Oilatum Emollient                                       

Insup Enalaprile

Indications

Enalapril Maleate is indicated in the treatment of all grades of high blood-pressure and in renovascular hypertension. It can be used as initial treatment by itself or together with other anti-hypertensive agents, especially diuretics.  Enalapril Maleate also is indicated in the treatment of congestive heart failure.

Insup must be administered only through oral doses. Since its absorption is not influenced by meals, Insup can be administered before, during or after any meal. The usual daily dose goes from 10 to 40 mg in all indications. It can be administered 1 or 2 times a day. Until this date, the maximum dose studied in men is of 80 mg per day. 

The tablets of Insup are dented to give the possibility to fraction them, if convenient, to a dose of 10mg (1/2 tablet) and 5mg (1/4 tablet).  In patients with kidney failure and congestive heart failure or in those patients who are being treated with diuretics, it may be necessary to start with a lower dose of Insup.

• This medicine is efficient in decreasing the blood-pressure and for several chest pains
• The patient must follow the doctors orders and take the number of tablets per day as indicated

• The patient must follow the doctors orders and take the number of tablets per day as indicated

• The patient must immediately suspend the treatment and visit a doctor in case of: Swelling of eyelids, lips and face, difficulties breathing, Dizziness sensation and faintness
• If dry coughing occurs consult your physician.

• At the beginning of the treatment, you can experience fatigue symptoms and sleepiness, instability sensation etc. Therefore, it is better that the patient does not engage in any activity that may require being alert (driving vehicles, using heavy machinery etc) until the patient has responded perfectly to the medicine.

• As with all medicines indicated in the treatment of blood-pressure, the patient must control the loss of liquid (vomiting, diarrhoea,, excessive sweating etc.)

• This formulation has lactose. There has been described cases of intolerance of this component in children and adolescents. Although, the present quantity in the preparation is not enough to start the intolerance symptoms, in case of appearance of diarrhoea a doctor should be consulted.

The initial recommended dose is of 5mg administered once a day. The usual maintenance dose is of 20mg once a day. This dose must be adjusted to the patient needs. In patients of 65 years or older, the initial recommended dose is of 2.5mg

Since in these patients the blood-pressure and the kidney function can be particularly sensible to the ECA (Angiotensin Conversion Enzyme) inhibition, the treatment must start with an initial low dose of 2.5 to 5mg in order to adjust it to fit the needs of the patient.  It is expected that most patients respond to one tablet of 20mg once a day.

Patients that are being treated with diuretic could experience hypotension after the initial dose of Enalapril Maleate, so precaution is recommended since these patients could have volume or salt depletion. The diuretic treatment must be suspended 2-3 days before the start of the Enalapril Maleate treatment. If it is not possible, the initial dose of Enalapril Maleate must be low (2.5 – 5 mg) to determine the initial effect over the blood-pressure and later on adjust the dose to the patient need.

The initial dose of Enalaprile Maleate in patients with congestive heart failure (especially those with altered kidney function or sodium and / or volume depletion) must be low (2.5 – 5mg) and it must be administered under careful medical supervision in order to determine the initial effect over the blood-pressure. If possible, the dosage of diuretics must be reduced before the start of the treatment. The appearing of hypotension after the initial dose of Enalapril Maleaate does not indicate that this would happen during the chronic treatment with Enalapril Maleate and does not exclude the continuos use of the medicine.

The maintenance usual dose is of 10 to 20 mg per day, administered in single doses or divided. These doses must be reached by gradual increases after the initial dose, and it can be achieved in a period of 2 to 4 weeks or more rapidly if the presence of signs and residual symptoms of heart failure indicate so.

Before and after the beginning of treatment with Insup the blood pressure must be closely supervised and the kidney function (see PRECAUTIONS) since some have experienced hypotension and also treatment failure.

Enalaspril Maleate is not indicated to those patients that show a hyper sensibility to this drug.

Symptomatic Hypotension

A very low percentage of patients (2,3% on global terms) experience symptomatic hypotension after the initial dose or during the treatment.

In high blood pressure patients it is most frequent when there is a reduction of volume (previous treatment with diuretics, salt restriction on the diet, dialysis, diarrhoea or vomiting) or in high blood pressure with high rennin, frequently secondary to the renal-vascular illness. On patients suffering heart failure, kidney function deficiencies (see dosage). If hypotension develops the patient must be put on supine position, it could be necessary to give the patient oral liquid in order to replete of volume, or normal saline serum intravenously. The treatment with Enalapril Maleate can be continued after restoring the blood volume and an efficient arterial pressure.

In some patients with congestive heart failure that have normal or low arterial pressure an additional decrease in the systematic arterial pressure could occur with Enalapril Maleate. This effect must be taken into consideration and generally it is not necessary to suspend treatment. If hypotension was to become symptomatic, it may be necessary to reduce the dose of Enalapril Maleate or stop the treatment.

Kidney Function Deficiencies

Patients with kidney failure may need lower or less frequent doses of Insup (see Dosage). In some patients with bilateral stenosis of the kidney arteries or stenosis of the artery of a sole kidney or transplanted kidney have experienced increases on the levels of urea and seric creatinine, that reverse as the treatment is stopped. This finding is specially given on patients with kidney failure.

Some hypotense patients with a clear lack of previous kidney illness have developed minimum and usually temporary increases in the urea and the seric creatinine, especially when Insup was administered together with a diuretic. It must be necessary then to reduce the dose of Insup or stop the intake of the diuretic.

In patients with congestive heart failure, the hypotension after the start of the treatment with Enalapril Maleate could induce a future kidney function deterioration. In this situation it has been prescribed acute kidney failure, usually reversible. Therefore, in those patients, it is recommended the control of the kidney function during the first weeks of the treatment

Hypersensibility, Angioneurotic Edema

In patients treated with inhibitors of the conversion enzyme, including Enalapril Maleate, on rare occasions, angioneurotic edema has appeared.in the face, eyelids, tongue glottis and/or larynx. In such circumstances, Enalapril Maleate treatment must be stopped at once and the patient must remain on observation until the swelling has disappeared. In those cases in which the swelling has been mainly on the face and the eyelids there has been no need for any treatment, however, anti-histaminic have proven themselves to improve the condition.

The angioneurotic edema with larynx edema could be deadly. When there is an affection on the tongue, glottis or larynx that produces an obstruction on the air tract epinephrine must be administered immediately through subcutaneous path in solution 1:1.000 (0,3 ml to 0,5 ml) and to restore other therapeutic measures that are considered suitable.

Surgery / Anasthesia

In patients that are going to be operated or are going to be treated during anaesthesia with agents that produce hypotension, Enalapril Maleate blocks the formation of secondary angiotensia II so that mechanism can be corrected by an expansion of the volume.

Seric Potassium

Seric potassium generally stays within the normal range. In patients with kidney failure, the dosage of Enalapril Maleate could increase the seric potassium, especially in patients with kidney failure, mellitus diabetes and/or concomitant diuretics potassium savers.

Usage during pregnancy

There are not adequate and well controlled studies on pregnant women. Enalapril Maleate can be used during pregnancy only if the potential benefit outweighs the potential risks for unborn child.

There is a potential risk of hypotension for the unborn child, low birth weight, renal perfusion or blockade in the unborn child after uterus exposure to the inhibitors of the conversion enzyme. Any new born that has been exposed to Enalapril Maleate during the intra-uterus, must be closely observed the urine flux and the blood pressure.

If required, the appropriated therapeutic measures must be adopted including the administration of fluids or dialysis to extract the Enalapril Maleate from the blood flow. Therefore, the routine use of inhibitors of the conversion enzyme during the last days of pregnancy is not advised.

Side Effects

Insup has shown to be generally well tolerated. In clinical Trials the global incidence of undesirable side effects was not larger with Enalapril Maleate than with placebo. For most of the patients, the undesirable effects have been slight and temporary. Treatment interruption was required in 6% of the patients.

The side effects more commonly described were loss of stability and headache. 2-3% of the patients experienced fatigability and asthenia. Other side effects with a lower incidence of 2% were: orthostatic hypotension, syncope, nausea, diarrhoea, muscle cramps and rash. It has also been described dry cough with a frequency between 1 and 2% and could require stoppage of treatment.

Package is in 28 tablets of 20mg