TELMISARTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)

Available from:

Zydus Lifesciences Limited

INN (International Name):

TELMISARTAN

Composition:

TELMISARTAN 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Telmisartan tablets, USP 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 class to which this drug principally belongs.   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 Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a vari

Product summary:

Telmisartan Tablets USP, 20 mg are mottled light brown to mottled brown-colored, round-shaped, flat face beveled edge, uncoated tablets debossed with  '471'  on one side  and plain on the other side and are supplied as follows: NDC 65841-804-06 in bottle of 30 tablets NDC 65841-804-16 in bottle of 90 tablets NDC 65841-804-01 in bottle of 100 tablets NDC 65841-804-05 in bottle of 500 tablets NDC 65841-804-10 in bottle of 1000 tablets NDC 65841-804-78 in cartons of 30 tablets (3 x 10 unit-dose) Telmisartan Tablets USP, 40 mg are mottled light brown to mottled brown-colored, oblong-shaped, biconvex, uncoated tablets debossed with  '472'  on one side  and plain on the other side and are supplied as follows: NDC 65841-805-06 in bottle of 30 tablets NDC 65841-805-16 in bottle of 90 tablets NDC 65841-805-01 in bottle of 100 tablets NDC 65841-805-05 in bottle of 500 tablets NDC 65841-805-10 in bottle of 1000 tablets NDC 65841-805-78 in cartons of 30 tablets (3 x 10 unit-dose) Telmisartan Tablets USP, 80 mg are mottled light brown to mottled-brown colored, oblong-shaped, biconvex, uncoated tablets debossed with  '473' on one side  and plain on the other side and are supplied as follows: NDC 65841-806-06 in bottle of 30 tablets NDC 65841-806-16 in bottle of 90 tablets NDC 65841-806-01 in bottle of 100 tablets NDC 65841-806-05 in bottle of 500 tablets NDC 65841-806-10 in bottle of 1000 tablets NDC 65841-806-78 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]. Protect from moisture. Tablets should not be removed from blisters or bottles until immediately before administration. Dispense in a tightly closed container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TELMISARTAN- TELMISARTAN TABLET
Cadila Healthcare Limited
----------
Patient Information
Telmisartan
(TEL-mi-SAR-tan)
Tablets, USP
Read this Patient Information before you start taking telmisartan
tablets and each time you get a refill. There
may be new information. This information does not take the place of
talking to your doctor about your
medical condition or your treatment.
What is the most important information I should know about telmisartan
tablets?
Telmisartan can cause harm or death to an unborn baby. Talk to your
doctor about other ways to lower your
blood pressure if you plan to become pregnant. If you get pregnant
while taking telmisartan, tell your doctor
right away.
What is telmisartan?
Telmisartan is a prescription medicine used:
•
to treat high blood pressure (hypertension)
It is not known if telmisartan is safe and effective in children.
Who should not take telmisartan?
You should not take telmisartan tablets if you are allergic
(hypersensitive) to the active ingredient
(telmisartan) or any of the other ingredients listed at the end of
this leaflet.
For patients with diabetes, if you are taking telmisartan you should
not take aliskiren.
What should I tell my doctor before taking telmisartan tablets?
Before you take telmisartan tablets, tell your doctor if you:
•
are pregnant or are planning to become pregnant. See
"WhatisthemostimportantinformationIshouldknowabouttelmisartantablets?"
•
are breast-feeding or plan to breast-feed. It is not known if
telmisartan passes into your breast milk.
You and your doctor should decide if you will take telmisartan tablets
or breastfeed. You should not
do both. Talk with your doctor about the best way to feed your baby if
you take telmisartan tablets.
•
have liver problems
•
have kidney problems
•
have heart problems
•
have any other medical conditions
Tell your doctor about all the medicines you take, including
prescription and non-prescription medicines,
vitamins, and herbal supplements.
For patients with diabetes, if you are taking telmisartan

Summary of Product characteristics

TELMISARTAN - TELMISARTAN TABLET
ZYDUS LIFESCIENCES LIMITED
----------
TELMISARTAN TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-804-05 in bottle of 500 tablets
Telmisartan Tablets USP, 20 mg
R only
500 tablets
NDC 65841-805-05 in bottle of 500 tablets
Telmisartan Tablets USP, 40 mg
R only
500 tablets
x
x
NDC 65841-806-05 in bottle of 500 tablets
Telmisartan Tablets USP, 80 mg
R only
500 tablets
TELMISARTAN
telmisartan tablet
x
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-804
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)
TELMISARTAN
20 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
FERRIC OXIDE RED (UNII: 1K09F3G675)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MEGLUMINE (UNII: 6HG8UB2MUY)
POVIDONE (UNII: FZ989GH94E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
SORBITOL (UNII: 506T60A25R)
PRODUCT CHARACTERISTICS
COLOR
BROWN (MOTTLED LIGHT BROWN TO MOTTLED BROWN)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
7mm
FLAVOR
IMPRINT CODE
471
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-804-
06
30 in 1 BOTTLE; Type 0: Not a Combination
Product
08/27/2014
2
NDC:65841-804-
16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
08/27/2014
3
NDC:65841-804-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
08/27/2014
4
NDC:65841-804-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
08/27/2014
5
NDC:65841-804-
10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
08/27/2014
6
NDC:65841-804-
78
30 in 1 CARTON
08/27/2014
6
NDC:65841-804-
30
1 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA203325
08/27/2014
TELMISARTAN
telmisartan tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRE