TWYNSTA® FOR HEALTHCARE PROFESSIONALS — Twynsta (telmisartan/amlodipine) tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents. They may be used in patients whose blood pressure is not adequately controlled on antihypertensive monotherapy. TWYNSTA tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. Read full indication statement Twynsta Home Important Safety Information Prescribing Information Side Effects & Safety Information — Amlodipine — Safety

Amlodipine Safety

Review safety data for amlodipine—A component of TWYNSTA, a fixed-dose ARB/CCB combining telmisartan and amlodipine for the treatment of hypertension

Review safety data for amlodipine—a component of TWYNSTA, the only ARB/CCB combining telmisartan and amlodipine for the treatment of hypertension
Amlodipine has been evaluated for safety in more than 11,000 patients in US 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 is presented in the following table.


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 the following table.


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, peripheral neuropathy, paresthesia, tremor, vertigo; Gastrointestinal: anorexia, constipation, dyspepsia,* dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia; 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; 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® (amlodipine besylate).

POSTMARKETING EXPERIENCE

The following adverse reactions have been identified during post-approval use of 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 the use of 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 o n one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to amlodipine.

NOTE: Because clinical studies are conducted under widely varying conditions, adverse reaction 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.

TWYNSTA and MICARDIS are registered trademarks of Boehringer Ingelheim International GmbH. Other brands listed are the trademarks of their respective owners and are not trademarks of Boehringer Ingelheim International GmbH.

Reference
1. Twynsta PI. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 2009.

TWYNSTA is available in 4 dosage strengths, so therapy can be individualized to your patients' needs.1

Review dosing information

Visit the MICARDIS for Healthcare Professionals Web site to access tools and resources designed to help you create individualized treatment plans for your hypertensive patients.

Go to www.MicardisPro.com

INDICATION

Twynsta® (telmisartan/amlodipine) tablets 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. It 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 TWYNSTA 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 TWYNSTA tablets. Consider the patient's baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy when deciding whether to use TWYNSTA tablets as initial therapy.

IMPORTANT SAFETY INFORMATION

WARNING: AVOID USE IN PREGNANCY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue TWYNSTA as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.

TWYNSTA is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or amlodipine or any other components of this product.

Symptomatic hypotension may occur in patients with an activated renin-angiotensin system. Correct volume and/or salt depletion in patients before initiating TWYNSTA or start treatment under close supervision with a reduced dose.

Patients taking TWYNSTA should be told not to use potassium supplements or salt substitutes that contain potassium without consulting their physician. Consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances.

Titrate slowly in patients with hepatic or severe renal impairment and closely monitor. Initial therapy with TWYNSTA is not recommended in hepatically impaired patients.

In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system such as patients with severe congestive heart failure or renal dysfunction, treatment with ACE inhibitors and an ARB such as TWYNSTA has been associated with oliguria and/or progressive azotemia and, rarely, with acute renal failure and/or death. In patients with renal artery stenosis, increases in serum creatinine or blood urea nitrogen may occur. When adding an ACE inhibitor to an ARB, monitor renal function closely. Use of TWYNSTA with ramipril is not recommended.

Uncommonly, patients starting or increasing their dose of a CCB have developed increased frequency, duration, or severity of angina or acute myocardial infarction.

Monitor patients with heart failure for worsening of their condition.

In clinical trials, the most common reasons for discontinuation of therapy with TWYNSTA were peripheral edema, dizziness, and hypotension. Adverse events that occurred at a ≥2% higher incidence with TWYNSTA than with placebo were peripheral edema, dizziness, and back pain.

Please see full Prescribing Information, including boxed WARNING, for TWYNSTA.



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