Amlodipine

Main information

  • Trade name:
  • Amlodipine 10 mg Tablet
  • Dosage:
  • 10 mg
  • Pharmaceutical form:
  • Tablet
  • Units in package:
  • Blister pack, PVC/PVdC-PVC/PVdC/aluminium in a acrdboard carton, 100 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Cadila Pharmaceuticals Ltd

Documents

Localization

  • Available in:
  • Amlodipine 10 mg Tablet
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 14741
  • Authorization date:
  • 22-11-2010
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

NEW ZEALAND DATA SHEET

Amlodipine [Ethics]

Tablets, Amlodipine Besylate Ph Eur, 5 mg and 10 mg (as amlodipine)

Please refer to the Medsafewebsite (www.medsafe.govt.nz) for the most recent version of

this prescribing information. Page 1 of 8

Presentation

Amlodipine [Ethics] 5 mg

White to off white, octagonal shaped, uncoated tablets, debossedAM 5onone face and

scored on the obverse face. Each tablet containsAmlodipine BesylatePh Eur equivalent to

amlodipine 5 mg.

Amlodipine [Ethics] 10 mg

White to off white, octagonal shaped, uncoated tablets, debossedAM 10on one face and

plain on the obverse face. Each tablet contains Amlodipine Besylate Ph Eur equivalent to

amlodipine 10 mg.

Uses

Pharmacotherapeutic group

C08CA01: member of C08CA -dihydropyridine derivatives, a subset of C08C – selective

calciumchannel blockers with mainly vascular effects.

Actions

Amlodipine is a calciumion influx inhibitor (slow channel blocker or calciumion antagonist)

that inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth

muscle.

The mechanismof the antihypertensive action of amlodipine is due to a direct relaxant effect

on vascular smooth muscle.

The precise mechanismby which amlodipine relieves angina has not been fully determined

but amlodipine reduces total ischaemic burdenby the following two actions. (1) Amlodipine

dilates peripheral arterioles and thus reduces the total peripheral resistance(afterload) against

which the heart works. Since the heart rate remains stable, this unloading of the heart reduces

myocardial energy consumption and oxygen requirements. (2) The mechanismof action of

amlodipine also probably involves dilatation ofthe main coronary arteries and coronary

arterioles, both in normal and ischaemic regions. This dilatation increases myocardialoxygen

delivery in patients with coronary artery spasm(Prinzmetal's or variant angina) and blunts

smoking induced coronary vasoconstriction.

In patients with hypertension, once daily dosing provides clinically significant reductions of

blood pressure in both the supine andstanding positionsthroughout the 24hour interval.

Due to the slow onset of action, acute hypotension is not a feature of amlodipine

administration.

In patients with angina, once daily administration of amlodipineincreasestotal exercise time,

time to angina onset and time to 1 mm ST segment depression, and decreases both angina

attack frequency and nitroglycerine tablet consumption.

Amlodipine [Ethics]

Tablets, Amlodipine Besylate Ph Eur, 5 mg and 10 mg (as amlodipine)

Please refer to the Medsafewebsite (www.medsafe.govt.nz) for the most recent version of

this prescribing information. Page 2 of 8

Use in patients with heart failure

Haemodynamic studies and exercisebased controlled clinical trial in NYHA Class II-IV heart

failure patients have shown thatamlodipine did not lead to clinical deterioration as measured

by exercise tolerance, leftventricular ejection fraction and clinical symptomatology.

A placebo-controlled study (PRAISE) designedto evaluate patients with NYHA Class III-IV

heart failure receiving digoxin, diuretics,and angiotensin converting enzyme(ACE)

inhibitors has shown that amlodipine did not lead to an increase in risk of mortality or

combinedmortality and morbidityinpatients with heart failure.

In a follow-up, long-term, placebo controlled study (PRAISE-2) of amlodipine in patients

with NYHA III and IV heart failure withoutclinical symptomsor objective findings

suggestive of underlying ischaemic disease, on stable doses of ACE inhibitors, digitalis and

diuretics, amlodipine had no effect on total cardiovascular mortality. Inthis samepopulation,

amlodipine was associated with increased reports of pulmonary oedemadespite no significant

difference in the incidence of worsening heart failure as compared to placebo (refer to

Warnings and precautions).

Amlodipine has not been associated with any adverse metaboliceffects or changes in plasma

lipids and is suitable for use in patients with asthma, diabetes and gout.

Pharmacokinetics

Absorption

Amlodipine is well absorbed orally with peakblood levels occurring6 to 12 hours post-dose.

Oral administration of a single therapeutic dose gave a mean absolute bioavailability of 64%

(range 52 to 88%). The absorption of amlodipine is unaffected by consumption of food.

Distribution

The volume of distributionis approximately 20 L/kg.In vitrostudies have shown that

approximately 97.5% of circulating amlodipine is bound to plasmaproteins.

Biotransformation

Amlodipine is extensively metabolisedby theliver to inactive metabolites with 10% ofthe

parent compound and 60% of metabolites excreted in the urine.

Elimination

The terminal plasmaelimination half-life is about 35 to 50 hours and isconsistentwithonce

daily dosing. Steady state plasmalevels are attained after 7 to 8 daysof consecutive dosing.

Amlodipine is not dialysable.

Indications

Amlodipine is indicated for the first line treatment of hypertension and can be used as the

sole agent tocontrolblood pressure in the majority ofpatients. Patients not adequately

controlled on a single antihypertensive agent may benefit from the addition of amlodipine,

which has been used in combination with athiazide diuretic, beta-adrenoceptor blocking

agent, or an angiotensin-converting enzymeinhibitor.

Amlodipine [Ethics]

Tablets, Amlodipine Besylate Ph Eur, 5 mg and 10 mg (as amlodipine)

Please refer to the Medsafewebsite (www.medsafe.govt.nz) for the most recent version of

this prescribing information. Page 3 of 8

Amlodipine is indicated for thefirst line treatment of myocardial ischaemia, whether due to

fixed obstruction (stable angina)and/or vasospasm/vasoconstriction (Prinzmetal's or variant

angina) of coronary vasculature. Amlodipinemay be used where the clinical presentation

suggests a possible vasospastic/vasoconstrictive componentbut where

vasospasm/vasoconstriction has not been confirmed. Amlodipine may be used alone as

monotherapy, or in combination with other antianginal medicines in patients with angina that

is refractory to nitratesand/or beta blockers.

Dosage and administration

For both hypertension and angina, the usual initial dose is amlodipine 5 mg once daily which

may be increased to a maximumdose of 10mgdepending on the individual patient's

response.

No dose adjustment of amlodipine is required upon concomitant administration of thiazide

diuretics, beta blockers and angiotensin-converting enzymeinhibitors.

Use in the elderly

The time to reach peak plasmaconcentrationsof amlodipine is similar in elderly and younger

subjects. Amlodipine clearance tends to bedecreased with resulting increases in AUC and

elimination half-life in elderly patients.

Increases in AUC and elimination half-life inpatients with congestiveheart failure were as

expected for the patient age group studied.

Amlodipine, used at similar doses in elderly or younger patients, is equally well tolerated.

Therefore normal dosage regimens are recommended.

Use in renal disease

Amlodipine is extensively metabolised toinactivemetabolites with 10% excreted as

unchanged medicine in the urine. Changes inamlodipine plasmaconcentrations are not

correlated with degree of renal impairment. Amlodipine may be used in such patients at

normal doses. Amlodipine is not dialysable.

Use in children

Amlodipine is not recommended for use in children.

Contraindications

Amlodipine is contraindicated in patientswith a known sensitivity to amlodipine,

dihydropyridines or any of the listed inactive ingredients.

Warnings and precautions

Use in patients with heart failure

In a long term placebo-controlled study (PRAISE-2) of amlodipine in patients with NYHA

III and IV heart failure ofnonischaemic aetiology, amlodipine was associated with increased

reports of pulmonary oedemadespite no significant difference in the incidence of worsening

heart failure as compared to placebo (referto Uses, Use in patients with heart failure).

Amlodipine [Ethics]

Tablets, Amlodipine Besylate Ph Eur, 5 mg and 10 mg (as amlodipine)

Please refer to the Medsafewebsite (www.medsafe.govt.nz) for the most recent version of

this prescribing information. Page 4 of 8

Pregnancy and lactation

Assigned Category C in the Australian Categorisation of risksystem. Category C refers to

medicines which, owing to their pharmacological effects, have caused or may be suspected of

causing, harmful effects on the humanfoetusor neonate without causing malformations.

These effects may be reversible. Accompanying texts should be consultedfor further details.

Specifically, calciumchannel blockers carry the potential to produce foetal hypoxia

associated with maternal hypotension.

Safety of amlodipine in human pregnancy orlactation has not been established. Amlodipine

did not demonstrate any foetotoxic nor teratogenic potential inanimal reproductive studies

other than to delay parturitionand prolong labour in rats at a dose level fifty times the

maximum recommended dose in humans. No mutagenic activity has been found in tests for

gene mutations or cytogenic assays. Accordingly, use in pregnancy is recommended only

when there is no safer alternative andwhen the disease itself carriesgreater risk for the

mother and foetus.

Use in patients with impaired hepatic function

As with all calciumchannel blockers, amlodipine half-life is prolonged in patients with

impaired liver function and dosage recommendations have not been established. The

compound should therefore be administered with caution in these patients.

Use in children

Safety and effectiveness of amlodipinein children have not been established.

Effects on ability to drive and use machinery

Clinicalexperience withamlodipine indicates thatit is unlikely to impairapatient’s ability to

drive or use machinery.

Adverse effects

Clinical trial data

Amlodipine is well-tolerated. Inplacebo controlled clinicaltrials involving patients with

hypertension or angina, the most commonlyobserved adverse effects were headache,

oedema, fatigue, somnolence, nausea, abdominal pain, flushing, palpitations and dizziness. In

these clinicaltrials no pattern ofclinicallysignificant laboratory testabnormalities related to

amlodipine has been observed.

Post-marketing surveillance data

Less commonly observed adverse effects in marketing experience include:

MedDRA System Organ Class Adverse Effects

blood and lymphatic systemdisorders leucopenia, thrombocytopenia

metabolismand nutrition disorders hyperglycaemia

psychiatric disorders insomnia,mood changes

nervous systemdisorders hypertonia, hypoesthesia/paraesthesia,

peripheral neuropathy, syncope, taste

perversion, tremor

Amlodipine [Ethics]

Tablets, Amlodipine Besylate Ph Eur, 5 mg and 10 mg (as amlodipine)

Please refer to the Medsafewebsite (www.medsafe.govt.nz) for the most recent version of

this prescribing information. Page 5 of 8

eye disorders visual disturbances

ear and labyrinth disorders tinnitus

vascular disorders hypotension, vasculitis

respiratory, thoracic and mediastinal

disorders cough, dyspnoea, rhinitis

gastrointestinal disorders alteredbowel habits, dry mouth, dyspepsia

(including gastritis),gingival hyperplasia,

pancreatitis, vomiting

skin and subcutaneous tissue disorders alopecia, increased sweating, purpura, skin

discolouration, urticaria

musculoskeletal and connective tissue

disorders arthralgia, back pain, muscle cramps,

myalgia

renal and urinary disorders increased urinary frequency, micturition

disorder, nocturia

reproductive systemand breast disorders gynaecomastia, impotence

general disorders andadministration site

conditions asthenia, malaise, pain

investigations weight increase/decrease

Rarely, allergic reactionsincluding pruritis,rash, angioedemaand erythema multiforme have

been reported.

Hepatitis, jaundice and hepatic enzymeelevations have also beenreported very infrequently

(mostly consistentwith cholestasis).Somecases severe enough torequire hospitalisation

have been reported in association with use of amlodipine. In many instances, causal

association is uncertain.

As with other calciumchannel blockers thefollowing adverse events have been rarely

reported and cannot be distinguished fromthe natural history of the underlying disease:

myocardial infarction, arrhythmia(including bradycardia, ventricular tachycardia and atrial

fibrillation) and chest pain.

INTERACTIONS

Amlodipine has been safely administered withthiazide diuretics,beta blockers, alpha

blockers, angiotensin-convertingenzymeinhibitors, long-actingnitrates, sublingual glyceryl

trinitrate, non-steroidal anti-inflammatory agents,antibiotics, and oral hypoglycaemic agents.

Plasma protein displacement

In vitrodata fromstudies with humanplasmaindicate that amlodipine has no effect on

protein binding of the medicines tested (digoxin, phenytoin, warfarin, or indomethacin).

Microsomal enzymes

CYP3A4 inhibitors

With concomitant use with the CYP3A4 inhibitor erythromycin in young patients and

diltiazemin elderly patients, the plasmaconcentration of amlodipine was increased. The

clinical relevance of this finding is uncertain. It cannot beruled out that strong inhibitors of

CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir) may increase the plasmaconcentrations

Amlodipine [Ethics]

Tablets, Amlodipine Besylate Ph Eur, 5 mg and 10 mg (as amlodipine)

Please refer to the Medsafewebsite (www.medsafe.govt.nz) for the most recent version of

this prescribing information. Page 6 of 8

of amlodipine to a greater extent than diltiazem. Amlodipine should be used with caution

together with CYP3A4 inhibitors.

CYP3A4 inducers

There are nodata available regarding the effect of CYP3A4 inducers on amlodipine. The

concomitant use of CYP3A4 inducers (e.g., rifampicin, Hypericumperforatumor St John’s

Wort) may give a lower plasmaconcentrationof amlodipine. Amlodipine should be used

with caution together with CYP3A4 inducers.

Effect of other medicines on amlodipine

Cimetidine

Co-administration of amlodipine with cimetidine did not alter the pharmacokinetics of

amlodipine.

Aluminium/Magnesium(antacid)

Co-administration of an aluminium/magnesiumbased antacids with a single dose of

amlodipine had no significant effecton the pharmacokinetics of amlodipine.

Sildenafil

A single 100 mgdose ofsildenafil in subjects with essential hypertension had no effect on the

pharmacokinetic parameters of amlodipine. When amlodipine and sildenafil were used in

combination, each agent independently exerted its own blood pressure lowering effect.

Effect of amlodipineon other medicines

Atorvastatin

Co-administration ofmultiple 10 mgdoses ofamlodipine with80 mgofatorvastatin resulted

in no significant changein the steadystatepharmacokinetic parameters of atorvastatin.

Digoxin

Co-administration of amlodipine with digoxindid not change serumdigoxin levels or digoxin

renal clearance innormal volunteers.

Warfarin

Co-administration of amlodipine with warfarin did not change the warfarin prothrombin

response time.

Cyclosporin

Pharmacokinetic studies with cyclosporin have demonstrated that amlodipine does not

significantlyalter the pharmacokinetics of cyclosporin.

Food and beverage

Grapefruit juice

Administration of amlodipine with grapefruit orgrapefruit juice is not recommended as

bioavailability may be increased in somepatients resulting in increased blood pressure

lowering effects.

Amlodipine [Ethics]

Tablets, Amlodipine Besylate Ph Eur, 5 mg and 10 mg (as amlodipine)

Please refer to the Medsafewebsite (www.medsafe.govt.nz) for the most recent version of

this prescribing information. Page 7 of 8

Alcohol

Single and multiple 10 mg doses ofamlodipine had no significant effect on the

pharmacokinetics of ethanol.

OVERDOSAGE

Signs and symptoms

Available data suggest that gross overdosage could result in excessive peripheral

vasodilatation and possibly reflex tachycardia. Marked andprobably prolonged systemic

hypotension up to and including shock withfatal outcomehas been reported.

Treatment

Administration of activated charcoal to healthy volunteersimmediately or up to two hours

after ingestion of amlodipine 10 mghas beenshown to significantly decrease amlodipine

absorption. Gastric lavage may be worthwhile in somecases. Clinically significant

hypotension due to amlodipineoverdosage calls for active cardiovascular support including

frequent monitoring of cardiac and respiratory function, elevation of extremities, and

attention to circulating fluidvolume and urine output. A vasoconstrictor may be helpful in

restoring vascular tone and blood pressure, provided that there is no contraindication to its

use. Intravenous calcium gluconate may be beneficial in reversing the effects of calcium

channel blockade. Dialysis is not likely to beof benefit since amlodipine is highly protein

bound.

PHARMACEUTICALPRECAUTIONS

Store below 30°C. Protect fromlight.

MEDICINE CLASSIFICATION

Prescription Medicine

PACKAGE QUANTITIES

Blister strips of 100 tablets.

FURTHER INFORMATION

List of inactive ingredients

Microcrystalline cellulose, mannitol, magnesiumstearate, sodiumstarch glycolate, colloidal

anhydrous silica.

NAME AND ADDRESS

MultichemNZ Limited

8 Apollo Drive,

Rosedale,

North Shore City 0632

Auckland

Telephone: (09) 488 0330

Amlodipine [Ethics]

Tablets, Amlodipine Besylate Ph Eur, 5 mg and 10 mg (as amlodipine)

Please refer to the Medsafewebsite (www.medsafe.govt.nz) for the most recent version of

this prescribing information. Page 8 of 8

DATE OF PREPARATION

25 May 2011

Version 1

1-1-2019

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Europe -DG Health and Food Safety

6-6-2018

Copalia (Novartis Europharm Limited)

Copalia (Novartis Europharm Limited)

Copalia (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3695 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/774/T/97

Europe -DG Health and Food Safety

4-6-2018

Twynsta (Boehringer Ingelheim International GmbH)

Twynsta (Boehringer Ingelheim International GmbH)

Twynsta (Active substance: telmisartan / amlodipine) - Centralised - Yearly update - Commission Decision (2018)3625 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

21-5-2018

EU/3/07/522 (Best Regulatory Consulting Ltd)

EU/3/07/522 (Best Regulatory Consulting Ltd)

EU/3/07/522 (Active substance: (manganese, dichloro [(4aR, 13aR, 17aR, 21aR)-1, 2, 3, 4, 4a, 5, 6, 12, 13, 13a, 14, 15, 16, 17, 17a, 18, 19, 20, 21, 21a-eicosahydro-11, 7-nitrilo-7H-dibenzo[ b,h] [1,4,7,10] tetraazacycloheptadecine-?N5, ?N13, ?N18, ?N21, ?N22]-)) - Transfer of orphan designation - Commission Decision (2018)3136 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/089/07/T/01

Europe -DG Health and Food Safety