Medicinal Products

BENAZEPRIL HYDROCHL TEVA HEALTH 10 mg / 12.5 mg

Generic drug of Briazide
Therapeutic class: Cardiology and angiology
active ingredients: Benazepril, Hydrochlorothiazide
laboratory: Teva Sante

Divisible coated tablet
Box of 90
All forms

Indication

· Treatment of high blood pressure in case of therapeutic failure of monotherapy with a conversion enzyme inhibitor.

Dosage BENAZEPRIL HYDROCHL TEVA HEALTH 10 mg / 12.5 mg Film-coated tablet scored 90

Each tablet contains 10 mg benazepril and 12.5 mg hydrochlorothiazide.

· Normal kidney function: The usual dosage is one tablet in one daily dose.

· Renal failure :

o creatinine clearance greater than or equal to 30 ml / min: the usual initial dosage is one tablet in one daily dose.In these patients, normal medical practice includes a periodic control of potassium and creatinine, for example all two months in a period of therapeutic stability;

o Creatinine clearance less than 30 ml / min or serum creatinine greater than 250 μmol / l: contraindication.

· Elderly: It is recommended to initiate the treatment at the dosage of half a tablet.

Against indications

Related to benazepril

This medicine should never be used in case of:

Hypersensitivity to benazepril,

· History of angioedema (angioedema) associated with the use of an angiotensin-converting enzyme inhibitor,

· In the 2nd and 3rd trimesters of pregnancy,

This medicine is generally not recommended in case of:

· Combinations with potassium-sparing diuretics, potassium salts, estramustine and lithium (see section Interactions with other medicinal products and other forms of interaction ),

Bilateral stenosis of the renal artery or functionally unique kidney,

· Hyperkalemia,

During the first trimester of pregnancy, in the woman who is breastfeeding.

Hydrochlorothiazide-related

This medicine should never be used in the following cases:

· Hypersensitivity to sulfonamides,

· Severe renal impairment (creatinine clearance <30 ml / min),

· Hepatic encephalopathy.

This drug is generally not recommended when used in combination with sultopride, lithium, estramustine, potassium-sparing diuretics, potassium salts (see section 4.5). breastfeeding case (see section on Pregnancy and breastfeeding ).

Side effects Benazepril Hydrochl Teva Sante

Related to benazepril

Clinically

Have been found:

· Headache, asthenia, vasomotor reactions, dizziness, palpitations,

Hypotension, orthostatic or not (see section Warnings and precautions for use ),

· Rash, pemphigus, Stevens-Johnson syndrome,

· Digestive disorders (nausea, vomiting, abdominal pain), dysgeusia,

· Isolated cases of liver injury,

· Dry cough has been reported with the use of angiotensin-converting enzyme inhibitors. It is characterized by its persistence as well as its disappearance at the end of treatment. The iatrogenic etiology should be considered in the presence of this symptom.

Exceptionally:

· Angioedema (Quincke's edema) (see Warnings and precautions for use ).

Biologically

· Moderate increase in urea and plasma creatinine, reversible upon discontinuation of treatment. This increase is more frequently encountered in cases of stenosis of the renal arteries, arterial hypertension treated with diuretics, renal failure.

· In case of glomerular nephropathy, administration of a conversion enzyme inhibitor may cause proteinuria.

· Hyperkalemia, usually transient.

· Anemia (see Warnings and Precautions ) has been reported with angiotensin-converting enzyme inhibitors on specific sites (kidney transplant, hemodialysis). Hemolytic anemia has been observed.

Hydrochlorothiazide-related

Clinically

· In case of hepatic insufficiency, possibility of occurrence of hepatic encephalopathy (see sections Contraindications and Warnings and precautions for use ).

· Hypersensitivity reactions, mainly dermatological, in subjects predisposed to allergic and asthmatic reactions.

· Possibility of worsening of pre-existing systemic lupus erythematosus, necrotizing vasculitis, exceptional Lyell syndrome.

· Uncommon: Cases of photosensitivity reaction have been reported (see Warnings and Precautions section ).

· Nausea, constipation, dizziness, asthenia, paresthesia, headache rarely seen and usually giving way to a reduction in dosage.

· Exceptionally: pancreatitis, visual disturbances at the beginning of treatment.

Biologically

· Potassium depletion with hypokalemia, especially in cases of intensive diuresis, and particularly severe in some at-risk populations (elderly, malnourished, cirrhotic, coronary, heart failure).

· Hyponatremia with hypovolemia leading to dehydration and orthostatic hypotension, or even confusional syndrome.

· The concomitant loss of chlorine ions can secondarily lead to a compensatory metabolic alkalosis: the incidence and the amplitude of this effect are weak.

· A rise in serum uric acid and blood glucose during treatment: the use of these diuretics will be carefully discussed in gouty and diabetic subjects.

· An increase in plasma lipids at a high dose.

Hematologic disorders, much rarer, thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia, haemolytic anemia.

· Hypercalcemia exceptional.

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