum potassium or sodium), or in metabolic function (including serum levels of cholesterol, triglycerides, HDL, LDL, glucose, or uric acid). In 30 hypertensive patients with normal renal function treated for 8 weeks with telmisartan 80 mg or telmisartan 80 mg in combination with hydrochlorothiazide 12.5 mg, there were no clinically significant changes from baseline in renal blood flow, glomerular filtration rate, filtration fraction, renovascular resistance, or creatinine clearance.

Telmisartan has indications other than hypertension which can be found in the Micardis ® (telmisartan) tablets package insert. Amlodipine Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilation resulting in a reduction of supine and standing blood pressures. These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing.

Although the acute intravenous administration of amlodipine decreases arterial blood pressure and increases heart rate in hemodynamic studies of patients with chronic stable angina, chronic oral administration of amlodipine in clinical trials did not lead to clinically significant changes in heart rate or blood pressures in normotensive patients with angina. With chronic once daily administration, antihypertensive effectiveness is maintained for at least 24 hours. Plasma concentrations correlate with effect in both young and elderly patients.

The magnitude of reduction in blood pressure with amlodipine is also correlated with the height of pretreatment elevation; thus, individuals with moderate hypertension (diastolic pressure 105 to 114 mmHg) had about a 50% greater response than patients with mild hypertension (diastolic pressure 90 to 104 mmHg). Normotensive subjects experienced no clinically significant change in blood pressure (+1/-2 mmHg). In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow without change in filtration fraction or proteinuria.

As with other calcium channel blockers, hemodynamic measurements of cardiac function at rest and during exercise (or pacing) in patients with normal ventricular function treated with amlodipine have generally demonstrated a small increase in cardiac index without significant influence on dP/dt or on left ventricular end diastolic pressure or volume. In hemodynamic studies, amlodipine has not been associated with a negative inotropic effect when administered in the therapeutic dose range to intact animals and man, even when co-administered with beta-blockers to man.

Similar… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Telmisartan and Amlodipine Tablets The efficacy of telmisartan and amlodipine tablets for treatment of hypertension was studied in 1 placebo-controlled and 2 active-controlled trials. An 8-week multicenter, randomized, double-blind, placebo-controlled, parallel group factorial study in patients with mild to severe hypertension was conducted to determine if treatment with telmisartan and amlodipine tablet was more effective in reducing blood pressure compared to the respective monotherapies. The study randomized 1461 patients with baseline systolic blood pressure between 117 and 179 mmHg (mean 153 mmHg) and a baseline diastolic blood pressure between 90 and 119 (mean 102 mmHg) to one of the 16 treatment arms.

Patients assigned to receive amlodipine 10 mg started on amlodipine 5 mg or combinations thereof for the first two weeks. The four key treatment combinations (including combinations of telmisartan 40 or 80 mg and amlodipine 5 or 10 mg) had statistically significant reduction in in-clinic seated trough cuff systolic and diastolic blood pressure compared to the respective individual monotherapies (Table 5). Table 5: Placebo-Subtracted Mean Change from Baseline in Seated Systolic/Diastolic Blood Pressure (mmHg): Combination Therapy vs Monotherapy Components Header$ Amlodipine, mg Telmisartan, mg 0 40 80 0 — -12.1/-7.2 -11.8/-7.8 5 -12.9/-7.2 -19.3/-10.3 -19.6/-12.0 10 -18.2/-10.9 -22.2/-14.0 -23.9/-13.9 The majority of the antihypertensive effect of the telmisartan/amlodipine combination was attained within 2 weeks after initiation of therapy.

In patients receiving a telmisartan/amlodipine combination significantly larger reductions in seated diastolic and systolic blood pressure compared to patients treated with the respective monotherapies were observed at every assessment (Week 2, 4, 6, and 8). The antihypertensive effect of telmisartan and amlodipine tablets was similar in patients ≥65 years than below 65 years of age, in male and female patients, and in patients with and without diabetes. The magnitude of blood pressure lowering in black patients approached that observed in non-black patients but the number of black patients was limited (237 of 1461 patients).

Automated ambulatory blood pressure monitoring (ABPM) performed in a subset of 562 patients confirmed the results seen with in-clinic systolic and diastolic blood pressure reductions over the entire 24-hour dosing period. In a double-blind, active-controlled study, a total of 1097 patients with mild to severe hypertension (mean baseline systolic/diastolic BP 149.5/96.6 mmHg) who were not adequately controlled on amlodipine 5 mg received telmisartan and amlodipine (40/5 mg or 80/5 mg) or amlodipine alone (5 mg or 10 mg).

After 8 weeks administration, each of the combination treatments was statistically significantly superior to both amlodipine monotherapy doses in reducing diastolic and systolic blood pressures. Edema related events (peripheral edema, generalized edema, and edema) in patients who received telmisartan and amlodipine (40/5 mg or 80/5 mg) were significantly lower as compared to patients who received amlodipine 10 mg (4.3% vs 27.2%, respectively). Table 6: Effect on Seated Systolic/Diastolic Blood Pressure: Combination Therapy vs Monotherapy 1 p<0.05 2 Mean change from baseline at Week 8 in seated systolic/diastolic blood pressure Header$ Treatment Group Mean Change 2 Difference from amlodipine 5 mg Difference from amlodipine 10 mg Telmisartan and amlodipine 40/5 mg; n=270 -13.6 / -9.4 -7.4 1 / - 3.6 1 -2.4 1 / -1.4 1 Telmisartan and amlodipine 80/5 mg; n=271 -15.0 / -10.6 -8.8 1 / -4.9 1 -3.9 1 / -2.7 1 Amlodipine 5 mg; n=255 -6.2 / -5.7 ---- ---- Amlodipine 10 mg; n=261 -11.1 / -8.0 ---- ---- In a second double-blind, active-controlled study, a total of 947 patients with mild to severe hypertension (mean baseline systolic/diastolic BP 147.5/95.6 mmHg) who were not adequately controlled on amlodipine 10 mg received telmisartan… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility 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/m 2 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 2 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). Amlodipine Rats and mice treated with amlodipine maleate in the diet for up to two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg amlodipine/kg/day, showed no evidence of a carcinogenic effect of the drug. For the mouse, the highest dose was, on mg/m 2 basis, similar to the maximum recommended human dose [MRHD] of 10 mg amlodipine/day.

For the rat, the highest dose was, on a mg/m 2 basis, about two and a half times the MRHD. (Calculations based on a 60 kg patient.) Mutagenicity studies conducted with amlodipine maleate revealed no drug-related effects at either the gene or chromosome level. There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses of up to 10 mg amlodipine/kg/day (about 10 times the MRHD of 10 mg/day on a mg/m 2 basis).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility 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/m 2 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 2 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). Amlodipine Rats and mice treated with amlodipine maleate in the diet for up to two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg amlodipine/kg/day, showed no evidence of a carcinogenic effect of the drug. For the mouse, the highest dose was, on mg/m 2 basis, similar to the maximum recommended human dose [MRHD] of 10 mg amlodipine/day.

For the rat, the highest dose was, on a mg/m 2 basis, about two and a half times the MRHD. (Calculations based on a 60 kg patient.) Mutagenicity studies conducted with amlodipine maleate revealed no drug-related effects at either the gene or chromosome level. There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses of up to 10 mg amlodipine/kg/day (about 10 times the MRHD of 10 mg/day on a mg/m 2 basis).

📄 Patient Package Insert ~3 min read ▾

Patient Information Telmisartan and Amlodipine Tablets, (TEL-mi-SAR-tan And am-LOE-di-peen) 40 mg/5 mg, 40 mg/ 10 mg, 80 mg/5 mg and 80 mg /10 mg Rx only Read this Patient Information before you start taking telmisartan and amlodipine 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 Amlodipine Tablets? Telmisartan and amlodipine tablets 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 amlodipine tablets, tell your doctor right away. What is Telmisartan and Amlodipine Tablet? Telmisartan and amlodipine tablet is a prescription medicine that contains telmisartan and amlodipine.

Telmisartan and amlodipine tablets may be used to treat high blood pressure (hypertension): when one of these medicines (or a similar one) is not enough to lower your high blood pressure as the first medicine to lower your high blood pressure if your doctor decides you are likely to need more than one medicine It is not known if telmisartan and amlodipine tablets are safe and effective in children. Who should not take Telmisartan and Amlodipine Tablets? You should not take telmisartan and amlodipine tablets if you are allergic (hypersensitive) to the active ingredients (telmisartan or amlodipine) or any of the other ingredients listed at the end of this leaflet.

For patients with diabetes, if you are taking telmisartan and amlodipine tablets you should not take aliskiren. What should I tell my doctor before taking Telmisartan and Amlodipine Tablets? Before you take telmisartan and amlodipine tablets, tell your doctor if you: are pregnant or are planning to become pregnant.

See " What is the most important information I should know about Telmisartan and Amlodipine Tablets ?" are breast-feeding or plan to breast-feed. Telmisartan and amlodipine tablets can pass into your breast milk and may harm your baby. You and your doctor should decide if you will take telmisartan and amlodipine tablets or breast-feed.

You should not do both. Talk with your doctor about the best way to feed your baby if you take telmisartan and amlodipine tablets. have liver problems have kidney problems have heart problems have any other medical conditions Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. For patients with diabetes, if you are taking telmisartan and amlodipine tablets you should not take aliskiren.

Telmisartan and amlodipine tablets may affect the way other medicines work, and other medicines may affect how telmisartan and amlodipine tablets works. Especially tell your doctor if you take: aliskiren digoxin (Lanoxin ® ) lithium (Lithobid®, lithium carbonate, lithium citrate) aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) other medicines that may be used to treat high blood pressure or a heart problem simvastatin (Zocor ® , Vytorin ® ) water pills (diuretics) 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 Amlodipine Tablets? Take telmisartan and amlodipine tablets exactly as your doctor tells you to take it. Your doctor will tell you how much telmisartan and amlodipine tablets to take and when to take it.

Your doctor may change your dose if needed. Take telmisartan and amlodipine tablets one time each day at the same time. Take telmisartan and amlodipine tablets with or without food.

If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time.

If you take too much telmisartan and amlodipine tablets, call your doctor or go to… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 71 words ▾

PRINCIPAL DISPLAY PANEL TELMISARTAN AND AMLODIPINE TABLETS Rx Only 40 mg/5 mg NDC 68180-196-06 A Bottle of 30 tablets TELMISARTAN AND AMLODIPINE TABLETS Rx Only 40 mg/10 mg NDC 68180-197-06 A Bottle of 30 tablets TELMISARTAN AND AMLODIPINE TABLETS Rx Only 80 mg/5 mg NDC 68180-198-06 A Bottle of 30 tablets TELMISARTAN AND AMLODIPINE TABLETS Rx Only 80 mg/10 mg NDC 68180-199-06 A Bottle of 30 tablets p 2 c g

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 10 tablets (68180-0196-12), 90 tablets (68180-0196-09). Each has its own NDC and its own page — see the package list near the top of this page.
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← 68180-0195-06 · Lupin 68180-0197-06 · Lupin →
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