Search The Medical Knowledge Base

Drug Details

Telmisartan Actavis 20 mg tablets

• Description
  Tablet White, round, flat tablets with logo T on one side.
• Indications
  

  Hypertension

  Treatment of essential hypertension in adults.

  Cardiovascular prevention

  Reduction of cardiovascular morbidity in patients with:

  i) manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
  ii) type 2 diabetes mellitus with documented target organ damage.

• Adult Dosage
  

  Treatment of essential hypertension:
  The usually effective dose is 40 mg once daily. Some patients may already benefit at a daily dose of 20 mg. In cases where the target blood pressure is not achieved, the dose of telmisartan can be increased to a maximum of 80 mg once daily. Alternatively, telmisartan may be used in combination
  with thiazidetype diuretics such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with telmisartan. When considering raising the dose, it must be borne in mind that the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment.

  Cardiovascular prevention:
  The recommended dose is 80 mg once daily. It is not known whether doses lower than 80 mg of telmisartan are effective in reducing cardiovascular morbidity.

  When initiating telmisartan therapy for the reduction of cardiovascular morbidity, close monitoring of blood pressure is recommended, and if appropriate adjustment of medications that lower blood pressure may be necessary.

  Telmisartan may be taken with or without food.

  Special patient populations:

  Renal impairment:
  No posology adjustment is required for patients with mild to moderate renal impairment. Limited experience is available in patients with severe renal impairment or haemodialysis.

  A lower starting dose of 20 mg is recommended in these patients.

  Hepatic impairment:
  In patients with mild to moderate hepatic impairment the posology should not exceed 40 mg once daily.

  Elderly
  No dose adjustment is necessary for elderly patients.

  Paediatric patients
  Telmisartan Actavis is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.

• Contra Indications
  
  • Hypersensitivity to the active substance or to any of the excipients
  • Second and third trimesters of pregnancy
  • Biliary obstructive disorders
  • Severe hepatic impairment
• Special Precautions
  

  Pregnancy
  Angiotensin II receptor antagonists should not be initiated during pregnancy. Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started.

  Hepatic impairment:
  Telmisartan Actavis is not to be given to patients with cholestasis, biliary obstructive disorders or severe hepatic impairment since telmisartan is mostly eliminated with the bile. These patients can be expected to have reduced hepatic clearance for telmisartan. Telmisartan Actavis
  should be used only with caution in patients with mild to moderate hepatic impairment.

  Renovascular hypertension:
  There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.

  Renal impairment and kidney transplantation:
  When Telmisartan Actavis is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of Telmisartan Actavis in patients with recent kidney transplantation.

  Intravascular hypovolaemia:
  Symptomatic hypotension, especially after the first dose of Telmisartan Actavis, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Telmisartan
  Actavis. Volume and/or sodium depletion should be corrected prior to administration of Telmisartan Actavis .

  Dual blockade of the renin-angiotensin-aldosterone system:As a consequence of inhibiting the renin-angiotensin-aldosterone system, hypotension, syncope, hyperkalaemia and changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system. Dual blockade of the renin-angiotensin-aldosterone system (e.g. by adding an ACE-inhibitor to an angiotensin II receptor antagonist) is therefore not recommended in patients with already controlled blood pressure and should be limited to individually defined cases with close monitoring of renal function.

  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 reninangiotensin- 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.

  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.

  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-angiotensinaldosterone 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-angiotensinaldosterone 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 diseases), cellular lysis (e.g. acute limb ischemia, rhabdomyolysis, extend trauma).

  Close-monitoring of serum potassium in at risk patients is recommended.

  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 nonblacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.

  Other:
  As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.

• Interactions
  

  Interaction studies have only been performed in adults.
  As with other medicinal products acting on the renin-angiotensin-aldosterone system, telmisartan may provoke hyperkalaemia. The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal antiinflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).

  The occurrence of hyperkalaemia depends on associated risk factors. The risk is increased in case of the above-mentioned treatment combinations. The risk is particularly high in combination with potassium sparing-diuretics and when combined with salt substitutes containing potassium. A
  combination with ACE inhibitors or NSAIDs, for example, presents a lesser risk provided that precautions for use are strictly followed.

  Concomitant use not recommended

  Potassium sparing diuretics or potassium supplements:
  Angiotensin II receptor antagonists such as telmisartan attenuate diuretic induced potassium loss.

  Potassium sparing diuretics e.g. spirinolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may lead to a significant increase in serum potassium. If concomitant use is indicated because of documented hypokalaemia, they should be used with caution and with frequent monitoring of serum potassium.

  Lithium:
  Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor antagonists, including telmisartan. If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended.

  Concomitant use requiring caution

  Non-steroidal anti-inflammatory medicinal products:
  NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and nonselective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists.

  In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of angiotensin II receptor antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.

  In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC0-24 and Cmax of ramipril and ramiprilat. The clinical relevance of this observation is not known.

  Diuretics (thiazide or loop diuretics):
  Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may result in volume depletion and in a risk of hypotension when initiating therapy with telmisartan.

  To be taken into account with concomitant use
  
  Other antihypertensive agents:
  The blood pressure lowering effect of telmisartan can be increased by concomitant use of other antihypertensive medicinal products.

  Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including telmisartan: Baclofen, amifostine.

  Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics or antidepressants.

  Corticosteroids (systemic route):
  Reduction of the antihypertensive effect.

• Adverse Drug Reactions
  

  The overall incidence of adverse events reported with telmisartan (41.4%) was usually comparable to placebo (43.9%) in placebo controlled trials in patients treated for hypertension. The incidence of adverse events was not dose related and showed no correlation with gender, age or race of the
  patients. The safety profile of telmisartan in patients treated for the reduction of cardiovascular morbidity was consistent with that obtained in hypertensive patients.

  The adverse drug reactions listed below have been accumulated from controlled clinical trials in patients treated for hypertension and from post-marketing reports. The listing also takes into account serious adverse events and adverse events leading to discontinuation reported in three clinical longterm studies including 21642 patients treated with telmisartan for the reduction of cardiovascular morbidity for up to six years.

  Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).

  Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

  Infections and infestations
  Uncommon: Upper respiratory tract infection including pharyngitis and sinusitis, urinary tract infection including cystitis
  Not known: Sepsis including fatal outcome¹

  Blood and the lymphatic system disorders
  Uncommon: Anaemia
  Rare: Thrombocytopenia
  Not known: Eosinophilia

  Immune system disorders
  Rare: Hypersensitivity
  Not known: Anaphylactic reaction

  Metabolism and nutrition disorders
  Uncommon: Hyperkalaemia

  Psychiatric disorders
  Uncommon: Depression, insomnia
  Rare: Anxiety

  Nervous system disorders
  Uncommon: Syncope

  Eye disorders
  Rare: Visual disturbance

  Ear and labyrinth disorders
  Uncommon: Vertigo

  Cardiac disorders
  Uncommon: Bradycardia
  Rare: Tachycardia

  Vascular disorders
  Uncommon: Hypotension², orthostatic hypotension
  Respiratory, thoracic and mediastinal disorders
  Uncommon: Dyspnoea

  Gastrointestinal disorders
  Uncommon: Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting
  Rare: Stomach discomfort, dry mouth
  
  Hepato-biliary disorders
  Rare: Hepatic function abnormal/liver disorder

  Skin and subcutaneous tissue disorders
  Uncommon: Hyperhidrosis, pruritus, rash
  Rare: Erythema, angioedema, drug eruption, toxic skin eruption, eczema
  Not known: Urticaria
  
  Muscoloskeletal and connective tissue disorders
  Uncommon: Myalgia back pain (e.g. sciatica), muscle spasms
  Rare: Arthralgia, pain in extremity
  Not known: Tendon pain (tendinitis like symptoms)
  
  Renal and urinary disorders
  Uncommon: Renal impairment including acute renal failure

  General disorders and administration site conditions
  Uncommon: Chest pain, asthenia (weakness)
  Rare: Influenza-like illness
  
  Investigations
  Uncommon: Blood creatinine increased
  Rare: Blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased, haemoglobin decreased

  ¹In the PRoFESS trial, an increased incidence of sepsis was observed with telmisartan compared with placebo. The event may be a chance finding or related to a mechanism currently not known.

  ²Reported as common in patients with controlled blood pressure who were treated with telmisartan for the reduction of cardiovascular morbidity on top of standard care.