• AMLOR*

135 mm
•
AMLOR*
(Amlodipine)
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1. TRADE NAME OF THE MEDICINAL PRODUCT
AMLOR5 mg
AMLOR 10 mg
amlodipine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
AMLOR5 mg
Amlodipine (besylale) . . .. .... . . .. .. . ... . .. .. 6.944 mg
equivalent to amlodipine
......5.000 mg
Microcrystalline cellulose
. .. .72.556 mg
Dried maize starch .... . .. ... . . .. ...... ... .. 20.000 mg
Magnesium stearate ........ . ..... ... ...... .0.500 mg
for one capsule n' 3 of 100 mg
AMLOR 10mg
Amlodipine (besylate) ... . ..... ... . . . . .. . ... 13,889 mg
equivalent to amlodipine ..
..10,000 mg
Microcrystalline cellulose
. ......... 65,611 mg
Dried maize starch .. .. . .. ..... .. ... .. .. .. .. 20.000 mg
Magnesium stearate . .. .. ... .. . .... ..... . . .. 0.500 mg
for one capsule n' 3 of 100 mg
composITion of the capsule coat:
body: gelatin, titanium dioxide
cap : gelatin, titanium dioxide, yellow
3. PHARMACEUTICAL FORM
Amlor 5mg:
Capsule (yellow / white): 30 capsules.
Amlor 10mg:
Capsule (grey): 30 capsules.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
- Preventive treatment of angina : stable angina and spontaneous angina (including Prinzmetal's angina)
- Hypertension
4.2 Posology and method of administration
• Hypertension : The starting dose is 1 capsule (5mg) once
a day, which may be increased to a single daily dose of 10
mg, depending on the treatment response.
• Angina Pectosis : The starting dose is 1 capsule (5mg)
once aday, which may be increased to asingle daily dose of
10 mg, depending on the treatment response.
The maximum daily dose is 10 mg.
Except in case of recent myocardial infraction, amlodipine can
be administered whatever the degree of left ventricular heart
failure.
• Use in the Elderly
Amlodipine, used at similar doses in elderly or younger
patients, is equally well tolerated .
• Use in Renal Failure
The treatment can be initiated at the usual recomended posology. Changes in amlodipine plasma concentrations are not
correlated with degree of renal impairment. Amlodipine is not
dialyzable.
No dose adjustment of amlodipine is required upon concomitant administration of thiazide diuretics, beta- blockers or
angiotensin-converting enzyme inhibitors.
4.3 Contra-indications
This medicine must never be taken in case of hypersensitivity
to dihydropyridines.
This medicine is generally unadvised in case of combination
with dantrolene (see section 4.5. " Interaction with other
medicines »).
4.4 Special warnings and special precautions for use
Special warnings :
Efficacy and safety has not been studied in children. It is
unadvisable to use amlodipine in children.
When clinical signs (asthenia, anorexia, persistant nausea), it
is recommanded to perform liver enzymes assays. If increased and especially in case of jaundice, the treatment must be
stopped.
Precaution for use :
- Use in patients with impaired hepatic function: Amlodipine
half-life is prolonged in patients with impaired liver function
(see. Section 5.2 " Pharmacokinetic properties»). Dosage
recommandations have not been established, so amlodipine
should be administered with caution in these patents.
- Pregnancy and lactation: (see. section 4.6).
4.5 Interaction with other medicines and other forms of interaction
Unadvisable combination (care measure):
- Dantrolene (infusion): in animals, cases of fatal ventricular
fibrillations are consistently observed when verapamil and
dantrolene are administered by IV route. Thus, the combination of acalcium-channel blocker with dantrolene is potentially dangerous. However, afew patients have received the combination nifedipine and dantrolene without any trouble.
Combination needing precaution:
- Alpha·1 blockers (alfuzosin , prazosin): increase in the
hypotensive effect. Risk of severe orthostatic hypotension.
Clinical monitoring. Research of any orthostatic hypotension
in the hours following the alpha-l blocker drug administration
(particularly at the beginning of the treatment).
- Baclofene : increase in the anti-hypertensiveeffect. Monitoring of the arterial pressure and posological adaptation olthe
anti-hypertensive drug if necessary.
- Rifampicine : described for verapamil, diltiazem and nifedipin . Decrease of the plasma levels of the calcium channel
blocker due to an increase of its hepatic metabolism. Clinical
monitoring and , eventually adjustment olthe dose of the calcium channel blocker during the treatment with rifampi cine
and after its withdrawal.
- Itraconazole : extrapolated from nifedipine, felodipine and
isradipine. Increased risk of oedema due to a decrease of the
dihydropyridine hepatic metabolism. Clinical monitoring and,
eventually adjustment of the dose of the dihydropyridine the
treatment with itraconazole and after its withdrawal.
135 mm
Combination to be taken into account:
- Beta-blockers: hypotension, heart failure in patients with
latent or un-controlled heart failure (in vitro negative inotropic
effect of the dihydropyridines, more or less marked depending on the products and susceptible to add to the negative
inotropic effects of beta-blockers). The presence of a betablocker treatment can moreover minimise the reflex sympathic reaction set into action in case of excessive hemodynamic repercussion.
- Imipramine antidepressants (tricyclics): antihypertensive
effect and risk of orthostatic hypotension increased (additive
effect).
- Corticosteroid, tetracosactid (general route): decrease in
the antihypertensive effect (hydrosodic retention of the corticosteroids) .
- Neuroleptics : antihypertensive effect and risk of orthostatic
hypotension increased (additive effect).
Furthermore, amlodipine does not modify the plasma levels
or the renal clearance of digoxine in the healthy volunteers.
4.6 Pregnancy and lactation
Pregnancy:
Animal studies did not show any teratogenic effects. Without
teratogenic effect in animal, malformations in humans are not
expected. To date, any substances responsible for malformations in humans haveeffectively been found to be teratogenic
in animals in properly conducted studies on both species.
Presently, there is no relevant or enough data to assess an
eventual malformation or foetotoxic effect of amlodipine
when administered during pregnancy. Consequently, as a
precaution mesure, it is preferable not to use amlodipine
during pregnancy.
Lactation:
There is no data regarding the excretion of amlodipine in
breast milk.
However, as with others dihydropyridines, the quantities
found in breast milk are low, and no undesirable effects were
notified on the basis of isolated cases.
As a precaution mesure, it is advisable to avoid if possible, the
administration of this medicine to the breast-feeding woman.
4.7 Effects on ability to drive and use machines:
At the beginning of the treatment, a special caution will have
to be observed by drivers or machines users, due to the risk
of giddiness (see section 4.8 « Undesirable effects »).
4.8 Undesirable effects
- Adverse reactions occurring most commonly are linked to
the vasodilator action of the drug. These essentially involve
headache, redness or feeling of heat of the face. These side
effects occur most often during the initial weeks oltreatment
and generally lessen as it continues. In common with other
dihydropyridines an ankle and/or facial edema could occur.
This is more frequent at high doses.
- There have been rarer reports of:
- Cardiac effects: tachycardia, palpitations, syncope.
. Cutaneomucous effects : alopecia, increased sweating, allergic reaction including pruritus, rash and angioedema. As with
other dihydropyridines, slight gingival enlargement has been
reported in patients with marked gingivitis/parodontitis. Such
enlargement can be avoided or disappear by careful oral
hygiene.
- Digestive effects : abdominal pain, dyspepsia, dysgueusia,
appetite loss, nausea, diarrhoea, constipation, dry mouth.
- Neuromuscular effects : muscular cramps, myalgia, arthralgia.
- Liver effects: Hepatitis, jaundice and hepatic enzyme elevations have been reported very rarely (mostly consistent with
cholestasis) with a few cases severe enough to require hospitalization. They are recovered at the treatment withdrawal.
- Lungs effects: dyspnea.
. Genito-urinary effects: pollakiuria, impotence as reported
with other anti-hypertensive drugs, gynecomastia.
- Neuropsychic effects : asthenia, giddiness, sleeping disorders, paresthesia, trembling , visual disturbances, depressive
disorders.
- General effect: malaise.
- Hematopoietic effect : thrombocytopenia.
- Vascular effect: vasculitis.
- As with other calcium-channel blockers, the following
events have been rarely reported : anginal pain , myocardial
infarction, arrythmiaThey can be linked tothe pathology preexistent to the treatment, and must lead to discuss the continuation of the treatment.
4.9 Overdose
Massive overdose could cause notable peripheral vasodilation leading to marked and probably prolonged systemic
hypotension. Any hypotension following acute poisoning
requires, monitoring in a cardiology intensive unit. A vasoconstrictor could be used to restore vascular tone and blood
pressure. Amlodipine is not dialysable.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
SELECTIVE CALCIUM INHIBITOR WITH VASCULAR EFFECT
Amlodipine is acalcium antagonist belonging to the dihydropyridines group wich acts on the calcium channel binding
sites of both 1-4 dihydropyridine and diltiazem. It causes prolonged inhibition of the entry of calcium via slow calcium
channels into smooth muscle and myocardial cells. As with
the other dihydropyridines, amlodipine has diuretic and
natriuretic properties in the animal.
The mechanism of its antihypertensive action is linked to a
direct relaxant effect on vascular smooth muscle.
Single daily administration in hypertensivepatients enables a
significant lowering of blood pressure levels in supine or
standing position throughout the 24-hour period, without any
concomitant acceleration in heart rate. The progressiveaction
of amlodipine avoids episodes of hypotension.
Amlodipine decreases total peripheral resistance (post-load)
without causing reflex tachycardia. This is accompanied by a
reduction in myocardial energy consumption and oxygen
requirements. It causes vasodilatation of the coronary arteries and arterioles, thus increasing myocardial oxygen supply.
Administration of amlodipine in angina patients increases
exercice tolerance time to angina onset, ST segment depression and reduces both the frequency of angina attacks and
nitroglycerin consumption.
As with the other calcium antagonists, amlodipine is metabolically neutral and has no effect on plasma lipid levels. It can
be used in patients with diabetes or gout.
In hypertensive renal transplant recipients treated with cyclosporine, amlodipine at the usual doses decreases blood pressure, increases renal perfusion and glomerular filtration rate
and lowers peripheral vascular resistance. The long term
consequences of these modifications on the graft's fonction
are not assessed.
5.2 Pharmacokinetic properties
After oral administration at therapeutic doses, amlodipine is
completely absorbed.
Amlodipine (absolute) biovailability has been estimated to be
between 64 and 80 %.
Peak plasma concentration occurs late, approximately 6 to 12
hours after dosing. The volume of distribution is 21 I/kg.
The terminal elimination half-life is 35 to 50 hours and
enables single daily administration
Steady state concentrations are reached after 7 to 8 days of
administration.
Amlodipine is almost entirely metabolised to inactive metabolites. Ten percent of the parent substance and 60% of metabolites are excreted in urine.
In vitro studies haveshown that circulating amlodipine is 97.5
% bound to plasma proteins.
Plasma concentrations of amlodipine in the elderly are higher
than in younger patients this being unaccompanied by clinical
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manifestations, the terminal elimination half-life remaining
unchanged.
An increase in half-life is observed in the presence of hepatic
failure.
Renal failure patients: plasma amlodipine concentrations are
not correlated with the degree of renal impairment.
6. PHARMACEUTICAL PARTICULARS
6.1 Shelf life
product should not be used after the expiry date printed on
the outer carton
6.2 Special precautions for storage
store below 30 ' C
6.3 Nature and contents of container
30 capsules: heat-formed blister pack (PVC/Aluminium).
7. DATE OF APPROVAL/REVISION:
Aug. 8,2001 PFIZER, FRANCE.
Manufactured by:Pfizer, France.
Packed by: Jamjoom Pharmaceuticals Co. Ltd. ,
Jeddah, Saudi Arabia.
Marketing Authorization Holder: Pfizer Saudi Arabia, LLC
• Trade mark of Pfizer Inc., New York, U.S.A.
To Report side effects
• Saudi Arabia
National Pharmacovigilance Center (NPC)
• Fax: +966 11 205 7662
• E-mail: [email protected]
• Website: www.sfda.gov.sa/npc
• Other GCC states:
Please contact the relevant competent authority.
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