TELMISARTAN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

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 variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.   Telmisartan may be used alone or in combination with other antihypertensive agents [see Clinical Studies ( 14.1)] . Use of telmisartan and ACE inhibitor is not recommended [see Warning and Precautions ( 5.6)]. Telmisartan is indicated for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors. High risk for cardiovascular events can be evidenced by a history of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack, or high-risk diabetes (insulin-dependent or non-insulin dependent) with evidence of end-organ damage [see Clinical Studies (14.2)] . Telmisartan can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy) [see Clinical Studies ( 14.2)]. Studies of telmisartan in this setting do not exclude the possibility that telmisartan may not preserve a meaningful fraction of the effect of the ACE inhibitor to which it was compared. Consider using the ACE inhibitor first, and, if it is stopped for cough only, consider re-trying the ACE inhibitor after the cough resolves. Use of telmisartan and ACE inhibitor is not recommended [see Warning and Precautions ( 5.6)]. Telmisartan tablets are contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to telmisartan or any other component of this product [see Adverse Reactions ( 6.2)]. Do not coadminister aliskiren with telmisartan in patients with diabetes [see Drug Interactions ( 7)]. Risk Summary Telmisartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death (see Clinical Considerations) . Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Studies in rats and rabbits with telmisartan showed fetotoxicity only at maternally toxic doses (see Data) . When pregnancy is detected, discontinue telmisartan as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal adverse reactions Use of drugs that act on the RAS in the second and third trimesters of pregnancy can result in the following: oligohydramnios, reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. In patients taking telmisartan during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation. If oligohydramnios is observed, discontinue telmisartan, unless it is considered lifesaving for the mother. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to telmisartan for hypotension, oliguria, and hyperkalemia. If oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function [ see Use in Specific Populations (8.4)] . Data Animal Data No teratogenic effects were observed when telmisartan was administered to pregnant rats at oral doses of up to 50 mg/kg/day and to pregnant rabbits at oral doses up to 45 mg/kg/day. In rabbits, embryolethality associated with maternal toxicity (reduced body weight gain and food consumption) was observed at 45 mg/kg/day [about 12 times the maximum recommended human dose (MRHD) of 80 mg on a mg/m 2 basis]. In rats, maternally toxic (reduction in body weight gain and food consumption) telmisartan doses of 15 mg/kg/day (about 1.9 times the MRHD on a mg/m 2 basis), administered during late gestation and lactation, were observed to produce adverse effects in neonates, including reduced viability, low birth weight, delayed maturation, and decreased weight gain. The no observed effect doses for developmental toxicity in rats and rabbits, 5 and 15 mg/kg/day, respectively, are about 0.64 and 3.7 times, on a mg/m 2 basis, the maximum recommended human dose of telmisartan (80 mg/day). Risk Summary There is no information regarding the presence of telmisartan in human milk, the effects on the breastfed infant, or the effects on milk production. Telmisartan is present in the milk of lactating rats (see Data). Because of the potential for serious adverse reactions in the breastfed infant including hypotension, hyperkalemia and renal impairment, advise a nursing woman not to breastfeed during treatment with telmisartan. Data Telmisartan was present in the milk of lactating rats at concentrations 1.5 to 2 times those found in plasma from 4 to 8 hours after administration. Safety and effectiveness in pediatric patients have not been established [see Clinical Pharmacology ( 12.3)]. Neonates with a history of in utero exposure to Telmisartan If oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. Of the total number of patients receiving telmisartan in hypertension clinical studies, 551 (19%) were 65 to 74 years of age and 130 (4%) were 75 years or older. No overall differences in effectiveness and safety were observed in these patients compared to younger patients and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Of the total number of patients receiving telmisartan in the cardiovascular risk reduction study (ONTARGET), the percentage of patients ≥65 to <75 years of age was 42%; 15% of patients were ≥75 years old. No overall differences in effectiveness and safety were observed in these patients compared to younger patients and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Monitor carefully and uptitrate slowly in patients with biliary obstructive disorders or hepatic insufficiency [ see   Warnings   and   Precautions   ( 5.4) ].

Product summary:

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: 70518-3300-00 PACKAGING: 30 in 1 CARTON, 1 in 1 BLISTER PACK Storage Store at 20°C to 25°C (68°F 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

REMEDYREPACK INC.
----------
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)
•
in certain high risk people aged 55 years and older to help lower
their risk of having certain
cardiovascular problems such as stroke, heart attack, or death
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
prescript

Summary of Product characteristics

TELMISARTAN- TELMISARTAN TABLET
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TELMISARTAN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TELMISARTAN TABLETS
TELMISARTAN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE TELMISARTAN AS SOON AS
POSSIBLE ( 5.1) _, (_
_8.1)_
DRUGS THAT ACT DIRECTLY ON THE RENNIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH
TO THE DEVELOPING FETUS ( 5.1) _, ( 8.1)_
INDICATIONS AND USAGE
Telmisartan tablets, USP are angiotensin II receptor blocker (ARB)
indicated for:
Treatment of hypertension, to lower blood pressure. Lowering blood
pressure reduces the risk of fatal
and nonfatal cardiovascular events, primarily strokes and myocardial
infarctions. ( 1.1)
Cardiovascular (CV) risk reduction in patients unable to take ACE
inhibitors ( 1.2)
DOSAGE AND ADMINISTRATION
May be administered with or without food ( 2.1)
When used for cardiovascular risk reduction, monitoring of blood
pressure is recommended, and if
appropriate, adjustment of medications that lower blood pressure may
be necessary ( 2.2)
HEADER$
INDICATION
STARTING DOSE
DOSERANGE
Hypertension
( 2.1)
40 mg once daily 40 to 80 mg
once daily
Cardiovascular Risk Reduction ( 2.2) 80 mg once daily
80 mg
once daily
DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg, 40 mg, 80 mg ( 3)
CONTRAINDICATIONS
Known hypersensitivity (e.g., anaphylaxis or angioedema) to
telmisartan or any other component of
this product ( 4)
Do not coadminister aliskiren with telmisartan in patients with
diabetes ( 4)
WARNINGS AND PRECAUTIONS
Avoid fetal or neonatal exposure ( 5.1)
Hypotension: Correct any volume or salt depletion before initiating
therapy. Observe for signs and
symptoms of hypotension ( 5.2)
Monitor carefully in patients with impaired hepatic ( 5.4) or renal
function ( 5.5)
Avoid concomitant use of an ACE inhibitor and angi