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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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28.90 23.12 20.80 | 
