Medicinal Products

ACUITEL 5 mg

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

Breakable coated tablet
Box of 90
All forms

Indication

- Hypertension.
- Congestive heart failure.

Dosage ACUITEL 5 mg Tablets breakable coated Box of 90

Quinapril tablet may be taken before, during or after meals, as food does not alter its bioavailability. Quinapril can be given in one or two daily doses.
ESSENTIAL ARTERIAL HYPERTENSION :
- In the absence of previous water-soluble depletion or renal insufficiency (in common practice): the effective dosage is 20 mg per day in a single dose. Depending on the response to the treatment, the dosage should be adjusted, in stages of 3 to 4 weeks, up to a maximum of 40 mg / 24 h, preferably twice daily.
If necessary, a non-hyperkalaemic diuretic may be combined to achieve a further decrease in blood pressure.
- In arterial hypertension previously treated with diuretics: either stop the diuretic: 3 days before to reintroduce it later if necessary; give initial doses of 5 mg, quinapril and adjust according to the blood pressure response.
It is recommended to dose plasma creatinine and serum potassium before treatment and within 15 days of starting therapy.
- In patients over 65 years of age (see section on warnings and precautions for use): initiate treatment with a lower dose (5 mg once daily).
- In renovascular hypertension: it is recommended to start the treatment at a dosage of 5 mg / day in one dose, to adjust it subsequently to the patient's blood pressure response.
Serum creatinine and serum potassium will be monitored to detect the onset of possible renal impairment (see section cautionary statements and precautions for use).
- In case of renal insufficiency: the dosage of quinapril is adjusted to the degree of this insufficiency:
. if the creatinine clearance is greater than or equal to 40 ml / min, there is no need to change the dosage;
. if the creatinine clearance is less than 40 ml / min, it is recommended to initiate the 5 mg dose in one dose, before increasing, if necessary, 3 to 4 weeks later depending on the response obtained tension.
. if the creatinine clearance is less than 15 ml / min : in the absence of sufficient data, further reduction in dosage may be considered, either by reducing daily doses or by spacing the intakes.
In these patients, normal medical practice includes periodic monitoring of potassium and creatinine, for example every 2 months in times of therapeutic stability.
The diuretics to be associated in this case are the so-called loop diuretics.
- In hypertensive hemodialysis: quinapril is weakly dialyzable (see section on warnings and precautions for use Warnings: hemodialysis).
CONGESTIVE HEART FAILURE :
- The initial dose should be low, especially in case of normal or low blood pressure at baseline, renal failure, hyponatremia, iatrogenic (diuretic) or not.
- It is recommended to initiate treatment with a single 5 mg dose under blood pressure monitoring and gradually increase it to the usual effective dose of up to 40 mg twice daily.
- Quinapril can be used in combination with a diuretic treatment, plus, if necessary, digitalis treatment: in this case, the effective dosage is 10 to 20 mg per day in two doses.
- The dose chosen, per unit dose, should not lower the systolic blood pressure in orthostatism below 90 mmHg.
- Symptomatic hypotension may occur in cardiac patients treated with diuretics. In this case, the initial dose should be halved. The creatinine and serum potassium tests should be done at each dose increase, then every 3 to 6 months depending on the stage of heart failure to control tolerability.

Against indications

This medicine MUST NEVER BE USED in case of:

· History of hypersensitivity to any of the excipients,

· A history of hypersensitivity to quinapril or any other angiotensin converting enzyme inhibitor,

· History of angioedema (angioedema) associated with the use of angiotensin-converting enzyme inhibitor and / or hereditary or idiopathic angioedema,

· 2nd and 3rd trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and lactation ).

This medicine IS GENERALLY NOT RECOMMENDED in case:

· In association with potassium diuretics, potassium salts, lithium and estramustine (see section 4.5).

Bilateral stenosis of the renal artery or functionally unique kidney;

· Hyperkalemia;

· 1st trimester of pregnancy.

Acuitel side effects

Clinically

Have been found:

· Headache, asthenia, dizziness, malaise,

Hypotension, orthostatic or not (see section Warnings and precautions for use ), more rarely chest pain, angina pectoris, syncope;

· Pruritus, rash, photosensitization or other skin 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 (Quincke's edema) (see Warnings and Precautions for Use section );

· Pneumonitis;

· More rarely: hepatitis.

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 ACE inhibitors on specific sites ( kidney transplant, hemodialysis );

· Thrombocytopenia.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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