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Twynsta
Overview
What is Twynsta?
TWYNSTA is a fixed dose combination of telmisartan
and amlodipine.
TWYNSTA tablets
contain telmisartan, a non-peptide angiotensin II receptor (type AT) antagonist. Telmisartan is a white to slightly yellowish
solid. It is practically insoluble in water and in the pH range of
3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric
acid), and soluble in strong base. Telmisartan is chemically described
as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic
acid. Its empirical formula is CHNO and
its structural formula is:
TWYNSTA tablets contain the besylate salt
of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine
besylate is a white to pale yellow crystalline powder, slightly soluble
in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical
name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
benzenesulphonate. Its empirical formula is CHClNO•CHOS and its structural formula is:
TWYNSTA tablets are formulated in
four strengths for oral administration with a combination of amlodipine
besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with
40 mg, or 80 mg of telmisartan provided in the following four combinations:
40/5 mg, 40/10 mg, 80/5 mg, and 80/10 mg.
TWYNSTA tablets also contain the following inactive
ingredients: sodium hydroxide, povidone, meglumine, sorbitol, magnesium
stearate, microcrystalline cellulose, pregelatinized starch, corn
starch, colloidal silicon dioxide, ferric oxide black, ferric oxide
yellow and FD&C blue #1.
TWYNSTA tablets are hygroscopic and require protection from moisture.
TWYNSTA tablets require protection from
light.
What does Twynsta look like?
What are the available doses of Twynsta?
TWYNSTA tablets
are formulated for oral administration in the following strength combinations:
The telmisartan/amlodipine non-scored,
multilayer tablets are of oval, biconvex shape. Tablets are white
to off-white on one side and blue on the other side. The white side
is debossed with the BOEHRINGER INGELHEIM symbol and with either A1,
A2, A3, or A4 for the 40/5 mg, 40/10 mg, 80/5 mg, and 80/10 mg strengths,
respectively.
What should I talk to my health care provider before I take Twynsta?
How should I use Twynsta?
TWYNSTA (telmisartan/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 TWYNSTA.
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.
TWYNSTA 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 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.
Patients
with moderate or severe hypertension are at relatively high risk for
cardiovascular events (such as strokes, heart attacks, and heart failure),
kidney failure, and vision problems, so prompt treatment is clinically
relevant. Consider the patient's baseline blood pressure, the target
goal, and the incremental likelihood of achieving goal with a combination
compared with monotherapy when deciding whether to use TWYNSTA tablets
as initial therapy. Individual blood pressure goals may vary based
upon the patient’s risk.
Data from
an 8-week, placebo-controlled, multidose, factorial trial provide
estimates of the probability of reaching a blood pressure goal with
TWYNSTA compared to telmisartan or amlodipine monotherapy and placebo .
The figures
below provide estimates of the likelihood of achieving systolic and
diastolic blood pressure control with TWYNSTA 80/10 mg tablets, based
upon baseline systolic or diastolic blood pressure. The curve of each
treatment group was estimated by logistic regression modeling. The
estimated likelihood at the right tail of each curve is less reliable
due to small numbers of subjects with high baseline blood pressures.
Figure 1a: Probability of Achieving Systolic
Blood Pressure <140 mmHg at Week 8
Figure 1b: Probability of Achieving Systolic
Blood Pressure <130 mmHg at Week 8
Figure 2a: Probability of Achieving
Diastolic Blood Pressure <90 mmHg at Week 8
Figure 2b: Probability of Achieving
Diastolic Blood Pressure <80 mmHg at Week 8
The figures above provide an approximation
of the likelihood of reaching a targeted blood pressure goal at 8
weeks. For example, a patient with a baseline blood pressure of 160/110
mmHg has about a 16% likelihood of achieving a goal of <140 mmHg
(systolic) and 16% likelihood of achieving <90 mmHg (diastolic)
on placebo. The likelihood of achieving these same goals on telmisartan
is about 46% (systolic) and 26% (diastolic). The likelihood of achieving
these same goals on amlodipine is about 69% (systolic) and 22% (diastolic).
These likelihoods rise to 79% for systolic and 55% for diastolic
with TWYNSTA.
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 TWYNSTA 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 .
TWYNSTA may be taken
with or without food.
What interacts with Twynsta?
Sorry No Records found
What are the warnings of Twynsta?
Sorry No Records found
What are the precautions of Twynsta?
Sorry No Records found
What are the side effects of Twynsta?
Sorry No records found
What should I look out for while using Twynsta?
TWYNSTA tablets are contraindicated in patients with known hypersensitivity
(e.g., anaphylaxis or angioedema) to telmisartan, amlodipine, or any
other component of this product .
Do not co-administer aliskiren with TWYNSTA
in patients with diabetes
What might happen if I take too much Twynsta?
Telmisartan
Amlodipine
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 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.
How should I store and handle Twynsta?
TWYNSTA tablets are available as non-scored, white–off-white/blue, multilayer tablets of oval, biconvex shape containing telmisartan and amlodipine in the strengths described below. TWYNSTA tablets are debossed with a Boehringer Ingelheim company symbol and an individual product tablet code on one side. TWYNSTA tablets are supplied for oral administration in the following strengths and package configurations:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Telmisartan
There is also an AT receptor found in many
tissues, but AT is not known to be associated
with cardiovascular homeostasis. Telmisartan has much greater affinity
(>3,000 fold) for the AT receptor than for
the AT receptor.
Blockade of the renin-angiotensin system with ACE inhibitors,
which inhibit the biosynthesis of angiotensin II from angiotensin
I, is widely used in the treatment of hypertension. ACE inhibitors
also inhibit the degradation of bradykinin, a reaction also catalyzed
by ACE. Because telmisartan does not inhibit ACE (kininase II), it
does not affect the response to bradykinin. Whether this difference
has clinical relevance is not yet known. Telmisartan does not bind
to or block other hormone receptors or ion channels known to be important
in cardiovascular regulation.
Blockade of the angiotensin II receptor inhibits the negative regulatory
feedback of angiotensin II on renin secretion, but the resulting increased
plasma renin activity and angiotensin II circulating levels do not
overcome the effect of telmisartan on blood pressure.
Amlodipine is a peripheral arterial vasodilator
that acts directly on vascular smooth muscle to cause a reduction
in peripheral vascular resistance and reduction in blood pressure.
Non-Clinical Toxicology
TWYNSTA tablets are contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan, amlodipine, or any other component of this product .Do not co-administer aliskiren with TWYNSTA in patients with diabetes
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 TWYNSTA as soon as possible .
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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