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DRUG INTERACTIONS
ANTIHYPERTENSIVE THERAPY
Additive effect may occur when RENITEC is used together with other
antihypertensive therapy.
SERUM POTASSIUM - SEE ALSO
PRECAUTIONS, HYPERKALEMIA.
In clinical trials, serum potassium usually remained within normal limits.
In hypertensive patients treated with RENITEC alone for up to 48 weeks, mean
increases in serum potassium of approximately 0.2 mEq/L were observed. In
patients treated with RENITEC plus a thiazide diuretic, the potassium-losing
effect of the diuretic was attenuated usually by the effect of enalapril.
If RENITEC is given with a potassium-losing diuretic, diuretic-induced
hypokalemia may be ameliorated.
Risk factors for the development
of hyperkalemia include renal insufficiency, diabetes mellitus, and
concomitant use of potassium-sparing diuretics (e.g. spironolactone,
eplerenone, triamterene or amiloride), potassium supplements, or
potassium-containing salt substitutes.
The use of potassium supplements, potassium-sparing diuretics, or
potassium-containing salt substitutes particularly in patients with impaired
renal function may lead to a significant increase in serum potassium. If
concomitant use of RENITEC and the above-mentioned agents is deemed
appropriate, they should be used with caution and with frequent monitoring
of serum potassium.
ANTIDIABETICS
Epidemiological studies have suggested that concomitant administration of
ACE inhibitors and antidiabetic medicines (insulins, oral hypoglycemic
agents) may cause an increased blood-glucose-lowering effect with risk of
hypoglycemia. This phenomenon appeared to be more likely to occur during the
first weeks of combined treatment and in patients with renal impairment. In
diabetic patients treated with oral antidiabetic agents or insulin, glycemic
control should be closely monitored for hypoglycemia, especially during the
first month of treatment with an ACE inhibitor.
SERUM LITHIUM
As with other drugs which eliminate sodium, lithium clearance may be
reduced. Therefore, serum lithium levels should be monitored carefully if
lithium salts are to be administered.
NON-STEROIDAL ANTI-IMFLAMMATORY DRUGS INCLUDING SELECTIVE CYCLOOXGENASE-2
INHIBITORS
Non-steroidal anti-inflammatory
drugs (NSAIDs) including selective cyclooxygenase-2 inhibitors (COX-2
inhibitors) may reduce the effect of diuretics and other antihypertensive
drugs. Therefore, the antihypertensive effect of ACE inhibitors may be
attenuated by NSAIDs including selective COX-2 inhibitors.
In some patients with compromised
renal function who are being treated with non-steroidal anti-inflammatory
drugs including selective cyclooxgenase-2 inhibitors, the coadministration
of ACE inhibitors may result in a further deterioration of renal function.
These effects are usually reversible.
GOLD
Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and
hypotension) have been reported rarely in patients on therapy with
injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor
therapy including enalapril.
SIDE EFFECTS
RENITEC has been demonstrated to be generally well tolerated. In clinical
studies, the overall incidence of side effects was no greater with RENITEC
than with placebo. For the most part, side effects have been mild and
transient in nature, and have not required discontinuation of therapy.
The following side effects have been associated with the use of Tablets and
Injection RENITEC:
Dizziness and headache were the more commonly reported side effects. Fatigue
and asthenia were reported in 2-3% of patients. Other side effects occurred
in less than 2% of patients, and included hypotension, orthostatic
hypotension, syncope, nausea, diarrhea, muscle cramps, rash, and cough. Less
frequently renal dysfunction, renal failure, and oliguria have been
reported.
Symptomatic hypotension occurred more frequently with Injection RENITEC than
with Tablets RENITEC.
HYPERSENSITIVITY / ANGIONEUROTIC EDEMA
Angioneurotic edema of the face, extremities, lips, tongue, glottis
and/or larynx has been reported rarely (see PRECAUTIONS).
Side effects which occurred very rarely, either during controlled clinical
trials or after the drug was marketed, include.
CARDIOVASCULAR
myocardial infarction or cerebrovascular accident, possibly secondary to
excessive hypotension in high risk patients (see PRECAUTIONS)
chest pain
palpitations
rhythm disturbances
angina pectoris
Raynaud's phenomenon
GASTROINTESTINAL
ileus
pancreatitis
hepatic failure
hepatitis - either hepatocellular or cholestatic
jaundice
abdominal pain vomiting dyspepsia
constipation anorexia stomatitis
METABOLIC
Cases of hypoglycemia in diabetic patients on oral antidiabetic agents or
insulin have been reported (see DRUG INTERACTIONS).
NERVOUS SYSTEM / PSYCHIATRIC
depression
confusion
somnolence
insomnia
nervousness
paresthesia
vertigo
dream abnormality
RESPIRATORY
pulmonary infiltrates
bronchospasm/asthma
dyspnea
rhinorrhea
sore throat and hoarseness
SKIN
diaphoresis
erythema multiforme
exfoliative dermatitis
Stevens-Johnson syndrome
toxic epidermal necrolysis
pemphigus
pruritus
urticaria
alopecia
OTHER
impotence
flushing
taste alteration
tinnitus
glossitis
blurred vision
A symptom complex has been reported which may include some or all of the
following: fever, serositis, vasculitis, myalgia/myositis, arthralgia/arthritis,
a positive ANA, elevated ESR, eosinophilia, and leukocytosis. Rash,
photosensitivity or other dermatologic manifestations may occur.
LABORATORY TEST FINDINGS
Clinically important changes in standard laboratory parameters were rarely
associated with administration of RENITEC. Increases in blood urea and serum
creatinine, and elevations of liver enzymes and/or serum bilirubin have been
seen. These are usually reversible upon discontinuation of RENITEC.
Hyperkalemia and hyponatremia have occurred.
Decreases in hemoglobin and hematocrit have been reported.
Since the drug was marketed a small number of cases of neutropenia,
thrombocytopenia, bone marrow depression, and agranulocytosis have been
reported in which a causal relationship to therapy with RENITEC could not be
excluded.
OVERDOSAGE
Limited data are available for overdosage in humans. The most prominent
features of overdosage reported to date are marked hypotension, beginning
some six hours after ingestion of tablets, concomitant with blockade of the
renin-angiotensin system, and stupor. Serum enalaprilat levels 100- and
200-fold higher than usually seen after therapeutic doses have been reported
after ingestion of 300 mg and 440 mg of enalapril, respectively.
The recommended treatment of overdosage is intravenous infusion of normal
saline solution. If available, angiotensin II infusion may be beneficial. If
ingestion is recent, induce emesis. Enalaprilat may be removed from the
general circulation by hemodialysis (see PRECAUTIONS, Hemodialysis
Patients).
STORAGE
Store Tablets RENITEC below 30°C (86°F) and avoid transient temperatures
above 50°C (122°F).
AVAILABILITY
RENITEC ( enalapril maleate) 5mg,10mg and 20mg are available in blister
packs of 30's.
SHELF LIFE
Please refer to the expiry date
on the outer carton.
APPEARANCE
RENITEC 5mg: White, barrel shaped biconvex tablet, one side scored, the
other side engraved RENITEC.
RENITEC 10mg: Rust red, barrel
shaped, biconvex tablet, one side scored, the other side engraved RENITEC.
RENITEC 20mg: Peach, barrel shaped biconvex tablet, one side scored, the
other side engraved RENITEC.
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