TELMISARTAN AND HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

Zydus Lifesciences Limited

INN (International Name):

TELMISARTAN

Composition:

TELMISARTAN 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Telmisartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, 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 the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Telmisartan and hydrochlorothiazide tablets. 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 Committ

Product summary:

Telmisartan and Hydrochlorothiazide Tablets USP, 40 mg/12.5 mg are biconvex two layered, oblong-shaped, uncoated tablets having plain telmisartan layer as mottled light brown to mottled brown colored and hydrochlorothiazide layer is white to off-white debossed with '513' and may contain brown specks of telmisartan layer and are supplied as follows: NDC 70771-1123-3 in bottle of 30 tablets NDC 70771-1123-9 in bottle of 90 tablets NDC 70771-1123-8 in cartons of 30 tablets (3 x 10 unit-dose) Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg are biconvex two layered, oblong-shaped, uncoated tablets having plain telmisartan layer as mottled light brown to mottled brown colored and hydrochlorothiazide layer is white to off-white debossed with '514' and may contain brown specks of telmisartan layer and are supplied as follows: NDC 70771-1124-3 in bottle of 30 tablets NDC 70771-1124-9 in bottle of 90 tablets NDC 70771-1124-8 in cartons of 30 tablets (3 x 10 unit-dose) Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg are biconvex two layered, oblong-shaped, uncoated tablets having plain telmisartan layer as mottled light brown to mottled brown colored and hydrochlorothiazide layer is yellow debossed with '515' and may contain brown specks of telmisartan layer and are supplied as follows: NDC 70771-1125-3 in bottle of 30 tablets NDC 70771-1125-9 in bottle of 90 tablets NDC 70771-1125-8 in cartons of 30 tablets (3 x 10 unit-dose) Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Tablets should not be removed from blisters or bottles until immediately before administration.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TELMISARTAN AND HYDROCHLOROTHIAZIDE - TELMISARTAN AND
HYDROCHLOROTHIAZIDE TABLET
ZYDUS LIFESCIENCES LIMITED
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TELMISARTAN AND HYDROCHLORTHIAZIDE TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1123-9 in bottle of 90 tablets
Telmisartan and Hydrochlorthaizide Tablets USP, 40 mg/12.5 mg
R only
90 tablets
NDC 70771-1124-9 in bottle of 90 tablets
Telmisartan and Hydrochlorthaizide Tablets USP, 80 mg/12.5 mg
R only
90 tablets
x
x
NDC 70771-1125-9 in bottle of 90 tablets
Telmisartan and Hydrochlorthaizide Tablets USP, 80 mg/25 mg
R only
90 tablets
TELMISARTAN AND HYDROCHLOROTHIAZIDE
telmisartan and hydrochlorothiazide tablet
x
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1123
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)
TELMISARTAN
40 mg
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE -
UNII:0J48LPH2TH)
HYDROCHLOROTHIAZIDE 12.5 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 2S7830E561)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MEGLUMINE (UNII: 6HG8UB2MUY)
POVIDONE (UNII: FZ989GH94E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
SORBITOL (UNII: 506T60A25R)
TALC (UNII: 7SEV7J4R1U)
PRODUCT CHARACTERISTICS
COLOR
BROWN (Mottled Light brown to Mottled Brown) , WHITE (WHITE TO OFF
WHITE)
SCORE
no score
SHAPE
OVAL (Oblong Shaped)
SIZE
15mm
FLAVOR
IMPRINT CODE
513
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1123-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
10/12/2017
2
NDC:70771-
1123-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
10/12/2017
3
NDC:70771-
1123-8
3 in 1 CARTON
10/12/2017
3
NDC:70771-
1123-2
10 in 1 BLISTER PACK; Type 0: Not a Combinatio