Telmisartan and Amlodipine

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Substitute telmisartan and amlodipine tablets for its individually titrated components for patients on amlodipine and telmisartan.
• Telmisartan and amlodipine tablets may also be given with increased amounts of amlodipine, telmisartan, or both, as needed.
• ( 2.2 , 2.3 ) Use telmisartan and amlodipine tablets to provide additional blood pressure lowering for patients not adequately controlled with amlodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone ( 2.3 ) Dosage may be increased after at least 2 weeks to a maximum dose of 80/10 mg once daily, usually by increasing one component at a time but both components can be raised to achieve more rapid control ( 2.1 , 2.2 ) Majority of antihypertensive effect is attained within 2 weeks ( 2.1 ) Initiate with 40/5 mg or 80/5 mg once daily ( 2.4 ) Switch patients who experience dose-limiting adverse reactions on amlodipine to telmisartan and amlodipine tablets containing a lower dose of that component ( 2.3 )
• 2.1 General Considerations Telmisartan is an effective treatment of hypertension in once daily doses of 20 to 80 mg while amlodipine is 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.
• 2.2 Replacement 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.
• 2.3 Add-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 )].
• 2.4 Initial 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 )].
• 2.5 Dosing 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.
• Titrate slowly in patients with hepatic impairment.
• Patients 75 Years of Age and Older In most patients, initiate amlodipine therapy at 2.5 mg.
• Titrate slowly in patients 75 years of age and older.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• 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.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• 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 )].

Quoted from the official label, section “Geriatric Use”.

Side effects

• 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.
• 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
• Telmisartan and Amlodipine Tablets The concomitant use of telmisartan and amlodipine has been evaluated for safety in more than 3700 patients with hypertension; approximately 1900 of these patients were exposed for at least 6 months and over 160 of these patients were exposed for at least 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 of ≥1% in Patients Treated with Telmisartan and at a Greater Rate than Patients Treated with Placebo Telmisartan n = 1455 % Placebo n = 380 % Upper respiratory tract infection 7 6 Back pain 3 1 Sinusitis 3 2 Diarrhea 3 2 Pharyngitis 1 0 In addition to the adverse events in the table, the following events occurred at a rate of ≥1% but were at least as frequent in the placebo group:
• influenza-like symptoms, dyspepsia, myalgia, urinary tract infection, abdominal pain, headache, dizziness, pain, fatigue, coughing, hypertension, chest pain, nausea, and peripheral edema.
• Discontinuation of therapy because of adverse events was required in 2.8% of 1455 patients treated with telmisartan tablets and 6.1% of 380 placebo patients in placebo-controlled clinical trials.
• The incidence of adverse events was not dose-related and did not correlate with gender, age, or race of patients.
• The incidence of cough occurring with telmisartan in 6 placebo-controlled trials was identical to that noted for placebo-treated patients (1.6%).
• In addition to those listed above, adverse events that occurred in >0.3% of 3500 patients treated with telmisartan monotherapy in controlled or open trials are listed below.
• It cannot be determined whether these events were causally related to telmisartan tablets:
• Autonomic Nervous System:
• Impotence, increased sweating, flushing Body as a Whole:
• Allergy, fever, leg pain, malaise Cardiovascular:
• Palpitation, dependent edema, angina pectoris, tachycardia, leg edema, abnormal ECG CNS:
• Insomnia, somnolence, migraine, vertigo, paresthesia, involuntary muscle contractions, hypoesthesia Gastrointestinal:
• Flatulence, constipation, gastritis, vomiting, dry mouth, hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache, non specific gastrointestinal disorders Metabolic:
• Gout, hypercholesterolemia, diabetes mellitus Musculoskeletal:
• Arthritis, arthralgia, leg cramps Psychiatric:
• Anxiety, depression, nervousness Resistance Mechanism:
• Infection, fungal infection, abscess, otitis media Respiratory:
• Asthma, bronchitis, rhinitis, dyspnea, epistaxis Skin:
• Dermatitis, rash, eczema, pruritus Urinary:
• Micturition frequency, cystitis Vascular:
• Cerebrovascular disorder Special Senses:
• Abnormal vision, conjunctivitis, tinnitus, earache.
• During initial clinical studies, a single case of angioedema was reported (among a total of 3781 patients treated).
• Clinical Laboratory Findings:
• In placebo-controlled clinical trials, clinically relevant changes in standard laboratory test parameters were rarely associated with administration of telmisartan tablets.
• Hemoglobin A greater than 2 g/dL decrease in hemoglobin was observed in 0.8% telmisartan patients compared with 0.3% placebo patients.
• No patients discontinued therapy due to anemia.
• Creatinine A 0.5 mg/dL rise or greater in creatinine was observed in 0.4% telmisartan patients compared with 0.3% placebo patients.
• One telmisartan-treated patient discontinued therapy due to increases in creatinine and blood urea nitrogen.
• Liver Enzymes Occasional elevations of liver chemistries occurred in patients treated with telmisartan; all marked elevations occurred at a higher frequency with placebo.
• No telmisartan-treated patients discontinued therapy due to abnormal hepatic function.
• Amlodipine Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials.
• Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity.
• In controlled clinical trials directly comparing amlodipine (n=1730) in doses up to 10 mg to placebo (n=1250), discontinuation of amlodipine due to adverse reactions was required in only about 1.5% of amlodipine-treated patients and was not significantly different from that seen in placebo-treated patients (about 1%).
• The most common side effects were headache and edema.
• The incidence (%) of side effects which occurred in a dose-related manner are presented in Table 3.
• Table 3:
• Incidence (%) of Dose-Related Adverse Effects with Amlodipine at Doses of 2.5 mg, 5.0 mg, and 10.0 mg or Placebo Header Adverse Event Amlodipine 2.5 mg n=275 % Amlodipine 5.0 mg n=296 % Amlodipine 10.0 mg n=268 % Placebo n=520 % Edema 1.8 3.0 10.8
• 0.6 Dizziness 1.1 3.4 3.4
• 1.5 Flushing 0.7 1.4 2.6
• 0.0 Palpitations 0.7 1.4 4.5
• 0.6 Other adverse experiences which were not clearly dose related but which were reported with an incidence greater than 1% in placebo-controlled clinical trials are presented in Table 4.
• Table 4:
• Incidence (%) of Adverse Effects Not Clearly Dose Related but Reported at an Incidence of >1% in Placebo-Controlled Clinical Trials Adverse Event Amlodipine n = 1730 % Placebo n = 1250 % Headache 7.3
• 7.8 Fatigue 4.5
• 2.8 Nausea 2.9
• 1.9 Abdominal pain 1.6
• 0.3 Somnolence 1.4
• 0.6 The following events occurred in <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:
• Cardiovascular:
• Arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, syncope, tachycardia, postural dizziness, postural hypotension, vasculitis Central and Peripheral Nervous System:
• Hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo Gastrointestinal:
• Anorexia, constipation, dyspepsia,** dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia, change of bowel habit General:
• Allergic reaction, asthenia,** back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease Musculoskeletal System:
• Arthralgia, arthrosis, muscle cramps,** myalgia Psychiatric:
• Sexual dysfunction (male** and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization, mood change Respiratory System:
• Dyspnea,** epistaxis Skin and Appendages:
• Angioedema, erythema multiforme, pruritus,** rash,** rash erythematous, rash maculopapular Special Senses:
• Abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus Urinary System:
• Micturition frequency, micturition disorder, nocturia Autonomic Nervous System:
• Dry mouth, sweating increased Metabolic and Nutritional:
• Hyperglycemia, thirst Hemopoietic:
• Leukopenia, purpura, thrombocytopenia. **These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies.
• The following events occurred in <0.1% of patients:
• cardiac failure, pulse irregularity, extrasystoles, skin discoloration, urticaria, skin dryness, alopecia, dermatitis, muscle weakness, twitching, ataxia, hypertonia, migraine, cold and clammy skin, apathy, agitation, amnesia, gastritis, increased appetite, loose stools, coughing, rhinitis, dysuria, polyuria, parosmia, taste perversion, abnormal visual accommodation, and xerophthalmia.
• Other reactions occurred sporadically and cannot be distinguished from medications or concurrent disease states such as myocardial infarction and angina.
• Amlodipine has not been associated with clinically significant changes in routine laboratory tests.
• No clinically relevant changes were noted in serum potassium, serum glucose, total triglycerides, total cholesterol, HDL cholesterol, uric acid, blood urea nitrogen, or creatinine.
• Amlodipine has been used safely in patients with chronic obstructive pulmonary disease, well-compensated congestive heart failure, coronary artery disease, peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles.
• Adverse reactions reported for amlodipine for indications other than hypertension may be found in the prescribing information for Norvasc ® .
• 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of telmisartan or amlodipine.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.
• Decisions to include these reactions in labeling are typically based on one or more of the following factors:
• (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to telmisartan or amlodipine.
• Telmisartan The most frequently spontaneously reported events include:
• headache, dizziness, asthenia, coughing, nausea, fatigue, weakness, edema, face edema, lower limb edema, angioneurotic edema, urticaria, hypersensitivity, sweating increased, erythema, chest pain, atrial fibrillation, congestive heart failure, myocardial infarction, blood pressure increased, hypertension aggravated, hypotension (including postural hypotension), hyperkalemia, syncope, dyspepsia, diarrhea, pain, urinary tract infection, erectile dysfunction, back pain, abdominal pain, muscle cramps (including leg cramps), myalgia, bradycardia, eosinophilia, thrombocytopenia, uric acid increased, abnormal hepatic function/liver disorder, renal impairment including acute renal failure, anemia, and increased CPK, anaphylactic reaction, tendon pain (including tendonitis, tenosynovitis), drug eruption (e.g. toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), hypoglycemia (in diabetic patients), and angioedema (with fatal outcome).
• Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers, including telmisartan.
• Amlodipine Gynecomastia has been reported infrequently and a causal relationship is uncertain.
• Jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine.
• Postmarketing reporting has also revealed a possible association between extrapyramidal disorder and amlodipine.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 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 )] .

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• 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'.

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 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.

Quoted from the official label, section “How Supplied”.

What is in it

• 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

Quoted from the official label, section “Description”.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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