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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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Quality
