ENAP-CO Tablets COMPOSITION - Pharma Dynamics

The routine use of diuretics in otherwise healthy pregnant women is not indicated and exposes mother
and foetus to unnecessary hazard. Diuretics do not prevent development of toxaemia of pregnancy and
there is no satisfactory evidence that they are useful in the treatment of toxaemia. Thiazides cross the
placental barrier and appear in cord blood. Hazards include foetal and neonatal jaundice,
thrombocytopenia and possibly other adverse reactions which occur in the adult.
Infants whose mothers have taken ENAP-CO should be closely observed for hypotension, oliguria and
hyperkalaemia. There is no experience with the removal of the combination product, ENAP-CO, from
the neonatal circulation. Enalapril, which crosses the placenta, has been removed from the neonatal
circulation by peritoneal dialysis with some clinical benefit. There is no experience with the removal of
hydrochlorothiazide, which also crosses the placenta, from the neonatal circulation.
Both enalapril and thiazides appear in human milk. If use of the medicine is deemed essential, the
patient should stop nursing.
After administration of the initial dose, symptomatic hypotension may occur. Hypotension is more likely
in patients who have received prior diuretic therapy. Discontinue diuretic therapy for 2-3 days before
therapy with ENAP-CO is initiated. In patients with ischaemic heart or cerebrovascular disease, therapy
should be administered with extreme caution because an excessive fall in blood pressure could result in
a myocardial infarction or cerebrovascular accident.
Minor increases in blood urea and serum creatinine have developed in some hypertensive patients with
no apparent pre-existing renal disease when enalapril has been given concomitantly with a diuretic.
Should this occur during therapy with ENAP-CO, the combination should be discontinued.
Minor alterations of fluid and electrolyte balance may precipitate hepatic encephalopathy and coma,
therefore, ENAP-CO should be used with caution in patients with impaired hepatic function or
progressive liver disease.
DOSAGE AND DIRECTIONS FOR USE:
Hypertension
The usual dosage is one tablet, once a day. The dosage may be increased to a maximum of two
tablets, administered once daily, if necessary.
Dosage in Renal Insufficiency
The use of thiazides may not be appropriate in patients with renal impairment. Thiazides are ineffective
at creatinine clearance values of 30 ml/min or below (i.e. moderate or severe renal insufficiency).
Do not use ENAP-CO as initial therapy in any patient with renal insufficiency.
ENAP-CO may however be used in patients with creatinine clearance greater than 30 and less than 80
ml/minute, but only after the individual components have been successfully titrated.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Dizziness and fatigue, the most common clinical side-effects, generally respond to dosage reduction.
Other side-effects include: muscle cramps, nausea, aesthenia, orthostatic effects including
hypotension, headaches, cough and impotence.
Less common side-effects which have been reported include:
Nervous System/Psychiatric
Insomnia, somnolence, paraesthesia, vertigo, nervousness.
Cardiovascular
Syncope, non-orthostatic hypotension, palpitations, tachycardia, chest pain.