Candalkan  Film Coated Tablets

Candesartan 4, 8 &16 mg

 

Usage and indications:

Candalkan is indicated for the:

Treatment of essential hypertension in adults.

Treatment of adult patients with heart failure and impaired left ventricular systolic function as add-on therapy to Angiotensin Converting Enzyme (ACE) inhibitors or when ACE inhibitors are not tolerated.

Dosage and administration:

The recommended initial dose and usual maintenance dose of Candalkan is 8 mg once daily.

Most of the antihypertensive effect is attained within 4 weeks. In some patients whose blood pressure is not adequately controlled, the dose can be increased to16 mg once daily and to a maximum of 32 mg once daily. Therapy should be adjusted according to blood pressure response. Candalkan may also be administered with other antihypertensive agents. Addition of hydrochlorothiazide has been shown to have an additive antihypertensive effect with various doses of Candalkan.

Elderly population: No initial dose adjustment is necessary in elderly patients.

Patients with intravascular volume depletion: An initial dose of 4 mg may be considered in patients at risk for hypotension, such as patients with possible volume depletion.

Patients with renal impairment: The starting dose is 4 mg in patients with renal impairment, including patients on haemodialysis. The dose should be titrated according to response.

There is limited experience in patients with very severe or end-stage renal impairment (Cl creatinine < 15 ml/min).

Patients with hepatic impairment: An initial dose of 4 mg once daily is recommended in patients with mild to moderate hepatic impairment. The dose may be adjusted according to response. Candalkan is contraindicated in patients with severe hepatic impairment and/or cholestasis. 

Undesirable effects:

Infections and infestations:  

Common: Respiratory infection

Blood and lymphatic system disorders:

Very rare: Leukopenia, neutropenia and agranulocytosis.

Metabolism and nutrition disorders:

Very rare: Hyperkalaemia, hyponatraemia. 

Nervous system disorders:  

Common: Dizziness/vertigo, headache.  

Respiratory, thoracic and mediastinal disorders:

Very rare: Cough.    

Gastrointestinal disorders:  

Very rare: Nausea.

Hepato-biliary disorders:

Very rare: Increased liver enzymes, abnormal hepatic function or hepatitis.

Skin and subcutaneous tissue disorders:

 Very rare: Angioedema, rash, urticaria, pruritus.

Musculoskeletal and connective tissue disorders:

Very rare: Back pain, arthralgia, myalgia.

Renal and urinary disorders:   

Very rare: Renal impairment, including renal failure in susceptible patients.  

Warnings and precautions:

  • Dual blockade of the rennin-angiotensin-aldosteron system (RAAS):
  •  There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or Aliskirin increase the risk of hypotension. Hyperkalemia and decreased renal function (include 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.

  •  Renal impairment:

As with other agents inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible patients treated with Candalkan.

  • Concomitant therapy with an ACE inhibitor in heart failure:

The risk of adverse reactions, especially renal function impairment and hyperkalaemia, may increase when Candalkan is used in combination with an ACE inhibitor.

Pack: box containing 7 or 14 tablets.

 

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