Medicinal Products

BIPRETERAX 4 mg / 1.25 mg

Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Perindopril, Indapamide
laboratory: Servier

Compressed
Box of 100
All forms

Indication

Treatment of essential hypertension. BIPRETERAX is indicated in patients for whom the blood pressure is insufficiently controlled by perindopril alone.

Dosage BIPRETERAX 4 mg / 1.25 mg Tablet Box of 100

Oral way.
- One tablet of BIPRETERAX per day in one daily dose preferably in the morning and before the meal.
- When possible, it is recommended to individually adjust the dosages of the components.
BIPRETERAX, tablet should be used if the blood pressure is insufficiently controlled by PRETERAX tablet.
- Direct switching from monotherapy to BIPRETERAX tablet may be considered if clinically appropriate.
- Elderly (see section on warnings and precautions for use):
Treatment should be initiated after taking into account the blood pressure response and renal function.
- Inadequate renal (see section on warnings and precautions for use):
. In case of severe renal insufficiency (creatinine clearance <30 ml / min), treatment is contraindicated.
. In patients with moderate renal impairment (creatinine clearance 30-60 ml / min) it is recommended to initiate treatment at the appropriate dosage of free combination.
. In patients with creatinine clearance greater than or equal to 60 ml / min, no dose adjustment is required.
. The usual medical follow-up will include a periodic check of creatinine and potassium.
- Hepatic impairment (see sections contraindications, warnings and precautions for use and pharmacokinetic properties):
. In case of severe hepatic impairment, treatment is contraindicated.
. In patients with moderate hepatic impairment, no dose adjustment is required.
- Child and teenager:
BIPRETERAX should not be used in children and adolescents because the efficacy and safety of perindopril in children and adolescents, alone or in combination, have not been established.

Against indications

CONTRAINDICATED:
RELATED TO PERINDOPRIL :
- hypersensitivity to perindopril or any other inhibitor of the conversion enzyme,
- history of angioedema (Quincke's edema) related to the intake of a converting enzyme inhibitor,
- hereditary or idiopathic angioedema,
- second and third trimesters of pregnancy: BIPRETERAX is contraindicated during the second and third trimesters of pregnancy. Prolonged exposure to ACE inhibitors during the second and third trimesters is known to induce fetotoxicity (decreased renal function, oligo-amnion, skull ossification delay) and neonatal toxicity (renal failure, hypotension, hyperkalemia ). Prolonged exposure to thiazide diuretics during the third trimester of pregnancy may reduce maternal plasma volume and uteroplacental blood flow that may lead to fetal-placental ischemia and growth retardation. In addition, some rare cases of neonatal hypoglycemia and thrombocytopenia have been reported following near-term exposure. If exposure to BIPRETERAX has been performed during the second trimester of pregnancy, an ultrasound of renal function and cranial vault is recommended.
- Children and adolescents: BIPRETERAX should not be used in children and adolescents because the efficacy and safety of perindopril in children and adolescents, alone or in combination, have not been established.
RELATED TO INDAPAMIDE :
- hypersensitivity to indapamide or any other sulfonamide,
- severe renal insufficiency (creatinine clearance <30 ml / min),
- hepatic encephalopathy,
- severe hepatic insufficiency,
- hypokalemia,
- Breastfeeding: BIPRETERAX is contraindicated during breastfeeding. The excretion of perindopril in breast milk is unknown. Indapamide is excreted in breast milk. Indapamide is closely related to thiazide diuretics that are involved in reducing or even suppressing milk during breastfeeding. Hypersensitivity to sulfonamide derivatives, hypokalemia, and neonatal kernicterus may occur. These two substances can lead to serious adverse effects in breastfed newborns, which is why a solution must be considered, either interrupting breastfeeding or stopping treatment, taking into account the importance of this treatment for the mother,
- as a rule, this medicine is not recommended when used with non-antiarrhythmic drugs that can cause torsades de pointes (see section on interactions).
RELATED TO BIPRETERAX :
- hypersensitivity to any of the excipients.
- Due to lack of data, BIPRETERAX should not be used at:
. dialysis patients,
. patients with untreated decompensated heart failure.
- Due to the presence of lactose, patients with congenital galactosemia, glucose and galactose malabsorption or lactase deficiency should not take this medicine.
NOT RECOMMENDED :
RELATED TO PERINDOPRIL :
- This drug is generally not recommended in case of bilateral renal artery stenosis or single functional kidney.
- Hyperkalaemia can lead to serious arrhythmias, sometimes fatal.
- Potassium sparing diuretics, potassium salts : the combination of perindopril and potassium-sparing diuretics or potassium salts is generally not recommended (see section on interactions).
COMMON TO PERINDOPRIL AND INDAPAMIDE :
- Pregnancy : Perindopril should not be used during the first trimester of pregnancy. BIPRETERAX should not be used during the first trimester of pregnancy. If pregnancy is planned or confirmed, alternative treatment should be initiated as soon as possible. There have been no controlled studies with ACE inhibitors in humans; but, in a limited number of cases exposed during the first trimester, no malformations were found which could correspond to human fetotoxicity.
- Lithium : the use of lithium with the combination of perindopril and indapamide is generally not recommended (see section interactions).

Bipreterax side effects

- The administration of Perindopril inhibits the renin-angiotensin-aldosterone axis and tends to reduce the potassium loss caused by indapamide. Four percent of patients treated with BIPRETERAX experienced hypokalaemia (potassium level <3.4 mmol / L).
- The following adverse effects have been observed during treatment and classified according to the following frequencies:
Very common (> 1/10); frequent (> 1/100, 1/1000, 1/10000, <1/1000), very rare (<1/10000), unknown (can not be estimated from the available data).
- Blood and lymphatic system disorders:
Very rare :
Thrombocytopenia, leukopenia / neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia.
Anemia (see Warnings and Precautions section) has been reported with angiotensin-converting enzyme inhibitors on specific sites (kidney transplant, hemodialysis).
- Psychiatric disorders:
Uncommon : mood or sleep disorders
- Nervous system disorders:
. Frequent : paresthesia, headache, asthenia, dizziness, vertigo.
. Very rare : confusion.
- Eye disorders:
Common : blurred vision
- Ear and labyrinth disorders:
Frequent : tinnitus.
- Vascular disorders:
Frequent : orthostatic hypotension or not (see section cautionary and precautions for use).
- Cardiac disorders:
Very rare : arrhythmias including bradycardia, ventricular tachycardia, atrial fibrillation, angina pectoris, and myocardial infarction, possibly secondary to excessive hypotension in high-risk patients (see section on warnings and precautions for use).
- Respiratory, thoracic and mediastinal disorders:
. Common : A dry cough has been reported with the use of angiotensin converting enzyme inhibitors. It is characterized by its persistence, as well as by its disappearance at the end of treatment. The iatrogenic etiology should be considered in the presence of this symptom. Dyspnea.
. Uncommon : bronchospasm.
. Very rare : eosinophilic pneumonia, rhinitis.
- Gastrointestinal disorders:
. Common : constipation, dry mouth, nausea, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhea.
. Very rare : pancreatitis.
- Hepatobiliary disorders:
. Very rare : cytolytic or cholestatic hepatitis (see section on warnings and precautions for use).
. Unknown : In cases of hepatic insufficiency, the occurrence of hepatic encephalopathy is possible (see sections contraindications and warnings and precautions for use).
- Skin and tissue disorders:
. Common : rash, pruritus, maculopapular rash.
. Uncommon :
Angioedema of the face, extremities, lips, mucous membranes, tongue, glottis and / or larynx, urticaria (see section on warnings and precautions for use).
Hypersensitivity reactions, mainly dermatological, in subjects predisposed to allergic or asthmatic reactions.
Purpura.
Possible aggravation of pre-existing systemic lupus erythematosus.
. Very rare : erythema multiforme, toxic epidermal necrosis, Stevens-Johnson syndrome.
Cases of photosensitivity have been reported (see Warnings and Precautions section).
- Muscle disorders, connective tissue and bone:
Frequent : muscle cramps.
- Renal and urinary disorders:
. Uncommon : renal failure.
. Very rare : acute renal failure.
- Disorders of the reproductive organs and the breast:
Uncommon : impotence
- General disorders:
. Frequent : asthenia.
. Uncommon : sweating.
- Biological parameters:
. Potassium depletion with significant decrease in serum potassium in some at-risk populations (see section on warnings and precautions for use).
Hyponatremia with hypovolemia causing dehydration and orthostatic hypotension.
Elevation of serum uric acid and blood glucose during treatment.
Moderate increase in plasma urea and creatinine, reversible upon discontinuation of treatment. This increase is more frequently encountered in cases of renal artery stenosis, diuretic-treated hypertension, and renal failure.
Elevation of plasma potassium levels, usually transient.
. Rare : increased serum calcium.

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