Use
Therapeutic indications
- Arterial hypertension;
- Prophylaxis of stress angina attacks;
- Long-term treatment after myocardial infarction;
- Treatment of certain rhythm disturbances: supraventricular (tachycardias, flutter and atrial fibrillations, junctional tachycardias) or ventricular (ventricular extrasystoles, ventricular tachycardias);
- Cardiovascular manifestations of hyperthyroidism and intolerance to replacement therapy for hypothyroidism;
- Functional signs of obstructive cardiomyopathy;
- Basic treatment of migraine and facial pain;
- Tremor, especially essential;
- Functional cardiac manifestations such as tachycardia and palpitations during transient emotional situations;
- Prevention of gastrointestinal bleeding due to esophageal varices rupture (primary prevention) and its recurrence (secondary prevention) in patients with cirrhosis: prevention of a first esophageal varices rupture is limited to patients with portal hypertension, in whom endoscopic examination reveals esophageal varices. of intermediate or bulky size (stage II or III).
Dosage and method of administration
Adults:
High blood pressure and prophylaxis of stress angina attacks, obstructive cardiomyopathy:
4 tablets per day in 2 divided doses (160 mg) on average.
The treatment can optionally be started with 2 tablets.
Long-term treatment after myocardial infarction:
- Initial treatment: should be instituted between the 5th and the 21st day after the acute episode of heart attack; 1 40 mg tablet 4 times a day for 2 to 3 days.
- Maintenance treatment: 4 tablets per day in 2 divided doses (i.e. 160 mg per day).
Rhythm disorders and hyperthyroidism:
1 to 2 tablets per day in various doses.
Migraines, facial pain, tremors:
1 to 3 tablets per day.
Cardiac functional manifestations such as tachycardia and palpitations during transient emotional situations:
On average 40 mg, 60 to 90 minutes before each stressful situation.
Primary and secondary prevention of digestive hemorrhages due to rupture of esophageal varices in cirrhotics:
Treatment will generally start with a dose of 160 mg per day. The dose will be adapted to each patient. It will be based in particular on heart rate, the decrease of which should be approximately 25%.
Children and adolescents:
Rhythm disturbances (arrhythmia): The dose should be adjusted individually and the following dose is for information only: 0.25 to 0.50 mg / kg 3 to 4 times a day. The dose should be adjusted according to the blood pressure response. A maximum dose of 1 mg / kg can be administered 4 times a day, but should not exceed 160 mg per day.
Prescription and delivery conditions
List I.
Duration and special precautions for conservation
Shelf life: 30 months.
Special storage precautions: This medicine does not require any special storage precautions.
Preclinical safety data
Aimlessly.
Incompatibilities
Aimlessly.
Employment precautions
Contraindications
- Chronic obstructive pulmonary disease and asthma: Nonselective beta-blockers are formally contraindicated in asthmatics (even if asthma is old and currently not symptomatic, regardless of dose).
- heart failure not controlled by treatment,
- Cardiogenic shock
- unpaired second and third degree atrioventricular blocks,
- Prinzmetal's Angina,
- sinus disease (including sinoatrial block),
- bradycardia (minus 45-50 beats per minute),
- Raynaud's phenomenon and peripheral arterial disorders,
- untreated pheochromocytoma,
- low blood pressure
- hypersensitivity to the active substance or to any of the excipients included in the Composition section,
- anaphylactic reaction history.
· As part of the primary and secondary prevention of gastrointestinal bleeding in cirrhotic patients: advanced liver failure with hyperbilirubinemia, massive ascites, hepatic encephalopathy.
Predisposition to hypoglycemia (such as after fasting or in the event of an abnormality in response to hypoglycemia).
This medication is generally not recommended in case of breastfeeding.
Pregnancy and lactation
Pregnancy
Animal studies have not shown any teratogenic effects. In the absence of a teratogenic effect in animals, a malformation effect is not expected in the human species.
In fact, to date, the substances responsible for malformations in the human species have been shown to be teratogenic in animals during well-conducted studies in two species.
Clinically, no teratogenic effects have been reported to date, and the results of prospective controlled studies with some beta-blockers have reported no birth defects. In the treated newborn mother, the beta-blocking action persists several days after birth and can cause bradycardia, respiratory distress, hypoglycemia; but most of the time, this remanence has no clinical consequences.
However, by reducing cardiovascular compensatory reactions, heart failure requiring hospitalization in intensive care (see section Overdose) may occur while avoiding fluid filling (risk of OAP). normal conditions of use, can be prescribed during pregnancy if necessary. For treatment until delivery, careful monitoring of the newborn (heart rate and blood sugar for the first 3 to 5 days of life) in specialized settings is recommended.
Breastfeeding
Beta-blockers are excreted in milk (see section Pharmacokinetic properties).
The appearance of hypoglycemia and bradycardia has been described for certain beta-blockers that are poorly linked to plasma proteins. As a result, breastfeeding is not recommended if treatment is needed.
Warnings and precautions for use
Warnings
Never suddenly stop treatment in angina; Stopping suddenly can cause severe rhythm disturbances, myocardial infarction, or sudden death.
In case of digestive bleeding, the risks of circulatory failure can be increased by taking propranolol.
Pharmacological interactions
The combination of propranolol with calcium antagonists (diltiazem, verapamil, bepridil) is not recommended (see section Interactions with other medicinal products and other forms of interaction)
Employment precautions
Stop treatment
Treatment should not be stopped suddenly, especially in patients with ischemic heart disease. The dose should be reduced gradually, i.e. over one or two weeks, starting at the same time, if necessary, replacement therapy, to avoid worsening of angina.
Heart failure
In patients with heart failure controlled by treatment and, if necessary, propranolol will be administered in very low doses, increasing progressively and under strict medical supervision.
Bradycardia
If the rate falls below 50-55 beats per minute at rest and the patient has symptoms related to bradycardia, the dose should be decreased.
First degree atrioventricular block
Given their negative dromotropic effect, beta-blockers should be administered with caution to patients with first-degree atrioventricular block.
Pheochromocytoma
The use of beta-blockers in the treatment of hypertension due to treated pheochromocytoma requires close monitoring of blood pressure.
Old subject
In the elderly, absolute compliance with contraindications is imperative. Care should be taken when initiating therapy with a low dose and to ensure close monitoring.
Kidney or liver failure
These two situations require caution in the institution of the initial dose.
Diabetic subject
Warn the patient and reinforce glycemic self-control at the start of treatment.
The warning signs of hypoglycemia can be masked, particularly tachycardia, palpitations, and sweating.
Hypoglycemia
Propranolol opposes the response of endogenous catecholamines to correct hypoglycemia.
Additionally, it masks the adrenergic warning signs of hypoglycemia.
Therefore, it can aggravate the hypoglycemia that occurs in risk situations, such as: the newborn, the child, the elderly, the hemodialysis patient, the patient treated with antidiabetic hypoglycemia, liver failure, fasting, as well as `` in case of overdose.
These hypoglycemias associated with taking propranolol may have occurred exceptionally in the form of seizures and / or coma.
Psoriasis
As a worsening of the disease has been reported with beta-blockers, the indication should be considered.
Allergic reactions
In patients who may experience a severe anaphylactic reaction from any source, especially with iodinated contrast media or floctafenine (see section Interactions with other medicinal products and other forms of interaction) or during treatment with beta-blockers may worsen the reaction and resistance to its treatment with adrenaline at the usual doses.
General anesthesia
Beta-blockers will cause a reduction in reflex tachycardia and an increased risk of hypotension. Continuous beta-blocker therapy decreases the risk of arrhythmia, myocardial ischemia, and hypertensive flares. The anesthesiologist must be informed that the patient is being treated with a beta-blocker.
- If discontinuation of treatment is considered necessary, a 48-hour suspension may be considered sufficient to allow reappearance of catecholamine sensitivity.
- In some cases, beta-blocker treatment cannot be stopped:
o In patients with coronary heart disease, it is advisable to continue treatment until the intervention, given the risk associated with abrupt discontinuation of beta-blockers.
o In the event of an emergency or if it is impossible to stop it, the patient must be protected from vaginal dominance by sufficient pre-medication of atropine, renewed as necessary. Anesthesia should use the fewest amount of myocardial depressant products and blood loss should be compensated.
- Anaphylactic risk must be taken into account.
Thyrotoxicosis
Beta-blockers are likely to mask cardiovascular signs.
Athletes
Athletes' attention is drawn to the fact that this specialty contains an active ingredient that can induce a positive reaction from tests performed during doping tests.
Gastrointestinal bleeding from cirrhosis.
Regular monitoring of blood counts, hematocrit and hemoglobin levels is essential to detect possible hidden bleeding.
Interaction with other medicinal products and other forms of interaction
Many drugs can cause bradycardia. This is the case of class Ia antiarrhythmics, beta-blockers, certain class III antiarrhythmics, certain calcium antagonists and anticholinesterases, pilocarpine.
Associations not recommended
(See section Warnings and precautions for use)
+ Bepridil (calcium antagonist)
Automatism disorders (excessive bradycardia, sinus arrest), sinoatrial and atrioventricular conduction disorders and an increased risk of ventricular rhythm disorders (torsades de pointes), as well as heart failure.
This association should only be performed under close clinical monitoring and ECG, particularly in the elderly or at the start of treatment.
+ Diltiazem and Verapamil (calcium antagonists)
Automatism disorders (excessive bradycardia, sinus arrest), sinoatrial and atrioventricular conduction disorders and heart failure.
This association should only be performed under close clinical monitoring and ECG, particularly in the elderly or at the start of treatment.
+ Fingolimod
Enhancement of bradycardic effects that can have fatal consequences. Beta-blockers are at higher risk because they avoid adrenergic compensation mechanisms.
Clinical monitoring and continuous ECG for 24 hours after the first dose.
Associations subject to precautions for use.
+ Amiodarone
Autism and conduction disorders (suppression of sympathetic compensatory mechanisms). Clinical monitoring and ECG.
+ Halogenated Volatile Anesthetics
Reduction of cardiovascular compensation reactions by beta-blockers. Beta-adrenergic inhibition can be raised during the intervention of beta-mimetics.
As a general rule, do not interrupt treatment with beta-blockers and, in any case, avoid abrupt interruption. Inform the anesthesiologist of this treatment.
+ Central antihypertensive drugs
Significant increase in blood pressure in case of abrupt interruption of treatment with central antihypertensive drugs.
Avoid abrupt discontinuation of central antihypertensive therapy. Clinical surveillance
+ Class I antiarrhythmics (except lidocaine)
Contractility, automatism and conduction disorders (suppression of sympathetic compensatory mechanisms). Clinical monitoring and ECG.
+ Baclofen
Increased risk of hypotension, particularly orthostatic.
Control of blood pressure and dose adjustment of the antihypertensive if necessary.
+ Ergotamine
Ergotism: some cases of arterial spasms with ischemia of the extremities (in addition to vascular effects) have been observed.
Reinforced clinical surveillance, particularly during the first weeks of association.
+ Fluvoxamine
Increased plasma concentrations of propranolol by inhibition of its hepatic metabolism, with increased activity and adverse effects, for example: significant bradycardia.
Increased clinical monitoring and, if necessary, dose adjustment of propranolol during fluvoxamine treatment and after discontinuation.
+ Insulin, hypoglycemic sulfonamides
All beta-blockers can mask certain symptoms of hypoglycemia: palpitations and tachycardia.
Warn the patient and strengthen, especially at the beginning of treatment, glycemic self-control.
+ Lidocaine IV (with lidocaine used IV)
Increased plasma lidocaine concentrations with the possibility of cardiac and neurological adverse effects (decreased lidocaine hepatic clearance).
Clinical ECG monitoring and possibly control of plasma lidocaine concentrations during combination and after stopping the beta-blocker. Adjustment of the lidocaine dose if necessary.
+ Medicines that give torsades de pointes (except sultopride)
or class Ia antiarrhythmics (quinidine, hydroquinidine, disopyramide)
or class III antiarrhythmics (amiodarone, dofetilide, ibutilide, sotalol)
o certain neuroleptics: phenothiazines (chlorpromazine, ciamemazine, levomepromazine, thioridazine), benzamides (amisulpride, sulpiride, thiapride), butyrophenones (droperidol, haloperidol), other neuroleptics (pimozide)
or others: cisapride, diphemanil, erythromycin IV, halofantrine, methadone, mizolastine, moxifloxacin, pentamidine, spiramycin IV, vincamine IV, lumefantrine, veralipride.
Increased risk of ventricular rhythm disturbances, especially torsade de pointes.
Clinical and electrocardiographic monitoring.
+ Propafenone
Contractility, automatism and conduction disorder (suppression of sympathetic compensatory mechanisms).
Clinical monitoring and ECG.
+ Rizatriptan
Increased plasma concentrations of rizatriptan by decreasing your liver metabolism by propranolol.
Reduce the dose of rizatriptan in half if you are taking propranolol.
+ Glinides
All beta-blockers can mask certain symptoms of hypoglycemia: palpitations and tachycardia.
Warn the patient and strengthen, especially at the beginning of treatment, glycemic self-control.
Associations to consider
+ NSAID
Reduction of the antihypertensive effect (inhibition of vasodilatory prostaglandins by NSAIDs and retention of water and sodium with pyrazole NSAIDs).
+ Alpha-blockers for urological purposes: alfuzosin, doxazosin, prazosin, tamsulosin, terazosin
Increased hypotensive effect. Increased risk of orthostatic hypotension.
+ Amifostine, imipramine antidepressants, nitrates and related derivatives.
Increased risk of hypotension, especially orthostatic.
+ Alpha-blocking antihypertensive drugs
Increased hypotensive effect. Increased risk of orthostatic hypotension.
+ Other bradycardias
Risk of excessive bradycardia (adding effects). + Dihydropyridines
Hypotension, heart failure in patients with latent or uncontrolled heart failure (addition of negative inotropic effects). The beta-blocker can also minimize the sympathetic reflex reaction involved in case of excessive hemodynamic repercussions.
+ Dipyridamole (route IV)
Increased antihypertensive effect.
+ Neuroleptics
Vasodilator effect and hypotension risks, especially orthostatic (additive effect).
Increased risk of hypotension, especially orthostatic.
+ Phenobarbital (by extrapolation of primidone), rifampicin (enzyme inducers)
Decreased plasma concentrations of propranolol with reduced clinical effects (increased liver metabolism).
+ Pilocarpine
Risk of excessive bradycardia (in addition to the effects of bradycardia).
+ Rifampicin
Decreased plasma concentrations and the effectiveness of the beta-blocker (increased liver metabolism).
Caution
Undesirable effects
The following side effects have been reported, presented by frequency and organ class:
Common (1-9.9%)
General: Asthenia.
Cardiovascular disorders: bradycardia, cooling of the extremities, Raynaud's syndrome.
Central nervous system disorders: insomnia, nightmares.
Uncommon (0.1-0.9%)
Digestive problems: gastralgia, nausea, vomiting, diarrhea.
Rare (0.01-0.09%)
General: dizzying sensations.
Hematopoietic system: thrombocytopenia.
Cardiovascular disorders: heart failure, slowing of atrioventricular conduction or intensification of an existing atrioventricular block, orthostatic hypotension that may be associated with syncope, worsening of existing intermittent claudication.
Central nervous system disorders: hallucinations, psychosis, mood swings, confusion, impotence.
Skin system: purpura, alopecia, psoriasiform eruptions, exacerbation of psoriasis, skin rash.
Neurological disorders: paresthesia.
Vision: dry eyes, altered vision.
Respiratory system: Bronchospasm can occur in patients with asthma or a history of asthma, sometimes with a fatal outcome.
Very rare (less 0.01%)
Endocrine system: hypoglycemia in subjects at risk (see section 4.4).
At the biological level: it has been observed, in rare cases, the appearance of antinuclear antibodies that are only exceptionally accompanied by clinical manifestations such as lupus syndrome and discontinuation of treatment.
Nervous system: Isolated cases of myasthenia gravis or exacerbation have been reported.
Unknown frequency, particularly in children and adolescents.
Hypoglycemia and seizures associated with hypoglycemia.
Overdose
In case of bradycardia or excessive drop in blood pressure, venous administration will be used:
- atropine, 1 to 2 mg bolus,
or glucagon at a dose of 10 mg as a slow bolus followed, if necessary, by an infusion of 1 to 10 mg per hour,
or then if necessary
Either isoprenaline in slow injection at a dose of 15 to 85 µg, the injection can be renewed, the total amount to be administered should not exceed 300 µg, or dobutamine 2.5 to 10 µg / kg / min.
In case of cardiac decompensation in the newborn mother treated with beta-blocker:
or glucagon based on 0.3 mg / kg,
or intensive care hospitalization,
or isoprenaline and dobutamine: in general, high doses and prolonged treatment require specialized control.
Package | Price |
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10 mg 360 pills | AUD 151.57 |
10 mg 270 pills | AUD 125.86 |
10 mg 180 pills | AUD 94.73 |
10 mg 120 pills | AUD 70.37 |
10 mg 90 pills | AUD 58.19 |
10 mg 60 pills | AUD 43.31 |
10 mg 30 pills | AUD 27.07 |
20 mg 360 pills | AUD 184.05 |
20 mg 270 pills | AUD 154.27 |
20 mg 180 pills | AUD 113.68 |
20 mg 120 pills | AUD 84.81 |
20 mg 90 pills | AUD 70.37 |
20 mg 60 pills | AUD 52.33 |
20 mg 30 pills | AUD 33.38 |
40 mg 360 pills | AUD 205.70 |
40 mg 270 pills | AUD 174.57 |
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