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Each tablet contains:
Composition:
Atorvastatin………...................................................10
mg
Amlodipine…………................................................
5 mg
Indications:
Lipirol-Am is a prescription drug. It is used in
patients with multiple risk factors for
heart disease such as family history,
high blood pressure, age, low HDL or
smoking to reduce the risk of heart
attack and stroke.
CONTRA-INDICATIONS
Amlodipine is contraindicated in
patients with a known sensitivity to
dihydropyridines, amlodipine, or any of
the inert ingredients.
.
WARNINGS
Use in the Elderly
Elderly patients may have higher plasma concentrations
of amlodipine than those in the younger
patients. The time to reach peak plasma
concentrations of amlodipine is similar
in elderly and younger subjects.
Amlodipine clearance is decreased with
resulting increases in AUC
(approximately 40-60%) and elimination
half-life in elderly and hepatically
insufficient patients. A similar
increase in AUC was observed in patients
with moderate to severe heart failure.
Elderly patients should start on a lower
dose.
Amlodipine is extensively metabolised to inactive
metabolites with 10% excreted unchanged
in the urine. Changes in amlodipine
plasma concentrations are not correlated
with mild renal impairment. NORVASC may
be used in such patients at normal
doses. In patients with severe renal
impairment, amlodipine dosages may need
to be reduced. Amlodipine is not
dialysable.
Amlodipine half-life is prolonged in patients with
impaired liver function. Amlodipine
should therefore be administered at
lower (5 mg) initial dose in these
patients.
Use in Children
Safety and effectiveness of amlodipine in children has
not been established.
COMPATIBILITY WITH OTHER MEDICINES
Amlodipine may be administered with thiazide diuretics,
beta blockers, angiotensin-converting
enzyme inhibitors, long-acting nitrates,
sublingual nitroglycerine, non-steroidal
antiinflammatory drugs, antibiotics, and
oral hypoglycemic medicines.
Studies have indicated that the co-administration of
NORVASC with digoxin did not change
serum digoxin levels or digoxin renal
clearance in normal volunteers, and that
coadministration of cimetidine did not
alter the pharmacokinetics of NORVASC.
In vitro data from studies with human plasma
indicate that amlodipine has no effect
on protein binding of the medicines
tested (digoxin, phenytoin, warfarin, or
indomethacin).In healthy male
volunteers, the co-administration of
amlodipine does not significantly alter
the effect of warfarin on prothrombin
response time.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
The most commonly observed side effects
were headache, oedema, fatigue,
somnolence, nausea, flushing,
palpitations and dizziness. Vomiting and
abdominal pain have occurred.
Less commonly observed side effects
include alopecia, altered bowel habits,
arthralgia, asthenia, back pain,
dyspepsia, dyspnea, gingival
hyperplasia, gynecomastia, hyperglycemia
impotence, increased urinary frequency,
leucopenia, malaise, mood changes and
depression, dry mouth muscle cramps,
myalgia, peripheral neurophathy,
pancreatitis, increased sweating,
syncope, thrombocytopenia, vasculitis,
and visual disturbances
Allergic reactions including pruritus,
rash, angioedema and erythema multiforme
have also been observed.
The following adverse events have been
reported but cannot be distinguished
from the natural history of the
underlying disease: myocardial
infarction, arrhythmia (including
ventricular tachycardia and atrial
fibrillation) and chest pain.
Hepatitis and jaundice and hepatic enzyme elevations
have been reported (mostly consistent
with cholestasis). Some cases severe
enough to require hospitalisation have
been reported in association with use of
amlodipine.
KNOWN SYMPTOMS OF OVERDOSAGE AND
PARTICULARS OF ITS TREATMENT
There is no well documented
experience with amlodipine overdosage.
Gastric lavage may be worthwhile.
Available data suggest that gross
overdosage could result in excessive
peripheral vasodilation with subsequent
marked and probably prolonged systemic
hypotension. Clinically significant
hypotension due to amlodipine overdosage
calls for active cardiovascular support.
Intravenous calcium gluconate may be
beneficial in reversing the effects of
calcium channel blockade. Since
amlodipine is highly protein-bound,
dialysis is not likely to be of benefit.
Dosage : As
per the physician’s advice.
Presentations:
15 tablets
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