Medicinal Products

ACUILIX 20 mg / 12.5 mg

Generic drug of the therapeutic class: Cardiology and angiology
Active Ingredients: Quinapril, Hydrochlorothiazide
laboratory: Pfizer Holding France

Divisible coated tablet
Box of 28
All forms

Indication

Treatment of arterial hypertension in case of therapeutic failure of monotherapy with a converting enzyme inhibitor.

Dosage ACUILIX 20 mg / 12.5 mg Film-coated tablet scored box of 28

Each tablet contains 20 mg of quinapril and 12.5 mg of hydrochlorothiazide.
- Normal renal function: the usual dosage is one tablet in one daily dose.
- Renal failure :
. creatinine clearance between 30 and 80 ml / min : the usual starting dose is half a tablet in one daily dose.
The physiological decline in renal function due to age should be taken into account for the determination of the initial dose.
In these patients, normal medical practice includes a periodic control of potassium and creatinine, for example every two months in times of therapeutic stability;
. creatinine clearance less than 30 ml / min or serum creatinine greater than 250 ╬╝mol / L : contraindication.

Against indications

CONTRAINDICATED:
Due to the presence of lactose, this drug is contraindicated in cases of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
RELATED TO QUINAPRIL :
This medicine MUST NEVER BE USED in case of:
- hypersensitivity to quinapril or to any of the constituents of the drug;
- history of angioedema (angioedema) related to the intake of a conversion enzyme inhibitor;
- 2nd and 3rd trimesters of pregnancy: the use of ACE inhibitors is contraindicated in the 2nd and 3rd trimesters of pregnancy . Exposure to ACE inhibitors in the 2nd and 3rd trimesters of pregnancy is known to cause fetotoxicity (decreased renal function, oligohydramnios, skull bone ossification delay) and toxicity in the neonate (renal failure hypotension, hyperkalemia). In case of exposure from the 2nd trimester of pregnancy it is recommended to do a fetal ultrasound to check the renal function and bones of the skull vault. Infants born to mothers treated with IEC should be monitored for blood pressure.
RELATED TO HYDROCHLOROTHIAZIDE :
This medicine MUST NEVER BE USED in case of:
- hypersensitivity to sulfonamides;
- severe renal insufficiency (creatinine clearance less than 30 ml / min);
- hepatic encephalopathy;
- breastfeeding: Thiazides are excreted in small quantities in breast milk. However, their use is not recommended during breastfeeding because of: a decrease or even a suppression of the milk secretion, their adverse effects, especially biological (potassium), their membership sulfa drugs with risks of allergy and of kernicterus. As a result, the use of this medication is contraindicated during the breastfeeding period.
NOT RECOMMENDED :
RELATED TO QUINAPRIL :
- Child: Efficacy and tolerance of quinapril in children have not been established.
- THIS MEDICATION IS GENERALLY NOT RECOMMENDED in case:
- breastfeeding: there are no data on the passage into breast milk;
- bilateral stenosis of the renal artery or functionally unique kidney;
- hyperkalemia;
- pregnancy (1st trimester): the use of IEC is not recommended during the first trimester of pregnancy . Available epidemiological data on the risk of malformation after exposure to ACE in the first trimester of pregnancy are inconclusive. However, a small increase in the risk of congenital malformation can not be ruled out. Unless IEC therapy is considered essential, it is recommended that antihypertensive therapy be modified in patients who are planning pregnancy for a drug with an established safety profile during pregnancy. If pregnancy is diagnosed, treatment with IEC should be stopped immediately and if necessary, alternative treatment should be started;
- associations with hyperkalemic diuretics, potassium salts, estramustine and lithium (see interactions).
RELATED TO HYDROCHLOROTHIAZIDE :
This medicine IS GENERALLY NOT RECOMMENDED when combined with lithium and non-antiarrhythmic drugs giving torsades de pointes (see section on interactions).

Acuilix side effects

CLINICAL PLAN :
- Related to quinapril :
Have been found:
. headache, asthenia, dizziness, malaise;
. hypotension, orthostatic or not (see section on warnings and precautions for use), more rarely chest pain, angina pectoris, syncope;
. pruritus, rash, photosensitization or other cutaneous manifestations, more rarely pemphigus, increased sweating; very rare cases of exfoliative dermatitis and erythroderma have been reported with other IEC;
. gastralgia, anorexia, nausea, abdominal pain, more rarely pancreatitis;
. 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: anaphylactoid reactions / angioedema (angioedema) (see section cautionary statements and precautions for use);
. pneumopathy;
. more rarely: hepatitis.
- Hydrochlorothiazide-related :
. in case of hepatic insufficiency, possibility of occurrence of hepatic encephalopathy (see sections contraindications and warnings and precautions for use);
. possibility of worsening of pre-existing disseminated acute lupus erythematosus, necrotizing vasculitis, exceptional Lyell syndrome;
. Skin and subcutaneous tissues: Uncommon: Cases of photosensitivity reaction have been reported (see section on warnings and precautions for use);
. 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.
AT THE BIOLOGICAL PLAN :
- Related to quinapril :
. moderate increase in urea and plasma creatinine, reversible upon discontinuation of treatment; this increase is more frequently encountered in cases of renal artery stenosis, arterial hypertension treated with diuretics, renal failure;
. in case of glomerular nephropathy, the administration of a conversion enzyme inhibitor may cause proteinuria;
. hyperkalemia, usually transient;
. anemia (see section on warnings and precautions for use) has been reported with angiotensin-converting enzyme inhibitors on specific sites (kidney transplant, hemodialysis);
. thrombocytopenia.
- Hydrochlorothiazide-related :
. potassium depletion with hypokalemia, particularly in the case of intensive diuresis, and particularly severe in certain at-risk populations (see section on warnings and precautions for use);
. hyponatremia with hypovolemia leading to dehydration and orthostatic hypotension or even confusional syndrome. The concomitant loss of chlorine ions may secondarily lead to a compensatory metabolic alkalosis: the incidence and magnitude of this effect are low;
. Elevation of serum uric acid and blood glucose levels 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;
. haematological disorders, much rarer, thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia, haemolytic anemia;
. exceptional hypercalcemia.

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