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Telmisartan Tablets USP Treatment of essential hypertension

20mg/40mg/80mg The usually effective dose is 40 mg once daily.

Some patients may already benefit at a daily
1. Name of the medicinal dose of 20 mg. In cases where the target blood
pressure is not achieved, the dose of telmisartan
product can be increased to a maximum of 80 mg once
Telmisartan Tablets USP 20mg Taj Pharma daily. Alternatively, telmisartan may be used in
Telmisartan Tablets USP 40mg Taj Pharma combination with thiazidetype diuretics such as
hydrochlorothiazide which has been shown to
Telmisartan Tablets USP 80mg Taj Pharma
have an additive blood pressure lowering effect
2. Qualitative and quantitative with telmisartan. When considering raising the
dose, it must be borne in mind that the
composition maximum antihypertensive effect is generally
attained four to eight weeks after the start of
a) Each Uncoated Tablet Contains:
treatment (see section 5.1).
Telmisartan USP 20mg
Excipients q.s. Cardiovascular prevention
b) Each Uncoated Tablet Contains: The recommended dose is 80 mg once daily. It
Telmisartan USP 40mg is not known whether doses lower than 80 mg of
Excipients q.s. telmisartan are effective in reducing
cardiovascular morbidity.
c) Each Uncoated Tablet Contains:
Telmisartan USP 80mg When initiating telmisartan therapy for the
Excipients q.s. reduction of cardiovascular morbidity, close
monitoring of blood pressure is recommended,
For the full list of excipients, see section 6.1.
and if appropriate adjustment of medications
3. Pharmaceutical form that lower blood pressure may be necessary.
Special populations
Tablet
Patients with renal impairment
4. Clinical particulars
Limited experience is available in patients with
4.1 Therapeutic indications severe renal impairment or haemodialysis. A
Hypertension lower starting dose of 20 mg is recommended in
these patients (see section 4.4). No posology
Treatment of essential hypertension in adults. adjustment is required for patients with mild to
Cardiovascular prevention moderate renal impairment.
Reduction of cardiovascular morbidity in adults Patients with hepatic impairment
with: Telmisartan is contraindicated in patients with
- manifest atherothrombotic cardiovascular severe hepatic impairment (see section 4.3).
disease (history of coronary heart disease, In patients with mild to moderate hepatic
stroke, or peripheral arterial disease) or impairment the posology should not exceed 40
- type 2 diabetes mellitus with documented mg once daily (see section 4.4).
target organ damage Elderly patients
4.2 Posology and method of administration
Posology
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No dose adjustment is necessary for elderly Telmisartan is not to be given to patients with
patients. cholestasis, biliary obstructive disorders or
severe hepatic impairment (see section 4.3) since
Paediatric population telmisartan is mostly eliminated with the bile.
The safety and efficacy of telmisartan in These patients can be expected to have reduced
children and adolescents aged below 18 years hepatic clearance for telmisartan. Telmisartan
have not been established. should be used only with caution in patients with
mild to moderate hepatic impairment.
Currently available data are described in section
5.1 and 5.2 but no recommendation on a Renovascular hypertension
posology can be made. There is an increased risk of severe hypotension
Method of administration and renal insufficiency when patients with
bilateral renal artery stenosis or stenosis of the
Telmisartan tablets are for once-daily oral artery to a single functioning kidney are treated
administration and should be taken with liquid, with medicinal products that affect the renin-
with or without food. angiotensin-aldosterone system.
4.3 Contraindications Renal impairment and kidney transplantation
- Hypersensitivity to the active substance or to
any of the excipients listed in section 6.1 When Telmisartan is used in patients with
impaired renal function, periodic monitoring of
- Second and third trimesters of pregnancy (see potassium and creatinine serum levels is
sections 4.4 and 4.6) recommended. There is no experience regarding
- Biliary obstructive disorders the administration of Telmisartan in patients
with recent kidney transplantation.
- Severe hepatic impairment
Intravascular hypovolaemia
The concomitant use of Telmisartan
withaliskiren-containing products is Symptomatic hypotension, especially after the
contraindicated in patients with diabetes mellitus first dose of Telmisartan , may occur in patients
or renal impairment (GFR < 60 ml/min/1.73 m2) who are volume and/or sodium depleted by
(see sections 4.5 and 5.1). vigorous diuretic therapy, dietary salt restriction,
diarrhoea or vomiting. Such conditions should
4.4 Special warnings and precautions for use be corrected before the administration of
Pregnancy Telmisartan . Volume and/or sodium depletion
Angiotensin II receptor antagonists should not should be corrected prior to administration of
be initiated during pregnancy. Unless continued Telmisartan .
angiotensin II receptor antagonist therapy is Dual blockade of the renin-angiotensin-
considered essential, patients planning aldosterone system (RAAS):
pregnancy should be changed to alternative
antihypertensive treatments which have an There is evidence that the concomitant use of
established safety profile for use in pregnancy. ACE-inhibitors, angiotensin II receptor blockers
When pregnancy is diagnosed, treatment with or aliskiren increases the risk of hypotension,
angiotensin II receptor antagonists should be hyperkalaemia and decreased renal function
stopped immediately, and, if appropriate, (including acute renal failure). Dual blockade of
alternative therapy should be started (see RAAS through the combined use of ACE-
sections 4.3 and 4.6). inhibitors, angiotensin II receptor blockers or
aliskiren is therefore not recommended (see
Hepatic impairment sections 4.5 and 5.1).
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If dual blockade therapy is considered absolutely
necessary, this should only occur under
specialist supervision and subject to frequent
close monitoring of renal function, electrolytes
and blood pressure.
ACE-inhibitors and angiotensin II receptor
blockers should not be used concomitantly in
patients with diabetic nephropathy.
Other conditions with stimulation of the renin-
angiotensin-aldosterone system
In patients whose vascular tone and renal
function depend predominantly on the activity of
the renin-angiotensin-aldosterone system (e.g.
patients with severe congestive heart failure or
underlying renal disease, including renal artery
stenosis), treatment with medicinal products that
affect this system such as telmisartan has been
associated with acute hypotension,
hyperazotaemia, oliguria, or rarely acute renal
failure (see section 4.8).
Primary aldosteronism
Patients with primary aldosteronism generally
will not respond to antihypertensive medicinal
products acting through inhibition of the renin-
angiotensin system. Therefore, the use of
telmisartan is not recommended.
Aortic and mitral valve stenosis, obstructive
hypertrophic cardiomyopathy
As with other vasodilators, special caution is
indicated in patients suffering from aortic or
mitral stenosis, or obstructive hypertrophic
cardiomyopathy.
Diabetic patients
antidiabetics
In these patients hypoglycaemia may occur
under telmisartan treatment. Therefore, in these
patients an approptiate blood glucose monitoring
should be considered; a dose adjustment of
insulin or antidiabetics may be required, when
indicated.
Hyperkalaemia
The use of medicinal products that affect the
renin-angiotensin-aldosterone system may cause
hyperkalaemia.
In the elderly, in patients with renal
insufficiency, in diabetic patients, in patients
concomitantly treated with other medicinal
products that may increase potassium levels,
and/or in patients with intercurrent events,
hyperkalaemia may be fatal.
Before considering the concomitant use of
medicinal products that affect the renin-
angiotensin-aldosterone system, the benefit risk
ratio should be evaluated.
The main risk factors for hyperkalaemia to be
considered are:
- Diabetes mellitus, renal impairment, age (> 70
years)
- Combination with one or more other medicinal
products that affect the renin-angiotensin-
aldosterone system and/or potassium
supplements. Medicinal products or therapeutic
class of medicinal products that may provoke
hyperkalaemia are salt substitutes containing
potassium, potassium-sparing diuretics, ACE
inhibitors, angiotensin II receptor antagonists,
non steroidal anti-inflammatory medicinal
products (NSAIDs, including selective COX-2
inhibitors), heparin, immunosuppressives
(cyclosporin or tacrolimus), and trimethoprim.
- Intercurrent events, in particular dehydratation,
acute cardiac decompensation, metabolic
acidosis, worsening of renal function, sudden
worsening of the renal condition (e.g. infectious
treated with insulin or diseases), cellular lysis (e.g. acute limb
ischemia, rhabdomyolysis, extend trauma).
Close-monitoring of serum potassium in at risk
patients is recommended (see section 4.5).
Ethnic differences
As observed for angiotensin converting enzyme
inhibitors, telmisartan and the other angiotensin
antagonists are apparently less effective in
lowering blood pressure in black people than in
non-blacks, possibly because of higher
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prevalence of low-renin states in the black Angiotensin II receptor antagonists such as

hypertensive population. telmisartan attenuate diuretic induced potassium
loss. Potassium sparing diuretics e.g.
Other spirinolactone, eplerenone, triamterene, or
As with any antihypertensive agent, excessive amiloride, potassium supplements, or potassium-
reduction of blood pressure in patients with containing salt substitutes may lead to a
ischaemiccardiopathy or ischaemic significant increase in serum potassium. If
cardiovascular disease could result in a concomitant use is indicated because of
myocardial infarction or stroke. documented hypokalaemia, they should be used
with caution and with frequent monitoring of
4.5 Interaction with other medicinal products serum potassium.
and other forms of interaction
Digoxin Lithium
When telmisartan was co-administered with Reversible increases in serum lithium
digoxin, median increases in digoxin peak concentrations and toxicity have been reported
plasma concentration (49%) and in trough during concomitant administration of lithium
concentration (20%) were observed. When with angiotensin converting enzyme inhibitors,
initiating, adjusting, and discontinuing and with angiotensin II receptor antagonists,
telmisartan, monitor digoxin levels in order to including telmisartan. If use of the combination
maintain levels within the therapeutic range. proves necessary, careful monitoring of serum
lithium levels is recommended.
As with other medicinal products acting on the
renin-angiotensin-aldosterone system, Concomitant use requiring caution
telmisartan may provoke hyperkalaemia (see Non-steroidal anti-inflammatory medicinal
section 4.4). The risk may increase in case of
products
treatment combination with other medicinal
products that may also provoke hyperkalaemia NSAIDs (i.e. acetylsalicylic acid at anti-
(salt substitutes containing potassium, inflammatory dosage regimens, COX-2
potassium-sparing diuretics, ACE inhibitors, inhibitors and nonselective NSAIDs) may
angiotensin II receptor antagonists, non steroidal reduce the antihypertensive effect of angiotensin
anti-inflammatory medicinal products (NSAIDs, II receptor antagonists.
including selective COX-2 inhibitors), heparin,
immunosuppressives (cyclosporin or In some patients with compromised renal
function (e.g. dehydrated patients or elderly
tacrolimus), and trimethoprim).
patients with compromised renal function) the
The occurrence of hyperkalaemia depends on co-administration of angiotensin II receptor
associated risk factors. The risk is increased in antagonists and agents that inhibit cyclo-
case of the above-mentioned treatment oxygenase may result in further deterioration of
combinations. The risk is particularly high in renal function, including possible acute renal
combination with potassium sparing-diuretics failure, which is usually reversible. Therefore,
and when combined with salt substitutes the combination should be administered with
containing potassium. A combination with ACE caution, especially in the elderly. Patients should
inhibitors or NSAIDs, for example, presents a be adequately hydrated and consideration should
lesser risk provided that precautions for use are be given to monitoring of renal function after
strictly followed. initiation of concomitant therapy and
periodically thereafter.
Concomitant use not recommended
In one study the co-administration of telmisartan
Potassium sparing diuretics or potassium and ramipril led to an increase of up to 2.5 fold
supplements
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in the AUC0-24 and Cmax of ramipril and contraindicated during the second and third
ramiprilat. The clinical relevance of this trimesters of pregnancy (see sections 4.3 and
observation is not known. 4.4).
Diuretics (thiazide or loop diuretics) There are no adequate data from the use of
Telmisartan in pregnant women. Studies in
Prior treatment with high dose diuretics such as animals have shown reproductive toxicity (see
furosemide (loop diuretic) and section 5.3).
hydrochlorothiazide (thiazide diuretic) may
result in volume depletion and in a risk of Epidemiological evidence regarding the risk of
hypotension when initiating therapy with teratogenicity following exposure to ACE
telmisartan. inhibitors during the first trimester of pregnancy
has not been conclusive; however a small
To be taken into account with concomitant use increase in risk cannot be excluded. Whilst there
Other antihypertensive agents is no controlled epidemiological data on the risk
with angiotensin II receptor antagonists, similar
The blood pressure lowering effect of risks may exist for this class of drugs. Unless
telmisartan can be increased by concomitant use continued angiotensin II receptor antagonist
of other antihypertensive medicinal products. therapy is considered essential, patients planning
pregnancy should be changed to alternative anti-
Clinical trial data has shown that dual blockade
hypertensive treatments which have an
of the renin-angiotensin-aldosterone-system
established safety profile for use in pregnancy.
(RAAS) through the combined use of ACE-
inhibitors, angiotensin II receptor blockers or When pregnancy is diagnosed, treatment with
aliskiren is associated with a higher frequency of angiotensin II receptor antagonists should be
adverse events such as hypotension, stopped immediately, and, if appropriate,
hyperkalaemia and decreased renal function alternative therapy should be started.
(including acute renal failure) compared to the
use of a single RAAS-acting agent (see sections Exposure to angiotensin II receptor antagonist
4.3, 4.4 and 5.1). therapy during the second and third trimesters is
known to induce human fetotoxicity (decreased
Based on their pharmacological properties it can renal function, oligohydramnios, skull
be expected that the following medicinal ossification retardation) and neonatal toxicity
products may potentiate the hypotensive effects (renal failure, hypotension, hyperkalaemia). (See
of all antihypertensives including telmisartan: section 5.3).
Baclofen, amifostine.
Should exposure to angiotensin II receptor
Furthermore, orthostatic hypotension may be antagonists have occurred from the second
aggravated by alcohol, barbiturates, narcotics or trimester of pregnancy, ultrasound check of
antidepressants. renal function and skull is recommended.
Corticosteroids (systemic route) Infants whose mothers have taken angiotensin II
receptor antagonists should be closely observed
Reduction of the antihypertensive effect.
for hypotension (see sections 4.3 and 4.4).
4.6 Fertility, pregnancy and lactation
Breast-feeding
Pregnancy:
Because no information is available regarding
The use of angiotensin II receptor antagonists is the use of Telmisartan during breast-feeding,
not recommended during the first trimester of Telmisartan is not recommended and alternative
pregnancy (see section 4.4). The use of treatments with better established safety profiles
angiotensin II receptor antagonists is
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during breast-feeding are preferable, especially 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare
while nursing a newborn or preterm infant. (< 1/10,000).
Fertility Within each frequency grouping, adverse
reactions are presented in order of decreasing
In preclinical studies, no effects of telmisartan
seriousness.
on male and female fertility were observed.
Infections and
4.7 Effects on ability to drive and use
infestations
machines
When driving vehicles or operating machinery it Uncommon: Urinary tract infection including
should be taken into account that dizziness or Rare: cystitis, upper respiratory tract
drowsiness may occasionally occur when taking infection including pharyngitis
antihypertensive therapy such as Telmisartan . and sinusitis
Sepsis including fatal outcome1
4.8 Undesirable effects
Blood and the lymphatic system disorders
Summary of the safety profile
Uncommon: Anaemia
Serious adverse drug reactions include Rare: Eosinophilia, thrombocytopenia
anaphylactic reaction and angioedema which
may occur rarely (≥1/10,000 to <1/1,000), and Immune system disorders
acute renal failure. Rare: Anaphylactic reaction,
hypersensitivity
The overall incidence of adverse reactions
reported with telmisartan was usually Metabolism and nutrition disorders
comparable to placebo (41.4% vs 43.9%) in Uncommon: Hyperkalaemia
placebo controlled trials in patients treated for
Rare: Hypoglycaemia (in diabetic
hypertension. The incidence of adverse reactions
Psychiatric patients)
was not dose related and showed no correlation
disorders
with gender, age or race of the patients. The
safety profile of telmisartan in patients treated Uncommon: Insomnia, depression
for the reduction of cardiovascular morbidity Rare: Anxiety
was consistent with that obtained in Nervous
hypertensive patients. system
The adverse reactions listed below have been disorders
accumulated from controlled clinical trials in Uncommon: Syncope
patients treated for hypertension and from post- Rare: Somnolence
marketing reports. The listing also takes into
account serious adverse reactions and adverse Eye disorders
reactions leading to discontinuation reported in Rare: Visual disturbance
three clinical long-term studies including 21642 Ear and
patients treated with telmisartan for the labyrinth
reduction of cardiovascular morbidity for up to disorders
six years.
Uncommon: Vertigo
Tabulated list of adverse reactions Cardiac
Adverse reactions have been ranked under disorders
headings of frequency using the following Uncommon: Bradycardia
convention: very common (≥ 1/10); common (≥ Rare: Tachycardia
1/100 to < 1/10); uncommon (≥ 1/1,000 to < Vascular
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disorders increased
Uncommon: Hypotension , orthostatic 2 1,2,3,4: for further descriptions, please see sub-
hypotension section 4 “Description of selected adverse
Respiratory, thoracic and mediastinal disorders reactions”
Uncommon: Dyspnoea, cough Description of selected adverse reactions
Very rare: Interstitial lung disease4 Sepsis
Gastrointestinal In the PRoFESS trial, an increased incidence of
disorders sepsis was observed with telmisartan compared
Uncommon: Abdominal pain, diarrhoea, with placebo. The event may be a chance finding
Rare: dyspepsia, flatulence, vomiting or related to a mechanism currently not known
Dry mouth, stomach discomfort, (see also section 5.1).
dysgeusia
Hypotension
Hepatobiliary
disorders This adverse drug reaction was reported as
Rare: Hepatic function abnormal/liver common in patients with controlled blood
disorder3 pressure who were treated with telmisartan for
Skin and subcutaneous tissue disorders the reduction of cardiovascular morbidity on top
of standard care.
Uncommon: Pruritus, hyperhidrosis, rash
Rare: Angioedema (also with fatal Hepatic function abnormal / liver disorder
outcome), eczema, erythema,
Most cases of hepatic function abnormal / liver
urticaria, drug eruption, toxic
disorder from post-marketing experience
skin eruption
occurred in patients in Japan, who are more
Muscoloskeletal and connective tissue disorders likely to experience these adverse reactions.
Uncommon: Back pain (e.g. sciatica), muscle
Rare: spasms, myalgia Interstitial lung disease
Arthralgia, pain in extremity, Cases of interstitial lung disease have been
tendor pain (tendinitis like reported from post-marketing experience in
symptoms) temporal association with the intake of
Renal and telmisartan. However, a causal relationship has
urinary not been established.
disorders
Reporting of suspected adverse reactions
Uncommon: Renal impairment including
acute renal failure Reporting suspected adverse reactions after
authorisation of the medicinal product is
General disorders and administration site
important. It allows continued monitoring of the
conditions
benefit/risk balance of the medicinal product.
Uncommon: Chest pain, asthenia (weakness)
Rare: Influenza-like illness 4.9 Overdose
Investigations There is limited information available with
regard to overdose in humans.
Uncommon: Blood creatinine increased
Rare: Haemoglobin decreased, blood Symptoms: The most prominent manifestations
uric acid increased, hepatic of telmisartan overdose were hypotension and
enzyme increased, blood tachycardia; bradycardia dizziness, increase in
creatine phosphokinase serum creatinine, and acute renal failure have
also been reported.
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Treatment: Telmisartan is not removed by maintained over 24 hours and still measurable
haemodialysis. The patient should be closely up to 48 hours.
monitored, and the treatment should be
symptomatic and supportive. Management Clinical efficacy and safety
depends on the time since ingestion and the Treatment of essential hypertension
severity of the symptoms. Suggested measures
include induction of emesis and / or gastric After the first dose of telmisartan, the
lavage. Activated charcoal may be useful in the antihypertensive activity gradually becomes
treatment of overdosage. Serum electrolytes and evident within 3 hours. The maximum reduction
creatinine should be monitored frequently. If in blood pressure is generally attained 4 to 8
hypotension occurs, the patient should be placed weeks after the start of treatment and is
in a supine position, with salt and volume sustained during long-term therapy.
replacement given quickly. The antihypertensive effect persists constantly
over 24 hours after dosing and includes the last 4
5. Pharmacological properties hours before the next dose as shown by
5.1 Pharmacodynamic properties ambulatory blood pressure measurements. This
Pharmacotherapeutic group: Angiotensin II is confirmed by trough to peak ratios
Antagonists. consistently above 80% seen after doses of 40
and 80 mg of telmisartan in placebo controlled
Mechanism of action clinical studies.
Telmisartan is an orally active and specific There is an apparent trend to a dose relationship
angiotensin II receptor (type AT1) antagonist. to a time to recovery of baseline systolic blood
pressure (SBP). In this respect data concerning
Telmisartan displaces angiotensin II with very
diastolic blood pressure (DBP) are inconsistent.
high affinity from its binding site at the
AT1 receptor subtype, which is responsible for In patients with hypertension telmisartan reduces
the known actions of angiotensin II. Telmisartan both systolic and diastolic blood pressure
does not exhibit any partial agonist activity at without affecting pulse rate. The contribution of
the AT1 receptor. Telmisartan selectively binds the medicinal product's diuretic and natriuretic
the AT1 receptor. The binding is long-lasting. effect to its hypotensive activity has still to be
Telmisartan does not show affinity for other defined. The antihypertensive efficacy of
receptors, including AT2 and other less telmisartan is comparable to that of agents
characterised AT receptors. The functional role representative of other classes of
of these receptors is not known, nor is the effect antihypertensive medicinal products
of their possible overstimulation by angiotensin (demonstrated in clinical trials comparing
II, whose levels are increased by telmisartan. telmisartan to amlodipine, atenolol, enalapril,
hydrochlorothiazide, and lisinopril).
Plasma aldosterone levels are decreased by
telmisartan. Telmisartan does not inhibit human Upon abrupt cessation of treatment with
plasma renin or block ion channels. Telmisartan telmisartan, blood pressure gradually returns to
does not inhibit angiotensin converting enzyme pre-treatment values over a period of several
(kininase II), the enzyme which also degrades days without evidence of rebound hypertension.
bradykinin. Therefore it is not expected to
potentiate bradykinin-mediated adverse effects. The incidence of dry cough was significantly
lower in patients treated with telmisartan than in
In human, an 80 mg dose of telmisartan almost those given angiotensin converting enzyme
completely inhibits the angiotensin II evoked inhibitors in clinical trials directly comparing the
blood pressure increase. The inhibitory effect is two antihypertensive treatments.
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Cardiovascular prevention as ONTARGET to telmisartan 80 mg (n = 2954)

or placebo (n = 2972), both given on top of
ONTARGET (ONgoing Telmisartan Alone and standard care. The mean duration of follow up
in Combination was 4 years and 8 months. No statistically
with Ramipril Global Endpoint Trial) compared significant difference in the incidence of the
the effects of telmisartan, ramipril and the
primary composite endpoint (cardiovascular
combination of telmisartan and ramipril on
death, non-fatal myocardial infarction, non-fatal
cardiovascular outcomes in 25620 patients aged stroke, or hospitalization for congestive heart
55 years or older with a history of coronary failure) was found [15.7% in the telmisartan and
artery disease, stroke, TIA, peripheral arterial 17.0% in the placebo groups with a hazard ratio
disease, or type 2 diabetes mellitus accompanied of 0.92 (95% CI 0.81-1.05, p = 0.22)]. There
by evidence of end-organ damage (e.g. was evidence for a benefit of telmisartan
retinopathy, left ventricular hypertrophy, macro- compared to placebo in the pre-specified
or microalbuminuria), which is a population at secondary composite endpoint of cardiovascular
risk for cardiovascular events. death, non-fatal myocardial infarction, and non-
Patients were randomized to one of the three fatal stroke [0.87 (95% CI 0.76-1.00, p =
following treatment groups: telmisartan 80 mg 0.048)], There was no evidence for benefit on
(n = 8542), ramipril 10 mg (n = 8576), or the cardiovascular mortality (hazard ratio 1.03, 95%
combination of telmisartan 80 mg plus ramipril CI 0.85-1.24).
10 mg (n = 8502), and followed for a mean
Two large randomised, controlled trials
observation time of 4.5 years. (ONTARGET (ONgoingTelmisartan Alone and
Telmisartan showed a similar effect to ramipril in combination with Ramipril Global Endpoint
in reducing the primary composite endpoint of Trial) and VA NEPHRON-D (The Veterans
cardiovascular death, non-fatal myocardial Affairs Nephropathy in Diabetes)) have
infarction, non-fatal stroke, or hospitalization for examined the use of the combination of an ACE-
congestive heart failure. The incidence of the inhibitor with an angiotensin II receptor blocker.
primary endpoint was similar in the telmisartan ONTARGET was a study conducted in patients
(16.7%) and ramipril (16.5%) groups. The with a history of cardiovascular or
hazard ratio for telmisartan vs. ramipril was 1.01 cerebrovascular disease, or type 2 diabetes
(97.5% CI 0.93 - 1.10, p (non-inferiority) =
mellitus accompanied by evidence of end-organ
0.0019 at a margin of 1.13). The all-cause
damage. VA NEPHRON-D was a study in
mortality rate was 11.6 % and 11.8 % among patients with type 2 diabetes mellitus and
telmisartan and ramipril treated patients,
diabetic nephropathy.
respectively.
These studies have shown no significant
Telmisartan was found to be similarly effective beneficial effect on renal and/or cardiovascular
to ramipril in the pre-specified secondary outcomes and mortality, while an increased risk
endpoint of cardiovascular death, non-fatal of hyperkalaemia, acute kidney injury and/or
myocardial infarction, and non-fatal stroke [0.99 hypotension as compared to monotherapy was
(97.5% CI 0.90 - 1.08), p (non-inferiority) = observed. Given their similar pharmacodynamic
0.0004], the primary endpoint in the reference properties, these results are also relevant for
study HOPE other ACE-inhibitors and angiotensin II receptor
(The Heart Outcomes Prevention Evaluation
blockers.
Study), which had investigated the effect of
ramipril vs. placebo. ACE-inhibitors and angiotensin II receptor
blockers should therefore not be used
TRANSCEND randomized ACE-I intolerant concomitantly in patients with diabetic
patients with otherwise similar inclusion criteria
nephropathy.
 Telmisartan 40 mg, 80 mg Tablets Taj Phar ma : Use s, Side Effect s, Interactions, Pi ctures, Warnings, T elmisartan D osage & Rx Info | Telmisartan Uses, Side E ffects - Antihyperten sive, Telmisartan : I ndi cations, Side Effects, Warnings , Telmisartan - Drug Infor mation - TajPhar ma, Tel misartan dose Taj phar mace uticals Tel misartan interacti ons, Taj P harma ceuti cal Telmisartan contraindications, Tel misartan price, Telmisarta n TajPhar ma Antihyperten sive Tablets SmPC - Taj Phar ma Stay connected to all update d on Tel misartan Taj P harma ceutical s Taj phar mace uticals Mumbai. Patient Infor mation Leaflets, SmPC.

ALTITUDE (Aliskiren Trial in Type 2 Diabetes The safety and efficacy of telmisartan in
Using Cardiovascular and Renal Disease children and adolescents aged below 18 years
Endpoints) was a study designed to test the have not been established.
benefit of adding aliskiren to a standard therapy
of an ACE-inhibitor or an angiotensin II receptor The blood pressure lowering effects of two
doses of telmisartan were assessed in 76
blocker in patients with type 2 diabetes mellitus
hypertensive, largely overweight patients aged 6
and chronic kidney disease, cardiovascular
disease, or both. The study was terminated early to < 18 years (body weight ≥ 20 kg and ≤ 120
because of an increased risk of adverse kg, mean 74.6 kg), after taking telmisartan 1
outcomes. Cardiovascular death and stroke were mg/kg (n = 29 treated) or 2 mg/kg (n = 31
both numerically more frequent in the aliskiren treated) over a four-week treatment period. By
group than in the placebo group and adverse inclusion the presence of secondary
events and serious adverse events of interest hypertension was not investigated. In some of
(hyperkalaemia, hypotension and renal the investigated patients the doses used were
dysfunction) were more frequently reported in higher than those recommended in the treatment
of hypertension in the adult population, reaching
the aliskiren group than in the placebo group.
a daily dose comparable to160 mg, which was
Cough and angioedema were less frequently tested in adults. After adjustment for age group
reported in patients treated with telmisartan than effects mean SBP changes from baseline
in patients treated with ramipril, whereas (primary objective) were -14.5 (1.7) mm Hg in
hypotension was more frequently reported with the telmisartan 2 mg/kg group, -9.7 (1.7) mm Hg
telmisartan. in the telmisartan 1 mg/kg group, and -6.0 (2.4)
in the placebo group. The adjusted DBP changes
Combining telmisartan with ramipril did not add from baseline were -8.4 (1.5) mm Hg, -4.5 (1.6)
further benefit over ramipril or telmisartan mm Hg and -3.5 (2.1) mm Hg respectively. The
alone. CV mortality and all cause mortality were
change was dose dependent. The safety data
numerically higher with the combination. In from this study in patients aged 6 to < 18 years
addition, there was a significantly higher appeared generally similar to that observed in
incidence of hyperkalaemia, renal failure, adults. The safety of long term treatment of
hypotension and syncope in the combination
telmisartan in children and adolescents was not
arm. Therefore the use of a combination of
evaluated.
telmisartan and ramipril is not recommended in
this population. An increase in eosinophils reported in this
patient population has not been recorded in
In the "Prevention Regimen For Effectively adults. Its clinical significance and relevance is
avoiding Second Strokes" (PRoFESS) trial in
unknown.
patients 50 years and older, who recently
experienced stroke, an increased incidence of These clinical data do not allow to make
sepsis was noted for telmisartan compared with conclusions on the efficacy and safety of
placebo, 0.70% vs. 0.49% [RR 1.43 (95% telmisartan in hypertensive paediatric
confidence interval 1.00- 2.06)]; the incidence of population.
fatal sepsis cases was increased for patients
taking telmisartan (0.33%) vs. patients taking 5.2 Pharmacokinetic properties
placebo (0.16%) [RR 2.07 (95% confidence Absorption
interval 1.14 3.76)]. The observed increased Absorption of telmisartan is rapid although the
occurrence rate of sepsis associated with the use amount absorbed varies. The mean absolute
of telmisartan may be either a chance finding or bioavailability for telmisartan is about 50%.
related to a mechanism not currently known.
When telmisartan is taken with food, the
Paediatric population reduction in the area under the plasma
 Telmisartan 40 mg, 80 mg Tablets Taj Phar ma : Use s, Side Effect s, Interactions, Pi ctures, Warnings, T elmisartan D osage & Rx Info | Telmisartan Uses, Side E ffects - Antihyperten sive, Telmisartan : I ndi cations, Side Effects, Warnings , Telmisartan - Drug Infor mation - TajPhar ma, Tel misartan dose Taj phar mace uticals Tel misartan interacti ons, Taj P harma ceuti cal Telmisartan contraindications, Tel misartan price, Telmisarta n TajPhar ma Antihyperten sive Tablets SmPC - Taj Phar ma Stay connected to all update d on Tel misartan Taj P harma ceutical s Taj phar mace uticals Mumbai. Patient Infor mation Leaflets, SmPC.

concentration-time curve (AUC0-∞) of (approximately 1,000 ml/min) compared with

telmisartan varies from approximately 6% (40 hepatic blood flow (about 1,500 ml/min).
mg dose) to approximately 19% (160 mg dose).
By 3 hours after administration plasma Special Populations
concentrations are similar whether telmisartan is Paediatric population
taken fasting or with food.
The pharmacokinetics of two doses of
Linearity/non-linearity telmisartan were assessed as a secondary
objective in hypertensive patients (n = 57) aged
The small reduction in AUC is not expected to
6 to < 18 years after taking telmisartan 1 mg/kg
cause a reduction in the therapeutic efficacy.
or 2 mg/kg over a four-week treatment period.
There is no linear relationship between doses Pharmacokinetic objectives included the
and plasma levels. Cmax and to a lesser extent determination of the steady-state of telmisartan
AUC increase disproportionately at doses above in children and adolescents, and investigation of
40 mg. age-related differences. Although the study was
too small for a meaningful assessment of the
Distribution pharmacokinetics of children under 12 years of
Telmisartan is largely bound to plasma protein age, the results are generally consistent with the
(> 99.5%), mainly albumin and alpha-1 acid findings in adults and confirm the non-linearity
glycoprotein. The mean steady state apparent of telmisartan, particularly for Cmax.
volume of distribution (Vdss) is approximately
Gender
500 l.
Gender differences in plasma concentrations
Biotransformation were observed, Cmax and AUC being
Telmisartan is metabolised by conjugation to the approximately 3-and 2-fold higher, respectively,
glucuronide of the parent compound. No in females compared to males.
pharmacological activity has been shown for the Elderly
conjugate.
The pharmacokinetics of telmisartando not differ
Elimination between the elderly and those younger than 65
Telmisartan is characterised by biexponential years.
decay pharmacokinetics with a terminal
Renal impairment
elimination half-life of > 20 hours. The
maximum plasma concentration (Cmax) and, to a In patients with mild to moderate and severe
smaller extent, the area under the plasma renal impairment, doubling of plasma
concentration-time curve (AUC) increase concentrations was observed. However, lower
disproportionately with dose. There is no plasma concentrations were observed in patients
evidence of clinically relevant accumulation of with renal insufficiency undergoing dialysis.
telmisartan taken at the recommended dose. Telmisartan is highly bound to plasma protein in
Plasma concentrations were higher in females renal-insufficient patients and cannot be
than in males, without relevant influence on removed by dialysis. The elimination half-life is
efficacy. not changed in patients with renal impairment.
After oral (and intravenous) administration Hepatic impairment
telmisartan is nearly exclusively excreted with
the faeces, mainly as unchanged compound. Pharmacokinetic studies in patients with hepatic
Cumulative urinary excretion is < 1% of dose. impairment showed an increase in absolute
Total plasma clearance (Cltot) is high bioavailability up to nearly 100 %. The
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elimination half-life is not changed in patients 6.3 Shelf life

with hepatic impairment. 3 years
5.3 Preclinical safety data 6.4 Special precautions for storage
In preclinical safety studies, doses producing Al/Al blisters:
exposure comparable to that in the clinical
therapeutic range caused reduced red cell Keep the container tightly closed in order to
parameters (erythrocytes, haemoglobin, protect from light.
haematocrit), changes in renal haemodynamics 6.5 Nature and contents of container
(increased blood urea nitrogen and creatinine), Al/Al blisters Packs.
as well as increased serum potassium in
normotensive animals. In dogs renal tubular Pack sizes: 7, 14, 28, 30, 50, 90, 100 or 500
dilation and atrophy were observed. Gastric tablets.
mucosal injury (erosion, ulcers or inflammation) Pack sizes: 30 or 250 tablets.
also was noted in rats and dogs. These
pharmacologically-mediated undesirable effects, Not all pack sizes may be marketed.
known from preclinical studies with both 6.6 Special precautions for disposal and other
angiotensin converting enzyme inhibitors and handling
angiotensin II receptor antagonists, were No special requirements.
prevented by oral saline supplementation.
7. Manufactured In India By:
In both species, increased plasma renin activity
TAJ PHARMACEUTICALS LTD.
and hypertrophy/hyperplasia of the renal
juxtaglomerular cells were observed. These Mumbai, India
changes, also a class effect of angiotensin Unit No. 214.Old Bake House,
converting enzyme inhibitors and other Maharashtra chambers of Commerce Lane,
angiotensin II receptor antagonists, do not Fort, Mumbai - 400001
appear to have clinical significance. at:Gujarat, INDIA.
No clear evidence of a teratogenic effect was Customer Service and Product Inquiries:
observed, however at toxic dose levels of 1-800-TRY-FIRST (1-800-222-434 & 1-800-
telmisartan an effect on the postnatal 222-825)
development of the offsprings such as lower Monday through Saturday 9:00 a.m. to 7:00 p.m.
body weight and delayed eye opening was
EST
observed.
E-mail: tajgroup@tajpharma.com
There was no evidence of mutagenicity and
relevant clastogenic activity in in vitro studies
and no evidence of carcinogenicity in rats and
mice.

6. Pharmaceutical particulars
6.1 List of excipients
Magnesium stearate, Croscarmellose sodium,
Mannitol, Povidone, Potassium Hydroxide
Pellets.
6.2 Incompatibilities
Not applicable.