TELMISARTAN- telmisartan tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
TELMISARTAN (UNII: U5SYW473RQ) (TELMISARTAN - UNII:U5SYW473RQ)
Available from:
Hisun Pharmaceuticals USA, 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 variet
Product summary:
Telmisartan tablets USP are available as white or off-white tablets containing 20 mg, 40 mg, or 80 mg of telmisartan USP. Tablets are marked with the HU on one side, and on the other side, with either 20, 40, or 80 for the 20 mg, 40 mg, and 80 mg strengths, respectively. Tablets are provided as follows: Telmisartan tablets USP 20 mg are round and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 42658-135-51). Telmisartan tablets USP 40 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 42658-136-51). Telmisartan tablets USP 80 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 42658-137-51). Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F)  [see USP Controlled Room Temperature]. Tablets should not be removed from blisters until immediately before administration.
Authorization status:
Abbreviated New Drug Application
Authorization number:
42658-135-51, 42658-136-51, 42658-137-51

TELMISARTAN- telmisartan tablet

Hisun Pharmaceuticals USA, Inc.

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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 renin-angiotensin system can cause injury and death to the developing

fetus (5.1, 8.1)

INDICATIONS AND USAGE

Telmisartan tablets USP are an 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)

DOSAGE AND ADMINISTRATION

May be administered with or without food ( 2.1)

Indic atio n

Starting Dose

Dose Range

Hypertension ( 2.1) 40 mg once daily 40 to 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 co-administer 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 angiotensin receptor blocker ( 5.6)

ADVERSE REACTIONS

Hypertension: The most common adverse events (≥1%) reported in hypertension trials are back pain, sinusitis, and

diarrhea ( 6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Hisun Pharmaceuticals USA, Inc. at 1-855-554-4786, or

FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

NSAIDS: Increased risk of renal impairment and loss of anti-hypertensive effect ( 7)

Do not co-administer aliskiren with telmisartan in patients with diabetes ( 7)

USE IN SPECIFIC POPULATIONS

Lactation: Do not breastfeed during treatment with telmisartan ( 8.2)

Geriatric Patients: No overall difference in efficacy or safety vs younger patients, but greater sensitivity of some older

individuals cannot be ruled out ( 8.5)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 3/2018

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: FETAL TOXICITY

1 INDICATIONS AND USAGE

1.1 Hypertension

2 DOSAGE AND ADMINISTRATION

2.1 Hypertension

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Fetal Toxicity

5.2 Hypotension

5.3 Hyperkalemia

5.4 Impaired Hepatic Function

5.5 Impaired Renal Function

5.6 Dual Blockade of the Renin-Angiotensin-Aldosterone System(RAS)

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Insufficiency

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Hypertension

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

Sections or subsections omitted from the full prescribing information are not listed.

WARNING: FETAL TOXICITY

When pregnancy is detected, discontinue telmisartan as soon as possible [see Warnings

and Precautions (5.1)and Use in Specific Populations (8.1)].

Drugs that act directly on the renin-angiotensin system can cause injury and death to the

developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

1 INDICATIONS AND USAGE

1.1 Hypertension

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 Warnings and Precautions (5.6)] .

2 DOSAGE AND ADMINISTRATION

2.1 Hypertension

Dosage must be individualized. The usual starting dose of telmisartan tablets is 40 mg once a day.

Blood pressure response is dose-related over the range of 20 to 80 mg [see Clinical Studies (14.1)].

Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally

attained after 4 weeks. When additional blood pressure reduction beyond that achieved with 80 mg

telmisartan is required, a diuretic may be added.

No initial dosage adjustment is necessary for elderly patients or patients with renal impairment,

including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood

pressure should be closely monitored.

Telmisartan tablets may be administered with other antihypertensive agents.

Telmisartan tablets may be administered with or without food.

3 DOSAGE FORMS AND STRENGTHS

20 mg, white or off-white, round tablets debossed with HU on one side and 20 on the other side.

40 mg, white or off-white, oblong tablets debossed with HU on one side and 40 on the other side.

80 mg, white or off-white, oblong tablets debossed with HU on one side and 80 on the other side.

4 CONTRAINDICATIONS

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 co-administer aliskiren with telmisartan tablets in patients with diabetes [see Drug Interactions

(7)].

5 WARNINGS AND PRECAUTIONS

5.1 Fetal Toxicity

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. Resulting

oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential

neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When

pregnancy is detected, discontinue telmisartan as soon as possible [see Use in Specific Populations (8.1)].

5.2 Hypotension

In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g.,

those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of

therapy with telmisartan. Either correct this condition prior to administration of telmisartan, or start

treatment under close medical supervision with a reduced dose.

If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an

intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to

further treatment, which usually can be continued without difficulty once the blood pressure has

stabilized.

5.3 Hyperkalemia

Hyperkalemia may occur in patients on ARBs, particularly in patients with advanced renal impairment,

heart failure, on renal replacement therapy, or on potassium supplements, potassium-sparing diuretics,

potassium-containing salt substitutes or other drugs that increase potassium levels. Consider periodic

determinations of serum electrolytes to detect possible electrolyte imbalances, particularly in patients at

risk.

5.4 Impaired Hepatic Function

As the majority of telmisartan is eliminated by biliary excretion, patients with biliary obstructive

disorders or hepatic insufficiency can be expected to have reduced clearance. Initiate telmisartan at low

doses and titrate slowly in these patients [see Use in Specific Populations (8.6) and Clinical Pharmacology

(12.3)].

5.5 Impaired Renal Function

As a consequence of inhibiting the renin-angiotensin-aldosterone system, anticipate changes in renal

function in susceptible individuals. In patients whose renal function may depend on the activity of the

renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure or renal

dysfunction), treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor

antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal

failure and/or death. Similar results have been reported with telmisartan [see Clinical Pharmacology

(12.3)].

In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in

serum creatinine or blood urea nitrogen were observed. There has been no long-term use of telmisartan

in patients with unilateral or bilateral renal artery stenosis, but anticipate an effect similar to that seen

with ACE inhibitors.

5.6 Dual Blockade of the Renin-Angiotensin-Aldosterone System(RAS)

Dual blockade of the RAS with angiotensin-receptor blockers, ACE inhibitors, or aliskiren is

associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including

acute renal failure) compared to monotherapy.

Patients receiving the combination of telmisartan and ramipril (in ONTARGET trial that enrolled 25,620

patients ≥55 years old with atherosclerotic disease or diabetes with end-organ damage) did not obtain

any additional benefit compared to monotherapy, but experienced an increased incidence of renal

dysfunction (e.g., acute renal failure) compared with groups receiving telmisartan alone or ramipril

alone.

In most patients no benefit has been associated with using two RAS inhibitors concomitantly. In general,

avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function, and electrolytes

in patients on telmisartan and other agents that affect the RAS.

Do not co-administer aliskiren with telmisartan in patients with diabetes. Avoid concomitant use of

aliskiren with telmisartan in patients with renal impairment (GFR <60 mL/min/1.73 m2).

6 ADVERSE REACTIONS

The following adverse reaction is described elsewhere in labeling:

Renal dysfunction upon use with ramipril [see Warnings and Precautions (5.6)]

6.1 Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reactions rates

observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of

another drug and may not reflect the rates observed in practice.

Hypertension

Telmisartan has been evaluated for safety in more than 3700 patients, including 1900 treated for over 6

months and more than 1300 for over one year. Adverse experiences have generally been mild and

transient in nature and have infrequently required discontinuation of therapy.

In placebo-controlled trials involving 1041 patients treated with various doses of telmisartan (20 to 160

mg) monotherapy for up to 12 weeks, the overall incidence of adverse events was similar to that in

patients treated with placebo.

Adverse events occurring at an incidence of ≥1% in patients treated with telmisartan and at a greater rate

than in patients treated with placebo, irrespective of their causal association, are presented in Table 1.

Table 1 Adverse Events Occurring at an Incidence of ≥1% in Patients

Treated with Telmisartan and at a Greater Rate Than Patients Treated with

Placebo

Telmis artan

Placebo

n=1455

n=380

%

%

Upper respiratory tract infection

Back pain

Sinusitis

Diarrhea

Pharyngitis

In addition to the adverse events in the table, the following events occurred at a rate of ≥1% but were at

least as frequent in the placebo group: influenza-like symptoms, dyspepsia, myalgia, urinary tract

infection, abdominal pain, headache, dizziness, pain, fatigue, coughing, hypertension, chest pain, nausea,

and peripheral edema. Discontinuation of therapy because of adverse events was required in 2.8% of

1455 patients treated with telmisartan and 6.1% of 380 placebo patients in placebo-controlled clinical

trials.

The incidence of adverse events was not dose-related and did not correlate with gender, age, or race of

patients.

The incidence of cough occurring with telmisartan in 6 placebo-controlled trials was identical to that

noted for placebo-treated patients (1.6%).

In addition to those listed above, adverse events that occurred in more than 0.3% of 3500 patients

treated with telmisartan monotherapy in controlled or open trials are listed below. It cannot be

determined whether these events were causally related to telmisartan tablets:

Autonomic Nervous System: impotence, increased sweating, flushing; Body as a Whole: allergy, fever,

leg pain, malaise; Cardiovascular: palpitation, dependent edema, angina pectoris, tachycardia, leg edema,

abnormal ECG; CNS: insomnia, somnolence, migraine, vertigo, paresthesia, involuntary muscle

contractions, hypoesthesia; Gastrointestinal: flatulence, constipation, gastritis, vomiting, dry mouth,

hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache, non-specific

gastrointestinal disorders; Metabolic: gout, hypercholesterolemia, diabetes mellitus; Musculoskeletal:

arthritis, arthralgia, leg cramps; Psychiatric: anxiety, depression, nervousness; Resistance Mechanism:

infection, fungal infection, abscess, otitis media; Respiratory: asthma, bronchitis, rhinitis, dyspnea,

epistaxis; Skin: dermatitis, rash, eczema, pruritus; Urinary: micturition frequency, cystitis; Vascular:

cerebrovascular disorder; and Special Senses: abnormal vision, conjunctivitis, tinnitus, earache.

During initial clinical studies, a single case of angioedema was reported (among a total of 3781 patients

treated).

Clinical Laboratory Findings

In placebo-controlled clinical trials, clinically relevant changes in standard laboratory test parameters

were rarely associated with administration of telmisartan tablets.

Hemoglobin: A greater than 2 g/dL decrease in hemoglobin was observed in 0.8% telmisartan patients

compared with 0.3% placebo patients. No patients discontinued therapy because of anemia.

Creatinine: A 0.5 mg/dL rise or greater in creatinine was observed in 0.4% telmisartan patients

compared with 0.3% placebo patients. One telmisartan-treated patient discontinued therapy because of

increases in creatinine and blood urea nitrogen.

Liver Enzymes: Occasional elevations of liver chemistries occurred in patients treated with telmisartan;

all marked elevations occurred at a higher frequency with placebo. No telmisartan-treated patients

discontinued therapy because of abnormal hepatic function.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of telmisartan. Because

these reactions are reported voluntarily from a population of uncertain size, it is not always possible to

estimate reliably their frequency or establish a causal relationship to drug exposure. Decisions to

include these reactions in labeling are typically based on one or more of the following factors: (1)

seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to

telmisartan.

The most frequent spontaneously reported events include: headache, dizziness, asthenia, coughing,

nausea, fatigue, weakness, edema, face edema, lower limb edema, angioneurotic edema, urticaria,

hypersensitivity, sweating increased, erythema, chest pain, atrial fibrillation, congestive heart failure,

myocardial infarction, blood pressure increased, hypertension aggravated, hypotension (including

postural hypotension), hyperkalemia, syncope, dyspepsia, diarrhea, pain, urinary tract infection, erectile

dysfunction, back pain, abdominal pain, muscle cramps (including leg cramps), myalgia, bradycardia,

eosinophilia, thrombocytopenia, uric acid increased, abnormal hepatic function/liver disorder, renal

impairment including acute renal failure, anemia, increased CPK, anaphylactic reaction, tendon pain

(including tendonitis, tenosynovitis), drug eruption (toxic skin eruption mostly reported as toxicoderma,

rash, and urticaria), hypoglycemia (in diabetic patients), and angioedema (with fatal outcome).

Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers,

including telmisartan.

7 DRUG INTERACTIONS

Aliskiren: Do not co-administer aliskiren with telmisartan in patients with diabetes. Avoid use of

aliskiren with telmisartan in patients with renal impairment (GFR <60 mL/min).

Digoxin: When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma

concentration (49%) and in trough concentration (20%) were observed. Therefore, monitor digoxin

levels when initiating, adjusting, and discontinuing telmisartan for the purpose of keeping the digoxin

level within the therapeutic range.

Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during

concomitant administration of lithium with angiotensin II receptor antagonists including telmisartan.

Therefore, monitor serum lithium levels during concomitant use.

Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2

Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with

compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with

angiotensin II receptor antagonists, including telmisartan, may result in deterioration of renal function,

including possible acute renal failure. These effects are usually reversible. Monitor renal function

periodically in patients receiving telmisartan and NSAID therapy.

The antihypertensive effect of angiotensin II receptor antagonists, including telmisartan may be

attenuated by NSAIDs including selective COX-2 inhibitors.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

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

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

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

basis, the maximum recommended human dose of telmisartan (80 mg/day).

8.2 Lactation

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.

8.4 Pediatric Use

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.

8.5 Geriatric Use

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.

8.6 Hepatic Insufficiency

Monitor carefully and uptitrate slowly in patients with biliary obstructive disorders or hepatic

insufficiency [see Warnings and Precautions (5.4)].

10 OVERDOSAGE

Limited data are available with regard to overdosage in humans. The most likely manifestation of

overdosage with telmisartan tablets would be hypotension, dizziness and tachycardia; bradycardia could

occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive

treatment should be instituted. Telmisartan is not removed by hemodialysis.

11 DESCRIPTION

Telmisartan tablets, USP are a non-peptide angiotensin II receptor (type AT

) antagonist.

Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-

yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C

, its molecular

weight is 514.63, and its structural formula is:

Telmisartan USP is a white or slightly yellowish crystalline powder. It is practically insoluble in water

and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid),

and soluble in strong base.

Telmisartan is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of

telmisartan USP. The tablets contain the following inactive ingredients: sodium hydroxide, meglumine,

povidone, mannitol, sodium stearyl fumarate, crospovidone and magnesium stearate. Telmisartan tablets

are hygroscopic and require protection from moisture.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme

(ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with

effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac

stimulation, and renal reabsorption of sodium. Telmisartan blocks the vasoconstrictor and aldosterone-

secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT

receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore

independent of the pathways for angiotensin II synthesis.

There is also an AT

receptor found in many tissues, but AT

is not known to be associated with

cardiovascular homeostasis. Telmisartan has much greater affinity (>3,000 fold) for the AT

receptor

than for the AT

receptor.

Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of

angiotensin II from angiotensin I, is widely used in the treatment of hypertension. ACE inhibitors also

inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because telmisartan does not

inhibit ACE (kininase II), it does not affect the response to bradykinin. Whether this difference has

clinical relevance is not yet known. Telmisartan does not bind to or block other hormone receptors or

ion channels known to be important in cardiovascular regulation.

Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on

renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do

not overcome the effect of telmisartan on blood pressure.

12.2 Pharmacodynamics

In normal volunteers, a dose of telmisartan 80 mg inhibited the pressor response to an intravenous

infusion of angiotensin II by about 90% at peak plasma concentrations with approximately 40%

inhibition persisting for 24 hours.

Plasma concentration of angiotensin II and plasma renin activity (PRA) increased in a dose-dependent

manner after single administration of telmisartan to healthy subjects and repeated administration to

hypertensive patients. The once-daily administration of up to 80 mg telmisartan to healthy subjects did

not influence plasma aldosterone concentrations. In multiple dose studies with hypertensive patients,

there were no clinically significant changes in electrolytes (serum potassium or sodium), or in

metabolic function (including serum levels of cholesterol, triglycerides, HDL, LDL, glucose, or uric

acid).

In 30 hypertensive patients with normal renal function treated for 8 weeks with telmisartan 80 mg or

telmisartan 80 mg in combination with hydrochlorothiazide 12.5 mg, there were no clinically significant

changes from baseline in renal blood flow, glomerular filtration rate, filtration fraction, renovascular

resistance, or creatinine clearance.

12.3 Pharmacokinetics

Absorption

Following oral administration, peak concentrations (C

) of telmisartan are reached in 0.5 to 1 hour

after dosing. Food slightly reduces the bioavailability of telmisartan, with a reduction in the area under

the plasma concentration-time curve (AUC) of about 6% with the 40 mg tablet and about 20% after a

160 mg dose. The absolute bioavailability of telmisartan is dose dependent. At 40 and 160 mg the

bioavailability was 42% and 58%, respectively. The pharmacokinetics of orally administered

telmisartan are nonlinear over the dose range 20 to 160 mg, with greater than proportional increases of

plasma concentrations (C

and AUC) with increasing doses. Telmisartan shows bi-exponential decay

kinetics with a terminal elimination half-life of approximately 24 hours. Trough plasma concentrations

of telmisartan with once daily dosing are about 10% to 25% of peak plasma concentrations. Telmisartan

has an accumulation index in plasma of 1.5 to 2.0 upon repeated once daily dosing.

Distribution

Telmisartan is highly bound to plasma proteins (>99.5%), mainly albumin and α

- acid glycoprotein.

Plasma protein binding is constant over the concentration range achieved with recommended doses. The

volume of distribution for telmisartan is approximately 500 liters indicating additional tissue binding.

Metabolism and Elimination

Following either intravenous or oral administration of

C-labeled telmisartan, most of the administered

dose (>97%) was eliminated unchanged in feces via biliary excretion; only minute amounts were found

in the urine (0.91% and 0.49% of total radioactivity, respectively).

Telmisartan is metabolized by conjugation to form a pharmacologically inactive acyl glucuronide; the

glucuronide of the parent compound is the only metabolite that has been identified in human plasma and

urine. After a single dose, the glucuronide represents approximately 11% of the measured radioactivity

in plasma. The cytochrome P450 isoenzymes are not involved in the metabolism of telmisartan.

Total plasma clearance of telmisartan is >800 mL/min. Terminal half-life and total clearance appear to

be independent of dose.

Specific Populations

Renal Insufficiency

No dosage adjustment is necessary in patients with decreased renal function. Telmisartan is not removed

from blood by hemofiltration [see Warnings and Precautions (5.5) and Dosage and Administration (2.1)].

Hepatic Insufficiency

In patients with hepatic insufficiency, plasma concentrations of telmisartan are increased, and absolute

bioavailability approaches 100% [see Warnings and Precautions (5.4) and Use in Specific Populations

(8.6)].

Gender

Plasma concentrations of telmisartan are generally 2 to 3 times higher in females than in males. In

clinical trials, however, no significant increases in blood pressure response or in the incidence of

orthostatic hypotension were found in women. No dosage adjustment is necessary.

orthostatic hypotension were found in women. No dosage adjustment is necessary.

Geriatric Patients

The pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years

[see Dosage and Administration (2.1)].

Pediatric Patients

Telmisartan pharmacokinetics have not been investigated in patients <18 years of age.

Drug Interaction Studies

Telmisartan

Ramipril and Ramiprilat: Co-administration of telmisartan 80 mg once daily and ramipril 10 mg once

daily to healthy subjects increases steady-state C

and AUC of ramipril 2.3- and 2.1-fold,

respectively, and C

and AUC of ramiprilat 2.4- and 1.5-fold, respectively. In contrast, C

AUC of telmisartan decrease by 31% and 16%, respectively. When co-administering telmisartan and

ramipril, the response may be greater because of the possibly additive pharmacodynamic effects of the

combined drugs, and also because of the increased exposure to ramipril and ramiprilat in the presence

of telmisartan.

Other Drugs: Co-administration of telmisartan did not result in a clinically significant interaction with

acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen.

Telmisartan is not metabolized by the cytochrome P450 system and had no effects in vitro on

cytochrome P450 enzymes, except for some inhibition of CYP2C19. Telmisartan is not expected to

interact with drugs that inhibit cytochrome P450 enzymes; it is also not expected to interact with drugs

metabolized by cytochrome P450 enzymes, except for possible inhibition of the metabolism of drugs

metabolized by CYP2C19.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

There was no evidence of carcinogenicity when telmisartan was administered in the diet to mice and rats

for up to 2 years. The highest doses administered to mice (1000 mg/kg/day) and rats (100 mg/kg/day)

are, on a mg/m

basis, about 59 and 13 times, respectively, the maximum recommended human dose

(MRHD) of telmisartan. These same doses have been shown to provide average systemic exposures to

telmisartan >100 times and >25 times, respectively, the systemic exposure in humans receiving the

MRHD (80 mg/day).

Genotoxicity assays did not reveal any telmisartan-related effects at either the gene or chromosome

level. These assays included bacterial mutagenicity tests with Salmonella and E. coli (Ames), a gene

mutation test with Chinese hamster V79 cells, a cytogenetic test with human lymphocytes, and a mouse

micronucleus test.

No drug-related effects on the reproductive performance of male and female rats were noted at 100

mg/kg/day (the highest dose administered), about 13 times, on a mg/m

basis, the MRHD of telmisartan.

This dose in the rat resulted in an average systemic exposure (telmisartan AUC as determined on day 6

of pregnancy) at least 50 times the average systemic exposure in humans at the MRHD (80 mg/day).

14 CLINICAL STUDIES

14.1 Hypertension

The antihypertensive effects of telmisartan have been demonstrated in six principal placebo-controlled

clinical trials, studying a range of 20 to 160 mg; one of these examined the antihypertensive effects of

telmisartan and hydrochlorothiazide in combination. The studies involved a total of 1773 patients with

mild to moderate hypertension (diastolic blood pressure of 95 to 114 mmHg), 1031 of whom were

treated with telmisartan. Following once daily administration of telmisartan, the magnitude of blood

pressure reduction from baseline after placebo subtraction was approximately (SBP/DBP) 6-8/6 mmHg

for 20 mg, 9-13/6-8 mmHg for 40 mg, and 12-13/7-8 mmHg for 80 mg. Larger doses (up to 160 mg) did

not appear to cause a further decrease in blood pressure.

Upon initiation of antihypertensive treatment with telmisartan, blood pressure was reduced after the first

dose, with a maximal reduction by about 4 weeks. With cessation of treatment with telmisartan tablets,

blood pressure gradually returned to baseline values over a period of several days to one week. During

long-term studies (without placebo control) the effect of telmisartan appeared to be maintained for up to

at least one year. The antihypertensive effect of telmisartan is not influenced by patient age, gender,

weight, or body mass index. Blood pressure response in black patients (usually a low-renin population)

is noticeably less than that in Caucasian patients. This has been true for most, but not all, angiotensin II

antagonists and ACE inhibitors.

In a controlled study, the addition of telmisartan to hydrochlorothiazide produced an additional dose-

related reduction in blood pressure that was similar in magnitude to the reduction achieved with

telmisartan monotherapy. Hydrochlorothiazide also had an added blood pressure effect when added to

telmisartan.

The onset of antihypertensive activity occurs within 3 hours after administration of a single oral dose.

At doses of 20, 40, and 80 mg, the antihypertensive effect of once daily administration of telmisartan is

maintained for the full 24-hour dose interval. With automated ambulatory blood pressure monitoring and

conventional blood pressure measurements, the 24-hour trough-to-peak ratio for 40 to 80 mg doses of

telmisartan was 70% to 100% for both systolic and diastolic blood pressure. The incidence of

symptomatic orthostasis after the first dose in all controlled trials was low (0.04%).

There were no changes in the heart rate of patients treated with telmisartan in controlled trials.

There are no trials of telmisartan demonstrating reductions in cardiovascular risk in patients with

hypertension, but at least one pharmacologically similar drug has demonstrated such benefits.

16 HOW SUPPLIED/STORAGE AND HANDLING

Telmisartan tablets USP are available as white or off-white tablets containing 20 mg, 40 mg, or 80 mg

of telmisartan USP. Tablets are marked with the HU on one side, and on the other side, with either 20,

40, or 80 for the 20 mg, 40 mg, and 80 mg strengths, respectively. Tablets are provided as follows:

Telmisartan tablets USP 20 mg are round and individually blister-sealed in cartons of 30 tablets as 3 x

10 cards (NDC 42658-135-51).

Telmisartan tablets USP 40 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets

as 3 x 10 cards (NDC 42658-136-51).

Telmisartan tablets USP 80 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets

as 3 x 10 cards (NDC 42658-137-51).

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP

Controlled Room Temperature]. Tablets should not be removed from blisters until immediately before

administration.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information)

Pregnancy

Advise female patients of childbearing age about the consequences of exposure to telmisartan during

pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report

pregnancies to their physicians as soon as possible [see Warnings and Precautions (5.1) and Use in

Specific Populations (8.1)] .

Lactation

Advise nursing women not to breastfeed during treatment with telmisartan [see Use in Specific

Populations (8.2)] .

Symptomatic Hypotension and Syncope

Advise patients that lightheadedness can occur, especially during the first days of therapy, and to report

it to their healthcare provider. Inform patients that inadequate fluid intake, excessive perspiration,

diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of

lightheadedness and possible syncope. Advise patients to contact their healthcare provider if syncope

occurs [see Warnings and Precautions (5.2)] .

Potassium Supplements

Advise patients not to use potassium supplements or salt substitutes that contain potassium without

consulting the prescribing healthcare provider [see Warnings and Precautions (5.3)] .

Distributed by:

Hisun Pharmaceuticals USA, Inc.

Bridgewater, NJ 08807 USA

Manufactured in China

Revised: 03/2018

Patient Information

Telmisartan (TEL-mi-SAR-tan) Tablets

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 tablets 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

tablets, tell your doctor right away.

What are telmisartan tablets?

Telmisartan tablets are a prescription medicine used:

to treat high blood pressure (hypertension)

It is not known if telmisartan tablets are safe and effective in children.

Who should not take telmisartan tablets?

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 tablets 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 “What is the most important information I

should know about telmisartan tablets?”

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 breast-feed. 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 tablets you should not take aliskiren.

Telmisartan tablets may affect the way other medicines work, and other medicines may affect how

telmisartan tablets work. Especially tell your doctor if you take:

aliskiren

digoxin (Lanoxin®)

lithium (Lithobid®, lithium carbonate, lithium citrate)

aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)

other medicines used to treat your high blood pressure or heart problem

water pills (diuretic)

Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist when you

get a new medicine.

How should I take telmisartan tablets?

Take telmisartan tablets exactly as your doctor tells you to take it.

Your doctor will tell you how many telmisartan tablets to take and when to take it.

Do not change your dose unless your doctor tells you to.

Take telmisartan tablets one time each day at the same time.

Take telmisartan tablets with or without food.

If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the

missed dose. Take the next dose at your regular time.

If you take too many telmisartan tablets, call your doctor, or go to the nearest hospital emergency

room right away.

Read the “How to Open the Blister” at the end of this leaflet before you use telmisartan tablets.

Talk with your doctor if you do not understand the instructions.

What are the possible side effects of telmisartan tablets?

Telmisartan tablets may cause serious side effects, including:

Injury or death to your unborn baby. See “What is the most important information I should

know about telmisartan tablets?”

Low blood pressure (hypotension) is most likely to happen if you also:

take water pills (diuretics)

are on a low-salt diet

get dialysis treatments

have heart problems

get sick with vomiting or diarrhea

If you feel faint or dizzy, lie down and call your doctor right away.

Kidney problems, which may get worse if you already have kidney disease. You may have changes

in your kidney test results, and you may need a lower dose of telmisartan tablets. Call your doctor if

you get:

swelling in your feet, ankles, or hands

unexplained weight gain

Call your doctor right away if you get any of the symptoms listed above.

High potassium in the blood (hyperkalemia). Your doctor may check your potassium levels as

needed.

Rare, serious allergic reactions may happen. Tell your doctor right away if you get any of these

symptoms:

swelling of the face, tongue, throat

difficulty breathing

skin rash

The most common side effects of telmisartan tablets include:

sinus pain and congestion (sinusitis)

back pain

diarrhea

These are not all the possible side effects with telmisartan tablets. Tell your doctor if you have any

side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-

FDA-1088.

How should I store telmisartan tablets?

Store telmisartan tablets between 68

F to 77

F (20

C to 25

C), excursions permitted between 59°F

to 86°F (15°C to 30°C).

Do not remove telmisartan tablets from blisters until right before you take them.

Keep telmisartan tablets and all medicines out of the reach of children.

General information about telmisartan tablets

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

Do not use telmisartan tablets for a condition for which it was not prescribed. Do not give telmisartan

tablets to other people, even if they have the same condition you have. It may harm them.

This Patient Information leaflet summarizes the most important information about telmisartan tablets. If

you would like more information, talk with your doctor. You can ask your pharmacist or doctor for

information about telmisartan tablets that is written for health professionals.

For more information, call Hisun Pharmaceuticals USA, Inc. at 1-855-554-4786.

What are the ingredients in telmisartan tablets?

Active Ingredient: telmisartan

Inactive Ingredients: sodium hydroxide, meglumine, povidone, mannitol, sodium stearyl fumarate,

crospovidone and magnesium stearate

What is High Blood Pressure (Hypertension)?

Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You

have high blood pressure when the force is too much. Telmisartan tablets can help your blood vessels

relax so your blood pressure is lower. Medicines that lower your blood pressure lower your chance of

having a stroke or heart attack.

High blood pressure makes the heart work harder to pump blood throughout the body and causes

damage to the blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack,

heart failure, kidney failure, and vision problems.

How to open the blister:

1. Tear (You may also use scissors to tear the blister apart)

2. Peel (Peel off the paper layer from the aluminum foil)

3. Push (Push the tablet through the foil

Trademarks are the property of their respective owners.

Distributed by:

Hisun Pharmaceuticals USA, Inc.

Bridgewater, NJ 08807 USA

Manufactured in China

Revised: 03/2018

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Telmisartan Tablets, USP 20 mg

NDC 42658-135-51

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Telmisartan Tablets, USP 40 mg

NDC 42658-136-51

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Telmisartan Tablets, USP 80 mg

NDC 42658-137-51

TELMISARTAN

telmisartan tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:426 58 -135

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

TELMISARTAN

20 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

MEGLUMINE (UNII: 6 HG8 UB2MUY)

PO VIDO NE K2 9 /3 2 (UNII: 39 0 RMW2PEQ)

MANNITO L (UNII: 3OWL53L36 A)

CRO SPO VIDO NE (UNII: 2S78 30 E56 1)

SO DIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

Product Characteristics

Color

white (White o r o ff-white)

S core

no sco re

S hap e

ROUND

S iz e

Flavor

Imprint Code

HU;20

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:426 58 -135-51 3 in 1 CARTON

0 8 /0 1/20 19

1

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 78 43

0 8 /0 1/20 19

TELMISARTAN

telmisartan tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:426 58 -136

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

TELMISARTAN

40 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

MEGLUMINE (UNII: 6 HG8 UB2MUY)

PO VIDO NE K2 9 /3 2 (UNII: 39 0 RMW2PEQ)

MANNITO L (UNII: 3OWL53L36 A)

CRO SPO VIDO NE (UNII: 2S78 30 E56 1)

SO DIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

Product Characteristics

Color

white (White o r o ff-white)

S core

no sco re

S hap e

OVAL

S iz e

12mm

Flavor

Imprint Code

HU;40

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:426 58 -136 -51 3 in 1 CARTON

0 8 /0 1/20 19

1

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 78 43

0 8 /0 1/20 19

TELMISARTAN

telmisartan tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:426 58 -137

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

TELMISARTAN

8 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

MEGLUMINE (UNII: 6 HG8 UB2MUY)

PO VIDO NE K2 9 /3 2 (UNII: 39 0 RMW2PEQ)

MANNITO L (UNII: 3OWL53L36 A)

CRO SPO VIDO NE (UNII: 2S78 30 E56 1)

SO DIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

Hisun Pharmaceuticals USA, Inc.

Product Characteristics

Color

white (White o r o ff-white)

S core

no sco re

S hap e

OVAL

S iz e

16 mm

Flavor

Imprint Code

HU;8 0

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:426 58 -137-51 3 in 1 CARTON

0 8 /0 1/20 19

1

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 78 43

0 8 /0 1/20 19

Labeler -

Hisun Pharmaceuticals USA, Inc. (961628505)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Hisun

Pha rma c e utic a l

(Hangzho u) Co .,

Ltd.

421250 8 70

api manufacture(426 58 -135, 426 58 -136 , 426 58 -137) , manufacture(426 58 -135, 426 58 -136 ,

426 58 -137) , analysis(426 58 -135, 426 58 -136 , 426 58 -137) , label(426 58 -135, 426 58 -136 ,

426 58 -137) , pack(426 58 -135, 426 58 -136 , 426 58 -137)

Revised: 3/2019

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