ENAP-CO Tablets COMPOSITION - Pharma Dynamics

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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.
Respiratory Dyspnoea Gastro-intestinal Diarrhoea, vomiting, dyspepsia, abdominal pain, flatulence, constipation. Hypersensitivity/Angioneurotic Oedema Angioneurotic oedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported (see Special Precautions). Other Renal dysfunction, renal failure, decreased libido, dry mouth, gout, tinnitus, arthralgia. A symptom complex which may include fever, serositis, vasculitis, myalgia, arthralgia/arthritis, a positive anti-nuclear antibody, elevated erythrocyte sedimentation rate, eosinophilia and leukocytosis, has been reported. Dermatologic manifestations, including skin rash and photosensitivity may occur. Skin Stevens-Johnson syndrome, rash, pruritus, diaphoresis. Laboratory Test Findings Cases of hyperglycaemia, hyperuricemia and hypokalemia have been recorded. In some patients, increases in blood urea and serum creatinine, and elevations of liver enzymes and/or serum bilirubin have occurred. These are usually reversible upon discontinuation of the combination medication. Hyperkalemia and hyponatremia have been noted. Decreases in haemoglobin, haematocrit, platelets and white cell count have been noted. Reports of neutropenia, thrombocytopenia and bone marrow depression have been received, but no direct casual relationship to the combination medication could be established. Side-effects reported for one of the individual components that may also contribute to side-effects encountered with this combination medication, include the following: Hydrochlorothiazide Anorexia, gastric irritation, jaundice (intrahepatic cholestatic jaundice), pancreatitis, sialoadenitis, xanthopsia, leukopenia, agranulocytosis, aplastic anaemia, haemolytic anaemia, purpura, photosensitivity, fever, urticaria, necrotizing angiitis (vasculitis), respiratory distress (including pneumonitis and pulmonary oedema), interstitial nephritis, anaphylactic reaction, glycosuria, electrolyte imbalance, including hyponatraemia, restlessness, muscle spasm, transient blurred vision. Enalapril Ileus, pancreatitis, hepatitis, either hepatocellular or cholestatic, jaundice, depression, confusion, bronchospasm/asthma, sore throat and hoarseness, cardiac rhythm disturbances, angina pectoris, myocardial infarction or cerebrovascular accident, possibly secondary to excessive hypotension in high risk patients, rhinorrhoea, photosensitivity, alopecia, flushing, taste alteration, anorexia, blurred vision, urticaria, stomatitis, glossitis, oliguria, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, pulmonary infiltrates, hepatic failure, pemphigus. Special Precautions: Anaphylactoid Reactions during Hymenoptera Desensitization Less frequently, patients receiving ACE inhibitors during desensitization with hymenoptera venom have experiences life-threatening anaphylactoid reactions. These reactions were avoided by temporarily withholding ACE-inhibitor therapy prior to each desensitization. Cough The use of ACE-inhibitors has been associated with cough. The cough is of a non-productive and persistent nature, which resolves after therapy is discontinued. ACE-inhibitor-induced cough should be considered as part of the differential diagnosis of cough.
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Page 9 and 10: Hipersensitiwiteit/Angioneurotiese
Page 11 and 12: Toenames in bloedureum en serumkrea

ENAP-CO Tablets COMPOSITION - Pharma Dynamics

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