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Cardiovascular Agents

Indopril 5/Indopril 10

 

Pack size:

Box of 3 blisters x 10 tablets.

 

Composition:

Each Indopril 5 tablet contains imidapril hydrochloride 5 mg.

Each Indopril 10 tablet contains imidapril hydrochloride 10 mg.

 

Shelf-life:  

24 months form the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

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

  • For the treatment of essential hypertension in adults.
  • Administered orally. It is recommended that the tablets be taken at about the same time of day about 15 minutes before meals, once daily. Dose is calculated on hydrochloride salt. 
  • Because some patients may have severe hypertension when starting treatment with angiotensin- converting enzyme inhibitors (ACE inhibitors), the initial dose should be taken before bedtime.
     
  • Adults
    Treatment should be initiated with 5 mg once a day.
    If optimum control of blood pressure has not been achieved after at least 3 weeks of treatment, the daily dose should be increased to 10 mg, which has been determined to be the most effective daily dose.
    However, in a small number of patients it might be necessary to increase the daily dose to 20 mg (recommended maximum dose) or preferably, to consider combination therapy with a diuretic.
    It has not been assessed whether hypertensive patients would benefit from a combination of imidapril with other antihypertensive therapies. 

  • Older people (65 years or older) 
    The initial dose is 2.5 mg once a day. The dose should be titrated according to blood pressure response. The recommended maximum dose is 10 mg once a day. 

  • Patients with renal impairment
    Renal function should be evaluated before commencing therapy with imidapril in patients suspected of renal impairment.
    - Clcr between 30 ml/min - 80 ml/min: Reduced doses are required for these patients and therefore it is recommended that treatment be initiated with 2.5 mg.
    - Clcr between 10 ml/min - 29 ml/min: Because of limited experience which has shown an increase in the AUC of imidaprilat, imidapril should not be administered to these patients.
    - Clcr 10 ml/min: The drug is contraindicated in these patients. 

  • Patients with hepatic impairment
    The recommended starting dose in patients with hepatic impairment is 2.5 mg once a day. Imidapril should be used with caution in patients with hepatic impairment. 

  • Paediatric population
    The safety and efficacy of imidapril in children have not been established. No data are available. 

  • Patients at increased risk for first dose hypotension
    Initiation of therapy requires, if possible, correction in salt and/or body fluids deficiencies, and discontinuation of an existing diuretic therapy for two to three days before ACE inhibition. If this is not possible, initial dose should be imidapril 2.5 mg. In hypertensive patients with concomitant cardiac failure symptomatic hypotension has been observed after treatment with ACE inhibitors.
    In these patients the initial dose should be 2.5 mg imidapril once a day under close medical supervision. Patients at high risk for severe acute first dose hypotension should be monitored medically, preferably in hospital, for up to 6-8 hours after administration of the first dose of imidapril and whenever the dose of imidapril or a concomitant diuretic is increased. The initial dose should be 2.5 mg. This also applies to patients with angina pectoris and cerebrovascular disease. These patients are at increased risk to experience myocardial infarction or cerebrovascular accident following excessive hypotension.

    * Use 2.5 mg imidapril hydrochloride tablets for the dose of 2.5 mg.


Or as prescribed by physicians. 

 

  • Hypersensitivity to the active substance or any other ACE inhibitor or to any ingredient of the drug.
  • History of angioneurotic oedema associated with previous ACE inhibitor therapy.
  • Hereditary/idiopathic angioedema.
  • Second and third trimesters of pregnancy.
  • Renal failure with or without haemodialysis (creatinine clearance < 10 ml/min). 

     

Common:
  • Headache, dizziness, fatigue/somnolence.
  • Cough.
  • Nausea.
Uncommon: 
  • Bronchitis, viral infection, upper respiratory tract infection.
  • Cerebrovascular disorders, syncope, paraesthesia.
  • Rhinitis.
  • Palpitations.
  • Vomiting, epigastric pain, dyspepsia.
  • Rash, pruritus.
  • Chest pain, pain in limbs, oedema (joint, peripheral).
  • Hyperkalaemia, Creatinine increased, Urea increased, GPT/ALAT increased, Gamma-GT increased.
Rare: 
  • Leucopenia, Anaemia.
  • Blood amylase increased, GOT/ASAT increased, Decreased albumin, AP increased, Serum protein decreased, Impaired renal function.

     

  • Hypotension: 
    Imidapril may cause a profound fall in blood pressure especially after the first dose. Symptomatic hypotension is rare in uncomplicated hypertensive patients. It is more likely to occur in patients who have been volume depleted by diuretic therapy, dietary salt restriction, dialysis, diarrhoea or vomiting. In these patients treatment should be started under very close medical supervision, with imidapril 2.5 mg and careful dose titration.  Such considerations apply also to patients with ischaemic heart- or cerebrovascular disease.
  • Imidapril should be used with cautions in patients with aortic or mitral valve stenosis or hypertrophic cardiomyopathy.
  • Haematopoietic disorders have been reported including neutropenia and granulocytopenia (especially in patients with renal impairment and patients with collagen vascular disease such as Lupus erythematosus and scleroderma), thrombocytopenia and anaemia. In case of necessity of imidapril, regular counts of white blood cell and leukocyte formula should be performed befor starting the treatment, once every two weeks, for the first three months and periodic follow-up. Signs of infection (sore throat, fever ...) might occur during treatment.
  • Patients with renal impairment:
    Patients with creatinine clearance < 30 ml/min are recommended not using imidapril. Reduced doses are required for patients with creatinine clearance between 30ml/min to 80ml/min. Close monitoring of renal function during therapy should be performed as during therapy. Renal failure has been reported in association with ACE inhibitors, mainly in patients with severe cardiac failure or underlying renal disease, including renal artery stenosis.
  • Patients with bilateral renal artery stenosis or renal artery stenosis in patients with one kidney. Careful monitoring is needed when initiating treatment, using low doses, careful dose adjustment and monitoring of renal function.
  • Angioneurotic oedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with angiotensin converting enzyme inhibitors, including imidapril. This may occur at any time during treatment. Patients treated with an ACE inhibitor undergoing LDL lipid apheresis with dextrane sulfate may experience anaphylactoid reactions similar to those seen in patients under-going haemodialysis with high-flux membranes. It is recommended that an agent from another class of antihypertensive drugs is used in these patients.
  • Patients with hepatic insufficiency: Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice or hepatitis and progresses to fulminant hepatic necrosis and (sometimes) death. 
  • The risk of severe hypotension, even hypotension in patients undergoing major surgery or undergoing anesthesia with antihypertensive drugs.
  • Hyperkalaemia: 
    Elevations in serum potassium have been observed in some patients treated with ACE inhibitors, including imidapril. Patients at risk for the development of hyperkalaemia include those with renal insufficiency, uncontrolled diabetes mellitus, or those using concomitant potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes; or those patients taking other drugs associated with increases in serum potassium (e.g. heparin). If concomitant use of imidapril and any of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended.
  • Proteinuria: 
    Proteinuria was rarely seen with imidapril. It may occur particularly in patients with existing renal function impairment.  
  • Diabetic patients:
    The glycaemia levels should be closely monitored in diabetic patients previously treated with oral antidiabetic drugs or insulin, namely during the first month of treatment with imidapril. .
  • Older patients:
    Imidapril should be used with cautions in elderly patients since some elderly, especially very old patients, may be more responsive to imidapril than younger patients. For elderly patients aged 65 years or older, the initial daily dose should be imidapril 2.5 mg. Evaluation of the renal function at the beginning of the treatment is recommended.
  • Paediatric population:
    ​Imidapril should not be administered to children until safety and efficacy have been established.
  • Imidapril should not be initiated during pregnancy due to a slightly increased risk of birth defects. When pregnancy is diagnosed, treatment with imidapril should be stopped immediately, and, if appropriate, alternative therapy should be started.
  • Because no information is available regarding the use of imidapril during breast-feeding, imidapril is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable.
  • No studies on the effects on the ability to drive have been performed. It should be taken into account that occasionally dizziness or weariness may occur while driving or using machines.

     

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