BENICAR HCT- olmesartan medoxomil and hydrochlorothiazide tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

Physicians Total Care, Inc.

INN (International Name):

OLMESARTAN MEDOXOMIL

Composition:

OLMESARTAN MEDOXOMIL 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BENICAR HCT® is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION ). BENICAR HCT® is contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Product summary:

BENICAR HCT® is supplied as 20 mg/12.5 mg: reddish-yellow, circular, film-coated tablets, approximately 8.5 mm in diameter, with "Sankyo" debossed on one side and “C22” on the other side. Each tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide. 40 mg/12.5 mg: reddish-yellow, oval, film-coated tablets, approximately 15 x 7 mm, with "Sankyo" debossed on one side and “C23” on the other side. Each tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide. 40 mg/25 mg: pink, oval, film-coated tablets, approximately 15 x 7 mm, with "Sankyo" debossed on one side and "C25" on the other side. Each tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide. Tablets are supplied as follows: Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Manufactured for Daiichi Sankyo, Inc., Parsippany, NJ  07054 Rx Only Copyright © Daiichi Sankyo, Inc. 2006. All rights reserved. P1800706 Rev. December 2006

Authorization status:

New Drug Application

Summary of Product characteristics

BENICAR HCT - OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLET,
FILM COATED
PHYSICIANS TOTAL CARE, INC.
----------
USE IN PREGNANCY
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.When
pregnancy is detected, BENICAR HCT should be discontinued as soon as
possible. See
WARNINGS, FETAL/NEONATAL MORBIDITY AND MORTALITY.
DESCRIPTION
BENICAR HCT (olmesartan medoxomil-hydrochlorothiazide) is a
combination of an angiotensin II
receptor antagonist (AT subtype), olmesartan medoxomil, and a thiazide
diuretic, hydrochlorothiazide
(HCTZ).
Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during
absorption from the
gastrointestinal tract.
Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl
4-(1-hydroxy-1-methylethyl)-2-propyl-1-[_p_-(_o_-1_H_-
tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic
2,3-carbonate.
Its empirical formula is C
H N O and its structural formula is:
Olmesartan medoxomil is a white to light yellowish-white powder or
crystalline powder with a
molecular weight of 558.6. It is practically insoluble in water and
sparingly soluble in methanol.
Hydrochlorothiazide is
6-chloro-3,4-dihydro-2_H_-1,2,4-benzo-thiadiazine-7-sulfonamide
1,1-dioxide.
Its empirical formula is C H ClN O S and its structural formula is:
®
®
1
29
30
6
6
7
8
3
4
2
Hydrochlorothiazide is a white, or practically white, crystalline
powder with a molecular weight of
297.7. Hydrochlorothiazide is slightly soluble in water but freely
soluble in sodium hydroxide
solution.
BENICAR HCT is available for oral administration in tablets containing
20 mg or 40 mg of
olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or
40 mg of olmesartan
medoxomil combined with 25 mg of hydrochlorothiazide. Inactive
ingredients include:
hydroxypropylcellulose, hypromellose, lactose, low-substituted
hydroxypropylcellulose, magnesium
stearate, microcrystalline cellulose, red iron oxide, talc, titanium
dioxide and