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Avalide
Overview
What is Avalide?
AVALIDE (irbesartan-hydrochlorothiazide) Tablets is a combination
of an angiotensin II receptor antagonist (AT subtype),
irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ).
Irbesartan is a non-peptide compound, chemically described as a
2-butyl-3-[-(-1-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one.
Its empirical formula is CHNO, and its structural formula is:
Irbesartan is a white to off-white crystalline powder with a molecular weight
of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water)
of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene
chloride and practically insoluble in water.
Hydrochlorothiazide is 6-chloro-3,4-dihydro-2-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its
empirical formula is CHClNOS and its
structural formula is:
Hydrochlorothiazide is a white, or practically white, crystalline powder with
a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water
and freely soluble in sodium hydroxide solution.
AVALIDE is available for oral administration in tablets containing either 150
mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide or 300
mg of irbesartan combined with 25 mg hydrochlorothiazide. Inactive ingredients
include: lactose monohydrate, microcrystalline cellulose, pregelatinized starch,
croscarmellose sodium, ferric oxide red, ferric oxide yellow, silicon dioxide,
and magnesium stearate. In addition, the 300/25 mg pink film-coated tablet
contains ferric oxide black, hypromellose-2910, PEG-3350, titanium dioxide, and
carnauba wax.
What does Avalide look like?
What are the available doses of Avalide?
AVALIDE (irbesartan-hydrochlorothiazide) 150/12.5 mg and
300/12.5 mg tablets are peach, biconvex, and oval with a heart debossed on one
side and "2775" or "2776" on the reverse side. The 300/25 mg film-coated tablet
is pink, biconvex, and oval with a heart debossed on one side and "2788" on the
reverse side.
What should I talk to my health care provider before I take Avalide?
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How should I use Avalide?
AVALIDE (irbesartan-hydrochlorothiazide)
Tablets is indicated for the treatment of hypertension.
AVALIDE may be used in patients whose blood pressure is not adequately
controlled on monotherapy.
AVALIDE may also be used as initial therapy in patients who are likely to
need multiple drugs to achieve their blood pressure goals.
The choice of AVALIDE as initial therapy for hypertension should be based on
an assessment of potential benefits and risks.
Patients with stage 2 (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. The decision to use a combination as initial therapy should be
individualized and may be shaped by considerations such as the baseline blood
pressure, the target goal, and the incremental likelihood of achieving goal with
a combination compared with monotherapy.
Data from Studies V and VI [see
]
provide estimates of the probability of reaching a blood pressure goal with
AVALIDE compared to irbesartan or HCTZ monotherapy. The relationship between
baseline blood pressure and achievement of a SeSBP less than 140 or less than 130 mmHg or
SeDBP less than 90 or less than 80 mmHg in patients treated with AVALIDE compared to
patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a
through 2b.
The above graphs provide a rough approximation of the likelihood of reaching
a targeted blood pressure goal (eg, Week 8 sitting systolic blood pressure less than or equal to 140
mmHg) for the treatment groups. The curve of each treatment group in each study
was estimated by logistic regression modeling from all available data of that
treatment group. The estimated likelihood at the right tail of each curve is
less reliable due to small numbers of subjects with high baseline blood
pressures.
For example, a patient with a blood pressure of 180/105 mmHg has about a 25%
likelihood of achieving a goal of less than 140 mmHg (systolic) and 50% likelihood of
achieving less than 90 mmHg (diastolic) on irbesartan alone (and lower still
likelihoods on HCTZ alone).
The likelihood of achieving these goals on AVALIDE rises to about 40%
(systolic) or 70% (diastolic).
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What interacts with Avalide?
Sorry No Records found
What are the warnings of Avalide?
Sorry No Records found
What are the precautions of Avalide?
Sorry No Records found
What are the side effects of Avalide?
Sorry No records found
What should I look out for while using Avalide?
Hypersensitivity to any component of this product
Anuria
Hypersensitivity to sulfonamide-derived drugs
When pregnancy is detected, discontinue AVALIDE
as soon as possible. When used in pregnancy during the second and third
trimesters, drugs that act directly on the renin-angiotensin system can cause
injury and even death to the developing fetus. [See.]
What might happen if I take too much Avalide?
Irbesartan
No data are available in regard to overdosage in humans. However, daily doses
of 900 mg for 8 weeks were well tolerated. The most likely manifestations of
overdosage are expected to be hypotension and tachycardia; bradycardia might
also occur from overdose. Irbesartan is not removed by hemodialysis.
To obtain up-to-date information about the treatment of overdosage, a good
resource is a certified regional Poison Control Center. Telephone numbers of
certified Poison Control Centers are listed in the (PDR). In managing overdose,
consider the possibilities of multiple-drug interactions, drug-drug
interactions, and unusual drug kinetics in the patient.
Laboratory determinations of serum levels of irbesartan are not widely
available, and such determinations have, in any event, no established role in
the management of irbesartan overdose.
Acute oral toxicity studies with irbesartan in mice and rats indicated acute
lethal doses were in excess of 2000 mg/kg, about 25- and 50-fold the MRHD
(300 mg) on a mg/m basis, respectively.
Hydrochlorothiazide
The most common signs and symptoms of overdose observed in humans are those
caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and
dehydration resulting from excessive diuresis. If digitalis has also been
administered, hypokalemia may accentuate cardiac arrhythmias. The degree to
which hydrochlorothiazide is removed by hemodialysis has not been established.
The oral LD of hydrochlorothiazide is greater than 10
g/kg in both mice and rats.
How should I store and handle Avalide?
Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].Enter section text here
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Irbesartan
Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a
reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II).
Angiotensin II is the principal pressor agent of the RAS and also stimulates
aldosterone synthesis and secretion by adrenal cortex, cardiac contraction,
renal resorption of sodium, activity of the sympathetic nervous system, and
smooth muscle cell growth. Irbesartan blocks the vasoconstrictor and
aldosterone-secreting effects of angiotensin II by selectively binding to the
AT angiotensin II receptor. There is also an AT receptor in many tissues, but it is not involved in
cardiovascular homeostasis.
Irbesartan is a specific competitive antagonist of AT
receptors with a much greater affinity (more than 8500-fold) for the AT receptor than for the AT receptor,
and no agonist activity.
Blockade of the AT receptor removes the negative
feedback of angiotensin II on renin secretion, but the resulting increased
plasma renin activity and circulating angiotensin II do not overcome the effects
of irbesartan on blood pressure.
Irbesartan does not inhibit ACE or renin or affect other hormone receptors or
ion channels known to be involved in the cardiovascular regulation of blood
pressure and sodium homeostasis. Because irbesartan does not inhibit ACE, it
does not affect the response to bradykinin; whether this has clinical relevance
is not known.
Hydrochlorothiazide
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal
tubular mechanisms of electrolyte reabsorption, directly increasing excretion of
sodium and chloride in approximately equivalent amounts. Indirectly, the
diuretic action of hydrochlorothiazide reduces plasma volume, with consequent
increases in plasma renin activity, increases in aldosterone secretion,
increases in urinary potassium loss, and decreases in serum potassium. The
renin-aldosterone link is mediated by angiotensin II, so coadministration of an
angiotensin II receptor antagonist tends to reverse the potassium loss
associated with these diuretics.
The mechanism of the antihypertensive effect of thiazides is not fully
understood.
Non-Clinical Toxicology
Hypersensitivity to any component of this productAnuria
Hypersensitivity to sulfonamide-derived drugs
When pregnancy is detected, discontinue AVALIDE as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. [See.]
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Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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