tients treated with irbesartan, respectively. The mean SeDBP was 4.7 mmHg lower (p<0.0001) and the mean SeSBP was 9.7 mmHg lower (p<0.0001) in the group treated with AVALIDE than in the group treated with irbesartan. Patients treated with AVALIDE achieved more rapid blood pressure control with significantly lower SeDBP and SeSBP and greater blood pressure control at every assessment (Week 1, Week 3, Week 5, and Week 7). Maximum effects were seen at Week 7.
Withdrawal rates were 2.2% on irbesartan and 2.1% on AVALIDE.
In Studies I–VI, there was no difference in response for men and women or in patients over or under 65 years of age. Black patients had a larger response to hydrochlorothiazide than non-black patients and a smaller response to irbesartan. The overall response to the combination was similar for black and non-black patients.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
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. AVALIDE® Tablets are supplied as follows:
Irbesartan
(mg) HCTZ
(mg) NDC 0087-xxxx-xx for unit of use
Bottle of 30 Bottle of 90
150 12.5 2775-31 2775-32
300 12.5 2776-31 2776-32
300 25 2788-31 2788-32
16.2 Storage
Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
17.1 Pregnancy
Female patients of childbearing age should be told that use of drugs like AVALIDE during the second or third trimesters of pregnancy can cause serious problems in the fetus and infant including: low blood pressure, poor development of skull bones, kidney failure, and death. These effects have not occurred with drug exposure limited to the first trimester. Women using AVALIDE who become pregnant should notify their physician as soon as possible.
17.2 Symptomatic Hypotension
Patients using AVALIDE should be told that they may feel lightheaded, especially during the first days of use. Patients should inform their physician if they feel lightheaded or faint. If fainting occurs, the patient should stop using AVALIDE and contact the prescribing doctor.
Patients using AVALIDE should be told that getting dehydrated can lower their blood pressure too much and lead to lightheadedness and possible fainting. Dehydration may occur with excessive sweating, diarrhea, or vomiting and with not drinking enough liquids.
Manufactured by:
Bristol-Myers Squibb Company
Princeton, New Jersey 08543 USA
Distributed by:
Bristol-Myers Squibb Sanofi-Synthelabo Partnership
New York, New York 10016
1243926A1
Rev November 2008
---------------------------------------------
REPRESENTATIVE PACKAGING
See How Supplied section for a complete list of available packages of AVALIDE.
30 Tablets
NDC 0087-2788-31
Avalide®
(irbesartan-hydrochlorothiazide) Tablets
300/25 mg
Rx only
Bristol-Myers Squibb Company
sanofi aventis
7 Tablets
300/25 mg each
Avalide®
(irbesartan-hydrochlorothiazide)
Physician Sample
NOT FOR SALE
Rx only
Bristol-Myers Squibb
sanofi aventis
AVALIDE |
