Medicinal Products

ENALAPRIL ALMUS 20 mg

Generic drug from Renitec
Therapeutic class: Cardiology and angiology
active ingredients: Enalapril
laboratory: Biogaran

Tablet breackable
Box of 28
All forms

Indication

- Treatment of arterial hypertension.
- Treatment of symptomatic heart failure.
- Prevention of symptomatic heart failure in patients with asymptomatic left ventricular dysfunction (ejection fraction <= 35%) (see pharmacodynamic properties).

Dosage ENALAPRIL ALMUS 20 mg scored tablet Box of 28

- The absorption of enalapril is not affected by food.
- The dose will be adapted according to the profile of the patient (see warnings and precautions for use) and the blood pressure response.
- Hypertension:
. The initial dose is 5 to 20 mg maximum, depending on the degree of hypertension and the patient's condition (see below). Enalapril is taken once a day. In mild hypertension, the recommended starting dose is 5 to 10 mg. Patients with a strongly stimulated renin-angiotensin-aldosterone system (eg, renovascular hypertension, fluid and / or sodium depletion, cardiac decompensation, or severe hypertension) may experience an excessive drop in blood pressure following the initial dose. An initial dose of 5 mg or less is recommended in such patients and initiation of treatment should be under medical supervision.
. Pretreatment with high doses of diuretics may result in fluid depletion and a risk of hypotension when initiating enalapril therapy. An initial dose of 5 mg or lower is recommended for such patients. If possible, diuretic therapy will be discontinued 2-3 days prior to initiation of enalapril therapy. Renal function and serum potassium will be controlled.
. The usual maintenance dose is 20 mg daily. The maximum maintenance dose is 40 mg daily.
- Heart Failure / asymptomatic left ventricular dysfunction:
In the management of heart failure, enalapril is used in addition to diuretics and, if necessary, digitalis or betablockers. The initial dose of enalapril in patients with symptomatic heart failure or asymptomatic left ventricular dysfunction is 2.5 mg and should be administered under close medical supervision to assess the initial effect on blood pressure. In the absence of symptomatic hypotension following initiation of enalapril treatment in cardiac failure or after effective management of the heart failure, the dose should be increased gradually up to the usual 20 mg maintenance dose. mg, given in a single dose or in two doses, depending on the patient's tolerance. It is recommended to make this adjustment of the dose over a period of 2 to 4 weeks. The maximum dose is 40 mg daily administered in two divided doses.
Diagram indicative of enalapril in patients with heart failure / asymptomatic left ventricular dysfunction:
Week: Dose in mg / day .
. Week 1 :
Days 1 to 3 : 2.5 mg / day * in a single dose.
Days 4 to 7 : 5 mg / day divided into two doses.
. Week 2 : 10 mg / day in a single dose or divided into two doses.
. Weeks 3 and 4 : 20 mg / day in a single dose or divided into two doses.
* Special precautions should be taken in patients with impaired renal function or taking diuretics (see warnings and precautions for use).
Both blood pressure and renal function should be closely monitored before and after initiation of enalapril therapy (see WARNINGS AND PRECAUTIONS) as hypotension and (more rarely) consecutive renal failure have been reported. In patients treated with diuretics, the dose should be reduced, if possible, before starting enalapril therapy. The occurrence of hypotension after the initial dose of enalapril does not imply that hypotension may again occur during maintenance therapy with enalapril and does not preclude continued treatment with the drug. Serum potassium and renal function will also be monitored.
- Dosage in case of renal insufficiency:
In general the interval between intake of enalapril should be increased and / or the dosage reduced.
Creatinine clearance (Clcr): Initial dose.
. <Clr <80 ml / min: 5-10 mg / day.
. <Clcr <= 30 ml / min: 2.5 mg / day.
. Clcr <= 10 ml / min: 2.5 mg / day on days of dialysis (see Warnings and Precautions for Use - Hemodialysis Patients).
Enalaprilat is dialysable. On days when patients are not dialysed, the dosage should be adjusted according to the blood pressure response.
- Elderly people:
The dose should take into account the renal function of the elderly patient (see warnings and precautions for use, Impaired renal function).
- Use in pediatrics:
. There is limited clinical experience with the use of enalapril in hypertensive children (see warnings and precautions for use, pharmacodynamic properties, and pharmacokinetic properties).
. For patients who can swallow tablets, the dose will be adjusted according to the patient's profile and blood pressure response. The recommended starting dose is 2.5 mg in patients of 20 to 50 kg. Enalapril is administered once a day. The dosage will be adjusted according to the needs of the patient to a maximum of 20 mg per day in patients of 20 to 50 kg (see warnings and precautions for use).
. Enalapril is not recommended in neonates and children with a glomerular filtration rate <30 ml / min / 1.73 m², as there are no data available.

Against indications

CONTRAINDICATED:
- Hypersensitivity to enalapril, to any of the constituents of the drug or any other IEC.
- History of angioedema associated with previous treatment with an IEC.
- Hereditary or idiopathic angioedema.
- Second and third trimesters of pregnancy: enalapril is contraindicated during the second and third trimesters of pregnancy. It is known that prolonged exposure to enalapril during the second and third trimesters of pregnancy leads to foetotoxicity (decreased renal function, oligoamnios, delayed ossification) and neonatal toxicity (renal failure, hypotension, hyperkalemia). If exposed during the second trimester of pregnancy, a renal ultrasound and cranial vault is recommended. Infants of mothers who have taken enalapril should be closely monitored for hypotension, oliguria and hyperkalemia. Enalapril, which crosses the placental barrier, has been purified from neonatal circulation by peritoneal dialysis with some clinical benefit, and theoretically can be eliminated by exsanguino-transfusion.
- Lactose : Enalapril contains lactose and should not be used in cases of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
Enalapril contains less than 200 mg of lactose per tablet.
- Pediatric use: experience with efficacy and safety of use is limited in hypertensive children> 6 years of age.
NOT RECOMMENDED :
- Renal Transplantation : There is no experience with enalapril administration in patients with recent kidney transplantation. Therefore treatment with enalapril is not recommended.
- Pregnancy: Enalapril should not be administered during the first trimester of pregnancy. When a pregnancy is planned or confirmed, a relay treatment should be started as soon as possible. Controlled studies with ACE inhibitors have not been performed in humans, but a limited number of pregnancies exposed in the first trimester did not appear to reveal malformations related to the fetotoxicity described in humans.
- Breast-feeding: Enalapril and enalaprilate are excreted in breast milk but their effect on the newborn has not been determined. Therefore, the use of enalapril is not recommended when breastfeeding.
- The combination of lithium and enalapril is generally not recommended (see interactions).

Adverse effects Enalapril Almus

The side effects reported with enalapril are:
[Very common (> 1/10); frequent (> 1/100, 1/1000, 1/10000, <1/1000); very rare <1/10000, of which isolated cases].
- Circulatory and lymphatic disorders:
. Uncommon : Anemia (including refractory and haemolytic).
. Rare : neutropenia, decreased hemoglobin, decreased hematocrit, thrombocytopenia, agranulocytosis, bone marrow suppression, pancytopenia, lymphadenopathy, autoimmune disease.
- Metabolism and nutrition disorders:
Uncommon : hypoglycemia (see Warnings and Precautions for Use, Diabetic Patients).
- Nervous system and psychiatric disorders:
. Common : headache, depression
. Uncommon : confusion, drowsiness, insomnia, nervousness, paresthesia, vertigo.
. Rare : abnormalities of the dream, sleep disorders.
- Eye disorders:
Very common : blurred vision.
- Cardiac disorders and vascular disorders:
. Very common : dizziness.
. Common : hypotension (including orthostatic hypotension), syncope, myocardial infarction or stroke, which may be secondary to excessive hypotension in patients at high risk (see warnings and precautions for use), chest pain, rhythm, angina pectoris, tachycardia.
. Uncommon : orthostatic hypotension, palpitations.
. Rare : Raynaud's syndrome.
- Respiratory, thoracic and mediastinal disorders:
. Very common : cough.
. Common : dyspnoea
. Uncommon : rhinorrhea, sore throat and hoarseness, bronchospasm / asthma.
. Rare : pulmonary infiltrate, rhinitis, allergic alveolitis / eosinophilic pneumonia.
- Gastrointestinal disorders:
. Very common : nausea.
. Common : diarrhea, abdominal pain, dysgeusia.
. Uncommon : ileus, pancreatitis, vomiting, dyspepsia, constipation, anorexia, gastric irritation, dry mouth, peptic ulcer.
. Rare : stomatitis / aphthous ulcers, glossitis.
. Very rare : intestinal angioedema.
- Hepatobiliary disorders:
Rare : liver failure, hepatitis - either hepatocellular or cholestatic, hepatitis including necrosis, cholestasis (including jaundice).
- Skin and subcutaneous tissue disorders:
. Common : rash, hypersensitivity / angioneurotic edema: Angioneurotic edema of the face, extremities, lips, tongue, glottis and / or larynx has been reported (see warnings and precautions for use).
. Uncommon : diaphoresis, pruritus, urticaria, alopecia.
. Rare : erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma.
. An association of symptoms has been reported which may involve some or all of the following signs: fever, serous inflammation, vasculitis, myalgia / myositis, arthralgia / arthritis, antinuclear antibody positive, elevated sedimentation rate, eosinophilia and leukocytosis.
. Rash, photosensitivity and other dermatological manifestations may occur.
- Renal and urinary disorders:
. Uncommon : renal dysfunction, renal failure, proteinuria.
. Rare : oliguria.
- Disorders of the reproductive organs and breasts:
. Uncommon : impotence
. Rare : Gynecomastia.
- General disorders and accidents related to the site of administration:
. Very common : asthenia.
. Frequent : tiredness
. Uncommon : muscle cramps, flushing, tinnitus, malaise, fever.
- Investigations:
. Frequent : hyperkalemia, increased serum creatinine.
. Uncommon : increased blood urea, hyponatremia.
. Rare : Elevated liver enzymes, elevated serum bilirubin.

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