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Each tablet
contains:
Composition:
Atorvastatin………...................................................10
mg
Amlodipine…………................................................
5 mg
Indications:
liposecam-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 |
Quality
