AVALIDE (irbesartan-hydrochlorothiazide) Tablets
is indicated for the treatment of hypertension. This fixed
dose combination is not indicated for initial therapy (see
DOSAGE AND ADMINISTRATION
).
DOSAGE AND ADMINISTRATION
The recommended initial dose of irbesartan is 150
mg once daily. Patients requiring further reduction in blood
pressure should be titrated to 300 mg once daily.
A lower initial dose of irbesartan (75 mg) is recommended
in patients with depletion of intravascular volume (e.g.,
patients treated vigorously with diuretics or on hemodialysis)
(see WARNING: Hypotension in Volume- or Salt-depleted
Patients). Patients not adequately treated by the
maximum dose of 300 mg once daily are unlikely to derive
additional benefit from a higher dose or twice-daily dosing.
Hydrochlorothiazide is effective in doses of 12.5 to 50
mg once daily.
To minimize dose-independent side effects, it is usually
appropriate to begin combination therapy only after a patient
has failed to achieve the desired effect with monotherapy.
The side effects (see WARNINGS) of irbesartan are generally
rare and apparently independent of dose; those of hydrochlorothiazide
are a mixture of dose-dependent (primarily hypokalemia)
and dose-independent phenomena (e.g., pancreatitis), the
former much more common than the latter. Therapy with any
combination of irbesartan and hydrochlorothiazide will be
associated with both sets of dose-independent side effects.
AVALIDE may be administered with other antihypertensive
agents. AVALIDE may be administered with or without food.
Replacement Therapy
The combination may be substituted for the titrated
components.
Dose Titration by Clinical Effect
A patient whose blood pressure is inadequately controlled
by irbesartan or hydrochlorothiazide alone may be switched
to once daily AVALIDE. Recommended doses of AVALIDE, in
order of increasing mean effect, are (irbesartan-hydrochlorothiazide)
150/12.5 mg, 300/12.5 mg, and 300/25 mg (two 150/12.5 mg
tablets). The largest incremental effect will likely be
in the transition from monotherapy to 150/12.5 mg. (See
CLINICAL PHARMACOLOGY: Clinical Studies). It takes 2-4 weeks
for the blood pressure to stabilize after a change in the
dose of AVALIDE.
The usual dose of AVALIDE is one tablet once daily. More
than two tablets once daily is not recommended. The maximal
antihypertensive effect is attained about 2–4 weeks
after initiation of therapy.
Use in Patients with Renal Impairment
The usual regimens of therapy with AVALIDE may
be followed as long as the patient's creatinine clearance
is >30 mL/min. In patients with more severe renal impairment,
loop diuretics are
Irbesartan
(mg)
HCTZ (mg)
NDC 0087-xxxx-xx for unit of use
Bottle of
Blister of
30
90
500
100
150
12.5
2775–31
2775–32
2775–15
2775–35
300
12.5
2776–31
2776–32
2776–15
2776–35
preferred to thiazides, so AVALIDE is not recommended.
Patients with Hepatic Impairment
No dosage adjustment is necessary in patients with hepatic
impairment.
HOW SUPPLIED
AVALIDE® (irbesartan-hydrochlorothiazide) Tablets
are peach, biconvex, and oval with a heart debossed on one
side and 2775 or 2776 on the reverse, supplied as follows:
Storage
Store at a temperature between 15° C and 30°
C (59° F and 86° F) [See USP].
Manufactured and Distributed by: Bristol-Myers Squibb Company,
Princeton, NJ 08543-4500
Comarketed by: Sanofi-Synthelabo, Inc., New York, Revised
August 2001
