1. Name of the medicative product
ADIZEM®-SR capsules ninety mg, 120 mg, 180 mg
2. Qualitative and quantitative composition
Each capsule contains ninety mg, one hundred twenty mg or a hundred and eighty mg calcium-channel blocker complex.
Excipients: additionally contains plant product eighteen.26 mg per capsule. (90 mg only)
Excipients: additionally contains plant product twenty four.35 mg per capsule. (120 mg only)
Excipients: additionally contains plant product thirty six.53 mg per capsule. (180 mg only)
For the complete list of excipients, see section half-dozen.1.
3. Pharmaceutical type
Prolonged unharness capsule
ADIZEM-SR capsules ninety mg square measure white capsules marked “90 mg”
ADIZEM-SR capsules one hundred twenty mg square measure capsules with white bodies and brown caps marked “120 mg”
ADIZEM-SR capsules a hundred and eighty mg square measure capsules with white bodies and pale brown caps marked “180 mg”
The capsules contain prolonged unharness microgranules.
4. Clinical particulars
4.1 Therapeutic indications
For the management of angina.
For the treatment of gentle to moderate high blood pressure.
ADIZEM-SR capsules square measure indicated to be used in adults solely.
4.2 pharmacology and methodology of administration
Posology
Angina
Adults:
The usual initial dose is ninety mg doubly daily. indefinite quantity is also enhanced step by step to one hundred twenty mg doubly daily, or a hundred and eighty mg doubly daily if needed. Patients' responses might vary and indefinite quantity needs will take issue considerably between individual patients.
Elderly and patients with impaired nephritic or internal organ function:
In the aged, indefinite quantity ought to start at sixty mg calcium-channel blocker complex doubly daily and therefore the dose rigorously titrated PRN.
Hypertension:
Adults:
The usual dose is one ADIZEM-SR one hundred twenty mg pill or capsule doubly daily. Patients might profit by titrating from a lower total daily dose.
Elderly and patients with impaired nephritic or internal organ function:
The beginning dose ought to be sixty mg calcium-channel blocker complex doubly daily, increasing to at least one ADIZEM-SR ninety mg capsule doubly daily then to at least one ADIZEM-SR one hundred twenty mg pill or capsule doubly daily if clinically indicated.
Paediatric population:
The ADIZEM preparations aren't suggested for kids. Safety and effectiveness in youngsters has not been established.
Method of administration
Oral.
To be taken at twelve hour intervals.
Dosage is also smitten or while not food, and may be enclosed whole and not chewed.
In order to avoid confusion, it's instructed that patients once titrated to a good dose victimization either ADIZEM-SR tablets or capsules ought to stay on this treatment and may not be modified between completely different displays.
ADIZEM-SR capsules mustn't be taken at constant time as Associate in Nursing drink (see section four.5).
4.3 Contraindications
Hypersensitivity to calcium-channel blocker or to any of the excipients.
Pregnancy and in girls of kid bearing capability.
Patients with severe arrhythmia (less than forty bpm), second or interrogatory Stokes-Adams syndrome, sick sinus syndrome, decompensated viscus failure, patients with left bodily cavity failure with congestion.
Concurrent use with dantrolene infusion attributable to the chance of arrhythmia (see section four.5).
4.4 Special warnings and precautions to be used
The product ought to be used with caution in patients with reduced left bodily cavity operate. Patients with gentle arrhythmia (risk of exacerbation), degree Ab block or prolonged PR interval ought to be determined closely.
Diltiazem is taken into account unsafe in patients with acute hereditary disease.
Prior to anaesthesia, the anaesthesist should be told of current calcium-channel blocker treatment. Depression of viscus ability, physical phenomenon and automaticity, additionally because the tube dilatation related to anaesthetics is also potentiated by metal channel blockers.
Increase of plasma concentrations of calcium-channel blocker is also determined within the aged and in patients with nephritic or internal organ insufficiency. The contraindications and precautions ought to be rigorously determined and shut observance, notably of pulse, ought to be administrated at the start of treatment.
Calcium channel interference agents, like calcium-channel blocker, is also related to mood changes, together with depression.
Like alternative metal channel antagonists, calcium-channel blocker has Associate in Nursing restrictive impact on viscus motility. thus it ought to be used with caution in patients in danger to develop Associate in Nursing enteropathy. pill residues from slow unharness formulations of the merchandise might pass into the patient's stools; but, this finding has no clinical connexion.
Patients with rare hereditary issues of laevulose intolerance, glucose-galactose absorption or sucrase-isomaltase insufficiency mustn't take this drugs.
4.5 Interaction with alternative medicative merchandise and alternative sorts of interaction
Concomitant use contraindicated:
Dantrolene (infusion): deadly arrhythmia is often determined in animals once endovenous calcium blocker and dantrolene square measure administered concomitantly. the mixture of a metal antagonist and dantrolene is thus probably dangerous (see section four.3).
Concomitant use requiring caution:
Lithium: Risk of increase in lithium-induced neurotoxicity.
Nitrate derivatives: enhanced hypotensive effects and faintness (additive vasodilatating effects): all told the patients treated with metal antagonists, the prescription of nitrate derivatives ought to solely be administrated at step by step increasing doses.
Theophylline: Increase in current aminophylline levels.
Alpha-antagonists: enhanced antihypertensive drug effects:
Concomitant treatment with alpha-antagonists might turn out or irritate cardiovascular disease. the mixture of calcium-channel blocker with Associate in Nursing alpha-antagonist ought to be thought of solely with the strict observance of the force per unit area.
Amiodarone, digoxin: enhanced risk of bradycardia:
Caution is needed once these square measure combined with calcium-channel blocker, notably in aged subjects and once high doses square measure used. calcium-channel blocker complex might cause little will increase in plasma levels of digitalis glycoside, requiring careful observance of Ab physical phenomenon.
Beta-blockers: risk of rhythm disturbances (pronounced arrhythmia, sinus arrest), sino-atrial and atrio-ventricular physical phenomenon disturbances and failure (synergistic effect). Patients with pre-existing physical phenomenon defects mustn't receive the mixture of calcium-channel blocker and beta-blockers. Such a mixture should solely be used below shut clinical and electrocardiogram observance, notably at the start of treatment.
Other antihypertensive drug medication: increased antihypertensive drug impact might occur with concomitant use of alternative antihypertensive drug drugs (e.g. beta-blockers, diuretics, ACE-inhibitors) or medication that cause cardiovascular disease like aldesleukin and antipsychotics.
Other medicament agents:
Since calcium-channel blocker has medicament properties, its concomitant prescription with alternative medicament agents isn't suggested (additive risk of enhanced viscus adverse effects). this mix ought to solely be used below shut clinical and electrocardiogram observance.
Carbamazepine: Increase in current carbamazepine levels:
It is suggested that the plasma carbamazepine concentrations be assayed which the dose ought to be adjusted if necessary.
Rifampicin: Risk of decrease of calcium-channel blocker plasma levels once initiating medical care with rifampicin: The patient ought to be rigorously monitored once initiating or discontinuing rifampicin treatment.
Anti-H2 agents (cimetidine, ranitidine): Increase in plasma calcium-channel blocker concentrations. Patients presently receiving calcium-channel blocker medical care ought to be rigorously monitored once initiating or discontinuing medical care with anti-H2 agents. Associate in Nursing adjustment in calcium-channel blocker daily dose is also necessary.
Protease inhibitors (e.g. atazanavir, ritonavir): Increase in plasma calcium-channel blocker concentrations.
Ciclosporin: Increase in current cyclosporin levels:
It is suggested that the cyclosporin dose be reduced, nephritic operate be monitored, current cyclosporin levels be assayed which the dose ought to be adjusted throughout combined medical care and once its conclusion.
General info to be taken into account:
Due to the potential for additive effects, caution and careful volumetric analysis square measure necessary in patients receiving calcium-channel blocker concomitantly with alternative agents glorious to have an effect on viscus ability and/or physical phenomenon.
Diltiazem is metabolized by CYP3A4. A moderate (less than 2-fold) increase of calcium-channel blocker plasma concentration in cases of co-administration with a stronger CYP3A4 substance has been documented. calcium-channel blocker is additionally a CYP3A4 isoform substance. Co-administration with alternative CYP3A4 substrates might lead to a rise in plasma concentration of either co-administered drug (e.g. , cilostazol, ivabradine, sirolimus, tacrolimus). Care ought to be exercised in patients taking these medication. Concomitant use of calcium-channel blocker with cilostazol and ivabradine ought to be avoided.
Co-administration of calcium-channel blocker with a CYP3A4 inducer might lead to a decrease of calcium-channel blocker plasma concentrations.
Barbiturates (phenobarbital, primidone): liquid body substance levels of calcium-channel blocker is also bated by concomitant usage of CYP3A4 inducers.
Phenytoin: liquid body substance levels of calcium-channel blocker is also bated by concomitant usage of CYP3A4 inducers. calcium-channel blocker might increase liquid body substance levels of hydantoin.
Benzodiazepines (midazolam, Halcion): calcium-channel blocker considerably will increase plasma concentrations of Versed and triazolam and prolongs their half-life. Special care ought to be taken once prescribing short-acting benzodiazepines metabolized by the CYP3A4 pathway in patients victimization calcium-channel blocker.
Diltiazem might increase bioavailability of antidepressant drug antidepressants.
Corticosteroids (methylprednisolone): Inhibition of methylprednisolone metabolism (CYP3A4) and inhibition of P-glycoprotein: The patient ought to be monitored once initiating methylprednisolone treatment. Associate in Nursing adjustment within the dose of methylprednisolone is also necessary.
Statins (simvastatin, lipid-lowering medication, lovastatin): calcium-channel blocker is Associate in Nursing substance of CYP3A4 and has been shown to considerably increase the AUC of some statins. the chance of pathology and rhabdomyolysis because of statins metabolised by CYP3A4 is also enhanced with concomitant use of calcium-channel blocker. once attainable, a non CYP3A4-metabolised medicament ought to be used in conjunction with calcium-channel blocker, otherwise shut observance for signs and symptoms of a possible medicament toxicity is needed.
ADIZEM-SR capsules mustn't be taken at constant time as alcohol, because it might increase the speed of unharness of calcium-channel blocker from the prolonged unharness preparation. additionally the mixture of alcohol Associate in Nursingd calcium-channel blocker might have an additive vasodilatory impact.
4.6 Fertility, physiological condition and lactation
Pregnancy
There is terribly restricted information from the utilization of calcium-channel blocker in pregnant patients. calcium-channel blocker has been shown to possess procreative toxicity in sure animal species (rat, mice, rabbit). calcium-channel blocker is contraindicated throughout physiological condition (see section four.3), additionally as in girls of child-bearing potential not victimization effective family planning.
Breast-feeding
Diltiazem is excreted in breast milk at low concentrations. Breast-feeding whereas taking this drug ought to be avoided. If use of calcium-channel blocker is taken into account medically essential, an alternate methodology of alimentation ought to be instituted.
4.7 Effects on ability to drive and use machines
Diltiazem has been rumored to cause adverse reactions like vertigo (common) and uncomfortableness (common), which can impair patients' ability to drive or operate machinery to a variable extent counting on the indefinite quantity and individual susceptibleness. However, no studies are performed. Therefore, patients mustn't drive or operate machinery if affected.
4.8 Undesirable effects
The following frequencies square measure the premise for assessing undesirable effects:
Very common (≥1/10); common (≥1/100 to
ADIZEM®-SR capsules ninety mg, 120 mg, 180 mg
2. Qualitative and quantitative composition
Each capsule contains ninety mg, one hundred twenty mg or a hundred and eighty mg calcium-channel blocker complex.
Excipients: additionally contains plant product eighteen.26 mg per capsule. (90 mg only)
Excipients: additionally contains plant product twenty four.35 mg per capsule. (120 mg only)
Excipients: additionally contains plant product thirty six.53 mg per capsule. (180 mg only)
For the complete list of excipients, see section half-dozen.1.
3. Pharmaceutical type
Prolonged unharness capsule
ADIZEM-SR capsules ninety mg square measure white capsules marked “90 mg”
ADIZEM-SR capsules one hundred twenty mg square measure capsules with white bodies and brown caps marked “120 mg”
ADIZEM-SR capsules a hundred and eighty mg square measure capsules with white bodies and pale brown caps marked “180 mg”
The capsules contain prolonged unharness microgranules.
4. Clinical particulars
4.1 Therapeutic indications
For the management of angina.
For the treatment of gentle to moderate high blood pressure.
ADIZEM-SR capsules square measure indicated to be used in adults solely.
4.2 pharmacology and methodology of administration
Posology
Angina
Adults:
The usual initial dose is ninety mg doubly daily. indefinite quantity is also enhanced step by step to one hundred twenty mg doubly daily, or a hundred and eighty mg doubly daily if needed. Patients' responses might vary and indefinite quantity needs will take issue considerably between individual patients.
Elderly and patients with impaired nephritic or internal organ function:
In the aged, indefinite quantity ought to start at sixty mg calcium-channel blocker complex doubly daily and therefore the dose rigorously titrated PRN.
Hypertension:
Adults:
The usual dose is one ADIZEM-SR one hundred twenty mg pill or capsule doubly daily. Patients might profit by titrating from a lower total daily dose.
Elderly and patients with impaired nephritic or internal organ function:
The beginning dose ought to be sixty mg calcium-channel blocker complex doubly daily, increasing to at least one ADIZEM-SR ninety mg capsule doubly daily then to at least one ADIZEM-SR one hundred twenty mg pill or capsule doubly daily if clinically indicated.
Paediatric population:
The ADIZEM preparations aren't suggested for kids. Safety and effectiveness in youngsters has not been established.
Method of administration
Oral.
To be taken at twelve hour intervals.
Dosage is also smitten or while not food, and may be enclosed whole and not chewed.
In order to avoid confusion, it's instructed that patients once titrated to a good dose victimization either ADIZEM-SR tablets or capsules ought to stay on this treatment and may not be modified between completely different displays.
ADIZEM-SR capsules mustn't be taken at constant time as Associate in Nursing drink (see section four.5).
4.3 Contraindications
Hypersensitivity to calcium-channel blocker or to any of the excipients.
Pregnancy and in girls of kid bearing capability.
Patients with severe arrhythmia (less than forty bpm), second or interrogatory Stokes-Adams syndrome, sick sinus syndrome, decompensated viscus failure, patients with left bodily cavity failure with congestion.
Concurrent use with dantrolene infusion attributable to the chance of arrhythmia (see section four.5).
4.4 Special warnings and precautions to be used
The product ought to be used with caution in patients with reduced left bodily cavity operate. Patients with gentle arrhythmia (risk of exacerbation), degree Ab block or prolonged PR interval ought to be determined closely.
Diltiazem is taken into account unsafe in patients with acute hereditary disease.
Prior to anaesthesia, the anaesthesist should be told of current calcium-channel blocker treatment. Depression of viscus ability, physical phenomenon and automaticity, additionally because the tube dilatation related to anaesthetics is also potentiated by metal channel blockers.
Increase of plasma concentrations of calcium-channel blocker is also determined within the aged and in patients with nephritic or internal organ insufficiency. The contraindications and precautions ought to be rigorously determined and shut observance, notably of pulse, ought to be administrated at the start of treatment.
Calcium channel interference agents, like calcium-channel blocker, is also related to mood changes, together with depression.
Like alternative metal channel antagonists, calcium-channel blocker has Associate in Nursing restrictive impact on viscus motility. thus it ought to be used with caution in patients in danger to develop Associate in Nursing enteropathy. pill residues from slow unharness formulations of the merchandise might pass into the patient's stools; but, this finding has no clinical connexion.
Patients with rare hereditary issues of laevulose intolerance, glucose-galactose absorption or sucrase-isomaltase insufficiency mustn't take this drugs.
4.5 Interaction with alternative medicative merchandise and alternative sorts of interaction
Concomitant use contraindicated:
Dantrolene (infusion): deadly arrhythmia is often determined in animals once endovenous calcium blocker and dantrolene square measure administered concomitantly. the mixture of a metal antagonist and dantrolene is thus probably dangerous (see section four.3).
Concomitant use requiring caution:
Lithium: Risk of increase in lithium-induced neurotoxicity.
Nitrate derivatives: enhanced hypotensive effects and faintness (additive vasodilatating effects): all told the patients treated with metal antagonists, the prescription of nitrate derivatives ought to solely be administrated at step by step increasing doses.
Theophylline: Increase in current aminophylline levels.
Alpha-antagonists: enhanced antihypertensive drug effects:
Concomitant treatment with alpha-antagonists might turn out or irritate cardiovascular disease. the mixture of calcium-channel blocker with Associate in Nursing alpha-antagonist ought to be thought of solely with the strict observance of the force per unit area.
Amiodarone, digoxin: enhanced risk of bradycardia:
Caution is needed once these square measure combined with calcium-channel blocker, notably in aged subjects and once high doses square measure used. calcium-channel blocker complex might cause little will increase in plasma levels of digitalis glycoside, requiring careful observance of Ab physical phenomenon.
Beta-blockers: risk of rhythm disturbances (pronounced arrhythmia, sinus arrest), sino-atrial and atrio-ventricular physical phenomenon disturbances and failure (synergistic effect). Patients with pre-existing physical phenomenon defects mustn't receive the mixture of calcium-channel blocker and beta-blockers. Such a mixture should solely be used below shut clinical and electrocardiogram observance, notably at the start of treatment.
Other antihypertensive drug medication: increased antihypertensive drug impact might occur with concomitant use of alternative antihypertensive drug drugs (e.g. beta-blockers, diuretics, ACE-inhibitors) or medication that cause cardiovascular disease like aldesleukin and antipsychotics.
Other medicament agents:
Since calcium-channel blocker has medicament properties, its concomitant prescription with alternative medicament agents isn't suggested (additive risk of enhanced viscus adverse effects). this mix ought to solely be used below shut clinical and electrocardiogram observance.
Carbamazepine: Increase in current carbamazepine levels:
It is suggested that the plasma carbamazepine concentrations be assayed which the dose ought to be adjusted if necessary.
Rifampicin: Risk of decrease of calcium-channel blocker plasma levels once initiating medical care with rifampicin: The patient ought to be rigorously monitored once initiating or discontinuing rifampicin treatment.
Anti-H2 agents (cimetidine, ranitidine): Increase in plasma calcium-channel blocker concentrations. Patients presently receiving calcium-channel blocker medical care ought to be rigorously monitored once initiating or discontinuing medical care with anti-H2 agents. Associate in Nursing adjustment in calcium-channel blocker daily dose is also necessary.
Protease inhibitors (e.g. atazanavir, ritonavir): Increase in plasma calcium-channel blocker concentrations.
Ciclosporin: Increase in current cyclosporin levels:
It is suggested that the cyclosporin dose be reduced, nephritic operate be monitored, current cyclosporin levels be assayed which the dose ought to be adjusted throughout combined medical care and once its conclusion.
General info to be taken into account:
Due to the potential for additive effects, caution and careful volumetric analysis square measure necessary in patients receiving calcium-channel blocker concomitantly with alternative agents glorious to have an effect on viscus ability and/or physical phenomenon.
Diltiazem is metabolized by CYP3A4. A moderate (less than 2-fold) increase of calcium-channel blocker plasma concentration in cases of co-administration with a stronger CYP3A4 substance has been documented. calcium-channel blocker is additionally a CYP3A4 isoform substance. Co-administration with alternative CYP3A4 substrates might lead to a rise in plasma concentration of either co-administered drug (e.g. , cilostazol, ivabradine, sirolimus, tacrolimus). Care ought to be exercised in patients taking these medication. Concomitant use of calcium-channel blocker with cilostazol and ivabradine ought to be avoided.
Co-administration of calcium-channel blocker with a CYP3A4 inducer might lead to a decrease of calcium-channel blocker plasma concentrations.
Barbiturates (phenobarbital, primidone): liquid body substance levels of calcium-channel blocker is also bated by concomitant usage of CYP3A4 inducers.
Phenytoin: liquid body substance levels of calcium-channel blocker is also bated by concomitant usage of CYP3A4 inducers. calcium-channel blocker might increase liquid body substance levels of hydantoin.
Benzodiazepines (midazolam, Halcion): calcium-channel blocker considerably will increase plasma concentrations of Versed and triazolam and prolongs their half-life. Special care ought to be taken once prescribing short-acting benzodiazepines metabolized by the CYP3A4 pathway in patients victimization calcium-channel blocker.
Diltiazem might increase bioavailability of antidepressant drug antidepressants.
Corticosteroids (methylprednisolone): Inhibition of methylprednisolone metabolism (CYP3A4) and inhibition of P-glycoprotein: The patient ought to be monitored once initiating methylprednisolone treatment. Associate in Nursing adjustment within the dose of methylprednisolone is also necessary.
Statins (simvastatin, lipid-lowering medication, lovastatin): calcium-channel blocker is Associate in Nursing substance of CYP3A4 and has been shown to considerably increase the AUC of some statins. the chance of pathology and rhabdomyolysis because of statins metabolised by CYP3A4 is also enhanced with concomitant use of calcium-channel blocker. once attainable, a non CYP3A4-metabolised medicament ought to be used in conjunction with calcium-channel blocker, otherwise shut observance for signs and symptoms of a possible medicament toxicity is needed.
ADIZEM-SR capsules mustn't be taken at constant time as alcohol, because it might increase the speed of unharness of calcium-channel blocker from the prolonged unharness preparation. additionally the mixture of alcohol Associate in Nursingd calcium-channel blocker might have an additive vasodilatory impact.
4.6 Fertility, physiological condition and lactation
Pregnancy
There is terribly restricted information from the utilization of calcium-channel blocker in pregnant patients. calcium-channel blocker has been shown to possess procreative toxicity in sure animal species (rat, mice, rabbit). calcium-channel blocker is contraindicated throughout physiological condition (see section four.3), additionally as in girls of child-bearing potential not victimization effective family planning.
Breast-feeding
Diltiazem is excreted in breast milk at low concentrations. Breast-feeding whereas taking this drug ought to be avoided. If use of calcium-channel blocker is taken into account medically essential, an alternate methodology of alimentation ought to be instituted.
4.7 Effects on ability to drive and use machines
Diltiazem has been rumored to cause adverse reactions like vertigo (common) and uncomfortableness (common), which can impair patients' ability to drive or operate machinery to a variable extent counting on the indefinite quantity and individual susceptibleness. However, no studies are performed. Therefore, patients mustn't drive or operate machinery if affected.
4.8 Undesirable effects
The following frequencies square measure the premise for assessing undesirable effects:
Very common (≥1/10); common (≥1/100 to
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