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Cardiovascular Agents

Telmisartan STADA® 40 mg

 

Pack size:

Box of 4 blisters x 7 tablets.


Composition:

Each tablet contains telmisartan 40 mg.


Shelf-life:

24 months from the date of manufacture.

Store in a well-closed container, in a dry place.

Protect from moisture. Do not store above 30oC.

 

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Hypertension: Treatment of essential hypertension in adults.
    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 thiazide-type 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: Reduction of cardiovascular morbidity in adults with:
    - Manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
    - Type 2 diabetes mellitus with documented target organ damage.
    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.
  • 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. No posology adjustment is required for patients with mild to moderate renal impairment.
  • Hepatic impairment:
    In patients with mild to moderate hepatic impairment, a daily dose should not exceed 40 mg once daily in monotherapy and combination therapy with hydroclorothiazid. The combination with thiazide diuretics is contraindicated in patients with severe hepatic impairment.
  • Elderly patients:
    No dose adjustment is necessary.
  • Adolescents aged below 18 years:
    The safety and efficacy of telmisartan have not been established.
  • Use of suitable dosage forms is recommended when using telmisartan with dose of 20 mg.
  • Administered orally, taken without regard to meals. Tablets should be taken out of the blister shortly before administration.


Or as prescribed by physicians.

 


 

  • Known hypersensitivity to any ingredient of the drug.
  • Second and third trimesters of pregnancy and lactation.
  • Biliary obstructive disorders.
  • Severe hepatic impairment.
  • The concomitant use of telmisartan with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2).

     


Uncommon:

  • Upper respiratory tract infection including pharyngitis and sinusitis, urinary tract infection including cystitis.
  • Anaemia.
  • Hyperkalaemia.
  • Depression, insomnia.
  • Syncope.
  • Vertigo.
  • Bradycardia.
  • Hypotension, orthostatic hypotension.
  • Dyspnoea, cough.
  • Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting.
  • Hyperhidrosis, pruritus, rash.
  • Myalgia, back pain (e.g. sciatica), muscle spasms.
  • Renal impairment including acute renal failure.
  • Chest pain, asthenia (weakness).

Rare:

  • Sepsis including fatal outcome.
  • Eosinophilia, thrombocytopenia.
  • Anaphylactic reaction, hypersensitivity.
  • Hypoglycaemia (in diabetic patients).
  • Anxiety.
  • Somnolence.
  • Visual disturbance.
  • Tachycardia.
  • Interstitial lung disease.
  • Stomach discomfort, dry mouth.
  • Hepatic function abnormal/liver disorder.
  • Angioedema (also with fatal outcome), eczema, erythema, urticaria, drug eruption, toxic skin eruption.
  • Arthralgia, pain in extremity, tendon pain (tendonitis like symptoms).
  • Influenza-like illness.


Investigations

  • Uncommon: Blood creatinine increased.
  • Rare: Blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased, haemoglobin decreased.

     

  • 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 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 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 transplant: When telmisartan 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 in patients with recent kidney transplantation.
  • Intravascular hypovolaemia: Symptomatic hypotension, especially after the first dose, 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.
  • Dual blockade of the renin-angiotensin-aldosterone system (RAAS): There is evidence that the concomitant use of ACE­ inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE­ inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended. 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 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.
  • Diabetic patients treated with insulin or antidiabetics: In these patients hypoglycaemia may occur under telmisartan treatment. Therefore, in these patients an appropriate blood glucose monitoring should be considered; a dose adjustment of insulin or antidiabetics may be required, when indicated.
  • Telmisartan may cause porphyria, it should be used only when there are no safer alternative therapies and caution should be exercised in patients with severe hypertension.
  • 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 classes 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.
  • Sorbitol: Telmisartan STADA® contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this drug.
  • Sodium ion: The maximum recommended daily dose (80 mg) of this medicinal product contains 3.864 mg sodium (found in NaOH). This is equivalent to approximately 0.2% of the recommended maximum daily intake of sodium for an adult.
  • Gastroduodenal ulcer can work or other stomach problems (increased risk of gastrointestinal bleeding) can occur.
  • Mild or moderate renal function impairment.
  • Other:
    As observed for angiotensin converting enzyme inhibitors, telmisartan and the other angiotensin II receptor antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.
    As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
  • Pregnancy; When used in pregnancy during the second and third trimesters, drugs that act directly on the renin - angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, telmisartan should be discontinued as soon as possible.
  • Lactation: It is not known whether telmisartan is excreted in human milk, but telmisartan was shown to be present in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
  • When driving vehicles or operating machinery it should be taken into account that vertigo or dizziness may occasionally occur when taking antihypertensive therapy such as telmisartan.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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